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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The opinions expressed in this article are those of the authors and are not to be construed as official or as representing the opinion of the US Food and Drug Administration.
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Current information on the FDA's review of genomic tests as part of drug discovery and development
Information on best practices for the VGDS process
Information on the preliminary thinking of the FDA about the co-development of diagnostics and drugs
Special controls for the first FDA-cleared microarray
Special controls for the first FDA-cleared microarray reader
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Gutman, S., Kessler, L. The US Food and Drug Administration perspective on cancer biomarker development. Nat Rev Cancer 6, 565–571 (2006). https://doi.org/10.1038/nrc1911
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DOI: https://doi.org/10.1038/nrc1911
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