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NEW YORK (GenomeWeb News) – Genentech last week filed a Citizen Petition with the US Food and Drug Administration urging the agency to take on greater oversight of diagnostic tests that are intended to guide therapeutic decisions and to regulate all laboratory-developed tests.
 
The biopharmaceutical firm has stepped into an issue that is on the minds of many molecular diagnostic manufacturers who are awaiting the FDA’s final guidance on In Vitro Diagnostic Multivariate Index Assays.

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