National Cancer Institute - NCI Division of Cancer Treatment and ...

Courtesy of NCI Visuals Online, Bill Branson, photographer.
with academic collaborators showed that
under properly controlled conditions, it
is possible to perform complete tumor
microarray analysis at several independent
laboratories for a single study. The investigators
assessed the comparability of data
from four laboratories that are conducting
a large microarray profiling confirmation
project in lung cancer. To test the feasibility
of combining data across laboratories,
the authors analyzed frozen tumor tissues,
cell lines, and purified RNA at each of
the four laboratories. The laboratories
used the same protocol for all of the
tissue-processing steps, RNA extraction,
and microarray analysis. The investigators
observed high within-laboratory and
between-laboratory correlations on the
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A CDP statistician working with academic collaborators showed
that under properly controlled conditions, it is possible
to perform complete tumor microarray analysis
at several independent laboratories for a single study.
purified RNA samples, cell lines, and frozen
tumor tissues. Correlations within laboratories
were only slightly stronger than
between laboratories.
Dobbin KK, Beer DG, Meyerson M, Yeatman TJ,
Gerald WL, Jacobson JW, Conley B, Buetow KH,
Heiskanen M, Simon RM, Minna JD, Girard L,
Misek DE, Taylor JM, Hanash S, Naoki K, Hayes
DN, Ladd-Acosta C, Enkemann SA, Viale A,
Giordano TJ. Interlaboratory comparability
study of cancer gene expression analysis using
oligonucleotide microarrays. Clin Cancer Res
2005:11;565–72.
Models for Diagnostic and
Predictive Biomarker Development
and Validation
CDP staff have worked with academic
investigators through PACCT to develop
strategies for effective development and
validation of diagnostic and predictive
biomarkers. CDP staff communicate these
strategies to the cancer research community
through a series of public presentations
and publications in order to facilitate
more effective development of clinical
tests. In combination with the REMARK
guidelines, these publications have the
potential to improve the quality of studies
carried out to demonstrate a biomarker’s
potential clinical utility.
Jessup JM, Lively TG, Taube SE. Program for the
Assessment of Clinical Cancer Tests (PACCT):
implementing promising assays into clinical
practice. Expert Rev Mol Diagn 2005:5;271–3.
Taube SE, Abrams, JS. Program for the Assessment
of Clinical Cancer Tests (PACCT): assisting
the development of tailored cancer therapy.
Personalized Med 2005:2;363–9.
Taube SE, Jacobson, JW, Lively TG. Cancer diagnostics:
decision criteria for marker utilization
in the clinic. Am J Pharmacogenomics 2005:5;
357–64.