"This is an important moment for people who want to know their genetic health risks and be more proactive about their health", said Anny Wojcicki, the CEO and co-founder of 23andME.
In GHR tests, more than 500,000 genetic variants are searched for, which may be associated with the diseases mentioned below. Apart from certain genetic variants, various environmental and lifestyle factors may be equally crucial in causing disease conditions.
The newly approved tests work by isolating DNA from a saliva sample. The presence or absence of these variants is linked with higher risk for any one of 10 diseases and conditions.
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. The market approval means consumers can have access to certain genetic risk information, but test results don't indicate with certainty that a person will or will not eventually develop a disease, according to Jeffrey Shuren, MD, director at the FDA Center for Devices and Radiological Health.
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The FDA also announced they intend to create an exemption for subsequent GHRs from the company, which would allow similar tests from other manufacturers to market their own test kits after a one-time FDA review.
The move on [April 6] is a turnaround for the agency, which had imposed a moratorium in 2013 on disease tests sold by the company, 23andMe, which is based in Mountain View, Calif.
The genetic health risk (GHR) tests are available from the 23andMe personal Genome Service. In addition, FDA said it is establishing criteria, known as special controls, to clarify the agency's expectations in assuring the tests' accuracy, reliability, and clinical relevance. Days after the FDA sent a warning letter, the company was sued for "falsely and misleadingly" advertising their tests could provide information on more than 240 conditions and traits.