FDA Issues Guidance for Multi-analyte Tests; Early for Proteomics Companies? | GenomeWeb

Up until now, it has been unclear how the US Food and Drug Administration will regulate multi-analyte diagnostic tests, including those comprising protein biomarkers.

This may soon change: In April, the FDA issued a draft guidance for industry on how to prepare submissions for so-called multiplex tests that assay more than one analyte simultaneously. But the jury is still out on how relevant the final guidance, which is geared towards nucleic acid-based tests like DNA microarrays, will be for protein-based assays.

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