Potential Regulation of Clinical LC/MS Tests to be Discussed at FDA Workshop Next Week | GenomeWeb

NEW YORK (GenomeWeb) – Next week, the US Food and Drug Administration will convene with experts in protein and peptide detection using liquid chromatography-mass spectrometry to discuss how to regulate in vitro diagnostic tests based on the method.

So far, the FDA has not had to regulate any aspect of a mass spec-based protein or peptide test, because nobody has submitted one for clearance or approval, according to Julia Lathrop, a scientist at the agency's Center for Devices and Radiological Health.

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