(Bloomberg) — 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.
23andMe, which scans people's saliva to provide information on their ancestry and inherited features, hasn't been able to include health analysis in its reports since a standoff began with the FDA in late 2013. Sales took a "big hit" and the Mountain View, California-based company has only recently recovered, partly by selling the health analyses outside the U.S., Chief Executive Officer Anne Wojcicki said in a January interview.
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