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TUMOR MARKER RECLASSIFICATION SHOULD INCLUDE QUALITATIVE ASSAYS, ADDITIONAL SAMPLE MATRICES, PANEL SAYS; DOWNCLASSIFICATION PROCESS COULD TAKE 1-2 YEARS

This article was originally published in The Gray Sheet

Executive Summary

FDA downclassification of tumor markers for patient monitoring should include qualitative and semi-quantitative tests as well as quantitative tests, FDA's Immunology Devices Advisory Panel recommended Dec. 1 at a meeting in Gaithersburg, Maryland. The unanimous recommendation broadens the downclassification sought in a citizen's petition by Centocor, which requested the change only for quantitative assays.
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