23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing.
This action updates a De Novo approval granted to the consumer genomics company in late 2018. That decision allowed 23andMe to market a test for one of 33 variants across multiple genes that could impact metabolization of certain medication, but came with a handful of "special controls." Among these were labeling requirements that warned consumers not to use the product for any medication decisions without additional independent testing.
According to the company, this new 510(k) removes that requirement for two medications, clopidogrel for certain heart conditions and citalopram for depression, with the CYP2C19 Drug Metabolism Report.
"This expanded indication for our pharmacogenetics report recognizes the accuracy of our results and enables doctors to use them in prescribing therapies," Anne Wojcicki, cofounder and CEO of 23andMe, said in a statement. "This is a great milestone in making personalized medicine a reality."
The company also notes that this test should be eligible for reimbursement when purchased by consumers with a flexible spending account or health savings account.
The FDA's decision was driven by additional method comparison studies that sought to include rare allele combinations that could be responsible for false-positives or false-negatives, the genomics company said. These efforts suggested greater than 99% agreement between 23andMe's test and Sanger sequencing.
While the results from the test may now stand on their own, consumers who receive these reports are still advised by 23andMe to continue adhering to their ongoing medications, and to only make a treatment decision in consultation with their healthcare provider. The company said that consumer comprehension data collected in the past would suggest that more than 95% of its customers understand the need for additional consultation – another factor it said the FDA took into consideration with this 510(k).
WHY IT MATTERS
Much as with its original De Novo, 23andMe is looking to bring personalized pharmacogenetic testing to the masses. Doing so would allow individuals to be more invested in their care, and improve conversations with their healthcare provider.
For patients and providers using this test to consider these two specific treatments, this 510(k) clearance cuts an additional step out of the process.
Speaking more broadly, direct-to-consumer genomics companies have faced plenty of hurdles over the years in their effort to break out of family lineages and into healthcare. As an extension of the 2018 De Novo approval, this decision further lays out the groundwork for 23andMe or other consumer genomics companies looking to clear their consumer health reports.
"23andMe remains the only company with direct-to-consumer pharmacogenetic reports cleared by the FDA," Kathy Hibbs, chief legal and regulatory officer for 23andMe, said in a statement. "Now that we have pioneered a regulatory path, we believe all companies marketing pharmacogenetic reports should go through the FDA review process to ensure the safety and effectiveness of their tests."
THE LARGER TREND
While this is certainly a win for 23andMe, the news comes about half a year after flagging demand forced the company to tighten its belt and lay off 100 of its employees. Prior to this it had announced a handful of new health research partnerships, but was also targeted by a $100 million lawsuit related to a reproductive health research contract signed in 2015.
And although 23andMe might be the best known of the bunch, there are certainly others looking to combine consumer genomics services with health insights. These competitors include the DNA Company, Nebula Genomics and MyHeritage.