FDA to exempt carrier tests from premarket review

FDA granted approval to the Bloom syndrome carrier test from 23andMe Inc. (Mountain View, Calif.) and said it intends to classify autosomal recessive carrier screening tests as class II devices and will exempt these tests from premarket review. The exemption will apply to class II carrier tests adherent to Clinical Laboratory Improvement Amendments (CLIA) that would have been subject to premarket review under FDA's proposed regulatory framework for laboratory developed tests (LDTs) (see BioCentury, Sept. 30, 2014).

The agency will issue a notice announcing its intent to make the exemptions and provide a 30-day public comment period. ...