By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Helix (San Francisco) believes it can vastly expand the nascent consumer genomics market. The company, which announced backing from sequencing giant Illumina (San Diego), will launch a pay-as-you go genomic analysis service next year that has been dubbed an "enormous app store for genetic information." Helix backers say the company intends to bring consumer genomics into the mainstream, while broadening the range of customers utilizing sequencing technology.
Illumina, along with venture capital firms Warburg Pincus and Sutter Hill Ventures, provided $100 million of financial backing for the newly formed company. Illumina CEO Jay Flatley will serve as chairman of Helix’s board of directors.
Currently, the most prevalent consumer-facing uses of genetic testing are medically-based cancer predisposition testing and carrier screening, as well as consumer-initiated genealogy testing. Unlike Ancestry.com or 23andMe, which both offer consumers $99 genetic genealogy testing, it is reported that Helix will subsidize the cost of genome sequencing in order to encourage consumers’ foray into consumer genetics. MIT Technology Review says that with the order of a $20 sports performance assessment app, for example, an individual’s "exome plus" will be sequenced and will be securely stored and ready for further analysis with the purchase of additional apps. Helix hopes to create "a vibrant ecosystem of high-quality content partners" that will spur ongoing, pay-as-you go analysis as consumers’ interest in understanding their own genome expands.
Partners will develop analysis tools for Helix, in a model similar to Apple’s app store. (Illumina previously launched BaseSpace, an app store for researchers, which was met with mixed reviews.) In a statement, Helix unveiled that the first two partners are LabCorp and the Mayo Clinic, which also made a strategic investment in Helix. Mayo’s Center for Individualized Medicine is developing applications initially focused on consumer education and health-related queries, while LabCorp will develop analysis and interpretation services, initially focused on medically actionable genetic conditions, accessible through Helix’s platform.
It is widely reported that profits will be shared between Helix and third-party analysis developers, in a fashion similar to Apple’s relationship with app store developers. However, Flatley told MIT Technology Review that the original partner that initially brings an individual into the Helix service, will continue to get a cut from all future apps accessed by the person. For developers, Helix investors say that the model effectively removes the costly barrier to enter the genomic space by eliminating the burden of setting up a laboratory, buying sequencing equipment, or building a database infrastructure.
“We believe that the digitization of the genome will unleash entrepreneurs and developers to create new applications for consumers in a way never before possible,” Noah Knauf, managing director of health care at Warburg Pincus, said in a statement.
To support its third-party partners, Helix will establish what it says is one of the world’s largest next-generation sequencing laboratories and build a secure and protected database, both designed in accordance with CLIA, CAP, and HIPAA guidelines. Results will be returned to consumers in a "responsible and ethical way," the company says, and individuals will be able to control how their data is accessed, "through a robust and granular consent process."
The regulatory purview of consumer genetics is lacking clear definition, but U.S. Food and Drug Administration (FDA) approval would likely be needed if app-based analysis dispensed diagnostic information. While Flatley says he has been talking to the FDA about Helix, analysts suspect that Helix’s initial offerings will be focused on areas such as genealogy, fitness or wellness, and inherited traits.
“Genomics is reaching an inflection point in cost, volumes, and knowledge, creating a significant opportunity to unlock information that is currently not widely accessible to individuals,” said Flatley in a statement. “Helix and its founding investors are committed to creating a neutral platform at the highest quality standard that will work with partners to accelerate consumer adoption of genomics.”