Earlier this week, the FDA gave its approval for commercialization to 23andMe.
Earlier this week, the U.S. Food and Drug Administration gave its approval for commercialization to 23andMe. This latter is a product which can test and offer genetic information directly from the user’s home and without any specialized medical involvement. It will be able to detect 10 medical conditions or diseases, including Parkinson’s, AD, or celiac disease.
The FDA published an announcement on the matter on its official page. In it, the agency offered details as to the utility and availability of this product. This mark a step forward in the area as this is the first direct-to-consumer DNA test to receive approval from the administration.
23andMe Should Help Detect Genetic Health Risks
According to 23andMe, the company’s DNA test kits should help identify several genetic health risks. This may help establish whether the respective person is at risk of developing a medical condition or disease. However, the test cannot determine for sure whether or not the patient will actually fall ill.
This cannot yet be determined due to a number of facts. For example, research has yet to establish all the genes associated with some of the tested diseases. At the same time, the environment and lifestyle can play an important role in developing, or not, an affection. As it is, the 23andMe testing kit should still be a useful tool.
It may help people determine whether they are at risk of developing a medical affection. Based on this result, they can bring changes to their lifestyle, visit a specialist, or gather more information on the matter, to state just a few possible consequences. However, the FDA warns people against taking drastic measures based solely on this result.
“Consumers can now have direct access to certain genetic risk information.” This is according to Jeffery Shuren. He is the director of the FDA Center for Devices and Radiological Health.
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