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Review
. 2006 Jul;6(7):565-71.
doi: 10.1038/nrc1911.

The US Food and Drug Administration perspective on cancer biomarker development

Steven Gutman  1 , Larry G Kessler
Affiliations
Review

The US Food and Drug Administration perspective on cancer biomarker development

Steven Gutman et al. Nat Rev Cancer. 2006 Jul.

Abstract

Despite the intense interest in biomarker development for cancer management, few biomarker assays for diagnostic uses have been submitted to the US Food and Drug Administration (FDA). What challenges must researchers overcome to bring cancer-detection technologies to the market and, therefore, into clinical use?

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