Shares of 23andMe Holding Co.
ME,
jumped 23% in the extended session Thursday after the genetics and biopharmaceutical company said that the U.S. Food and Drug Administration has cleared it to add more gene variants to the company’s direct-to-consumer health reports on genetic risks for certain cancers. The 41 gene variants in question are associated with higher risk for breast, ovarian, prostate, pancreatic, and potentially other cancers, 23andMe said. The company received the first FDA authorization for its direct-to-consumer genetic test for cancer risk in 2018 to report only three variants, mostly found in people of Ashkenazi Jewish descent. “Many of the 41 BRCA variants added through this clearance are known to have a higher rate of occurrence in populations traditionally underserved by genetic testing, including the African American and Hispanic/Latino communities,” the company said. “We continue to be the first and only company with FDA clearance to provide genetic information on cancer risk directly to consumers, without a prescription,” Chief Executive Anne Wojcicki said in a statement. The company plans to release the report update by the end of fiscal 2024. As with other genetic health-risk reports, people will have to specifically opt in to receive the information, and the report will include an educational component, the company said. Shares of 23andMe ended the regular trading day down 19%.
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