Concierge Medicine Today

Startup Under Federal Scrutiny for Selling Genetic Tests Without Legal Certification

By Kristen V. Brown

When a consumer genetic testing company planned to give away free DNA tests to Baltimore Ravens fans in September, the federal government intervened and prompted a last-minute cancellation. Now, a federal agency has found that the startup, Orig3n, does not have the necessary legal certification to sell genetic tests related to health. Orig3n had planned to offer cheek swabs and genetic analysis testing for four different genes to game attendees, including one related to the body’s ability to regulate vitamin D flagged as health-related by the Centers for Medicare and Medicaid Services. In a letter dated Oct. 30 sent to Orig3n, CMS identified 18 heath-related genes in Orig3n’s tests that the company will either have to stop including in its testing products or seek to obtain a certificate saying that it meets what’s known as the Clinical Laboratory Improvement Amendments of 1988. A CLIA certificate is something akin to an FDA approval alternative, validating not the results of a test but that the lab that produced them operated according to certain quality standards. Orig3n sells tests that claim to assess traits related to fitness, nutrition, and beauty for as much as $149. In a response to CMS, the company argued that it was exempt from certification because it does not claim to provide health information. CMS found otherwise, responding that its tests indeed “provide genetic testing that provides information for the assessment of health.” The genes the agency cited include those related to cholesterol, bone strength, sugar sensitivity, and vitamin regulation.



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