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The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. REUTERS/Jason Reed

The U.S. Food and Drugs Administration has approved the marketing of 23andMe’s Bloom Syndrome carrier test, which can determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. The carrier screening tests have also been classified as class I, but the administration and these devices will be exempt from the FDA premarket review.

“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,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press announcement. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”

Though the FDA has not but any limitations on who can use the test and how many times, it does require 23andMe to explain to the consumer in the product labeling what the results might mean for prospective parents interested in seeing if they carry a genetic disorder. When sold over the counter, the manufacturers will also have to educate the customer about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling.

To test the effectiveness and safety of the test, 23andMe conducted two separate studies. One study conducted at two laboratories tested a total of 123 samples, including samples from known carriers of the disease. An additional study evaluated 105 samples at two additional laboratories. Both studies showed equivalent results in detecting carrier status of Bloom syndrome when the same samples were tested.

In November 2013, 23andMe came under the wrath of the FDA. The administration asked them to stop selling their Personal Genome Service (PGS) due to lack of scientific evidence of its effectiveness. The kit claims to identify genetic health risks associated with 250 diseases and conditions.

"Months after you submitted your 510(k)s and more than [five] years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests," the FDA stated in their letter to the company.

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