In Surprise Draft Guidance, FDA Suggests It, Not CLIA, Should Regulate Multivariate Index Assays | GenomeWeb
The US Food and Drug Administration last week issued a draft guidance to industry that signaled its wish to begin regulating tests that use algorithms to interpret gene and protein data.
The devices, which the FDA calls in vitro diagnostic multivariate index assays, are relatively new to the market and are currently used by CLIA labs as homebrew tests. But some FDA officials believe they are growing at such a rapid pace that they have raised concerns about their impact on patient care.

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