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Under the Rules

US regulators have determined that some of Orig3n's tests are subject to Clinical Laboratory Improvement Amendments rules, according to Buzzfeed News.

Orig3n caught the eye of regulators when it was to stage a promotion at a Baltimore Ravens football game. About 55,000 fans were to receive free genetic testing of four genes, including one linked to power and sprinting ability, but in addition to privacy issues, concerns popped up as to whether the company had the proper lab certification and the giveaway was postponed.

Buzzfeed has now obtained a letter between Centers for Medicare & Medicaid Services and Orig3n that says that the company's athletic ability and metabolism tests do measure health and thus are subject to CLIA rules. In particular, CMS highlights the company's testing of 18 genes in particular as measuring health. According to Buzzfeed, Orig3n had argued that its tests do not provide health information.

Orig3n tells Buzzfeed that it has been seeking CLIA certification and that it will stop selling the tests that use those 18 genes. "Going forward," Orig3n's chief operating officer Kate Blanchard adds, "we will continue to work with CMS, California, Massachusetts, and the other states to ensure that we are meeting all federal and state regulatory requirements regarding our products."