VIable

NDHI
NAT IONAL DIALOGUE FOR
Healthcare Innovation
4Kscore Test
Organization Overview
• BioReference is the third-largest full service clinical
diagnostic laboratory in the US, processing over 9
million laboratory test requisitions in 2014 alone
• BioReference offers a comprehensive list of innovative
and cost-conscious testing options for providers,
focused on the ultimate goal of improving patient
outcomes
Background
Prostate cancer accounted for approximately 27% of
newly-diagnosed cancers in men in 2014, making it the
most commonly diagnosed male cancer in the United
States. Since the widespread use of prostate-specific
antigen (PSA) for prostate screening began in the early
1990s, the US has seen a 45% reduction in prostate
cancer deaths. However, PSA testing is unable to differentiate
aggressive prostate cancers from indolent
prostate cancer, or even benign prostatic disease.
With approximately 75% of prostate biopsies resulting
in no or indolent cancer, the United States Preventative
Services Task Force (USPSTF) began to recommend
against routine PSA screening for prostate cancer in
2012, to reduce unnecessary prostate biopsies and
overtreatment of indolent prostate cancer. However,
this puts many men at high risk, as 20% to 30% of
men who are currently diagnosed with prostate cancer
have high-grade cancer at the time of its discovery.
Screening for prostate cancer is important; it is the
subsequent overutilization of biopsy procedures that
must be better controlled to enhance patient safety
and reduce system-wide costs.
Product Details
The 4Kscore is a blood test made up of a combination
of four prostate-specific biomarkers and clinical findings.
This test provides men with accurate risk measurements
for aggressive prostate cancer, and a long term
risk assessment for cancer metastasis over a 20 year
period. This innovative technology was developed in
an academic-industry collaboration between leading
researchers at Memorial Sloan Kettering Cancer Center
and OPKO Health. The test was commercialized by
OPKO Health in 2014 and is now offered through its
subsidiary, BioReference Laboratories. The 4Kscore
test has been extensively evaluated in at least 12
studies with over 20,000 subjects. To date, the test
has been ordered approximately 40,000 times by over
5,000 physicians across the country.
The 4Kscore test addresses the critical public policy
issue of providing men with an accessible, easy to
understand, risk score for aggressive prostate cancer
after an abnormal screening test with PSA and/or digital
rectal examination. The test arms patients and their
care providers with a more comprehensive understanding
of the patient’s risk when deciding if they need to
undergo an invasive prostate biopsy, thereby reducing
unnecessary procedures and health care costs.
An Initiative of the
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4Kscore Test