First Breast Cancer Home-Screening DNA Test Cleared By FDA
While the FDA cautioned that regular checkups and screenings are still needed, the decision allows people to initiate testing on their own for three genetic mutations that put them at a substantially higher risk of developing breast and ovarian cancer.
The Associated Press:
FDA Clears DNA Test To Spot Cancer Genes, But With Warnings
U.S. regulators have approved the first direct-to-consumer breast cancer gene test. But the Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe. The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene mutations. It cannot determine a person's overall risk of developing cancer. (3/6)
The New York Times:
F.D.A. Approves First Home Testing For 3 Breast Cancer Mutations, With Caveats
The agency’s action on Tuesday permits the testing company, 23andMe, to report results as part of its $199 Health and Ancestry product, which uses DNA from saliva samples to inform customers about their families’ countries of origin, along with information on genetic health risks. There will be no extra charge for the additional reports, which should be available in a few weeks to customers who actively opt in and request to see them, company officials said. (Rabin, 3/6)
The Washington Post:
23andMe Gets FDA Approval To Report Breast Cancer Risk Without A Doctor
The Food and Drug Administration decision is a step forward for the evolving world of consumer genomics. The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population. Those mutations are not the most common BRCA mutations in the broader population. (Johnson, 3/6)
Stat:
FDA Approves First Direct-To-Consumer Test For Breast Cancer Risk
Federal regulators approved the first direct-to-consumer test for the BRCA genes, which increase the risk of breast and ovarian cancer, the agency announced on Tuesday. The test for the BRCA1 and BRCA2 genes, from 23andMe, uses a saliva sample. But it assesses only three of the more than 1,000 known BRCA1/2 mutations, raising concerns that women who are told they do not have any of those variants will be lulled into believing that, as a result, they do not have an elevated risk for breast and ovarian cancer. (Begley, 3/6)
