Thursday, 22 June, 2017

FDA Approves Marketing Of Consumer Genetic Tests For Some Conditions

First Consumer Genetic Health Risk Test Gets FDA Approval FDA OKs 1st At-Home Genetic Tests for 10 Disorders
Arthur Frazier | 08 April, 2017, 00:30

The presence or absence of some of these variants is linked to an elevated risk for developing any one of the following diseases or conditions: Parkinson disease, late-onset Alzheimer 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.

The tests are meant to be used to "make decisions about lifestyle choices or to inform discussions with a health care professional", the FDA stated in a news release.

The tests work by isolating DNA from a saliva sample; this sample is then tested for 500,000 genetic variants.

The 10 conditions are all heavily determined by DNA variants - and the company has demonstrated the ability to relay the risk factors in consumer-friendly ways that have been backed by peer-reviewed science, the federal agency announced.

EU regulators approve Fox plans to buy Sky
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In a historical approval by the U.S. FDA, 23andMe, a personal genomics and biotechnology company based in California, has been allowed to directly market to consumers its Personal Genome Service Genetic Health Risk (GHR) tests for as many as 10 conditions or diseases. It said it may also exempt such tests from other companies that meet preliminary expectations.

The FDA said 23andMe will not be required to submit additional tests for review prior to being marketed. Genetic tests used for diagnosis or to determine a preventative course of treatment-such as the BRCA test, which indicates a high risk for breast and ovarian cancer and often leads to prophylactic surgery-are excluded from this FDA approval. In 2013, the company was under tough scrutiny by the FDA, and received a warning letter regarding the accuracy of their results for over 250 health conditions.

Users of these tests should consult a health care professional with questions or concerns about results, the FDA said.

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