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Genetic test maker 23andMe is seeking approval from the Food and Drug Administration to approve its personalized DNA test for use by consumers.
The company is part of a fledgling industry that allows consumers to gain knowledge about their genetic code, and seek reference about their ancestry and future health. It’s salivia-based kits have attracted scrutiny due to their claim to aid users in the detection of illnesses like breast cancer, heart disease, and Alzheimer’s, a claim that is not without a plethora of critics.
23andMe’s decision to submit material to the FDA may give them competitive advantage over other rival companies, such as deCODE Genetics and Navigenics, which market similar tests.
The company stated Monday that they had submitted an initial batch of seven health-related tests to the FDA for review and also plans to submit 100 additional test in separate installments before the end of the year.
Even some of the harshest critics of the genetic testing industry agree that 23andMe is taking the right approach.
Dr. James Evans of University of North Carolina said he considers much of the information reported by 23andMe, “relatively useless,” and “in the realm of entertainment.” He believes patients benefit more from pursuing a healthy lifestyle than parsing the potential risks of developing various diseases.
But as test makers begin analyzing larger portions of genetic code, there are rare cases when the findings may help doctors identify patients with a higher risk of treatable health problems, such as colon cancer.
Proponents of genetic testing say 23andMe’s bid for FDA approval is an important step in regulating an emerging application for genetic information.
However, it remains to be seen if the FDA will endorse 23andMe’s tests for consumers.