Women's Health

FDA Approves Historic First At-Home Breast Cancer Genetic Test

With a lot of caution, this test could help drive a consumer-driven healthcare model

Despite the safety and reasonable effectiveness of the at-home genetic test for breast cancer, most mutations in BRCA genes that increase an individual’s risk are not detected by this test. Moreover, the results may be overwhelming and upsetting, potentially burdening one’s mental health and putting them in a tailspin or providing them with a false sense of security. Regardless, the at-home genetic test is risk information that is relevant, affordable, and can lead to potentially life-saving interventions, so a balance must be made. “We will continue pioneering a path for greater access to health information, and promoting a more consumer-driven, preventative approach to healthcare,” said Wojcicki.

References

https://cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet

https://newsweek.com/fda-approves-first-ever-breast-cancer-genetic-test-home-use-landmark-decision-832392

https://mediacenter.23andme.com/press-releases/23andme-granted-first-fda-authorization-direct-consumer-genetic-test-cancer-risk/

https://medscape.com/viewarticle/893540

https://fda.gov/newsevents/newsroom/pressannouncements/ucm599560.htm

https://radiologybusiness.com/topics/care-delivery/fda-approves-1st-direct-consumer-genetic-test-cancer-risk