- This FDA statement reports approval for DTC testing by 23andMe for 3 mutations in the BRCA genes. However, there are over 5400 mutations in BRCA1 and BRCA2 which are not tested for in this test.
- For those who test positive, this test is very relevant especially if they did not find out about their mutation any other way.
- However, this test is only relevant for the very small percentage of individuals who carry the 3 BRCA founder mutations. For those who meet testing criteria, these mutations as well as all other known BRCA mutations are routinely screened for in a clinical setting.
- While the FDA cautions anyone using this test about its limitations, it is likely that many consumers will not understand their cancer risks along with strategies for cancer prevention and early detection.
- The approval states that the company submitted data on user comprehension studies that showed instructions and reports were generally easy to follow and understood by a consumer; however, these results have not been released to the general public. Thus it is impossible to critically evaluate and/or repeat these studies which will be needed to confirm that consumers do indeed understand the test and implications of the results.
Research Timeline: Post-Approval