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When is a genomic classifier ready for prime time?

Nature Clinical Practice Oncology volume 1, pages 4–5 (2004)Cite this article

DNA microarray technology is widely used to examine gene expression for the elucidation of biological mechanisms. Gene-expression profiles are now being used as classifiers of patients' prognosis and response to therapy.1

The development of traditional prognostic and diagnostic biomarkers has been largely disappointing. The extensive literature on this topic is often contradictory and relatively few oncologic biomarkers have been adopted in clinical practice.2,3 One reason is that biomarker studies are generally performed retrospectively using heterogeneous specimens with no prespecified hypotheses. Generally, this approach does not provide an appropriate context for reliable development of a therapeutically relevant classifier. Many studies of primary breast cancer, for example, include node-negative and node-positive patients, some of whom are receiving chemotherapy. Such studies often contain numerous data-driven subset analyses, and are not conducted according to accepted standards for reliable prospective clinical trials of therapeutics.4

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  1. Chief of the Biometric Research Branch at the National Cancer Institute, Bethesda, MD, USA

    Richard Simon

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  1. Richard Simon
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Correspondence to Richard Simon.

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The author declares no competing financial interests.

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Simon, R. When is a genomic classifier ready for prime time?. Nat Rev Clin Oncol 1, 4–5 (2004). https://doi.org/10.1038/ncponc0006

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