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  • A biomarker that is measured in an analytical test system with well-established performance characteristics and for which there is a scientific framework or body of evidence that appears to elucidate the physiologic, toxicologic, pharmacologic, or clinical significance of the test results. A probable valid biomarker may not have reached the status of a known valid marker because, for example, of any one of the following reasons: the data elucidating its significance may have been generated within a single company and may not be available for public scientific scrutiny; the data elucidating its significance, although highly suggestive, may not be conclusive; independent verification of the results may not have occurred. (From: Pharmacogenomic Data Submissions, FDA Guidance for Industry.)
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