After previously issuing a warning letter to 23andMe for marketing a genetic test to consumers without FDA clearance or approval, the agency authorized the company to market its Bloom Syndrome carrier test, which is a direct-to-consumer ("DTC") genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the disorder. This is the first FDA authorization for a DTC genetic carrier test. In a press release, the agency stated, "[t]he 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." FDA plans to issue a notice announcing the agency's intent to exempt those tests from premarket notification that will provide for a 30-day comment period.
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