Lawmakers probe consumer genetic testing kits

After Pathway Genomics proposed selling genetics tests directly to consumers without Food and Drug Administration approval and "despite concerns" about accuracy, lawmakers have launched an investigation and requested information about the products according to letters sent to three firms by a House panel, The Washington Post reports. The firms are Pathway, 23&Me and Navigenics. Walgreens drug stores withdrew their plan to sell Pathway's test after the FDA raised concerns last week (Stein, 5/19).

The Wall Street Journal: The products are already being sold over the Internet. "The test, which Pathway currently sells through its website, is designed to predict a person's risk for developing certain diseases or how they might respond to certain drugs. It can also predict the risk of 37 genetic diseases caused by recessive genes that might be passed to a child from parents." Pathway said it doesn't think the product needs FDA approval and is working with the agency to sort the matter out (Dooren, 5/20).

Reuters: Because Pathway's reports -- which provide information on up to 70 health conditions, such as an individual's potential response to prescription drugs -- are meant to help consumers "modify their lifestyles," not diagnose, treat, mitigate or cure a disease, the company says it doesn't need FDA approval. But, the lawmakers who initiative the inquiry, "two Democrats and two Republicans, said in a statement there was 'concern from the scientific community regarding the accuracy of test results'" (Richwine, 5/19).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.