FDA To Regulate Direct-To-Consumer Genetic Tests
This article was originally published in The Gray Sheet
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
You may also be interested in...
DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says
The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.
What's Next For LDTs? FDA May Be Eyeing A New Game Plan
Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.
Pathway Genomics Remains In FDA Crosshairs For Genetic Testing Service
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.