FDA Allows 23andMe To Sell Genetic Tests For Disease Risk
08 April, 2017, 07:11 | Author: Michele Stevens
The Food and Drug Administration (FDA) is now allowing the first at-home genetic testing kit to be sold to consumers. "But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won't ultimately develop a disease".
The approval - granted to the California-based company 23andMe Inc. - could help test users make lifestyle choices or spark important discussions with health care providers, the FDA said.
But some are stillconcerned about whether the genes in question actually correspond to a higher risk of disease reliably enough to warrant direct-to-consumer marketing and testing, as opposed to genetic testing with the guidance of a professional.
The approval of the 23andMe GHR tests was supported by data from peer-reviewed, scientific literature that demonstrated a link between specific genetic variants and each of the 10 health conditions.
The newly approved tests work by isolating DNA from a saliva sample.
The other three are glucose-6-phosphate dehydrogenase deficiency (or G6PD), a red blood cell condition; an iron overload disorder called hereditary hemochromatosis; and hereditary thrombophilia, a blood clot disorder. Along with general controls, special controls provide sufficient assurance of safety and efficacy of the GHR and similar tests. In 2013, the company was under tough scrutiny by the FDA, and received a warning letter regarding the accuracy of their results for over 250 health conditions.
Google is one of the companies that have provided venture capital to 23andMe. As a result, the FDA will allow several other biotech companies developing GHR tests to enter the market after a one-time review process by the agency.
News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services.
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