NEW YORK – 23andMe said Thursday that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its pharmacogenetics report for SLCO1B1 that includes interpretive drug information for simvastatin. The clearance modifies labeling of a previously approved clearance for SLCO1B1 to remove a requirement for confirmatory testing before prescribing the drug for high cholesterol and triglycerides based on the 23andMe report.
To earn the right to remove the need for confirmatory testing, the consumer-focused genetics company provided the FDA with data showing that the 23andMe SLCO1B1 report was 99 percent in concordance with Sanger sequencing.
"This is an important win for consumers, as they will have access to critical information on how they may respond to a commonly prescribed medication, based on their genetics," Noura Abul-Husn, 23andMe's VP of genomic health, said in a statement. "With this clearance, we are continuing to champion access to actionable health information so that everyone can benefit from a personalized healthcare experience, and avoid negative side effects of medications where possible."
Simvastatin is sold as Zocor by Merck and as FloLipid by Salerno Pharma.