23andMe Gains U.S. FDA Approval for First Genetic Test Kits
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23andMe Inc., the genetic-testing company backed by Google Inc., gained U.S. regulatory permission to sell consumers its first screening kit to detect whether they carry the risk of a rare genetic disorder.
The approval of 23andMe’s test for Bloom syndrome, which is associated with short stature, sun sensitivity and higher cancer risk, ends a conflict with the Food and Drug Administration. The agency, in its approval notice on Thursday, also announced it intends to exempt other such “carrier screening tests” from premarket review.