FDA Clears 1st At-Home DNA Test, Eases Future Hurdles

Law360, New York (February 20, 2015, 6:58 PM EST) -- The U.S. Food and Drug Administration on Thursday approved an at-home DNA test sold by 23andMe Inc. and said that it would not require advance clearance for similar genetic products in the future, marking a milestone for the field of personalized medicine.

Thursday’s action represented the first such clearance of a direct-to-consumer "carrier test" that detects the presence of gene mutations that can cause diseases when passed on to children by both parents. The 23andMe product is geared toward spotting gene variants that can cause Bloom...
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