In what may be touted as a major development in the healthcare space, the U.S. FDA has approved 23and Me’s screening tests for breast & ovarian cancer genes. The Federal agency of the country described the clinical trials as the first step toward self-testing. Reportedly, these trials have been designed for three BRCA1/BRCA2 mutations generally observed in Jewish, Ashkenazi, and East European population. Experts predict that such genetic mutations raise an individual’s risk for acquiring breast & ovarian cancer.
It has been reported however, that this approval is subject to various cautions & caveats. One of the cautions that FDA has issued for the individual is that if one tests positive for the BRCA1 or BRCA2 gene mutation, the person should not go for any forms of treatment such as prophylactic oophorectomy or breast removal. The nation’s federal agency has further advised that the users should not go undergo any further therapies without consulting a doctor or genetic counselor.
According to Donald Pierre, the Acting Director of the Radiological Health dept. in FDA’s Center, a very less percentage of U.S. residents are at the risk of suffering from breast & ovarian cancer, since most of them do not carry one of the three BRCA1 or BRCA2 gene mutations. He further added that though the three mutations identified by the tests show high probability of breast cancer occurrence in an individual, the test is not engineered to recognize many of the other BRCA mutations that can cause cancer.
Anne Wojcicki, the co-founder of 23andMe, has announced that the FDA approval of its screening tests is a key milestone for the firm across the consumer health sector. Experts are of the view that the new self-tests will create awareness about the BRCA gene mutations among the female populace that is more prone to breast & ovarian cancer.