FDA Gives the Direct-to-Consumer Cancer Risk Test of 23andMe a Go-Signal

By The U.S. Food and Drug Administration (FDA Sign & Bldg 21 at Entrance) [Public domain], via Wikimedia Commons

For a lot of people, cancer screening is not all that accessible — as people would usually need an obvious genetic background that suggests that they are at risk, which does not help if you fall between those cracks. People should not have to cover that gauntlet for much longer.

The Food and Drug Administration of the United States has approved a direct-to-consumer test of 23andMe that details the risks of ovarian, prostate, and breast cancer based on BRCA1 and BRCA2 genetic mutations. Once the report is made available, people would not have to worry about qualifying for a screening — people could easily send in a sample of their saliva and learn the results on their own terms.

Previously, 23andMe had offered tests on genetic health risks. However, it suspended the tests in order to get approval from the FDA. Last year, the agency had given a go-signal on health risk tests that are related to disease and deficiency and had streamlined the agency’s approval process later that same year.

The company is prompt to warn that the said test does not rule out cancer, and would not diagnose people if they already have it. 23andMe said that people would still want to turn to health care providers if they are going to take any action. And the kind of cancer that the test will be looking for is not very common. There is a two percent risk of it for Ashkenazi Jewish women. However, it will have a risk of less than 0.1 percent for everyone else. It is said to be the first approved test of its kind, however, and the said test hints at a future where those who are not willing to wait for formal screenings (or are denied of access) can take action early enough to possibly prevent cancer.