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(Sample)
Report of Comprehensive
Health Screening
`
It s about time
© 2019 Novomed All Rights Reserved
Sample Report of
Novomed
Comprehensive
Health Screening
Program
Novomed Comprehensive Health Screening
Date of Examination
Name
Date of birth
Patient Number
Toll-Free: 800 6686633
Suite 30, 3004 th Floor | Marina Plaza | Dubai
Our focus on providing the most comprehensive check-up in the industry at
reasonable prices reflects our management's commitment to preventing and
reversing diseases. Interest-free and financing available
• If you have experienced any adverse reaction to contrast media or sedative medication during a
checkup at another hospital, please inform us when you make a reservation.
• Please bring any MRI, CT, labs, and checkups you have done over the last three years and a list of
your current medication.
• Please bring your ID or passport.
• Do not eat or drink anything on the day of the check up (Will serve you snacks after we draw blood)
• Bring loose clothes and wear running or tennis shoes suitable for your treadmill stress test and PFTs.
• Do not wear
or heavy make-up.
• Take your medications as prescribed by your doctor with a sip of water, except for blood thinners.
Page 5 / 5
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Fill in the questionnaire that shall be sent to your email
or smart phone ahead of booking your appointment.
The check up involves booking appointments with a
dozen doctors and professionals. A non-refundable
deposit of 1,000 AED is required.
Summary of Medical Examination
• Elevated blood glucose level, suspected to be diabetes – Consult with a specialist
•
Doctor's Name: Dr. Ghassan F. Nakad
Specialty: Interventional Cardiology Specialist
Doctor Notes:
• Overweight (pre-obesity) – Try not to gain more weight. Regular aerobic exercise and a balanced
diet are recommended.
• Abdominal obesity – it increases the risk of diabetes, hypertension, and hyperlipidemia. Manage it
through regular exercise and a healthy diet habit.
• CRP, the inflammatory indicator, is slightly elevated. It can be temporarily elevated by cold. If you
don’t have symptoms, observe for now.
• There is no hepatitis B antibody. Vaccination is recommended (0 ,1 ,6 months; 3 shots).
Page 1 / 5
Detailed Results
small variations depending on your age, current symptoms and concerns, medical history, family
Nutritional Diet
92% of food and nutrition research is conducted by institutions or doctors receiving money from the
sugar, dairy, meat, alcohol and big pharma lobbies. The research is designed to deliberately confuse
consumers with conflicting advice so that they finally give up and succumb to the thousands of ads
designed to sell their harmful food or their drugs.
Good food is the basis for good health... but do not worry about getting sick from bad food as big
pharma has a pill for every ill. And if the pill creates side effects, there is another pill to address that.
There is plenty of evidence that we should drink mostly water and avoid sugary drinks, packaged foods,
refined sugar, and substitute whenever possible, animal fat and protein with plant derived fat and
protein.
Eat in moderation even healthy food. The WHO declared that there is no such animal as “safe drinking”
as even small amounts of alcohol are cancerogenic and harm your brain. Your liver is your biggest
source of antioxidants which is what you need to clean all the poisons that we cannot escape. So do
not tax your liver with obesity, unnecessary medications or alcohol. Get enough quality sleep. After age
45, exercise is not optional. Avoid toxic relationships and keep your good friends. Never retire even if
you can afford it. Get a yearly health check-up as it is a very good investment as opposed to waiting till
it is too late.
Nutritional Diet
Nutritional Diet Report
Nutritional Diet
The obesity criteria is defined as body mass index of weight for square of height. (Low body weight , <
18.5 ~ 22.9 18.5 Standard body weight, 23 ~ 24.9 Overweight, > 25 Obesity, > 30 Morbid Overweight).
The ideal range for blood pressure is < 120/80mmHg. If the systolic is 120-139 or diastolic is
80-89mmHg, it is high of normal range (prehypertension) and if the systolic is > 140 or diastolic is >
90mmHg, it is classified as hypertension.
Body Mass Index and Blood Pressure
BMI Report
Body Mass Index and Blood Pressure
This is a test to check the number of white blood cells, red blood cells (hemoglobin), and platelets in
the blood. If you have anemia (low hemoglobin), iron-related tests (Fe, TIBC, Ferritin) may be helpful
in identifying the cause. CRP is an indicator of inflammation and infection in the body.
Reference
Results
White Blood Cells (WBC)
3
4~10 x 10 /
5.6
Red Blood Cells (RBC)
4.2~6.3 x 10^6 /
5.95
Hemoglobin
13~17 g/dL
14.8
Hematocrit
39~52 %
47.7
Mean Corpuscular Volume (MCV)
81~96 fL
80.2
Mean Corpuscular Hemoglobin (MCV)
27~33 pg
24.9
Cell Hemoglobin Concentration (MCHC)
32~36 g/dL
31.1
Red Cell Distribution Width (RDW)
11.5~14.5 %
14.3
Platelet
3
130~400 x 10 /
144
Neutrophil
50~75 %
36.6
Lymphocyte
20~44 %
49.7
Monocyte
2~9 %
9.0
Eosinophil
1~5 %
1.6
Basophil
0~2 %
0.6
C-Reactive Protein (CRP)
0~0.5 mg/dL
1.03
Basic Blood Test
Tumor marker
AFP is a tumor marker test for liver cancer, CA1-9t9 for pancreatic cancer and biliary tract cancer,
CEA for colorectal cancer, CA125 for ovarian cancer, and PSA for prostate cancer. However, tumor
markers may rise in cases other than cancer. In particular, the level of CEA may be high in smokers,
the level of CA125 may be high during menstruation, and the level of PSA may be high in benign
prostatic hyperplasia. Even if the tumor marker is normal, cancer may be present, so this test
cannot replace an examination, such as endoscopy, ultrasound, and CT.
Reference
Results
Prostatic Specific Antigen (PSA)
0~3 ng/mL 0.450
CA 19-9 (Digestive System)
0~37 U/mL
6
Alpha Fetoprotein (AFP)
0.89~8.78 ng/mL
2.14
Carcinoembryogenic Antigen (CEA)
0~5 ng/mL
1.1
Basic Blood Test
Cardiovascular Exams
Lipid blood tests are total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, Apo A, Apo B,
and etc. when LDL-cholesterol, Apo B, and triglyceride increase, the occurrence of cardiovascular
diseases is high. When HDL-cholesterol and Apo A increase, the occurrence of cardiovascular
diseases is low. LDL-cholesterol is also called as bad cholesterol and high LDL-cholesterol level
occur atherosclerosis and can lead myocardial infarction or stroke.
Reference
Results
Total cholesterol
0~240 mg/dL 169
Triglyceride 0~200 mg/dL
85
HDL-cholesterol
40~60 mg//dL
45
LDL-cholesterol
0~130 mg/dL
118
Oxidised LDL
<0.60 ug/mL
<1.0
Very Low Density Lipid (VLDL)
0~40 mg/dL
21
Inflammation Markers
Reference
Results
CRP hs
< 5.0 mg/L 1.55
Ferritin 13~50 mg/dL
31.79
Fibrinogen
200~400 mg//dL
(TG/LDL ratio)
LP(a)
< 75 nmol/I
210.30
Homocysteine
4~15 umo l/L
17.7
B12 160~800 pg/ml
241.6
Cardiovascular Exam
(
Electrocardiography
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ECG test can obtain basic information about irregular heartbeat, heart rate, and heart
Ankle Brachial Index (ABI
It is a biomarker of cardiovascular risk with both sensitivity and specificity exceeding 90%. In
addition to peripheral obstructive arterial disease about 20% of clients seen have an ABI below
0.9 carrying an increased risk of heart attack or stroke.
Stress Echocardiography
In a stress test, you walk on a treadmill that makes your heart work progressively harder. An
electrocardiogram (ECG) monitors your heart's electrical rhythms. The test sheds light on the
heart's chambers, how well the heart is pumping blood, and whether the heart has any damaged or
dead muscle.
It is useful to do for a sedentary person who suddenly wants to start exercising. Stress echo is not
100% accurate in detecting silent coronary artery disease; but helps decide what the next step
should be and is radiation free. For men with unexplained shortness of breath on exertion, or a
woman who is not sure if her pain is cardiac or anxiety related; an abnormal stress test points to a
higher risk of coronary disease. An abnormal test is more worrisome in a man or woman who also
has risk factors like a family history of heart disease, a heavy smoker, a man older than 40, a woman
older than 50, being overweight, or high small LDL cholesterol. Tests take 45 minutes.
Is a low radiation test using our new super-fast CT scan, that can be recommended by our
cardiologist or internist, as a follow up to stress echo testing; usually if you have a strong family
Cardiovascular Exam
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Electrocardiography Report
Cardiovascular Exam
ً
Ankle Brachial Index Report
Cardiovascular Exam
ً
Stress Echocardiography Report
Cardiovascular Exam
ً
CAC: Calcium Scoring Report
Cardiovascular Exam
Male Hormones
Testosterone
Dehydroepiandrosterone - Sulfate
Reference
Estrogen
Progesterone
0.69 30 - ~ 2.60 400 nmol/L pg/ml
Total testosterone
DHEA
65.1 - 368 ug/dl
Results
0.58
341.60
Dihydrotestosterone 0.33 - 3.01 nmol/L
1.10
Prostate ultrasound
Prostate ultrasound is an imaging examination that uses sound waves to check for any abnormalities
in the prostate. The test consists of inserting a small lubricated probe in the rectum, which creates
sound waves that bounce off the prostate and create images by using a special device. This test helps
the doctor detect the size of the prostate and diagnose any growth or problem.
Urologic Exam
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PSA
Urologic Exam
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Penile Blood Flow Report
Urologic Exam
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Prostate Ultrasound Report
Urologic Exam
s
Liver function test is essential to diagnosis of hepatitis. As the liver cells are destroyed, the serum
level of liver enzymes (ALT/GPT, AST/GOT) increases to suspect hepatitis.
Reference
Results
Total protein
6.0~8.0 g/dL
6.9
Albumin 3.3~5.2 g/dL
4.3
Total Bilirubin
0.2~1.2 mg//dL
0.7
Alkaline phosphatase
30~115 IU/L
41
AST (GOT)
64~83 g/L
73
ALT (GPT)
Amylase
28~100 U/L
67
Anti-H.pylori, Antibody, IgG
Negative IU/mL
Negative 0.621
Aspartate
Up to 35
18.3
Globulin
16-36 g/L
25
Liver fibroscan is to assess liver fibrosis as checking the liver elasticity by ultrasound. It also
analyzes quantitatively the amount of fat deposition in the liver.
Gastroenterologic Exam
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Liver Fibroscan Report
Gastroenterologic Exam
s
If HAV antibody is positive, it means you have been infected by hepatitis A or received hepatitis A
vaccination. If HAV antibody is negative, the vaccination is recommended. If HBs antigen is positive,
it means you are infected by hepatitis B. If HBs is negative and HBs antibody is positive, it means
you have received hepatitis B vaccination. If HBs is negative, hepatitis B vaccination is
recommended. If your HCV antibody test results is positive, there is a possibility of a hepatitis C
virus infection. However, it may be false and appear to be positive, even if the HCV infection has
already been cured. If your HCV antibody test result is positive, an in-depth examination is necessary.
Reference
Results
HAV antibody (IgG)
Positive
Positive
HBs antigen
Negative
Negative
Anti-HBs antibody
10 ~ mIU/mL
0.0
Anti-HCV antibody
Negative (<1.0 S/CO)
Negative
Anti-HIV antibody
Negative
Negative
Syphilis TP Ab
Nonreactive
Nonreative
Serology and Immunologic Exam
Stool Exam for parasites
An ova and parasite (O&P) exam is a microscopic evaluation of a stool sample that is used
to look for parasites that may infect the lower digestive tract, causing symptoms such as
diarrhea. The parasites and their eggs (ova) are shed from the lower digestive tract into
the stool. We only need one pea size amount of stool, the fresher the better.
H.Pylori
A positive H. pylori stool antigen that a person's gastrointestinal pain is likely caused by a
peptic ulcer due to these bacteria. A negative test result means that it is unlikely that the
individual has an H. pylori infection and their signs and symptoms may be due to another
cause.
Undigested fat
Impaired digestion or absorption can result in fatty stools. Possible causes include
salts, which reduces micelle formation, and small intestinal disease producing
malabsorption.
Serology and Immunologic Exam
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Stool Exam Report
Serology and Immunologic Exam
ً
Colonoscopy
Requires bowel preparation for two days prior with laxatives to empty the colon. May be
done with our CT scan also called virtual colonoscopy; more radiation but no need for
anesthesia, or with the traditional scope requiring sedation and without radiation. Must
discuss with your doctors as the test may not be necessary for your specific situation,
age and family history. Test takes 45 minutes.
Examines the esophagus, stomach and duodenum to diagnose reflux esophagitis or GERD,
esophageal cancer, gastritis, stomach ulcer, stomach cancer, and duodenal ulcer. A biopsy
can be taken when necessary for accurate diagnosis. Since it requires intravenous
sedation, it is done only if our doctors find medical reasons to subject you to it. It is done
in our Novomed Surgical Hospital in Um Suqeim (Dubai) and requires the patient to be
pre-screened by our anesthesiologist. Patients must be fasting for seven hours before
undergoing this test. Test takes 45 minutes.
٪90
المحيطية، فإن حوالي ٪ 20 من العملاء الذين حققوا نسبة أقل من 0٫9 على مؤشر الضغط الكاحلي العضدي لديهم نسبة أعلى للاصابة بنوبة
قلبية أو سكتة دماغية
Serology and Immunologic Exam
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Colonoscopy Report
Serology and Immunologic Exam
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Esophagogastroduodenoscopy Report
Serology and Immunologic Exam
Endocrinologic Exams
Blood glucose and glycated hemoglobin (HbA1c) are blood tests to diagnose diabetes mellitus.
Fasting blood sugar is a blood glucose test after 8 hours fasting. HbA1c reflects average blood
glucose level of the past 2~3 months.
Diabetes is suspected when fasting blood glucose is higher than 126mg/dL or when HbA1c is higher
than 6.5 %. In diabetic patients, blood glucose and glycated hemoglobin are also used as an index to
evaluate the blood glucose control status.
Reference
Results
Fasting Blood Sugar
~ 99 mg/dL 131
Hemoglobin A1c ~ 5.6 %
7.4
Insulin Resistance Score
less than 33
50
Thyroid function Test
TSH, T4, and T3 tests evaluate thyroid function. Hyperthyroidism or hypothyroidism can be confirmed.
Reference
Results
Thyroid Stimulating Hormone
0.35 ~ 4.94 uIU/mL 3.45
Free thyroxine ( Free T4) 0.70 ~1.48 ng/dL
0.99
Thyroid Ultrasonography
Thyroid sonography is a test to detect nodule, inflammation, and mass of thyroid gland. If thyroid
nodules with suspected thyroid cancer, it can be confirmed by thyroid biopsy (FNA).
Endocrinologic Exam
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Thyroid Ultrasonography Report
Endocrinologic Exam
Metabolic Syndrome
Metabolic syndrome is caused by abdominal obesity and insulin resistance. Insulin resistance means
that insulin action to control the blood glucose level is disturbed despite of the normal amount of
insulin, and it develops various diseases such as hypertension, dyslipidemia, diabetes mellitus,
stroke, and myocardial infarction.
When metabolic syndrome is diagnosed in comparison with having a single disease, the risk of type
2 diabetes or cardiovascular diseases such are much higher.
Metabolic syndrome is diagnosed if you
have more than 3 out of 5 risk factors
Risk Factors Diagnostic Criteria Result
Abdominal Obesity - Waist
circumference 9cm)
Triglyceride (mg/dL)
Male: >90
Female: >85
>150
98
85
HDL-Cholesterol (mg/dL) Male: < 40 / Female: < 50
45
Blood Pressure (mmHg)
> 130/85 or taking medication
120 / 85
Fasting Blood Sugar (mg/dL)
> 100 or taking medication
131
You have metabolic syndrome
Metabolic Syndrome
Vitamin D helps calcium absorption which is important for bone formation and maintenance.
Vitamin D is produced in response to sunlight hitting skin and rich in fatty fishes with blue back.
Reference
Results
25(OH) Vitamin D3 30 ~ 100 ng/mL 32.8
Is the gold standard and most accurate test to detect bone fragility and prevent osteoporosis. Bone
health is improved by quitting smoking and alcohol, weight bearing exercises, hormone rebalancing
when necessary, good nutrition and minimizing the use of medications for gastric acidity by
accurately diagnosing and fixing the underlying problem. Test takes 15 minutes.
الاستروجين
البروجستيرون
مجموع التستوستيرون
ديهيدرو إيبي أندروستيرون
Endocrinologic Exam
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DEXA Scan Report
Endocrinologic Exam
s
Microscopic urinalysis Test
Urynalysis is to see if there is blood, protein, or inflammation cell in the urine and is helpful to
diagnose kidney and urology diseases like urinary tract infection, urinary disease, or tumor.
Uric acid increases in relation with alcohol, meat consumption, and obesity and it causes gout,
kidney/urinary tract stones, and decreased kidney function.
Reference
Results
Color
(straw)
Appearance
(Clear)
pH
5.0 ~ 8.5
5.5
Specific Gravity
1.005 ~ 1.030
1.005
Nitrite
- Negative
Urobilinogen
+_
+/-
Occult blood
- Negative
Bilirubin
- Negative
Albumin
- Negative
Glucose
- Negative
Ketone
- Negative
White Blood Cells
0 ~ 4 /HPF
< 1
Red Blood Cells
0 ~ 4 /HPF
< 1
Kidney/ Urologic Exam
Kidney function is evaluated by creatinine test. The elevated creatinine level means the decline in
kidney function. If uric acid level is high, it can occurs gouts, urinary tract stone, and decreased
kidney function.
Reference
Results
Calcium
8.8 ~ 10.5 mg/dL
9.2
Phosphorus
2.5 ~ 4.5 mg/dL
3.7
Sodium (Na)
135 ~ 145 mmol/L
139
Potassium (K)
3.5 ~ 5.5 mmol/L
4.0
Chloride (CI)
98 ~ 110 mmol/L
100
Urea
10 ~ 26 mg/dL
15
Creatinine
0.70 ~ 1.40 mg/dL
0.99
Uric acid
3.0 ~ 7.0 mg/dL
7.7
Renal ultrasonography is a noninvasive study that requires no contrast and provides useful
information about the renal parenchyma. This imaging modality can be performed at the bedside in
a hemodynamically unstable patient, and it can help to detect hydronephrosis, pyonephrosis, and
perirenal abscess
Measurement of the postvoid residual by bladder scan or ultrasonography should be performed on
every patient admitted to the hospital for uraniary tract infection, irritable or nervous bladder,
prostate problems, and uraniary incontinance in women.
Kidney/ Urologic Exam
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Kidney Ultrasonography Report
Kidney/ Urologic Exam
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Bladder Ultrasonography Report
Kidney/ Urologic Exam
ُ
ً
s
Simple chest x-ray inspects lungs and detects lung cancer, pneumonia, and tuberculosis.
Small lung lesion cannot be detected and there is limitation to observe the lesion overlapped with
thorax structure like rib cages. Low-dose chest CT can more accurately observe lung abnormalities
than simple chest X ray and is useful for early diagnosis of various lung disease including lung
cancer.
Pulmonary function Test
What you can expect?
A spirometry test requires you to breathe into a tube attached to a machine called a spirometer.
Before you do the test, your pulmonologist will give you specific instructions. Listen carefully and
ask questions if something is not clear. Doing the test correctly is necessary for accurate and
meaningful results.The entire process usually takes less than 15 minutes.
Results:
Forced vital capacity (FVC). This is the largest amount of air that you can forcefully exhale after
breathing in as deeply as you can. A lower than normal FVC reading indicates restricted breathing.
Forced expiratory volume (FEV). This is how much air you can force from your lungs in one second.
This reading helps your doctor assess the severity of your breathing problems. Lower FEV1- readings
indicate more significant obstruction.
Should you have any problem with this screening test, we would then recommend a more
Pulmonologic Exam
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Chest X-ray Report
Pulmonologic Exam
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Pulmonary Function Test Report
Pulmonologic Exam
Skin Exams
Skin Testing
Is part of your comprehensive exam to detect suspicious skin lesions that can harbor melanomas
and an advanced infrared computerized camera to detect accelerated skin aging from smoking, sun
damage, poor nutrition, poor sleep or skin laxity from yo-yo dieting. Tests take 20 minutes.
يُستخدم الفيبروسكان لتقييم تليّف الكبد عن طريق تفحّ
ُحلّل كميّاً مقدار الدهون المترسبة في الكبد
Skin Exam
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Skin Testing Report
Skin Exam
Ophthalmologic Exams
Vision and Tonometry Test
Visual acuity test is divided into the corrected vision which measures when wearing glasses or
contact lenses and the unaided vision which measures with bare eyes. The corrected vision is more
important since it measures the maximum visual acuity. Therefore, it is recommended to wear the
glasses or contact lenses that you normally wear for the visual acuity test.
Intraocular tonometry is to measure the pressure inside of eye and the compressed air is shooting
to the surface of eye using non-contact tonometer. If the pressure is high, the chance of glaucoma
occurrence is also increased. If it is severely increased, the retest can be done with contact
tonometer for more accurate measurement.
Fundus Photo
Fundus photo (retina imaging) test is a test to examine the optic disk, macula, and major retinal
vessels by photographing the center of the back of the eye. Through the examination, ophthalmic
diseases can be detected early on such as glaucoma, macular degeneration, and diabetic
retinopathy, which are major causes of vision loss, and indirectly are signs pointing to the condition
of systemic diseases, such as arteriosclerosis, can be obtained.
Ophthalmologic Exam
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Vision and Tonometry Test Report
Ophthalmologic Exam
Otorhinolaryngologic Exams
Laryngoscopy is to check the structural abnormality and tumor of larynx including the vocal
Otorhinolaryngologic Exam
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Audiometry Report
Otorhinolaryngologic Exam
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Laryngoscopy Test Report
Otorhinolaryngologic Exam
Dental Examination Results
Dental exam is to diagnose various oral and dental diseases through inspection and percussion by a
dentist with panoramic dental x-ray. It evaluates gum diseases, tooth decay, abrasion, damaged
fillings, broken teeth, wisdom teeth abnormality, soft tissue diseases in the oral cavity, or jaw joint
12
11
21
22
23
Oral Examination Results
14
15
16
Right | Left
24
25
26
*Prevention
-Needs proper tooth-brushin
plaque control.
17
18
Wisdom Teeth
27
28
Wisdom Teeth
-Recommends using dental floss or proxabrush (interdental brush)
for interdental cleaning.
*Periodontal Treatment
-Needs scaling. Then needs scaling annually.
48
38
47
37
46
Right | Left
36
45
35
44
34
43
42
41 31 32
33
تصوير الغدة الدرقية بالموجات فوق الصوتية هو اختبار للكشف عن العقد والالتهابات والكتل في الغدة الدرقية. إذا كان هناك اشتباه بوجود سرطان الغدة
Dental Examination Results
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Oral Examination Test Report
Dental Examination Results
Optional Tests
Depending on your medical condition, family
history, budget, and personal preferences, you may
benefit from additional tests that are now available
at much lower prices than before thanks to the
great advances in gene identification and targeted
cell therapy.
The tests are conducted in the USA at FDA approved
laboratories at an additional cost and results take
seven to ten days.
ً ً ً
results
guidebook
a step by step guide to making the most of your results
How to understand
the results
The list of food and drink intolerances are listed in order of Reaction,
Borderline and No Reaction. Here is an explanation of what each
category means.
Reaction
Borderline
Indicates raised IgG antibody levels to these
food or drink ingredient(s) and you should try to eliminate
them completely from your diet.
Indicates a borderline reaction to these food and drink
ingredient(s) and you may benefit by limiting their
consumption.
No
Reaction
These ingredients can be eaten without restriction, unless
you already know that they cause a reaction and you have
been avoiding them, in which case you should continue to
do so.
Book the nutritional consultation
_______________________________________________________________________
To help get the most from your results and to make the changes as
easy as possible, we provide a telephone consultation with one of our
Novomed Centers registered Nutritional Therapists.
To book your appointment simply call our
Customer Care team upon receiving the
results. Once the appointment is booked, our
Nutritional Therapist will call you and your
consultation will last 30 minutes. Please come
prepared with a list of questions to ensure you
get the most out of your appointment.
N.B the advice given is
not intended to replace
any recommendations
offered by your
Doctor or Healthcare
Practitioner, as they
will have full details of
your medical history.
What to expect from your new diet
_______________________________________________________________________
You may be lucky enough to achieve good results immediately. On
average, 3 out of 4 people feel better after acting on the results of Food
Intolerance Programmes, the majority within 3 weeks.
Some people may feel worse for the first few days, this is likely to be
withdrawal symptoms – if this continues it is important to seek medical
advice. Symptoms of withdrawal can include fatigue and mood swings –
but once you have adjusted to your diet you should be back to normal.
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TOP TIPS
Always check ingredient labels – if in doubt,
don’t eat or drink it
Get as much advice as possible
Do not go without meals or fluids
Drink plenty of water
Vary your diet as much as possible
Be strict, it is the only way you know it will work
It may not be forever – many people are able to
reintroduce foods and drinks eventually
Go for basic ingredients that are not processed
or refined
Make sure you speak to one of our Nutritional
Therapists who can advise on how to keep
your elimination diet nutritious - This is
extremely important
If you have any
concerns about
any physical
changes speak
to your Doctor
or Healthcare
Practitioner.
Some of our customers find that
they notice a change in weight or
body shape; this is not a cause
for concern! You will find your
overall health improving and that
you have an increased amount of
energy.
Vitamins
&Minerals
_______________________________________________________________________
VITAMINS &
MINERALS
Vitamin A
D
E
C
B1
B2
B3
B5
B6
B12
FOLIC ACID
BIOTIN
ESSENTIAL
FATTY ACIDS
(EFA’S)
CALCIUM
MAGNESIUM
IRON
ZINC
MANGANESE
SELENIUM
CHROMIUM
FOOD TYPES
Specific nutrients can be gained from eating the following foods
red/yellow/orange fruit & vegetables, dark green leafy vegetables, dairy
products, egg yolk, cod & halibut liver oil, liver (Take care! May be high in toxins)
fortified soya milk, skin exposed to sun, dairy products, egg, fortified margarine,
herring, mackerel, salmon, oysters, cod & halibut liver oil
nuts, seeds, wholegrain cereals, vacuum packed wheatgerm, cold pressed vegetable
& nut oils, pinenuts, avocados, dairy, eggs, salmon, sardines, tuna
blackcurrants, broccoli, green peppers, strawberries, watercress, spinach, potatoes,
all fruit & vegetables
whole brown rice, potato, whole grain cereals, nuts, pulses, yeast extract, lentils,
pork, beef
lentils, green leafy vegetables, soya bean products, cereals, dairy products, eggs,
mackerel, meat
lentils, yeast extract, brewer’s yeast, nuts, pulses, dairy products, tuna, salmon,
chicken, turkey, lamb, red meats
whole grains, wheatgerm, brewer’s yeast, nuts, pulses, eggs, meat
green leafy vegetables, whole grain cereals, nuts, bananas, avocados, brewer’s yeast,
seeds, cheese, egg yolk, meat, fish, herring, oysters
fortified cereals & soya milk, fermented soya products – tempeh, miso, soya sauce,
yeast extract, barley malt syrup, edible seaweed, blackeyed beans, brewer’s yeast,
cheese, eggs, oysters, sardines, tuna, shrimp, turkey & chicken, meat, liver
green leafy vegetables, whole grain cereals, nuts, brewer’s yeast, mushroom, dates,
peanuts, root vegetables, sprouted seeds, blackeyed beans, milk, eggs, liver, kidneys
yeast, mushrooms, brown rice, nuts, brewer’s yeast, cauliflower, cabbage, watermelon, sweetcorn,
peas, tomatoes, milk, egg yolk
walnuts, seaweed, flaxseed oil, linseed, wheatgerm oil, rapeseed oil, soya beans, tofu,
hemp seeds, sunflower seed, evening primrose seed oil, nuts and seeds, oily fish
(EFA’S) EPA/DHA supplements
green leafy vegetables, broccoli, soya milk fortified with calcium, nuts, seeds – esp.
sesame/tahini, pulses, bread, fortified soya products, whole grains, dairy products esp.
low fat yoghurts, tinned fish including bones
vegetables, nuts, whole grains, green leafy vegetables, cocoa powder, wheatgerm,
brewer’s yeast, buckwheat, beans, raisins, peas, soya, crab
nuts, seeds, lentils, beans, whole grains, wheatgerm, spinach, pulses, dates, prunes,
cocoa, yoghurt, shell fish, red meat, liver, black pudding
pumpkin seeds, nuts, wholegrains, seeds, wheatgerm, pulses, some vegetables, dairy,
egg yolk, oyster, haddock, shrimp, red meats
nuts, wholegrain cereals, pulses, green leafy vegetables, tea, fruit – especially tropical
wholegrain cereals, walnuts, Brazil nuts, molasses, mushrooms, cabbage, courgettes,
cheese, eggs, cod, oysters, tuna, herring, chicken, beef, liver
molasses, rice bran, brewer’s yeast, wholegrain products, wheatgerm, green peppers,
cornmeal, apples, mushroom, asparagus, egg yolk, swiss cheese, oysters, chicken, lamb
What happens if
things go wrong?
_______________________________________________________________________
If you get a craving or have the urge to comfort eat then ask yourself why?
Is it because you are tired or fed up? If so then find an alternative. Take
a short break and a bit of fresh air for a quick fix energy boost. You don’t
need high fat or sugar food or a glass of wine to give you comfort. What
about a warming soup or mashed root vegetables or a fruit smoothie?
We often crave things that are bad for our health because they give us a
quick fix boost. This is known as masking. If you consume something your
body does not like, it triggers off a small stress response which releases
adrenaline and this gives you a short burst of energy. Unfortunately this
burst is very short lived, usually about half an hour after which time your
body feels worse than it did before because of this additional strain. Your
brain then tells you it does not like feeling this bad, it wants to experience
that boost it felt half an hour ago, so you can reach for another unhealthy
quick fix and so it goes on. Once you break this unhealthy cycle, you can
break the craving.
Even if you do give in to temptation, don’t
give up. Remind yourself how well you
have done so far and get yourself back on
track. You can learn from the experience,
think about how you can divert your
attention next time but accept the fact
that it was never going to be an easy run
from A to B. It’s not worth emotionally
beating yourself up, just move on.
You may have to go back
to square one but do not
give up –that offers no
chance of success.
It’s important not to let boredom set in, so don’t let your diet become too
samey or bland, and don’t make it dominate your life so that you stop
having a social life. If you have good friends they will understand, they
should love you for you, not your eating and drinking habits. Sadly you
may experience lack of encouragement, sarcasm or criticism from people
around you but don’t be disheartened. Try to explain the benefits you
hope to achieve or have achieved so far. Ask for their support, if it is not
forthcoming then just be
discreet with your efforts
and don’t bring it up in
conversation.
Any change brings a new
set of dilemmas but keep
reminding yourself how
you will look and feel
when improvements start
to appear and remind
yourself how far you have
managed to come.
If you don’t feel a positive change from your diet, then
review what you are doing.
| Are you being strict enough?
| Are there hidden ingredients?
| Are you being honest with yourself?
| Have you given it enough time?
| Is there some other factor in your lifestyle that is hindering your
progress?
Re-introducing
‘Reaction’ foods
_______________________________________________________________________
We recognise that many people wish to start re-introducing foods into their
diet following the exclusion processes.
This must be done with care and it is important to start slowly.
At a time convenient to your individual needs, introduce one food at a time
and leave one week between that food and the next.
If there are no symptoms after a few days then use that food on a four day
or more rotation to maintain increased tolerance.
If at any time
your symptoms
start to return or
you start to feel
ill DO NOT
continue with the
re-introduction
of that food.
Some re-introduction
suggestions
_______________________________________________________________________
Everyone is different with different ingredients to avoid, so as a general
guide the re-introduction of food and drinks may be as follows;
| If dairy has been avoided then a plain bio/live yoghurt is the best to test
first – if no reactions occur over a five-day period then try a small amount
of milk.
| If wheat has been avoided then try a wheat only product such as
Shredded Wheat. Likewise with oats, make porridge with oats and water so
it is only the oats themselves you are testing. The same is advisable with
other grains.
| Egg is best tested by trying the cooked yolk only. If there is no reaction
within five days then egg white could be tested next.
| When testing any of the foods choose a pure food to be tested so you are
positive it contains no other products.
| Always allow one week between re-introducing new ingredients. Any
reaction and symptoms need to be monitored over the testing period.
FAQs
Does cooking get rid of allergens in food?
Some people react to raw food but not cooked food. If you have a reaction
to a food on the test, you should avoid it and then test it in its different
forms individually, unless you are instructed otherwise by your Healthcare
Practitioner.
Does the programme test for reactions to other factors such
as sulphites in drinks?
Unfortunately the blood test can only test for antibody reactions to food
and drink ingredients, and sulphite reactivity cannot be tested in this way.
However, if you are reacting to sulphites in wines you may be able to
recognise a pattern in your symptoms using your Food & Drinks Diary.
Do I have to be wary of the
ingredients tested in supplements
and herbal medicines that I take?
Yes you do. The ingredients
tested are also included in many
supplements and herbal medicines
so anything you ingest needs to be
checked out to see if it is suitable.
Can I react to some parts of egg and
not to others?
Yes, we do find that some people
react to egg white and not as much to
egg yolk, or occasionally vice-versa.
Also, most but not all who react to
chicken eggs are able to tolerate duck
eggs and goose eggs without any
problem.
FAQs
Do I have to avoid alcohol all together?
With any lifestyle change it is important to review
your drinking habits, as well as other aspects of
your lifestyle. If you do react to ingredients
present in alcoholic drinks then there are usually
alternatives for you. You should discuss these when
you have your Nutritional Therapist appointment.
What milk alternatives can I use?
When people are asked to remove milk from their diet they are faced with
an array of different products that they can choose from. Supermarkets
spread their milk alternatives over
different shelves. Some can be found
next to cow’s milk in the chiller section,
some with the long-life (UHT) milks
and some in the “free-from” section.
Lactose-free milk is one of the
alternatives on offer and we often get
asked if this milk is suitable for those
needing to remove cow’s milk from
their diet. Lactose is a milk sugar, and
lactose-free milk is needed for people
that are deficient in the enzyme lactase
(they are lactase deficient and suffer
from lactose intolerance). However,
lactose-free milk is not suitable for
those reacting to dairy products as
lactose-free milk still contains the milk
proteins responsible for the intolerance
reaction. For alternatives to milk that
are suitable try soya, almond, hazelnut,
hemp, rice, oat or coconut milk
instead.
FAQs
Is there much difference between baker’s and
brewer’s yeast?
They are closely related strains of yeast and
show very little allergenic difference.
What is the importance of food families?
It has long been known that if you react to one
member of a biological family, you are more likely
to react to other members of the same family.
Is gluten free the same as wheat free?
No, a product can be wheat-free and not gluten-free and vice versa. There
are however, products which are both gluten-free and wheat-free. Read
labels carefully. Codex Alimentarius, the international standard setting
division of the World Health Organisation, divides gluten-free foods in two
groups:
1 | Consisting of, or containing ingredients such as cereals, wheat, rye
barley or oats in their constituents, which have been rendered as
‘gluten-free’
2 | In which any ingredients normally present containing ‘gluten’ have been
substituted by other ingredients not containing ‘gluten’
Gluten-free wheat starch (1) is produced by washing gluten out of wheat flour. Foods made from naturally
gluten-free ingredients (2) by their nature are free from wheat as well. If you are intolerant to wheat and
gluten, then you are advised to avoid all products containing wheat and gluten. Some people may also find it
helpful to avoid barley and rye because of the similarities of the gluten proteins found in these grains.
Your questions for your
nutritional consultation
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PHARMACOGENETIC Testing
Requisition
City State Zip
Physician
Name
Address
NPI#
City
Phone
DOB
Gender D Male
□Female
Ancestry Fax
D Caucasian D Eastern European D Northern European
D Western European D Native American □ Middle Eastern
African American D Asian D Pacific Islander
Caribbean □ CentraVSouth American D Other:
□ Ashkenazi Jewish D Hispanic
----------- Specimen Type Date of
Colle tion c
1------------------------------------i D Whole Blood □ Mouthwash □ Saliva
PLEASE PROVIDE LIST OF CURRENT MEDICATIONS
State
4. BILLING INFORMATION
Zip
Phone
lime of
Collection
Patient has had a blood transfusion Yes If "Yes" - Date of
□ No the last transfusion
i r:t ti ;:;!t;h;;!i had allogeneic bone marrow transplants.
□ AM
□ PM
BILL: D Insurance D HSA D Medicaid D Medicare D Se Pay D Worker's Compensation
Name of
Policyholder
DOB Medicare# Medicaid#
Relationship to Policyholder
□ Se D Spouse □ Dependant □ Other ____________________ _
Worker's
Comp.Claim#
Date of
Injury j ',
ICD-10 DIAGNOSIS CODES: _ _ _
D MEDICAL MANAGEMENT
ABCB1, APOE, COMT, CYP2C19, CYP2C9, CYP2D6, CYP1A2
CYP286, CYP3A4, CYP3A5, DRD2, Factor II, Factor V, MTHFR
OPRM1, SLCO181, VKORC1
D CARDIAC AND BLOOD CLOT
ApoE,CYP2C9,CYP2D6,CYP3A4,CYP3A5,CYP1A2,ABCB1
CYP286, CYP2C19, SLCO181, VKORC1, Factor II, Factor V, MTHFR
D PHYCHIATRY AND ADDICTION
CYP286, DRD2, CYP1A2, OPRM1, CYP2D6, CYP3A4, COMT
CYP2C19,CYP3A5,CYP2C9
D PAIN MEDICATION
CYP2C19,CYP3A4,CYP2C9,CYP1A2,CYP2D6,CYP3A5
OPRM1, COMT
D ACID REFLUX AND ANTIEMETICS
CYP3A4, CYP1A2, CYP2C19, CYP2D6, CYP2C9, ABCB1
D ANTI-SEIZURE MEDICATION
CYP3A4, CYP1A2, CYP2C19, CYP2D6, CYP2C9, ABCB1
D WARFARIN
D PLAVIX
CYP2C9 VKORC1
CYP2C19
Tests can be ordered as a panels or individually
6. PATIENT CONSENT 7. MEDICAL NECESSITY FOR TESTING
Billing ABN and Patient Plan Information: A completed Advance Beneficiary Notice (ABN) of
coverage is required for Medicare patients who do not meet medical criteria for testing. This does not
apply to specific site analyses. Insurance pre-qualification will not be performed for these tests, unless
specifically requested. All tests ordered shall be processed and billed based on payor.
Patient Acknowledgment: I am covered by insurance and authorize Novomed Specialized Clinics to
give my designated insurance plan on this form and other information provided by my health care provider
necessary for reimbursement. I authorize Novomed Specialized Clinics to inform my Plan of my test
results only test results are required for preauthorization of or payment for reflex/additional testing.
I authorize Plan benefits to be payable to Novomed Specialized Clinics. I further authorize payment of
benefits directly to the laboratory. I understand acceptance of insurance does not relieve me from any
responsibility concerning payment for laboratory services and that I am financially responsible for all charges
whether or not they are covered by my insurance. I understand that any payment I receive for services
rendered by the laboratory from my insurance provider should be forwarded immediately to the laboratory.
The data may also reveal secondary or incidental findings such as, that you may be at risk for
certain genetic diseases or you are a carrier of disease associated mutations.
Patient Consent: My signature below constitutes my acknowledgment that the benefits, risks, and
limitations of this testing have been explained to my satisfaction by a qualified health professional and
I have received a copy of the full informed consent document. I have been given the opportunity to ask
questions before I sign, and I have been told that I can ask questions at any other time. I voluntarily
agree to genetic testing.
Patient Consent for Research: □ By checking this box I DO NOT consent for the remaining part
of my sample to be used for research purposes by Novomed Specialized Clinics.
Personal information will not be shared and will be kept confidential by Novomed Specialized Clinics.
This test is medically necessary for the diagnosis or detection of a disease, illness, impairment,
syndrome or disorder, and these results will be used in the medical management and treatment for
this patient. Furthermore, additional results recipients' information is true and correct to the best of
my knowledge. The person listed as the Ordering Physician or genetic counselor is authorized by
law to order the test(s) requested herein. I confirm that I have provided pharmacogenetic testing
information to the patient and they have consented to genetic testing. Please check all that apply:
□ I confirm that the above patient's gene testing is medically necessary and the result will be
used in the medical management and dosing or consideration of medications for this
individual patient's therapy.
□ I agree to allow Novomed Specialized Clinics to transfer the information contained in this
requisition to an Letter of Medical Necessity (LMN) using the ordering physician's name as
his/her signature for insurance billing purposes.
D I have attached a LMN for insurance billing purposes.
D Patient meets clinical/genetic testing criteria for the above ordered tests.
HEALTH CARE PROVIDER'S SIGNATURE
TEST SUBMISSION CHECKLIST
If Signature is other than patient's. Printed Name ______________ _ D Copy of Patient Demographics Collected by:
□ Current Meds List
D ICD-10 Diagnosis Codes
D Patient's/Provider's Signatures
1-----------------------------------1 D Copy of Insurance Card (Front/Back)
PATIENT'S OR RESPONSIBLE PARTY'S SIGNATURE DATE □ Attach Patient's Insurance Pre-Authorization Form Signature ><
.__ ________________________________ .__ _______________________________ __,&:
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
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Letter of Medical Necessity
PHARMACOGENETIC TESTING
Date: ________ _ Patient Name: _______________________ _
DOB: _______ _ Gender: □ M □ F
Insurance Company:, _____________________ _
Subscriber Name: ______________________ _
Policy#: __________________________ _
Dear Claims Specialist:
I am writing this letter on behalf of my patient, ------------------ to request coverage for the
Pharmacogenetic testing offered through Novomed Specialized Clinics. The Pharmacogenetic testing is performed in a high
complexity CUA certified laboratory located in Frisco, Texas.
My patient has not reached their therapeutic goal on the current regimen and may be experiencing adverse drug reaction(s)
to one or more medications. I am seeking to choose safer or more efficacious dosages. I request coverage for DNA
microarray and PCR analysis of targeted genes to identify genetic variants. This knowledge will help avoid
harmful and costly adverse drug events, optimize medication dose, and increase chances of patient's treatment success.
Test Information and Impact of Results on Medical Management:
The pharmacogenetics panel offered by Novomed Specialized Clinics targets genes that when mutated are known to
impact patient's response to medication.
The result of this pharmacogenetic testing will have a direct impact on this patient's medication management.
Genetics account for much of the variability seen in our patients' responses to drug therapies and the implications of
pharmacogenetics have been well documented. Currently there are at least 230 U.S. Food and Drug Administration (FDA)
approved drugs with Pharmacogenomic information in their labeling. The labeling for some of the products includes specific
actions to be taken based on the biomarker information. In order to choose the more suitable medication and avoid potential
but serious adverse drug events, it is extremely important to perform this panel of Pharmacogenetic tests.
Patient's personal and/or family history as well as current medication regimen are suggestive of high risk for adverse drug
events based on my evaluation and review of latest available literature. In this patient's case, pharmacogenetics testing is
crucial in order to establish and confirm a genetic diagnosis, guide appropriate and immediate medical management,
predict disease prognosis, and eliminate potential adverse drug events.
Informed Consent:
The patient has provided a signed informed consent for pharmacogenetic testing, based on my discussion of the personal
and/or family history, the potential test results, and the implications for medical management. The patient is aware of the
benefits, risks, and limitations of the testing and has voluntarily agreed to the pharmacogenetic test.
Conclusion:
Knowledge of this patient's genetic information is important for me to accurately assess patient's medication regimen and
will guide my recommendations for treatment plan. I have chosen to send the patient's test to Ayass Lung Clinic, PLLC with
highly sensitive, rapid, and cost-effective pharmacogenetic which will provide helpful medical treatment planning information
for my patient.
Thank you for your review and consideration. I hope you will support this request for genetic testing coverage for my patient.
If you have questions, or if I can be of further assistance, please do not hesitate to call me at:
Sincerely,
Physician's Name: _________________________________________ _
Signature:----------------------------------------------
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
nov0n,ed
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Informed Consent for Genetic Testing
Genetic Testing can be complex. If warranted, obtain professional genetic counseling prior to giving consent to fully
understand what the risks and benefits are.
I request and authorize Novomed Specialized Clinics to test my (or my child's) sample for the below designated genetic
condition(s). My signature below constitutes my acknowledgment that the benefits, risks, and limitations of this testing
have been explained to my satisfaction by a qualified health professional and I have been provided a copy of the
corresponding technical bulletin describing testing for the condition(s) listed below.
DNA analysis for the condition(s):
The intended purpose is: Diagnosis / Predictive / Other:
It has been explained to me and I understand that:
• DNA test results may:
1. Diagnose whether or not I have (or my child has) this condition or am at risk for developing this condition.
2. Indicate whether or not I (or my child) am a carrier for this condition.
3. Predict another family member has, is at risk for developing, or is a carrier of this condition.
4. Be indeterminate due to technical limitations or familial genetic patterns.
5. Reveal non-paternity.
• DNA testing is specific only for the condition(s) named above and will not detect all causative mutations.
• The significance of a positive and a negative test result based on my family history has been explained.
• Although DNA testing usually yields precise information, several sources of error are possible.
These include, but are not limited to, clinical misdiagnosis of the condition, sample misidentification,
and inacurate information regarding family relationships.
• If a gene mutation is identified, insurance rates, obtaining disability or life insurance, and employability
could be affected. Federal law extends some protections regarding genetic discrimination
(http://www.genomegov/10002328). It is my responsibility to consider the possible impact of these results.
All test results are released to the ordering health care provider and those parties entitled to them by state
and local laws.
• The performance characteristics of this test were validated by Ayass Lung Clinic, PLLC. The U.S. Food and
Drug Administration (FDA) has not approved this test; however, FDA approval is currently not required for clinical
use of this test. Ayass Lung Clinic, PLLC is authorized under Clinical Laboratory Improvement Amendments
of 1988 (CLIA) and by all states to perform high-complexity testing. The results are not intended to be used
as the sole means for clinical diagnosis or patient management decisions.
• I will be responsible for payment after the genetic testing has begun, even if I decide not to receive results.
• Genetic counseling is recommended prior to, as well as following, genetic testing.
• My (or my child's) DNA sample may be stored indefinitely to be used for test validation or educational
purposes after personal identifiers are removed. No clinical tests other than the ones authorized will be
performed. I may request disposal of my blood and DNA sample following completion of the test requested
above by contacting the Ayass Lung Clinic, PLLC at 972-668-6005 or initializing in the section described below.
My signature below acknowledges my voluntary participation in the test. I understand that the genetic analysis
performed by Novomed Specialized Clinics is specific only for this disease and in no way guarantees my health,
the health of an unborn child, or the health of other family members.
Patient's Signature:
Patient's Name
OM OF
Birth Date:
Date:
I indicate my desire to opt out of participation in anonimized research studies using my DNA sample by initialing here _ __ _
Physician's or Counselor's Statement: I have explained DNA testing and its limitations to the patient
or legal guardian and answered all questions.
Physician's/Counselor's Signature:
Physician's/Counselor's Name:
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
Date:
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Saliva Cell Sample Collection Instruction
ORAcollect.Dx is intended for use in the
non-invasive collection of saliva samples.
Human DNA from the saliva sample is isolated,
stabilized and is suitable for use in molecular
diagnostic applications.
1. Refrain from eating, smoking, or chewing for at least 30
minutes before sample collection.
2. Donors with xerostomia (dry mouth) may not collect
adequate sample using these instructions resulting in low
yield DNA. In that case DNA extracted from whole blood is
recommended.
3. Open package from the end with the 'open here arrow'.
Saliva Cell Collection
USING ORAL SWAB ORAcollect.Dx COLLECTION KIT
4. Remove collector by its handle from the package while
ensuring that the sponge tip does not come in contact with
any surface prior to collection.
5. Place sponge as far back in the mouth as comfortable
(Figure 2).
3
®
6. Gently rub along lower gum in a back and forth motion 10
times. Avoid rubbing the teeth.
7. Choking Hazard: Caution must be taken when inserting the
sponge into the donor's mouth.
8. Repeat rubbing motion on opposite side along the lower
gum for another 10 times.
9. Hold the tube with the blue liquid upright to prevent it from
spilling.
10. Unscrew the blue cap from the tube without touching the
sponge (Fugure 3).
11. Turn the cap upside down and insert the sponge into
the tube and close the cap tightly (Figure 4).
12. Invert capped tube and shake vigorously 10 times (Figure 5).
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
noven,ed
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CARDIAC Conditions
Hereditary Assessment
Requisition
City State Zip
Physician
Name
Address
Phone DOB Gender City State
D Male D Female
Ancestry
D Caucasian
D Western European
D African American
D Caribbean
D Ashkenazi Jewish
D Eastern European
D Native American
D Asian
D Central/South American
D Hispanic
D Northern European
0 Middle Eastern
D Pacific Islander
D Other:
Fax
Paben! has had a blood transfusion B s
1- ------------------------------------1 2-4 weeks of wan time is required for some testing.
PLEASE PROVIDE LIST OF CURRENT MEDICATIONS
Name of
Policyholder
Relabonship to Policyholder
4. BILLING INFORMATION
Zip
Phone
If "Yes" - Date of the last transfusion:
Specimens are not accepted for patients who have had allogeneic bone marrow transplants.
BILL: D Insurance D HSA D Medicaid D Medicare D Se Pay D Worl<er's Compensation
□ Se □ Spouse □ Dependant □ Other _____________________ _
DOB:
Medicare#
Worker's Comp
Claim#
Medicaid#
Date
of Injury
ICD-10 DIAGNOSIS CODES: _ _ _
□ CARDIAC PANEL - 174 GENES
ABCC9, ABCG5, ABCG8, ACTA1, ACTA2, ACTC1, ACTN2, AKAP9, ALMS1, ANK2
ANKRD1, APOA4, APOA5, APOB, APOC2, APOE, BAG3, BRAF, CACNA1C, CACNA2D1
CACNB2, CALM1, CALR3, CASQ2, CAV3, CBL, CBS, CETP, COL3A1, COL5A1, COL5A2
COX15, CREB3L3, CRELD1, CRYAB, CSRP3, CTF1, DES, DMD, DNAJC19, DOLK, DPP6
DSC2, DSG2, DSP, DTNA, EFEMP2, ELN, EMO, EYA4, FBN1, FBN2, FHL1, FHL2, FKRP
FKTN, FXN, GAA, GATAD1, GCKR, GJA5, GLA, GPD1L, GPIHBP1, HADHA, HCN4
HFE, HRAS, HSPB8, ILK, JAG1, JPH2, JUP, KCNA5, KCND3, KCNE1, KCNE2, KCNE3
KCNH2, KCNJ2, KCNJ5, KCNJ8, KCNQ1, KLF10, KRAS, LAMA2, LAMA4, LAMP2, LDB3,
LDLR, LDLRAP1, LMF1, LMNA, LPL, LTBP2, MAP2K1, MAP2K2, MIB1, MURC (CAVIN4)
MYBPC3, MYH11, MYH6, MYH7, MYL2, MYL3, MYLK, MYLK2, MYO6, MYOZ2m MYPN
NEXN, NKX2-5, NODAL, NOTCH1, NPPA, NRAS, PCSK9, PDLIM3, PKP2, PLN, PRDM16
PRKAG2, PRKAR1A, PTPN11, RAF1, RANGRF, RBM20, RYR1, RYR2, SALL4, SCN1B
SCN2B, SCN3B, SCN4B, SCN5A, SCO2, SDHA, SEPN1, SGCB, SGCD, SGCG, SHOC2
SLC25A4, SLC2A10, SMAD3, SMAD4, SNTA1, SOS1, SREBF2, TAZ, TBX20, TBX3, TBX5
TCAP, TGFB2, TGFB3, TGFBR1, TGFBR2, TMEM43, TMPO, TNNC1, TNNI3, TNNT2
TPM1, TRON, TRIM63, TRPM4, TTN, TTR, TXNRD2, VCL, ZBTB17, ZHX3, ZIC3
6. PATIENT CONSENT 7. MEDICAL NECESSITY FOR TESTING
Billing ABN and Patient Plan Information: A completed Advance Beneficiary Notice (ABN) of coverage
is required for Medicare patients who do not meet medical criteria for testing. This does not apply to specific
site analyses. Insurance pre-qualification will not be performed for these tests, unless specifically requested.
All tests ordered shall be processed and billed based on payor.
Patient Acknowledgment: I am covered by insurance and authorize Novomed Specialized Clinics to
give my designated insurance carrier(s) plan on this form and other informabon provided by my health care
provider necessary for reimbursement. I authorize Novomed Specialized Clinics to inform my Plan of my
test results only if test results are required for preauthorizabon of or payment for reflex/additional testing.
I authorize Plan benefits to be payable to Novomed Specialized Clinics. I further authorize payment of
benefits directly to the laboratory. I understand acceptance of insurance does not relieve me from any
responsibility concerning payment for laboratory services and that I am financially responsible for all charges
whether or not they are covered by my insurance. I understand that any payment I receive for services
rendered by the laboratory from my insurance provider should be forwarded immediately to the laboratory.
The data may also reveal secondary or incidental findings, such as that you may be at risk for certain
genebc diseases or that you are a carrier of disease associated mutations.
Patient Consent: My signature below consrnutes my acknowledgment that the benefits, risks, and
limnations of this testing have been explained to my satisfaction by a qualified health professional and
I have received a copy of the full informed consent document. I have been given the opportunity to ask
questions before I sign, and I have been told that I can ask questions at any other time. I voluntarily
agree to genetic testing.
Patient Consent for Research: □ By checking this box I DO NOT consent for the remaining part
of my sample to be used for research purposes by Novomed Specialized Clinics.
Personal information will not be shared and will be kept confidenbal by Novomed Specialized Clinics.
If Signature is other than patent's. Printed Name ________________ __,
This test is medically necessary for the diagnosis or detection of a disease, illness, impairment, syndrome
or disorder, and these results will be used in the medical management and treatment for this patient.
Furthermore, recipients' information is true and correct to the best of my knowledge.
The person listed as the Ordering Physician or genebc counselor is authorized by law to order the test(s)
requested herein. I confirm that I have provided genetic tesbng informabon to the patient and they have
consented to genetic testing.
Please check all that apply:
□ I confirm that the above patient's gene testing is medically necessary and the result will be used
to assess pabent for Mure cardiac conditions risk.
□ I agree to allow Novomed Specialized Clinics to transfer the information contained in this
requisibon to an LMN (Letter of Medical Necessity) using the ordering physician's name as his/her
signature for insurance billing purposes.
D I have attached a LMN for insurance billing purposes.
D Patient meets clinical/genetic tesbng criteria for the above ordered tests.
0----------------------------------t"lil
HEALTH CARE PROVIDER'S SIGNATURE
TEST SUBMISSION CHECKLIST
D Copy of Patient Demographics
Collected by:
D Current Meds List
lO
D ICD-10 Diagnosis Codes Print Name D Patient's/Provider's Signatures
D Copy of Insurance Card (Front/Back)
i
.Ill
PATIENT'S OR RESPONSIBLE PARTY'S SIGNATURE DATE
□ Attach Patient's Insurance Pre-Authorizaton Form Sgnature 1l
,_ _________________________________ ___. __________________________________ _,o
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
DATE
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Cardiovascular Genetics ICD-10 Code Reference Sheet
CODE
142.0
142.2
142.8
143
142.8
145.81
146.2
148.0
148.91
149.1
149.5
023.8
R00.2
H27.10
H52.12
134.1
171.01
171.1
171.9
177.810
J93.11
J93.81
L90.6
M35.7
O66.0
067.6
068.1
087.410
087.42
R23.3
E75.5
E78.01
E78.2
E78.4
H18.411
H18.413
125.10
125.700
125.720
125.750
125.790
G71.0
134.0
O23.0
087.89
R06.02
Z13.6
Z86.74
Z95.2
Z14.8
Z82.41
Z82.69
Z83.42
Z84.89
DESCRIPTION CODE DESCRIPTION
CARDIOMYOPATHY
Dilated cardiomyopathy 142.1 Hypertrophic obstructive cardiomyopathy
Hypertrophic non-obstructive cardiomyopathy 142.5 Cardiomyopathy, other restrictive
Other cardiomyopathies 142.9 Cardiomyopathy, unspecified
Syndromic cardiomyopathy 151.7 Ventricular hypertrophy
ARRHYTHMIA
Arrhythmogenic right ventricular dysplasia (ARVD) 144.2 Atrioventricular block, complete
Long QT syndrome 145.89 Other specified conduction disorders
Cardiac arrest due to underlying cardiac condition 147.2 Ventricular tachycardia
Paroxysmal atrial fibrillation 148.2 Chronic atrial fibrillation
Unspecified atrial fibrillation 149.01 Ventricular fibrillation
Atrial premature depolarization (PACs) 149.3 Ventricular premature depolarization (PVCs)
Sick sinus syndrome 149.8 Other specified cardiac arrhythmias
Brugada syndrome R00.1 Bradycardia, unspecified
Palpitations R94.31 Abnormal electrocardiogram (ECG)(EKG)
AORTIC ANEURYSMS/MARFAN SYNDROME
Unspecified dislocation of the lens H52.11 Myopia, right eye
Myopia, left eye H52.13 Myopia, bilateral eyes
Mitral valve prolapse 171.00 Dissection of unspecified site of aorta
Dissection of thoracic aorta 171.01 Dissection of abdominal aorta
Thoracic aortic aneurysm, ruptured 171.2 Thoracic aortic aneurysm, without rupture
Aortic aneurysm of unspecified site, ruptured 171.9 Aortic aneurysm of unspecified site, without rupture
Thoracic aortic ectasia J93.0 Spontaneous tension pneumothorax
Primary spontaneous pneumothorax J93.12 Secondary spontaneous pneumothorax
Chronic pneumothorax J93.83 Other pneumothorax
Stria Atrophicae (stretch marks) L98.8 Other specified disorders of skin and subcutaneous tissue
Hypermobility Syndrome 012.1 Congenital displaced lens
Congenital Talipes Equinovarus ("club foot") 067.5 Congenital deformity of the spine (scoliosis)
Pectus excavatum 067.7 Pectus Carinatum
Arachnodactvlv ("Conaenital deformitv of finaer(s) and hand") 087.40 Marfan svndrome
Marfan syndrome with aortic dilation 087.418 Marfan syndrome with other cardiovascular manifestations
Marfan syndrome with ocular manifestations
087.43 Marfan syndrome with skeletal manifestations
Spontaneous Ecchymoses (easy bruising)
CHOLESTEROL/CORONARY ARTERY DISEASE
Other lipid storaae disorders E78.0 Pure h'{Percholesterolemia
Familial hypercholesterolemia E78.1 Pure hyperglyceridemia
Mixed hyperlipidemia E78.3 Hyperchylomicronemia
Other hyperlipidemia E78.5 Hyperlipidemia, unspecified
Arcus senilis, right eve H18.412 Arcus senilis, left eve
Arcus senilis, bilateral eves 120.0 Unstable angina
Atherosclerotic heart disease of native 125.110 Atherosclerotic heart disease of native coronary
coronarv artery without anaina oectoris
artery with unstable anaina oectoris
Atherosclerosis of coronary artery bypass graft(s), 125.710 Atherosclerosis of autologous vein coronary
unsoecified with unstable anaina oectoris
arterv bvoass araft/s) with unstable anaina oectoris
Atherosclerosis of autologous artery coronary artery 125.730 Atherosclerosis of nonautogous biological coronary
bvoass graft(s) with unstable angina oectoris
arterv bvoass graft(s) with unstable anaina oectoris
Atherosclerosis of native coronary artery of transplanted 125.760 Atherosclerosis of bypass graft of coronary artery
heart with unstable angina pectoris
of transplanted heart with unstable angina pectoris
Atherosclerosis of other coronary artery bypass T46.6X5A Adverse effect of antihyperlipidemic and
graft(s) with unstable angina pectoris
antiarteriosclerotic drugs (statin intolerance)
OTHER
Hereditary progressive muscular dystrophy 110 Essential (primary) hypertension
Mitral valve prolapse 146.9 Cardiac arrest, cause unspecified
Aortic stenosis, congenital 020.9 Congenital heart disease (NOS)
Noonan svndrome R55 Svncooe and collapse
Shortness of breath Z01.810 Encounter for oreorocedural cardiovascular examination
Encounter for screening for cardiovascular conditions Z79.01 Long term (current) use of anticoagulants
Personal history of sudden cardiac arrest
Presence of prosthetic heart valve
Z95.0 Presence of cardiac pacemaker
FAMILY HISTORY
Genetic carrier of other disease Z15.89 Genetic susceptibility to other disease
Family history of sudden cardiac death Z82.49 Family history of ischemic heart disease and
other diseases of the circulatorv svstem
Family history of other diseases of the Z82.69 Family history of other congenital malformations,
musculoskeletal system and connective tissue
deformations and chromosomal abnormalities
Family history of familial hypercholesterolemia
Family history of other specified conditions
Z84.81 Family history of carrier of genetic disease
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
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Letter of Medical Necessity
CARDIAC CONDITIONS HEREDITARY ASSESSMENT
Date: ______________ _
Patient Name: ________________________
DOB: ______________ Gender: □ M □ F
Insurance Company: ______________________
Subscriber Name: _______________________
Policy#: ___________________________
Dear Claims Specialist:
I am writing this letter on behalf of my patient:, ______________________
to request coverage for the Hereditary Assessment for Cardiac Conditions, a genetic test offered through
Novomed Specialized Clinics. This genetic testing is performed in a CUA certified laboratory located in Frisco, Texas.
The patient is suspected to have genetic predisposition to cardiac problems.
Patient has a family history for _______________________ _
Personal and/or family history is suggestive of a higher risk for cardiac disease. I would like to assess this patient's future
Cardiac risk by performing genetic testing for Hereditary Assessment for Cardiac Conditions. The results of this genetic
test will have a direct impact on this patient's treatment and management.
Test Information and Impact of Results on Medical Management:
Cardiac Arrest, not to be confused with a heart attack, occurs when the heart stops beating as a whole. It is the leading
cause of nontraumatic death in the United States with genetic factors constituting 25% of cardiac arrest cases. Mutations
in genes can affect the way the heart cells communicate, the strength of the heart muscle, and rhythm of the heart,
resulting in fast, chaotic heartbeats. Identifying these genetic factors plays an important role in the prognosis, of the
disease, therapy, and therefore outcome.
Informed Consent: This Hereditary Assessment for Cardiac Conditions offered by Novomed Specialized Clinics focuses
on identifying inherited cardiac conditions. It targets 174 genes with known associations to 17 inherited cardiac conditions
including cardiomyopathy, arrhythmia, hypercholesterolemia, hypertriglyceridemia, aortopathy and more. This assay is
performed using genomic DNA isolated from blood collected via capillary puncture or a swab. The test is intended for
predictive genetic testing to determine the chances that a healthy individual with or without a family history of a cardiac
condition might develop that disease. It is also performed as a pre-symptomatic genetic testing in order to
determine whether an individual with a family history of a cardiac disease, but no current symptoms, has the gene
alterations associated with the disease. Additional, it is !intended for post-symptomatic genetic testing to identify the
potential underlying cause of an existing cardiac disease. This test is a next-generation sequencing (NGS) to provide
comprehensive coverage of the genes associated with hereditary heart disease.
The patient has provided a signed informed consent for genetic testing, based on my discussion of the personal and/or
family history, the potential test results, and the implications for medical management. The patient is aware of the benefits,
risks and limitations of the testing and has voluntarily agreed to the genetic test.
Conclusion:
Knowledge of this patient's cardiac genetic information is important for me to accurately assess the patient's cardiac risks
and will guide my recommendations for the care. The value of genetic testing for these syndromes has been extensively
documented in the medical literature. In 2006, the American Heart Association, the American College of Cardiology, and
the European Cardiac Society issued joint Medical/Scientific Guidelines on the management of patients with ventricular
arrhythmias and prevention of sudden cardiac death.
Thank you for your review and consideration. I hope you will support this request for genetic testing coverage for my
patient.
If you have questions, or if I can be of further assistance, please do not hesitate to call me at: ___________ _
Sincerely,
al
E
Physician's Name: _________________________________________ _
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
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Informed Consent for Genetic Testing
Genetic Testing can be complex. If warranted, obtain professional genetic counseling prior to giving consent to fully
understand what the risks and benefits are.
I request and authorize Novomed Specialized Clinics to test my (or my child's) sample for the below designated genetic
condition(s). My signature below constitutes my acknowledgment that the benefits, risks, and limitations of this testing
have been explained to my satisfaction by a qualified health professional and I have been provided a copy of the
corresponding technical bulletin describing testing for the condition(s) listed below.
DNA analysis for the condition(s):
The intended purpose is: Diagnosis / Predictive / Other:
It has been explained to me and I understand that:
• DNA test results may:
1. Diagnose whether or not I have (or my child has) this condition or am at risk for developing this condition.
2. Indicate whether or not I (or my child) am a carrier for this condition.
3. Predict another family member has, is at risk for developing, or is a carrier of this condition.
4. Be indeterminate due to technical limitations or familial genetic patterns.
5. Reveal non-paternity.
• DNA testing is specific only for the condition(s) named above and will not detect all causative mutations.
• The significance of a positive and a negative test result based on my family history has been explained.
• Although DNA testing usually yields precise information, several sources of error are possible.
These include, but are not limited to, clinical misdiagnosis of the condition, sample misidentification,
and inacurate information regarding family relationships.
• If a gene mutation is identified, insurance rates, obtaining disability or life insurance, and employability
could be affected. Federal law extends some protections regarding genetic discrimination
(http://www.genomegov/10002328). It is my responsibility to consider the possible impact of these results.
All test results are released to the ordering health care provider and those parties entitled to them by state
and local laws.
• The performance characteristics of this test were validated by Ayass Lung Clinic, PLLC. The U.S. Food and
Drug Administration (FDA) has not approved this test; however, FDA approval is currently not required for clinical
use of this test. Ayass Lung Clinic, PLLC is authorized under Clinical Laboratory Improvement Amendments
of 1988 (CLIA) and by all states to perform high-complexity testing. The results are not intended to be used
as the sole means for clinical diagnosis or patient management decisions.
• I will be responsible for payment after the genetic testing has begun, even if I decide not to receive results.
• Genetic counseling is recommended prior to, as well as following, genetic testing.
• My (or my child's) DNA sample may be stored indefinitely to be used for test validation or educational
purposes after personal identifiers are removed. No clinical tests other than the ones authorized will be
performed. I may request disposal of my blood and DNA sample following completion of the test requested
above by contacting the Ayass Lung Clinic, PLLC at 972-668-6005 or initializing in the section described below.
My signature below acknowledges my voluntary participation in the test. I understand that the genetic analysis
performed by Novomed Specialized Clinics is specific only for this disease and in no way guarantees my health,
the health of an unborn child, or the health of other family members.
Patient's Signature:
Patient's Name
OM OF
Birth Date:
Date:
I indicate my desire to opt out of participation in anonimized research studies using my DNA sample by initialing here _ __ _
Physician's or Counselor's Statement: I have explained DNA testing and its limitations to the patient
or legal guardian and answered all questions.
Physician's/Counselor's Signature:
Physician's/Counselor's Name:
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
Date:
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Saliva Cell Sample Collection Instruction
ORAcollect.Dx is intended for use in the
non-invasive collection of saliva samples.
Human DNA from the saliva sample is isolated,
stabilized and is suitable for use in molecular
diagnostic applications.
1. Refrain from eating, smoking, or chewing for at least 30
minutes before sample collection.
2. Donors with xerostomia (dry mouth) may not collect
adequate sample using these instructions resulting in low
yield DNA. In that case DNA extracted from whole blood is
recommended.
3. Open package from the end with the 'open here arrow'.
Saliva Cell Collection
USING ORAL SWAB ORAcollect.Dx COLLECTION KIT
4. Remove collector by its handle from the package while
ensuring that the sponge tip does not come in contact with
any surface prior to collection.
5. Place sponge as far back in the mouth as comfortable
(Figure 2).
3
®
6. Gently rub along lower gum in a back and forth motion 10
times. Avoid rubbing the teeth.
7. Choking Hazard: Caution must be taken when inserting the
sponge into the donor's mouth.
8. Repeat rubbing motion on opposite side along the lower
gum for another 10 times.
9. Hold the tube with the blue liquid upright to prevent it from
spilling.
10. Unscrew the blue cap from the tube without touching the
sponge (Fugure 3).
11. Turn the cap upside down and insert the sponge into
the tube and close the cap tightly (Figure 4).
12. Invert capped tube and shake vigorously 10 times (Figure 5).
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
nov0n,ed
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HEREDITARY CANCER Testing
Requisition
City State Zip
Physician
Name
Address
Phone DOB Gender City State Zip Phone
Ancestry
D Caucasian
D Western European
D African American
D Caribbean
D Ashkenazi Jewish
D Eastern European
D Native American
D Asian
D Central/South American
D Hispanic
D Northern European
0 Middle Eastern
D Pacific Islander
D Other:
D Male D Female
Fax
Paben! has had a blood transfusion B s
1- ------------------------------------1 2-4 weeks of wan bme is required for some testing.
PLEASE PROVIDE LIST OF CURRENT MEDICATIONS
Name of
Policyholder
4. BILLING INFORMATION
If "Yes" - Date of the last transfusion:
Specimens are not accepted for patients who have had allogeneic bone marrow transplants.
BILL: D Insurance D HSA D Medicaid D Medicare D Se Pay D Worl<er's Compensation
DOB: Medicare# Medicaid#
Relabonship to Policyholder
□ Se □ Spouse □ Dependant □ Other _____________________ _
Insurance
Company
Worker's Comp
Date
Claim# of Injury j'
Policy #
Group#
0 NO PERSONAL HISTORY O Ovarian Cancer, Age at Ox _ _ _
0 NO KNOWN CANCER AT THE PRESENT TIME O I AM CURRENTLY DIAGNOSED WITH CANCER
D Bladder, Age at Ox
D Melanoma, Age at Ox ___ _
□ Breast Cancer, Age at Ox
D Pancreabc Cancer, Age at Ox _ _ _
Please describe what type(s) of cancer
Date of Ox
□ Bilateral D Premenopausal □ Prostate Cancer, Age at Ox _ _ _
D Triple Negative (ER-, PR-, HER2-)
Gleason Score ___ _
□ Colorectal cancer, Age at ox
Testicular Cancer, Age at Ox _ _ _
D Gastric Cancer, Age at Ox □ Uterine/Endometrial Cancer, Age at Ox _ _
□ Kidney (Renal), Age at Ox D Colon Polyps (How Many_), Age at Ox _ _
D Other Cancer Type(s) ________________ Age at Ox. ___ _
6. FAMILY HISTORY OF CANCER 8. HEREDITARY CANCER TEST SELECTION
0 NO KNOWN FAMILY HISTORY OF CANCER
D Known familial mutation: Gene
Relationship
Gene
D Adopted (history unknown)
Mutation
Mutation
Maternal Paternal Cancer Site Age at Ox
ICD-10 DIAGNOSIS CODES: _ _ _
□ HEREDITARY CANCER COMPREHENSIVE PANEL - 108 GENES
ABCB1 ;ACTRT3;AIMP2;AKT1 ;ALK;APC;AR;ARHGAP44;ATF1 ;ATM;AXIN2;BAG6;BMPR1A;
BRAF;BRCA1;BRCA2,BRIP1;BUB1B;CASC17;CASC8;CCHCR1;CDH1;CDK10;CDKN1A;
CDKN2A;CHEK2;CHRNA3;CLPTM1L;COLCA1;CTD-2194D22.4;DBNDD1;DICER1;EGFR;
EHBP1;ELAC2;EPCAM;ETS2;FGF10;FGFR4;FH;FLACC1;FLCN;HNF1B;HPDL;HYKK;IRF1;
ITGA6;KLK3;KRAS;LAMA5;LMTK2;MAP2K7;MAP4K2;MAX;MEN1;MIR5580;MITF;MLH1;
MLH3;MLPH;MSH2;MSH6;MSMB;MSR1;MTAP;MT-ND3;MUTYH;MXl1;NF1;NUDT11;PADl6;
PALB2;PCAT2;PDLIM5;PIGU;PMS2;POU5F1B;PTEN;RAD51;RAD54B;RAD54L;RB1;RET;
RFX6;RHPN2;RNA5SP299;RNASEL;RNU1-19P;RRAS2;RUNX1;SDHB;SDHC;SDHD;
SLC22A3;SMAD4;SMAD7;STK11 ;TERT;THADA;TMEM127;TP53;TP63;TSC1 ;TUBB3;VHL;
WEE1 ;XRCC1 ;XXYLT1
9. PATIENT CONSENT 10. MEDICAL NECESSITY FOR TESTING
Billing ABN and Patient Plan Information: A completed Advance Beneficiary Notice (ABN) of coverage
is required for Medicare patients who do not meet medical criteria for testing. This does not apply to specific
site analyses. Insurance pre-qualification will not be performed for these tests, unless specifically requested.
All tests ordered shall be processed and billed based on payor.
Patient Acknowledgment: I am covered by insurance and authorize Novomed Specialized Clinics to
give my designated insurance carrier(s) plan on this form and other informabon provided by my health care
provider necessary for reimbursement. I authorize Novomed Specialized Clinics to inform my Plan of my
test results only if test results are required for preauthorizabon of or payment for reflex/additional testing.
I authorize Plan benefits to be payable to Novomed Specialized Clinics. I further authorize payment of
benefits directly to the laboratory. I understand acceptance of insurance does not relieve me from any
responsibility concerning payment for laboratory services and that I am financially responsible for all
charges whether or not they are covered by my insurance. I understand that any payment I receive for
services rendered by the laboratory from my insurance provider should be forwarded immediately to the
laboratory.
The data may also reveal secondary or incidental findings, such as that you may be at risk for certain
genebc diseases or that you are a carrier of disease associated mutations.
Patient Consent: My signature below consrnutes my acknowledgment that the benefits, risks, and
limnations of this testing have been explained to my satisfaction by a qualified health professional and
I have received a copy of the full informed consent document. I have been given the opportunity to ask
questions before I sign, and I have been told that I can ask questions at any other time. I voluntarily
agree to genetic testing.
Patient Consent for Research: □ By checking this box I DO NOT consent for the remaining part
of my sample to be used for research purposes by Novomed Specialized Clinics.
Personal information will not be shared and will be kept confidenbal by Novomed Specialized Clinics.
If Signature is other than patent's. Printed Name ________________ _
This test is medically necessary for the diagnosis or detection of a disease, illness, impairment, syndrome
or disorder, and these results will be used in the medical management and treatment for this patient.
Furthermore, recipients' information is true and correct to the best of my knowledge.
The person listed as the Ordering Physician or genebc counselor is authorized by law to order the test(s)
requested herein. I confirm that I have provided genetic tesbng informabon to the patient and they have
consented to genetic testing.
Please check all that apply:
□ I confirm that the above patient's gene testing is medically necessary and the result will be used
to assess pabent for Mure cancer risk.
□ I agree to allow Novomed Specialized Clinics to transfer the information contained in this requisition
to an LMN (Letter of Medical Necessity) using the ordering physician's name as his/her signature
for insurance billing purposes.
D I have attached a LMN for insurance billing purposes.
D Patient meets clinical/genetic tesbng criteria for the above ordered tests.
HEALTH CARE PROVIDER'S SIGNATURE
TEST SUBMISSION CHECKLIST
D Copy of Patient Demographics Collected by: i:
D Current Meds List
D ICD-10 Diagnosis Codes
Print Name
D Patient's/Provider's Signatures
i1_
D Copy of Insurance Card (Front/Back)
a:
PATIENT'S OR RESPONSIBLE PARTY'S SIGNATURE DATE O Attach Patient's HG Insurance Pre-Authorizaton Form Sgnature c'j
,__________________________________ _.__________________________________ _,I
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
DATE
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Letter of Medical Necessity
PHARMACOGENETIC TESTING
Date: ________ _ Patient Name: _______________________ _
DOB: _______ _ Gender: □ M □ F
Insurance Company:, _____________________ _
Subscriber Name: ______________________ _
Policy#: __________________________ _
Dear Claims Specialist:
I am writing this letter on behalf of my patient, ------------------ to request coverage for the
Pharmacogenetic testing offered through Novomed Specialized Clinics. The Pharmacogenetic testing is performed in a high
complexity CUA certified laboratory located in Frisco, Texas.
My patient has not reached their therapeutic goal on the current regimen and may be experiencing adverse drug reaction(s)
to one or more medications. I am seeking to choose safer or more efficacious dosages. I request coverage for DNA
microarray and PCR analysis of targeted genes to identify genetic variants. This knowledge will help avoid
harmful and costly adverse drug events, optimize medication dose, and increase chances of patient's treatment success.
Test Information and Impact of Results on Medical Management:
The pharmacogenetics panel offered by Novomed Specialized Clinics targets genes that when mutated are known to
impact patient's response to medication.
The result of this pharmacogenetic testing will have a direct impact on this patient's medication management.
Genetics account for much of the variability seen in our patients' responses to drug therapies and the implications of
pharmacogenetics have been well documented. Currently there are at least 230 U.S. Food and Drug Administration (FDA)
approved drugs with Pharmacogenomic information in their labeling. The labeling for some of the products includes specific
actions to be taken based on the biomarker information. In order to choose the more suitable medication and avoid potential
but serious adverse drug events, it is extremely important to perform this panel of Pharmacogenetic tests.
Patient's personal and/or family history as well as current medication regimen are suggestive of high risk for adverse drug
events based on my evaluation and review of latest available literature. In this patient's case, pharmacogenetics testing is
crucial in order to establish and confirm a genetic diagnosis, guide appropriate and immediate medical management,
predict disease prognosis, and eliminate potential adverse drug events.
Informed Consent:
The patient has provided a signed informed consent for pharmacogenetic testing, based on my discussion of the personal
and/or family history, the potential test results, and the implications for medical management. The patient is aware of the
benefits, risks, and limitations of the testing and has voluntarily agreed to the pharmacogenetic test.
Conclusion:
Knowledge of this patient's genetic information is important for me to accurately assess patient's medication regimen and
will guide my recommendations for treatment plan. I have chosen to send the patient's test to Ayass Lung Clinic, PLLC with
highly sensitive, rapid, and cost-effective pharmacogenetic which will provide helpful medical treatment planning information
for my patient.
Thank you for your review and consideration. I hope you will support this request for genetic testing coverage for my patient.
If you have questions, or if I can be of further assistance, please do not hesitate to call me at:
Sincerely,
Physician's Name: _________________________________________ _
Signature:----------------------------------------------
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
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Informed Consent for Genetic Testing
Genetic Testing can be complex. If warranted, obtain professional genetic counseling prior to giving consent to fully
understand what the risks and benefits are.
I request and authorize Novomed Specialized Clinics to test my (or my child's) sample for the below designated genetic
condition(s). My signature below constitutes my acknowledgment that the benefits, risks, and limitations of this testing
have been explained to my satisfaction by a qualified health professional and I have been provided a copy of the
corresponding technical bulletin describing testing for the condition(s) listed below.
DNA analysis for the condition(s):
The intended purpose is: Diagnosis / Predictive / Other:
It has been explained to me and I understand that:
• DNA test results may:
1. Diagnose whether or not I have (or my child has) this condition or am at risk for developing this condition.
2. Indicate whether or not I (or my child) am a carrier for this condition.
3. Predict another family member has, is at risk for developing, or is a carrier of this condition.
4. Be indeterminate due to technical limitations or familial genetic patterns.
5. Reveal non-paternity.
• DNA testing is specific only for the condition(s) named above and will not detect all causative mutations.
• The significance of a positive and a negative test result based on my family history has been explained.
• Although DNA testing usually yields precise information, several sources of error are possible.
These include, but are not limited to, clinical misdiagnosis of the condition, sample misidentification,
and inacurate information regarding family relationships.
• If a gene mutation is identified, insurance rates, obtaining disability or life insurance, and employability
could be affected. Federal law extends some protections regarding genetic discrimination
(http://www.genomegov/10002328). It is my responsibility to consider the possible impact of these results.
All test results are released to the ordering health care provider and those parties entitled to them by state
and local laws.
• The performance characteristics of this test were validated by Ayass Lung Clinic, PLLC. The U.S. Food and
Drug Administration (FDA) has not approved this test; however, FDA approval is currently not required for clinical
use of this test. Ayass Lung Clinic, PLLC is authorized under Clinical Laboratory Improvement Amendments
of 1988 (CLIA) and by all states to perform high-complexity testing. The results are not intended to be used
as the sole means for clinical diagnosis or patient management decisions.
• I will be responsible for payment after the genetic testing has begun, even if I decide not to receive results.
• Genetic counseling is recommended prior to, as well as following, genetic testing.
• My (or my child's) DNA sample may be stored indefinitely to be used for test validation or educational
purposes after personal identifiers are removed. No clinical tests other than the ones authorized will be
performed. I may request disposal of my blood and DNA sample following completion of the test requested
above by contacting the Ayass Lung Clinic, PLLC at 972-668-6005 or initializing in the section described below.
My signature below acknowledges my voluntary participation in the test. I understand that the genetic analysis
performed by Novomed Specialized Clinics is specific only for this disease and in no way guarantees my health,
the health of an unborn child, or the health of other family members.
Patient's Signature:
Patient's Name
OM OF
Birth Date:
Date:
I indicate my desire to opt out of participation in anonimized research studies using my DNA sample by initialing here _ __ _
Physician's or Counselor's Statement: I have explained DNA testing and its limitations to the patient
or legal guardian and answered all questions.
Physician's/Counselor's Signature:
Physician's/Counselor's Name:
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
Date:
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Saliva Cell Sample Collection Instruction
ORAcollect.Dx is intended for use in the
non-invasive collection of saliva samples.
Human DNA from the saliva sample is isolated,
stabilized and is suitable for use in molecular
diagnostic applications.
1. Refrain from eating, smoking, or chewing for at least 30
minutes before sample collection.
2. Donors with xerostomia (dry mouth) may not collect
adequate sample using these instructions resulting in low
yield DNA. In that case DNA extracted from whole blood is
recommended.
3. Open package from the end with the 'open here arrow'.
Saliva Cell Collection
USING ORAL SWAB ORAcollect.Dx COLLECTION KIT
4. Remove collector by its handle from the package while
ensuring that the sponge tip does not come in contact with
any surface prior to collection.
5. Place sponge as far back in the mouth as comfortable
(Figure 2).
3
®
6. Gently rub along lower gum in a back and forth motion 10
times. Avoid rubbing the teeth.
7. Choking Hazard: Caution must be taken when inserting the
sponge into the donor's mouth.
8. Repeat rubbing motion on opposite side along the lower
gum for another 10 times.
9. Hold the tube with the blue liquid upright to prevent it from
spilling.
10. Unscrew the blue cap from the tube without touching the
sponge (Fugure 3).
11. Turn the cap upside down and insert the sponge into
the tube and close the cap tightly (Figure 4).
12. Invert capped tube and shake vigorously 10 times (Figure 5).
Novomed Specialized Clinics • Suite 3002 - 3005 30th Floor, Marina Plaza, Dubai Marina, Dubai, UAE • Phone : 971 4 247 3100
Tests are performed in USA, results in one week.
If there are any questions about the results, do not hesitate to contact
us.
If follow-up tests and further additional tests are necessary at the Novomed Centers, the
reservation and further instruction will be informed.
Release of Medical records
For requesting medical records and image data (USB copy), please inform us before visiting to shorten the
waiting. Since referral letter and medical certificate need to be filled out by the attending physician,
please make a request by phone in advance.
Result
Consultation
Location :Suite 3004, 30th Floor | Marina Plaza | Dubai, UAE
Operation hours :Saturday-Wednesday: 9am-9pm | Thursday: 9am-6pm
Contact number:800 6686633
Body Composition Analysis 720
Height
Date/Time
50781450 48
170.6cm Male 21/06/2019
08:21:43(98480)
partments Values Total Body Water Soft Lean Mass Fat Free Mass Weight Normal Range
W 25.4
22.3~27.3
40.7
W 15.3
52.3
13.7~16.7
55.5
11.0
84.8 9.6~11.8
2
VFA (cm )
250
200
150
3.87
non osseous
osseous: 3.17
3.33~4.07
100
29.3
7.7~15.4
50
Mineral is estimated
0
20
40 60 80 Years
Under Normal Over
Unit %
Normal Range
55 70 85 100 115 130 145 160 175 190 205
70 80 90 100 110 120 130 140 150 160 170
54.4~73.6
27.3~33.4
Protien
Mineral
Fat
Normal
Normal
Normal
Deficlent
Deficlent
Deficlent
Excessive
40 60 80 100 160 220 280 340 400 460 520
7.7~15.4
Weignt Management
Weight Normal
Under
Over
Diagnosis
Under
Normal
Over
Normal Range
SMM
Fat
Normal
Normal
Strong
Under
Under
Over
10 15 18.5 22 25 30 35 40 45 50 55
0 5 10 15 20 25 30 35 40 45 50
0.70 0.75 0.80 0.85 0.90 0.95 1.00 1.05 1.10 1.15 1.20
0.326
Date/Time Weight SMM Fat Score ECW/TBW
21/06/2019 84.8 31.1 29.3 62 0.376
08:21
18.5~25.0
Lean Lean/Ideal Lean x100 (%) Fat Mass
Under
Normal
Over Unit % Segmental Edema
Edema
ECF/TBF ECW/TBW ECF/TBF ECW/TBW
55 70 85 100 115 130 145 160
55 70 85 100 115 130 145 160
70 80 90 100 110 120 130 140
70 80 90 100 110 120 130 140
70 80 90 100 110 120 130 140
0.327
0.330
0.330
0.332
0.372
0.374
0.376
0.377
0.379
Segmental fat is estimated
10.0~20.0
0.80~0.90
0.41
0.38
0.35
0.33
0.31
0.28
0.25
0.330
0.46
0.43
0.40
0.38
0.36
0.33
0.30
0.376
Normal
Normal
WHR
Normal
Upper Balanced
Balanced
Balanced
Upper Normal
Normal
Muscle Normal
Health Diagnosis
Normal
Edema Normal
Normal
Weight Control
Target Weight
Weight Control
Fat Control
Muscle Control
Fitness Score
Under
Extremely Over
Over
Over
Slightly
Unbalanced
Slightly
Unbalanced
Slightly
Unbalanced
Developed
Developed
Developed
Under
Slight Edema
Over
Extremely
Over
Extremely
Over
Extremely
Unbalanced
Extremely
Unbalanced
Extremely
Unbalanced
Weak
Weak
Weak
Edema
Alert Risky
Highlu Risky
65.3 kg
_ 19.5 kg
_ 19.5 kg
0.0 kg
62
Points
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Feel Free to download the U.S best seller E-booklet by Dr.
Max at https://www.novomed.com/food-habits/
Commitment Form – Result Consultation
This commitment form is to allow Healthcare System Novomed Centers to provide medical
information to the certain person mentioned below. Novomed Centers will never provide your medical
check up results and consultation information to a third party except the person below. If the
results are disclosed or destroyed due to any other reasons below, Novomed Centers shall not be
a. The result incurred due to your negligence in management.
b. Unavoidable circumstance such as natural disasters.
I or (testee), the undersigned, hereby make, constitute, and appoint
Name:
Address:
Tel:
Relationship:
As my true and lawful attorney, with full power and authority to have the test results (Date of
examination (MM/DD/YY): / /20 ; Form as printed version and USB copy)
and medical consultation with one of the center’s physician.
Date: / / 20 (MM/DD/YY)
Testee (or Guardian)
Signature
If you are not the testee yourself, please fill out the following questions.
Relationship with testee:
Address:
Residence ID number:
Phone number:
This request is valid with the testee’s signature or seal, but if the testee is a minor or with
Any and all legal hearings will only be tried under the jurisdiction of UAE law.
Suite 3002 – 300 th Floor, Marina Plaza,Dubai Marina, Dubai, UAE
800 NOVOMED (668 6633) @novomedcenters www.novomed.com