Genetic testing for health conditions (such as risk for cancer) typically requires a prescription from a doctor. Until recently, direct-to-consumer (DTC) genetic testing has focused on tests to learn your ancestry and find 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 warns people about the limitations of the 23andMe test. (03/19/18)
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.
NCCN cautions about genetic testing through companies that provide ancestry testing (such as 23andMe). Commercial entities providing ancestry (and sometimes health) information typically do so through a type of testing known as “SNP-based testing”. This testing has not been validated for clinical use. Research suggests that the error rate for these tests may be substantial.
In their approval, the FDA make the following notes about test results through 23andMe:
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.