23andMe (NASDAQ:ME) shares are on the rise today after the genetics and biopharmaceutical company bagged a 510(k) clearance from the U.S. Food and Drug Administration to expand its current BRCA1/BRCA2 genetic health risk report.
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This clearance means the company can now report an additional 41 variants in the two genes. BRCA1 and BRCA2 are associated with an increased risk of breast, ovarian, prostate, and pancreatic cancer. The company’s first authorization (in 2018) for a genetic test for cancer risk covered 3 variants in BRCA 1 and BRCA2.
Impressively, this is the fourth FDA clearance for genetic cancer risk for 23andME. Furthermore, the healthcare regulator has also granted a Predetermined Change Control Plan (PCCP) to 23andME. This will enable 23andME to add additional variants and associated risk information for BRCA1 and BRCA2 into its report without the need for any additional premarket review.
Remarkably, 23andME is the first company in the market to provide genetic information about cancer risk to consumers without the necessity of a prescription.
Overall, the Street has a consensus price target of $3.88 for ME, along with a Moderate Buy consensus rating. This points to a mouth-watering 233% potential upside for the stock.
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