23andMe Granted New FDA Clearance to Provide Interpretive Drug Information for a Commonly Prescribed Cholesterol Medication
FDA 510(k) clearance allows 23andMe to report genetics associated with processing of certain statins, provides interpretive drug information for simvastatin, and removes the requirement for confirmatory testing of the 23andMe result
SOUTH SAN FRANCISCO, Calif., Oct. 27, 2022 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company with a mission to help people access, understand, and benefit from the human genome, today reported that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its pharmacogenetics (PGt) report for SLCO1B1 to include interpretive drug information for simvastatin, a common drug used to treat high cholesterol and triglyceride levels. The 510(k) clearance modifies the labeling of the previously authorized 23andMe SLCO1B1 Drug Transport report, removing the need for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors for simvastatin.
“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,” said Noura Abul-Husn, M.D. Ph.D., Vice President of Genomic Health at 23andMe. “A complete health picture requires a number of inputs, including genetics, which too often are left off the table in healthcare. With this clearance we are continuing to champion access to actionable health information so that everyone can benefit from a personalized health care experience, and avoid negative side effects of medications where possible.”
Simvastatin is a medication in the statin family of drugs, commonly prescribed to lower cholesterol to help reduce the risk of heart attack and stroke. In 2020, simvastatin was the second-most commonly prescribed statin, and the thirteenth-most commonly prescribed medication overall, in the U.S.* A variation of a particular gene, SLCO1B1, influences the body’s response to simvastatin. In certain ethnicities, up to 38% of people have a SLCO1B1 genotype that increases the possibility of experiencing side effects related to taking simvastatin, particularly statin-associated musculoskeletal symptoms (SAMS) risk**.
23andMe underwent rigorous analytical validation in order to meet FDA requirements to remove the need for confirmatory testing of the 23andMe pharmacogenetics report for SLCO1B1. This included method comparison studies with expanded sample collection activities in order to further mitigate the risk for false positive and false negative results. Accuracy testing achieved 99% concordance with Sanger sequencing.
As with its previously authorized pharmacogenetics reports, both 23andMe and the FDA also want to ensure that consumers understand these reports and use them properly, which includes adhering to their current medications and consulting with their healthcare providers. Based on 23andMe's previous consumer comprehension studies, over 95 percent of users understood that they should not use the report to make any changes to treatment without consulting their doctor.
About 23andMe
23andMe is a genetics-led consumer healthcare and therapeutics company empowering a healthier future. For more information, please visit .
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*Source:
**Source: Sychev DA et al. (2016). “The frequency of SLCO1B1*5 polymorphism genotypes among Russian and Sakha (Yakutia) patients with hypercholesterolemia.” Pharmgenomics Pers Med. 9:59-63.
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