FDA to consider approval of personalized DNA testing kit to determine disease risk

fda logo FDA to consider approval of personalized DNA testing kit to determine disease riskGenetic test maker 23andMe has applied for Food and Drug Administration (FDA) approval of a saliva-based DNA test that would enable consumers to look at their genetic code for information about their ancestry and what diseases they may develop in the years to come.

Such personalized kits have caught flack for claiming to help users detect if they are likely to develop diseases such as breast cancer, heart disease and Alzheimer’s disease. Geneticists say that how DNA variations lead to certain diseases is still poorly understood and that tests that claim to predict these risks is not reliable.

But the gamble is enough for Google co-founder Sergey Brin to invest millions in the company. Brin is also married to Anne Wojcicki, CEO and co-founder of 23andMe. Wojcicki says the test kit has expanded and can now measure the risk of developing more than 115 diseases. The idea is that consumers who find out they are at risk for a particular ailment would have the opportunity to work with their physician on how to manage their health.

In an effort to gain FDA approval, 23andMe has submitted this week an initial batch of seven health-related tests for review, with plans to submit an additional 100 tests in separate installments by the end of the year. Tests involving family history and non-medical trials will not be a part of the review since they do not fall under FDA oversight.

The FDA currently regulates a variety of genetic tests but they are administered by health care professionals. These tests include tests for pregnant women to determine cystic fibrosis risk and testing for the breast cancer gene. If approved, 23andMe would be the first at-home DNA testing kit of its kind approved for personal use.

Source: Lex18