- 23andMe's latest FDA will allow it to steer customers of its pharmacogenetics reports toward drugs for treating two separate depression and heart conditions without requiring additional testing.
- Here's why we think genetic testing startups could make valuable partners for digital therapeutics vendors.
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The genetic testing giant received a clearance from the FDA that will allow it to steer customers of its pharmacogenetics reports toward drugs for treating two separate depression and heart conditions without requiring additional testing, per MobiHealthNews.
The FDA's decision updates a 2018 approval that permitted 23andMe to sell a test for variants across several genes that could influence the metabolization of certain medications, but 23andMe had to warn consumers not to use the report to inform medication decisions without additional independent testing. 23andMe can now suggest the two drugs if its test reveals consumers would be a good fit for either them, though it will still encourage users to consult with healthcare providers before making changes to their treatments.
This FDA clearance adds a layer of validity to its tests — but we're not sure doctors will readily rely on them to steer more personalized treatments:
- Genetic testing companies are focusing more on how their tests can fuel healthcare treatments, and personalized medicine is at the center of 23andMe's push. Its pharmacogenetic reports help patients understand how they would react to certain treatments — which could help doctors choose therapies best suited for their patients. And the recent FDA clearance could boost the value of these reports: The decision was driven by studies showing there's a 99% agreement between 23andMe's test and traditional sequencing methods.
- But physicians may not be equipped to integrate pharmacogenetic testing services into their care delivery yet. Clinicians have concerns about utilizing genetic screenings: 44% of US physicians think genetic screening for health risks is "very beneficial" for their patients, but only about half as many (21%) feel "very prepared" to use it in their practice, according to a 2020 Stanford Medicine survey. And studies across physician practices have shown that doctors lack knowledge about pharmacogenetics, which may make them wary about relying on these sorts of reports. But doctors aren't opposed to learning about how to use pharmacogenetics: In a December 2019 survey of US- and Japan-based pediatricians, 83% said they were interested in educational opportunities on pharmacogenetics.
We think 23andMe and its competitors will now eye tie-ups with digital therapeutics (DTx) companies to better inform and tailor digital therapies. Many DTx developers are focused on making their platforms customizable to each user, so genetic testing companies could use genomic insights to help make treatments more effective for users. And we've seen a bit of convergence between these spaces: For example, DTx startup Lark partnered with 23andMe in January 2019 to offer certain 23andMe customers access to Lark's programs for weight loss and diabetes prevention.
But as 23andMe, Ancestry, and the likes roll out new healthcare-focused tools and boost their validity in the eyes of healthcare agencies, we could see more DTx companies looking to team up with them to access their valuable data.
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