“DTC genetic tests will have their own pharmacy aisle soon.” With the closing of AncestryHealth, the FDA GHR approval will not make the transition to readily-available consumer genomics. In the 510(k) submission, they demonstrated the test is substantially equivalent to a previously approved device the 23andMe Personal Genome Service (PGS) Genetic Health Risk Test For Hereditary Thrombophilia ( DEN160026). Just shy of one year after launching their physician-mediated model, in mid-August 2020, Ancestry received an FDA 510(k) approval for their Factor V Leiden Genetic Health Risk Test ( K192944). In August 2020, working with Quest Diagnostics, Ancestry upgraded their testing technology from an array-based test to a next-generation sequencing (NGS) product, becoming the first widely available NGS test on the market.Īncestry partnered with PWNHealth, a national network of doctors and genetic counselors, to offer AncestryHealth through the consumer-initiated, physician-mediated model. It also reported carrier status for three conditions to help with family planning and included some nutrition and fitness-based wellness insights. The test looked at genetic health risks for some hereditary cancers, heart and blood conditions, and connective tissue disorders. Launched in October 2019, AncestryHealth was designed to give customers actionable health and wellness insights based on targeted DNA analysis. These tests are not regulated by the FDA as they fall under the umbrella of ‘tests prescribed by a doctor’. Physician-mediated tests-marketed directly to consumers but mediated by a third-party physician who reviews the test requisition and/or results.These tests are regulated by the US Food & Drug Administration (FDA).
I GOTTA GET THRU THIS GHR PROFESSIONAL
Direct-to-Consumer (DTC) tests-marketed directly to consumers with no healthcare professional involved.CI tests generally follow one of two pathways to consumers:
Consumer-initiated test typesĬonsumer-initiated (CI) genetic health risk (GHR) tests are marketed to the public and ordered by patients themselves. This move comes just months after receiving FDA approval for a direct-to-consumer product, which was achieved using SoundRocket user comprehension study services. More news in the consumer genomics space came this month when direct-to-consumer genetic testing company Ancestry announced they are discontinuing their AncestryHealth business.