SAN FRANCISCO — Consumer genetics giant 23andMe announced Thursday that it would move deeper into the business of clinical trial recruitment, partnering with a fast-growing startup to help match its customers with nearby study sites based on their diseases, demographics, and DNA.
The Silicon Valley company has for months been quietly making inroads into clinical trial recruitment by emailing customers who’ve opted in with recommendations about studies that might be appropriate for them. It has recruited for studies, both interventional and observational, in disease areas including Alzheimer’s, Parkinson’s, attention-deficit hyperactivity disorder, eczema, and liver disease, a spokesperson for the company confirmed.
But the new partnership with TrialSpark, which offers a tech-powered alternative to traditional contract research organizations, may help 23andMe address one of the biggest challenges in clinical trial recruitment: geography. The idea is that patients who want to enroll in a clinical trial centered out of, say, Memorial Sloan Kettering Cancer Center, won’t have to fly to New York and can instead participate by visiting their local doctor’s office.
The partnership comes as 23andMe moves aggressively into the world of drug development, internally mining its massive database for therapeutic targets and inking research partnerships with drug makers, universities, and nonprofits. The company’s giant trove of genetic data — and email addresses — collected from its millions of customers has the potential to give it a leg up on the contract research organizations that have traditionally helped drug companies find participants for their studies.
23andMe is tight-lipped about its growing business around clinical trial recruitment. The company declined to answer STAT’s questions about how many of its customers it’s helped enroll into clinical trials, how many studies it’s recruited for, or whether it’s charging study sponsors to do that recruiting for them.
Study recruitment also offers 23andMe a chance to put its own twist on the personalized advertising businesses that have turned big tech companies into some of the world’s most valuable corporations. But whereas companies like Facebook and Google charge all sorts of firms for targeted ads based on what you click on online, 23andMe could make serious money charging drug makers to serve up what are essentially personalized ads for medical research.
That could hold significant appeal for some customers. Not only can the company’s spit kits find disease risks lurking in their genes — but they may also be a route to accessing experimental drugs and cutting-edge research that could potentially help them and others with their condition.
23andMe’s vice president of business development, Emily Drabant Conley, said the company has yet to do any advertising or marketing to its customers around its clinical trial recruitment business.
But as researchers struggle to fill their clinical trials using traditional methods, “we feel like we have this new way of doing things where we can help connect people who may be interested to trials that may be a fit,” Drabant Conley told STAT. “We think that we could be meeting a very interesting need. It’s still early, but it’s something that we feel excited about.”
Drabant Conley said 23andMe only started recruiting for clinical trials in the past 18 months or so. In the company’s early days, “frankly, we didn’t really have enough customers for it to make sense, and now we’re at a place where that has changed,” she said.
Of 23andMe’s 10 million customers, it considers about 8 million of them to be engaged research participants, meaning that they’ve opted to participate in research and regularly log into their account. More than 75% of 23andMe’s customers complete at least one of the surveys that the company hosts on its site asking them about any medical conditions they may have, among other things.
The company uses the information in these surveys to determine which customers to email about clinical trials options, Drabant Conley said. 23andMe mostly recruits based on the medical conditions that customers report having, as well as their demographic information such as age and gender. But the company has also in some cases recruited based on customers’ genetic information, such as healthy people who have a variant of the APOE gene associated with an elevated risk for Alzheimer’s disease.
Drabant Conley said 23andMe has primarily recruited for interventional drug trials, though it has also recruited for observational studies. For example, as part of a partnership with the drug maker GlaxoSmithKline announced last year, 23andMe has helped recruit Parkinson’s patients with the LRRK2 gene variant for observational research. A drug GSK is developing targeting LRRK2 is not yet in clinical trials.
When 23andMe’s customers receive an email about a study, they can express interest by clicking through to a site with more details and answering a few additional questions to determine their eligibility, like whether they’re pregnant or which medications they’re taking. They also agree to be contacted by the coordinator running the study.
At that point, 23andMe generally hands off its customers to the study site that’s leading the clinical trial — often an elite academic medical institution that may be far away from where customers live — or to the contract research organization helping run it. But that hasn’t always worked smoothly, Drabant Conley said. “Sometimes those places are super engaged, and they would call our customers right away. And sometimes those places aren’t that engaged, because they’re focused on other things, and so our customers may want to participate in a trial — and they may not get a call back,” Drabant Conley said.
Under the new partnership, 23andMe will hand off its customers to TrialSpark, so that the startup can help them enroll at a study site that’s close to where they live, according to Shawn Tedman, who directs 23andMe’s clinical trial business.
New York-based TrialSpark makes money by charging sponsors to expand the reach of their clinical trials. TrialSpark does that by providing the tech infrastructure and support staff to help community physicians open up study sites — sometimes enrolling no more than one participant. The goal is for patients who live far away from the urban hubs where most clinical studies are run to be able to enroll in a trial by going to the office of their own primary care provider or specialist physician, or to another local doctor.
To launch the partnership, 23andMe and TrialSpark are soliciting proposals from clinical researchers interested in recruiting participants from 23andMe’s customer base. The two companies will select up to three studies to work with initially.
Study sponsors will have to pay to work with 23andMe and TrialSpark, according to TrialSpark CEO Benjamine Liu, though he declined to specify who or how much those sponsors would be paying.
Neither 23andMe nor TrialSpark will be paying each other as part of the newly announced deal, Liu said.