Mayo Clinic Ups Stake in DIY Genetic Testing Firm, Sees Health Benefits in New Tech
The Mayo Clinic is continuing to make venture capital investments in direct-to-consumer genetic testing, which scholars from its own Center for Individualized Medicine recently determined could be “potentially beneficial” for the public under a new generation of products designed to improve protection of users’ personal information.
The market potential of do-it-yourself genetic testing services, which don’t require the direct participation of a medical provider, is thought to be considerable, estimated by some observers to be set to grow from its current annual level of $117 million to around $600 million by 2026 – a nearly 20 percent annual growth rate.
Those kinds of projections have been spurred by recent moves from the U.S. Food and Drug Administration allowing new types of direct-to-consumer genetic tests go forward into the market.
That comes after earlier efforts had raised alarms over how users’ genetic information was handled and shared. There were also questions about whether users, left without medical guidance, were misinterpreting the results, triggering costly and unnecessary doctors’ visits.
These concerns prompted a regulatory crackdown by the FDA starting in 2011.
One of the new-generation DIY genetic testing providers is Helix, a Silicon Valley-based spin-off of genetic sequencing giant Illumina (NASDAQ: ILMN). Helix offers users a menu of smartphone apps on its platform boasting a variety of services from third-party providers available to interpret the results of a single genetic sequencing test.
Helix says the genetic data it produces is “securely stored” and not shared unless consent is given – a key difference from the earlier products. For instance, Helix users can give consent to send their genetic data to the National Geographic, which offers to trace the “migration paths your ancient ancestors followed” while analyzing “the details of your ancestral makeup.”
Mayo Clinic, meanwhile, is developing a series of apps for the Helix platform through which it will provide health-risk interpretations of genetic sequencing data. Mayo Clinic Ventures was an early investor in the company, participating in an initial $100 million financing in 2015.
This month, the Rochester institution upped its stake in Helix by taking part in a Series B round of $200 million, led by DFJ Growth and with participation from all its founding investors including Mayo, Illumina, Kleiner Perkins Caufield Byers, Sutter Hill Ventures, and Warburg Pincus.
The goal of the latest round is to boost the array of services available on the Helix app store from the current 35 to “over 50” in 2018, including “major launches” of health products from Mayo Clinic and others.
Mayo’s Center for Individualized Medicine is managing the relationship with Helix. Its motivation, aside from a possible smart financial investment, is to support the goal of “democratizing” the availability of patients’ own genetic information while also answering the previous concerns about users misinterpreting the data.
Center director Keith Stewart said in a statement that Mayo’s app will give Helix users “information that they can trust” while also “empowering them with a deeper understanding” of their health.
The new investment comes shortly after Mayo researchers published a paper tracing the history of the direct-to-consumer genetic testing market and looking at “new hybrid models” such as Helix, which combine the “infotainment” aspects of earlier services with input from actual medical professionals.
Co-authored by Mayo bioethicist Megan Allyse, the study found that the combination of intense commercial competition, high consumer interest and large-scale research on the effect of genetics on human health has combined to form “an intense and rapidly shifting landscape” for the DIY testing market, with the idea of linking data results to specific purposes such as ancestry and health risk assessments still in its early stages.
It’s still unclear how the new kinds of tests will perform either in the marketplace or in public health settings, the Mayo authors cautioned.
Nevertheless, they added, “it is clear that genetic information is increasingly moving out of medical institutions and into the private commercial sector. If they succeed, (testing) companies may usher in new collaborations between patients, consumers, medical providers and regulators that maximize the benefits of genetic information through the empowerment of patients and providers.”