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23andMe Garners FDA Clearance for CYP2C19 PGx Test Report

NEW YORK – 23andMe has received 510(k) clearance from the US Food and Drug Administration for its CYP2C19 Drug Metabolism Report, which informs customers whether their genotypes may influence their ability to respond to clopidogrel and citalopram without the need for confirmatory testing.

The FDA in 2018 authorized 23andMe to sell test reports for 33 pharmacogenetic variants directly to consumers. The agency's action came with caveats that the reports did "not describe an association between the detected variants and any specific drug nor whether a person will or will not respond to a particular drug." Additionally, if individuals wanted their doctors to use insights from 23andMe's reports to guide treatment decisions, they had to order confirmatory testing from a lab conducting clinical testing. 

The 510(k) clearance amends the label for the CYP2C19 test report and removes these caveats, allowing the company to characterize how customers' CYP2C19 genotypes may impact their ability to specifically respond to the stroke prevention drug clopidogrel and the antidepressant citalopram. Studies show that individuals with specific CYP2C19 variants may not respond well to these drugs and may be at higher risk for serious and sometimes life-threatening side effects. 

When 23andMe looked at 2 million of its customers from various ethnic backgrounds, the company noted that more than half had at least one CYP2C19 variant associated with their ability to metabolize these two drugs.

"This expanded indication for our pharmacogenetics report recognizes the accuracy of our results and enables doctors to use them in prescribing therapies," 23andMe CEO Anne Wojcicki said in a statement.

The company, which has worked to garner regulatory authorization of its test reports after having to cease its DTC offerings following a 2013 FDA warning letter, highlighted that it is the only consumer genomics company to have achieved this step. 

"23andMe remains the only company with direct-to-consumer pharmacogenetic reports cleared by the FDA," Kathy Hibbs, 23andMe's chief legal and regulatory officer, 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 regulatory milestone for 23andMe comes at a precarious time for other labs marketing clinical PGx tests through CLIA-certified labs. For the past two years, the FDA has been pressuring PGx testing and software companies to stop selling PGx tests without its approval or clearance. In October 2018 the agency issued a safety alert calling out unapproved PGx tests and software used to make clinical recommendations as a public health risk. The agency then sent a warning letter to at least one lab leading to the removal of its PGx testing services, and reached out to many others asking them to remove references to drugs in PGx reports.

 Some in industry have pushed back, asserting that the FDA lacks authority to regulate laboratory-developed tests, and calling the agency's actions out for lacking transparency and consistency. A coalition has filed a Citizen Petition enumerating the agency's "unlawful" enforcement actions. All the while, the agency has defended its actions as being in the best interest of public health. Most recently, in February, the agency unveiled a table of gene-drug associations for which it believes there is sufficient scientific evidence.

According to 23andMe, in order to remove the confirmatory testing requirements, it provided FDA with analytical validation for CYP2C19 genotyping. The company also conducted comparison studies with expanded sample collection to ensure that its tests could detect rare genotypes involving the *3 allele, and reduced the risk for false-positive and false-negative results. The company's tests demonstrated 99 percent concordance with Sanger sequencing.

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