Saturday, June 19

Ancestry’s new 510(k) clearances point toward OTC consumer genetic health risk testing

Consumer genomics company Ancestry recently received two FDA 510(k)s – one for an in vitro molecular test that detects genomic variants tied to potential disease risk, and another for a saliva-based DNA specimen-collection kit.

Both of these submissions were received by the FDA in October of last year, which officially cleared them on August 13, according to the agency’s 510(k) database.

Each was filed as a Class II medical device, with the risk-assessment test landing under the same review pathway for over-the-counter genetic test reports eventually ironed out by 23andMe in early 2017.


Ancestry has been offering genetics-based health insights since last October, when it launched its AncestryHealth service for consumer-facing, nondiagnostic health-risk reports. However, these health risk tests are not cleared or approved by the FDA, according to a disclaimer on the company’s product page.

Rather, the tests are ordered by a physician staffed by an independent clinician network partner who does not directly interact with the consumer. This approach allowed the company to sidestep the FDA’s requirements and instead fall under the Centers for Medicare and Medicaid Services’ jurisdiction as a physician-ordered diagnostic test. Once customers received their report, Ancestry would then provide access to a genetic counselor and online education to help them interpret the results.

With its platform cleared by the FDA for over-the-counter use, Ancestry would likely have the option to cut out the middleman and sell its reports directly to customers – a shift that has the potential to reduce Ancestry’s expenses and increase access among consumers.

It’s still worth highlighting that the product classification’s “special controls” include a handful of labeling requirements. The company will still need to inform consumers of the test’s limited use for disease diagnosis, for example, and provide information on how to obtain access to a healthcare professional to discuss the results.

MobiHealthNews has reached out to a spokesperson for Ancestry for more information about the new clearances and how they may change AncestryHealth’s offerings. This article will be updated with their response.


The new 510(k)s come about a week and a half after the launch of AncestryHealth powered by Next Generation Sequencing, a new offering that the company said will screen for genes associated with breast cancer, heart disease, colon cancer and blood disorders. Shortly after came word that the consumer genomics company had a new majority owner: private equity firm Blackstone, which bought its stake for $4.7 billion.

Meanwhile, 23andMe announced its own 510(k) updating a direct-to-consumer personal pharmacogentics report for which it received De Novo classification back in 2018. The company kicked off the new year by laying off 100 of its employees, a move attributed to reduced consumer demand for genetic testing services.


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