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FDA green-lights more 23andMe genetic tests

FDA green-lights more 23andMe genetic tests

While the GHR tests may provide genetic risk information, they can not determine a person's overall risk for developing a disease, as other factors beyond genetics (ie, environment, lifestyle) may also influence risk. "Consumers can now have direct access to certain genetic risk information", said Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health.

The "Personal Genome Service Genetic Health Risk" tests the FDA approved include tests for Parkinson's disease, Celiac disease and late-onset Alzheimer's among others. In addition, the FDA looked at studies which showed that 23andMe GHR tests correctly and consistently identified variants associated with these conditions from saliva samples.

But some are stillconcerned about whether the genes in question actually correspond to a higher risk of disease reliably enough to warrant direct-to-consumer marketing and testing, as opposed to genetic testing with the guidance of a professional. With GHRs, a person can bypass their doctor and test their predisposition to develop certain medical diseases or conditions without obtaining a prescription.

Somehealth professionals worry that consumers will "take the results and run", as Mary Freivogel put it. Freivogel, a certified genetic counselor and the president of the National Society of Genetic Counselors, added that genetics are just "one piece to the story when it comes to developing a disease".

Deadly Truck Attack In Sweeden
The auto bomb never went off and after setting fire to the Audi, he was unable to detonate the other two explosives as planned. Sweden's King Carl Gustaf said in a statement: "Our thoughts are going out to those that were affected, and to their families".

Thrombophilia (hereditary); a blood clot disorder. The agency also established criteria known as special controls clarifying its expectations for assuring the tests' accuracy and reliability.

The FDA said it does not plan exemptions for genetic health risk tests that function as diagnostic tests, which might be used for major treatment decisions.

Google is one of the companies that have provided venture capital to 23andMe. "Putting this in the hands of the consumer with a test that has that gray zone of false positive, false negative, is going to be a disaster", Minazad said.


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