Wednesday, 23 January, 2019

FDA gives nod to 23andMe for no-prescription breast cancer gene testing

FDA gives nod to 23andMe for no-prescription breast cancer gene testing FDA gives nod to 23andMe for no-prescription breast cancer gene testing
Melissa Porter | 07 March, 2018, 14:46

The test detects only three out of more than 1,000 known BRCA mutations and are not the most common ones in the general population, the drug regulator said.

US regulators have approved the first direct-to-consumer breast cancer gene test.

In a prepared statement, Donald St. Pierre, acting director of the office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, called the approval a step forward with "a lot of caveats".

This test analyzes a sample of saliva and screens for three mutations of the BRCA1 and BRCA2 genes. In addition to testing, it is important for patients to discuss cancer risk related to lifestyle factors with their providers, according to the release. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the U.S., and could significantly raise the number of people aware of having the cancer-related mutations. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor. It can not determine a person's overall risk of developing cancer.

Genetic testing powerhouse 23andMe announced today that it's officially received the FDA go-ahead to launch a direct-to-consumer testing kit for genes linked to various forms of cancer. For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations. The variants also are associated with ovarian cancer in women and breast and prostate cancer in men. Anne Wojcicki, co-founder and chief executive of 23andMe, said the company's experience selling the test before 2013 in the U.S., United Kingdom and Canada had provided insight into how useful the information can be, particularly to customers who did not realize they had Ashkenazi Jewish heritage. The regulator said it reviewed data for the company's test under a pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. At this time, the FDA is also establishing special controls that outline the agency's expectations for accuracy, reproducibility, clinical performance, and labeling.

23andMe earned the authorization based on data showing accurate identification of these three variants in saliva.