Pathway Genomics Remains In FDA Crosshairs For Genetic Testing Service
This article was originally published in The Gray Sheet
An untitled letter from FDA targets Pathway Genomics' recent launch of a cancer screening assay that FDA says is being marketed directly to consumers without proper FDA review.
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The Google-backed firm's carrier screening assay for a rare disease called Bloom syndrome is the first DTC genetic test to achieve sign off from FDA. More importantly, the marketing authority was awarded in a manner that could significantly streamline the path to market for future DTC carrier-screening assays.
Citing the need to prove that direct-to-consumer genetic assays are analytically and clinically accurate, CDRH sent letters to five genetic testing firms June 10 requesting pre-market submissions for the companies' already-marketed services
A particularly public preemptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans last week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests