(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.

Complete your profile to continue reading and get FREE access to BenefitsPRO, part of your ALM digital membership.

Your access to unlimited BenefitsPRO content isn’t changing.
Once you are an ALM digital member, you’ll receive:

  • Breaking benefits news and analysis, on-site and via our newsletters and custom alerts
  • Educational webcasts, white papers, and ebooks from industry thought leaders
  • Critical converage of the property casualty insurance and financial advisory markets on our other ALM sites, PropertyCasualty360 and ThinkAdvisor
NOT FOR REPRINT

© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.