FDA Approves Genetic Test for Disease Risk [VIDEO]
The regulators at the Center for Devices and Radiological Health of the US Food and Drug Administration (FDA) have approved the sale and marketing of a genetic test for disease risk from the genetic-testing company 23andME last week.
The company aims to allow consumers to have access to personal testing kits that will give information on certain genetic risk factors. The genetic test for disease risk is to be released in the market as 23andMe Personal Genome Service Genetic Health Risk (GHR) where samples of the consumer's DNA from the saliva is tested for 500,000 genetic variants, the FDA said in a press release. The likelihood of developing a certain disease or condition depends whether the variant is there or not.
The GHR claims to be able to provide risk information on 10 conditions or diseases which include Alzheimer's, Parkinson's, and celiac disease. The company markets this product as a direct-to-consumer product where the consumer spits into a collection tube and registers the sample online before sending it to the laboratory. The results of the genetic test for disease risk will be available online in as little as six weeks.
Like all test kits, the GHR can also produce false positives and false negatives. The observers of the FDA decision to approve the kit are worried because the market might take advantage of the product to jack up prices of follow-up treatments or insurance non-coverage, the Scientific American reported.
It will not be able to rank or grade a person's predisposition to develop the disease, only that the person does have the genetic variants. The FDA also discourages consumers from using the results of diagnosis or treatment decisions.
So while the GHR is handy, the surest way to know will still be through a physician or a genetic counselor. The medical representatives will be able to correctly assess and put into context the likelihood of developing a condition based on health status, lifestyle, and environmental influences.