NEW YORK (GenomeWeb) – Based on its experience with the Healthy Nevada Project, consumer genomics firm Helix is betting that other health systems are similarly interested in incorporating genomics into population health research and into patient care.
Last week, the company announced a new strategic focus to offer turnkey sequencing solutions and services to health systems, payors, and researchers interested in population health genomics, and it appointed a new CEO, Marc Stapley, to lead the company in this direction. At the same time, Helix also announced a new partnership with Central Florida-based health system AdventHealth to sequence 10,000 participants in a study of how genomic health risk information can impact care.
"For the average community health system ... it's incredibly appealing to be able to say that they're starting to be on the leading edge of precision medicine," said Justin Kao, Helix's senior VP of business development and partnerships.
However, Kao emphasized that the changes at the company do not mean that Helix is abandoning its consumer-focused ethos and its overarching goal of incorporating genomics into the everyday lives of individuals. "We are not backing away from our belief that millions of people are interested in their genome … and that every person has the right to control their data, to use that data through their lifetime and to use it repeatedly," Kao said. "That is Helix."
However, after working with the Renown Institute for Health Innovation on the Healthy Nevada Project for the past year, Helix has been able to better define its plan for achieving those aims. In the Healthy Nevada Project, Renown Health and environmental studies-focused Desert Research Institute are investigating the health determinants of the local population in northern Nevada, and building a repository of the clinical, genetic, environmental, and socioeconomic data to fuel that research.
But the leaders behind the project also recognized that these kinds of longitudinal studies are difficult to enroll and keep participants engaged in over many years. They decided to partner with a consumer genomics firm as a way to garner the genomic data on participants for research and at the same time give back some test results that can pique their interest and demonstrate the value of the project to their daily lives.
The strategy has been effective in generating interest. Initially working with 23andMe to provide participants access to reports on ancestry, traits, wellness, and carrier status, Renown was able to enroll 10,000 participants in 48 hours. Based on that, Renown partnered with Helix to incorporate exome sequencing data in the study and set its sights on enrolling 40,000 participants, who would also get access to ancestry and traits information as a benefit of enrollment.
Helix highlighted at a recent genetics research conference that the project was able to enroll and sequence 25,000 participants in six months. In this first subset of enrollees, among those who had previously never interacted with the healthcare system, 40 percent initiated their first interaction with Renown after enrolling in the study.
"That was incredible to us, because the hardest thing in healthcare is getting people to engage with their health before they're sick," Kao said. "And these people that actually decided to get engaged [with Renown,] they were not people who have serious disease."
And yet, after learning about Healthy Nevada and getting some genetic information back about themselves, they decided to engage further with Renown. It remains to be seen if the initial interest among Healthy Nevada participants will continue into sustained engagement, which will be particularly important for a population health project aiming to track outcomes over a long time, but Kao said the early signs are encouraging.
For example, Healthy Nevada offers the opportunity to quickly launch studies in specific areas of interest. For example, one of the researchers wanted to evaluate individuals who have the highest genetic risk of coronary artery disease. Helix reached out to the consented participants who based their genetic factors fell in the top 10 percent of risk and within an hour enrolled 250 individuals.
"I think that there's some power to this that we're very eager to replicate," Kao said. "We've hit on something very special and that was also a motivating factor in deciding to really focus on this side of the business."
Within the Healthy Nevada project, Renown now has ambitions to enroll 250,000 participants throughout the state. The project, which has largely been enrolling participants in Northern Nevada, yesterday opened 25,000 testing slots in Las Vegas.
Meanwhile, health systems around the country have also taken an interest in engaging with patients around genomics research and are launching similar population-health focused projects. For example, Evanston, Illinois-based NorthShore University HealthSystem has partnered with consumer-facing genomics firm Color to study the clinical utility of providing genetic testing to 10,000 patients in the primary care setting.
Color uses a next-generation sequencing panel to identify variants associated with the risk of hereditary cancer, hereditary cardiovascular risk, and drug response. Participants in the study will receive this testing and genetic counseling for free, and their test results will be incorporated into their EMRs. NorthShore doctors will be able to use clinically actionable results in the care of patients, and researchers will track the impact of this information on patients' health and care costs. Before expanding the study to 10,000 participants, NorthShore saw significant interest among doctors and patients for this type of a project and was able to enroll a 1,000-patient pilot in under two months.
Jefferson Health, which services Philadelphia and parts of New Jersey, also partnered with Color to offer free testing to 30,000 of its employees, and it similarly saw ample interest. David Nash, dean of Jefferson College of Population Health at Jefferson Health, previously estimated that in the first two months of the program more than 6,200 employees signed up.
Healthcare systems investing in these population health projects say they're doing so to try to better engage with the patients they serve, prevent disease, and reduce runaway healthcare costs. This aligns with a larger shift within healthcare toward more risk-sharing models. But when it comes to genomics projects, most healthcare systems lack the expertise.
"What we see is that health systems need an end-to-end turnkey solution," Kao said. "They're not genetic experts. They're providers. But when a platform like Helix can deliver the consumer engagement, can deliver the clinical grade data, and can help with long-term research in a way that benefits our community, I think people are eager for that."
Helix is looking to help other health systems engage with their local population in the same way Renown has been able to, and according to Kao, its partnership with AdventHealth in Florida is the first of several collaborations the company will announce throughout the year.
Within the WholeMe project, AdventHealth will begin to enroll 10,000 Floridians in July and screen them for variants in genes linked to familial hypercholesterolemia, an underdiagnosed genetic condition that causes high cholesterol, and if untreated can result in cardiovascular disease and heart attacks. Helix will test participants using its Exome-plus test, which combines exome sequencing with sequencing of important noncoding regions across the genome, and report likely pathogenic and pathogenic variants in four genes linked to FH.
"We understand that genomics is becoming part of standard medicine and it's only going to grow over time," said Wes Walker, AdventHealth's associate chief medical information officer. "We want to engage the community, really increase awareness around genomics and genetics, and ... we want to see what effect having this information has on people's healthcare and lifestyle decisions."
"We want to help make genetics standard of care to impact millions of lives," Kao said. "We believe projects like Healthy Nevada and WholeMe are the right starting points as we start to do that."
Although initially focused on FH, based on this initial effort, AdventHealth may decide to report out genetic risk results for other similarly underdiagnosed conditions, such as Lynch syndrome and hereditary breast and ovarian cancer syndrome, and study the impact of that information. Healthy Nevada participants also got the option to learn their FH risk first, and so far 115 participants have learned their risk for the condition through the project and more than 90 percent would not have been diagnosed under current standard practices and guidelines.
As in the Healthy Nevada project, WholeMe participants will also gain access to free genetic testing reports on ancestry and traits, and have access to post-test genetic counseling. Although the Florida study hasn't yet begun enrolling, an AdventHealth spokesperson said that more than 700 people have expressed an interest in the study since it was announced last week.
Kao hinted that there is also a lot of interest in using the exome data Helix has amassed with Renown for third-party research projects. "We're starting to explore what those [research initiatives] would look like," he said.
Ultimately, the strategic shift to working with health systems is an opportunity for companies like Color and Helix to diversify revenue streams. And while consumer genomics companies have become adept at marketing test kits online, on TV, and through Black Friday sales, partnerships with healthcare systems offer opportunities for engagement beyond getting people to spit into a tube.
The DTC marketing strategy has worked very well for some consumer genetics firms because of the enormous public interest in genealogy, but as Kao described it, Helix doesn't want to grow by selling ancestry DNA tests. The Helix model, where individuals are sequenced once and then can buy different apps to have their data interpreted in healthcare, ancestry, or other entertainment contexts, relies on patients coming back to their genomic data again and again.
While Helix uses genetic testing for ancestry and traits as a way to capture the interest of participants in projects like Healthy Nevada and WholeMe, the company's strategic direction recognizes that the incorporation of genomics into patients' lives cannot ignore the other players in the complex healthcare ecosystem. "We always believed that the core mission of Helix was to use the power of genomics to transform health and to help people live healthier lives," he said. "You don't run the world's largest clinical exome lab if you just want to sell a lot of ancestry tests."