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FDA grants marketing authorization for direct-to-consumer genetic test for Bloom syndrome
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The FDA has authorized marketing of 23andMe’s Bloom Syndrome Carrier Status test, a direct-to-consumer genetic test that could determine whether a healthy person has the gene variant that could lead to offspring inheriting the disorder.
The FDA evaluated the 23andMe’s Personal Genome Service 510(k) submission for the Bloom Syndrome Carrier Status test report through the de novo regulatory pathway, according to a press release from 23andMe.
According to a separate FDA press release, the administration is now classifying carrier tests as class II, as the FDA intends to exempt the devices from premarket review. A notice that announces the intent to exempt these tests will be issued, and a 30-day period for public comment will be provided, the release stated.
“The FDA believes that in many circumstances, it is necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” Albert Guiterrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the FDA release. “These tests have the potential to provide people with information about the possible mutations in their genes that could be passed on to their children.”
Bloom syndrome is rare and is more common in people of Central and Eastern European, or Ashkenazi, Jewish background, according to the 23andMe release. Short stature, sun-sensitive skin changes and increased risk of cancer are characterizations of the disorder.
The company is required to explain in product labeling what the results might mean for prospective parents interested in determining whether they carry a genetic disorder, the FDA release stated. Additionally, if sold over the counter, the FDA also is requiring 23andMe to provide information to consumers on how to gain access to board-certified molecular geneticists or the equivalent to assist in counseling.
Two separate studies were conducted by 23andMe to demonstrate that the test was accurate in detecting Bloom syndrome carrier status, according to the FDA release.
References: www.fda.gov, www.23andme.com.