WASHINGTON — The largest U.S. drugstore chain, Walgreen Co., said Wednesday that it will hold off selling what was poised to be the first over-the-counter genetic test, after the Food and Drug Administration said the kit has not been proven effective.
Pathway Genomics announced Tuesday that its saliva swab would be on Walgreen’s shelves later this month, offering millions of Americans the chance peek into their genetic code for signs of inheritable diseases such as Alzheimer’s.
But within 24 hours, the company’s plan was met with stiff response from FDA regulators who said the products may run afoul of federal laws governing medical tests. On Wednesday, the FDA posted a letter to Pathways online, indicating the San Diego-based company never submitted its product for federal review, a requirement for medical devices.
