Friday, September 1, 2023


US Food and Drug Administration

FDA Roundup: September 1, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

  • On Thursday, the FDA cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). It is a direct-to-consumer (DTC) test that reports selected BRCA1/BRCA2 genetic variants from human saliva collected from individuals 18 years or older. The test was updated to add 41 BRCA1/BRCA2 variants to the previously authorized test. 

    The test analyzes DNA from a self-collected saliva sample and generates personalized reports that describe if the genetic variants detected in that sample are associated with an increased risk of developing breast and ovarian cancer and may be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers. The variants included in this report do not represent the majority of the BRCA1/BRCA2 variants in people of most ethnicities. This means a negative result does not rule out the presence of other variants that increase cancer risk. These reports provide genetic information to inform discussions with a healthcare professional. Consumers and health care providers should not use the test results to substitute for healthcare visits for recommended cancer screenings or appropriate follow-up, and results from this test should not be used to determine any treatments. 

    This is the latest example of the FDA’s ongoing commitment to advance access to safe and effective DTC genetic testing intended to aid patients in having informed conversations with their healthcare providers.
  • On Wednesday, the FDA issued a Safety Alert to advise restaurants and retailers not to serve or sell and consumers not to eat certain cultured mussels from East River Shellfish, Inc. due to a possible salmonella and E. coli contamination.

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