FDA approves Google-backed home genetic test
The Food and Drug Administration (FDA) authorization pertains to a carrier screening test for Bloom Syndrome.
The FDA announced that it would “exempt these devices [carrier screening tests] from FDA premarket review,” and that it will take public comments on the change for the next 30 days.
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers,” said Alberto Gutierrez, director of FDA's office for diagnostics, in a press release.
“These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”
"Today, 23andMe was granted authorization … to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US," she wrote Thursday.
"This is also the first-time the FDA has granted authorization to market a direct-to-consumer genetic test, and it gives 23andMe a regulatory framework for future submissions. While this authorization is for a single carrier status test only, we are committed to providing US customers with health information once more tests have been through this process and we have a more comprehensive product offering."
The company ran afoul of the FDA in 2013 when it was forced to cease selling its basic, $99 at-home DNA testing kit, first marketed in 2006 as a test for more than 250 disease markers. According to WRAL TechWire, the FDA said at the time that despite many meetings and "hundreds of email exchanges,” the company did not prove its tests held scientific merit. The company’s tests were marketed as a "first step in prevention" against diseases like heart disease and breast cancer.
The test offered by 23andMe aims to detect DNA markers that indicate a gene mutation that causes Bloom Syndrome, a disorder signified by short stature, heightened cancer risk, and other health problems.
One is considered a carrier for a genetic disorder if they have one mutated and one normal gene related to that particular disorder. For a child to develop the disorder, she must inherit two genetic mutations.