Devices

FDA OKs Genetic Risk Tests for Certain Conditions

FDA says that 23andMe can market its Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions. An agency statement says they are the first direct-to-consumer tests authorized by FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help people make decisions about lifestyle choices or to inform discussions with a healthcare professional.

While the tests are intended to provide genetic risk information to consumers, they cannot determine a person’s overall risk of developing a disease or condition. The 23andMe tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants. The presence or absence of some of the variants, FDA says, is associated with an increased risk for developing any one of these diseases or conditions: Parkinson’s disease, late-onset Alzheimer’s disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, glucose-6 phosphate dehydrogenase deficiency, hereditary hemochromatosis, and hereditary thrombophilia.

FDA reviewed data for the tests through its de novo premarket review pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. The agency says it intends to exempt additional 23andMe genetic health risk tests from premarket review, and such tests from other companies may be exempt after submitting their first premarket notification. It says that such an exemption would allow other similar tests to enter the market as quickly as possible and in the least burdensome way, after a one-time FDA review.

Excluded from this marketing authorization and any future related exemption are genetic health risk tests that function as diagnostic tests.

Risks associated with the tests include false positive and false negative readings.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome