MyHeritage, an Israeli company that has been doing ancestry-related genetic testing since 2016, has announced a new product that brings the company into the health-focused consumer DNA testing space alongside the likes of 23andMe.
MyHeritage DNA Health+Ancestry is a single test that includes a wide-range of genetic aptitudes for possible health conditions: specifically, the company will offer 11 genetic risk reports, including a hereditary breast cancer (BRCA) report that tests 10 pathogenic variants; three polygenic risk reports; and 15 carrier status reports. Genetic risk reports include hereditary breast cancer, late-onset Alzheimer’s disease and late-onset Parkinson’s disease. Polygenic risk reports include heart disease and Type 2 diabetes, and carrier status reports include Tay-Sachs disease and cystic fibrosis.
MobiHealthNews has reached out to MyHeritage for clarification, but it appears that the test is not FDA cleared (the company warns that "the new health product is not intended to independently diagnose, prevent or treat any disease or condition, or tell users anything about their current state of health in the absence of medical and clinical information."). The tests are processed in a CLIA-certified lab.
The company also takes a hard line on data privacy.
"All health data is protected by state-of-the-art encryption," MyHeritage wrote in the release announcing the new product. "Health report data is secured using additional password protection and is so secure that even MyHeritage employees cannot access it. MyHeritage has never licensed or sold user data, and has committed to never do so without obtaining explicit user consent. MyHeritage is the only consumer DNA company that has pledged to never sell data to insurance companies. It also applies a strict policy to prohibit use of its DNA services by law enforcement agencies."
Finally, MyHeritage is partnering with PWNHealth to offer physician oversight and genetic counseling to US customers.
The testing kit is selling for $199 plus shipping. A subscription which would allow the user to get results from new tests as they're added is available for an additional charge, but a 12-month subscription will be free for a limited time.
WHY IT MATTERS
MyHeritage is jumping into the space with an impressively large slate of tests, including a polygenic test for Type 2 diabetes, which 23andMe only added in March. The comparison to 23andMe is fairly self-evident — the price is exactly the same and even the design of the test kit box is similar. While there are many new entrants to the consumer genomics market, and will continue to be as the cost of testing decreases, no one has had much success in reaching the "household name" level of 23ndMe.
FDA status may prove to be a big differentiator, as 23andMe has clearances for many of its tests, and the agency has shown a willingness to go after non-cleared tests in the past. However, more recently the regulator implemented a premarket exemption for certain genetic tests, which could work in MyHeritage's favor.
WHAT'S THE TREND
Consumer genomics is a big market that's growing fast with some analysts predicting a $2.5 billion market by 2025, and expanding into health allows a company to address that much more of the market. But it's not necessarily an easy move to make: Ancestry.com tried to make the move into healthcare in 2015 and ended up walking it back. Today Ancestry seems to have returned to an exclusive focus on family history.
One thing that suggests MyHeritage could pull off the pivot is that it has done so before; in fact, it didn't start in genetic testing at all. When it launched in 2003 the company offered software for geneology and family tree research. It only launched genetic testing in 2016.
As more companies pivot into the healthcare space, there have been questions about the accuracy of these consumer tests, which the industry will need to overcome.
ON THE RECORD
“Our Health+Ancestry test is the next step in the evolution of MyHeritage. After 16 years of changing lives for the better through family history research and genetic genealogy, we are excited to expand our mission and try to improve and save lives as well. Our vision is to integrate our successful family history technologies with the new health product in innovative ways that bridge heritage and heredity to deliver deeper insights for our users,” Gilad Japhet, founder and CEO of MyHeritage, said in a statement. “We are proud to be part of a movement to democratize healthcare globally and make genetic testing accessible to millions of people, and allow them to discover what makes them unique.”