Ancestry closes DNA Health Business only months after obtaining FDA DTC Approval (K192944) with SoundRocket help

by | Jan 28, 2021 | FDA User Experience Study, Genetic Testing

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.  This move comes just months after receiving FDA approval for a direct-to-consumer product, which was achieved using SoundRocket FDA user comprehension study services.

Consumer-initiated test types

Consumer-initiated (CI) genetic health risk (GHR) tests are marketed to the public and ordered by patients themselves. But not all CI tests are alike. CI tests generally follow one of two pathways to consumers:

  1. Direct-to-Consumer (DTC) tests—marketed directly to consumers with no healthcare professional involved. These tests are regulated by the US Food & Drug Administration (FDA).
  2. 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 not regulated by the FDA as they fall under the umbrella of ‘tests prescribed by a doctor’.

Launched in October 2019, AncestryHealth was designed to give customers actionable health and wellness insights based on targeted DNA analysis. The test looked at genetic health risks for some hereditary cancers, heart and blood conditions, and connective tissue disorders. It also reported carrier status for three conditions to help with family planning and included some nutrition and fitness-based wellness insights. 

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. 

Ancestry partnered with PWNHealth, a national network of doctors and genetic counselors, to offer AncestryHealth through the consumer-initiated, physician-mediated model.

FDA DTC authorization was in-hand

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 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). 

With the closing of AncestryHealth, the FDA GHR approval will not make the transition to readily-available consumer genomics.

SoundRocket User Comprehension Study

“DTC genetic tests will have their own pharmacy aisle soon.”

— Scott D. Crawford, Chief Vision Officer @ SoundRocket

Soundrocket partnered with the AncestryHealth team in the development and user comprehension testing of the Factor V Leiden test report. Through a multi-stage iterative effort, SoundRocket guided improvements to the test report while also designing and implementing a user comprehension study which demonstrated the illusive 90% comprehension in key areas (i.e.: domains) such as test results, test purpose, test limitations, appropriate next steps, and other FDA required comprehension topics. 

“While we have been involved in numerous similar studies, we are most proud of our Ancestry partnership as it represented the first start to finish effort bringing a report from conception to approval,” said Scott D. Crawford, SoundRocket founder and Chief Vision Officer. 

While the Ancestry decision may mean a turn in the consumer market for genetic health reports, Crawford sees a strong future in DTC genetic tests. “Personalized medicine providers are recognizing that DTC consumer testing can be a hook to bring customers to personalized medicine solutions they offer. DTC genetic tests will have their own pharmacy aisle soon,” said Crawford. 

Want to know more about user or label comprehension studies? They’re kind of our thing. Whether you’re preparing for an FDA pre-market submission or simply want to make consumer-driven and meaningful improvements to your content, we’ve got you covered with our iterative user comprehension process. To schedule a consultation with SoundRocket, contact us here!

About the Author

Jill Furnival

Jill Furnival is a certified genetic counselor and science writer based in Toronto, Canada. When she’s not helping people better understand genetics, you may find her walking her dog, or in downward dog! She joined SoundRocket in Fall 2020 to consult on user comprehension studies for the FDA authorization of direct-to-consumer genetic tests.