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The US Food and Drug Administration (FDA) has granted the personal genomics company 23andMe authorization to market direct-to-consumer (DTC) tests that provide information about a person’s genetic risk for 10 conditions, including late-onset Alzheimer’s disease, celiac disease, and hereditary thrombophilia. This authorization, announced yesterday (April 6), does not extend to diagnostic tests associated with potentially preventative action, such as those for BRCA genes.
The FDA emphasized that while results from these tests may help inform customers’ lifestyle choices or conversations with medical professionals, the results should not be considered a diagnosis or be used to inform treatment decisions. The agency also noted the risk for false-positive and false-negative findings.
“Consumers can now have direct access to certain genetic risk information,” Jeffrey Shuren, director of the ...
