23andMe Granted FDA Clearance to Expand Genetic Risk Reports for Cancer

by Warren Seah

Shares of 23andMe Holding Co. experienced a noteworthy surge of 23% during the extended session on Thursday. This significant increase comes after the genetics and biopharmaceutical company revealed that it has obtained clearance from the U.S. Food and Drug Administration (FDA) to include additional gene variants in its direct-to-consumer health reports, focusing specifically on genetic risks associated with certain types of cancer.

The latest clearance sets 23andMe apart as the sole company granted FDA approval to provide genetic information regarding cancer risk directly to consumers, eliminating the need for a prescription. Chief Executive Officer Anne Wojcicki expressed her satisfaction with this achievement, stating, “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.”

Promisingly, the expanded range of 41 BRCA variants will be particularly beneficial for populations that have been historically underserved in terms of genetic testing. This includes African American and Hispanic/Latino communities who will now have access to valuable information related to their specific genetic profiles.

The report update, anticipated for release by the end of fiscal 2024, will require individuals to actively opt in to receive the updated information. As with other genetic health-risk reports offered by 23andMe, the report will also incorporate an educational component to enhance understanding and awareness.

Although 23andMe experienced a decline of 19% in shares at the close of regular trading earlier in the day, the recent FDA clearance and the subsequent expansion of its genetic risk reports for cancer represent a significant milestone for the company and its commitment to empowering consumers with vital information pertaining to their health and well-being.

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