Print

FDA approves at-home test kits for inherited cancer: how useful are they?

https://www.facingourrisk.org/XRAYS/fda-approves-dtc-testing
Full article: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm

Interest in personalized genetic testing is growing. Genetic testing about health conditions typically requires a prescription from a health care provider. Until recently, the direct-to-consumer (DTC) testing market has focused on ancestry and discovery of unknown branches of family trees. A laboratory called 23andMe that provides direct-to-consumer genetic testing has been given FDA approval to report results for 3 mutations found in the BRCA1 and BRCA2 genes. The FDA statement provides details about this approval and cautions consumers about the limitations of the 23andMe test. (03/19/18)

Expert Guidelines

At the present time, this approval does not lead to any changes in recommendations for genetic counseling and testing. The National Comprehensive Cancer Network is a consortium of experts in cancer and genetics. They publish consensus guidelines for genetic counseling and testing for cancer risk.

In their approval, the FDA make the following notes about test results through 23andMe:

Questions To Ask Your Health Care Provider

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.