FDA asks gene test kit company to show regulatory approval

BEIJING, May 13 (Xinhuanet) -- U.S. Food and Drug Administration (FDA) asked the Pathway Genomics Corp to show it has regulatory approval for its saliva genetic test kits, according to media reports Thursday.

The agency released a May 10 letter to the privately-held Pathway saying the agency was "unable to identify" FDA approval for its Genetic Health Report.

The letter said the kit appears to be a medical device. If Pathway doesn't think the gene test requires FDA clearance, it should provide its reasoning to the agency.

Pathways Genomics, the San Diego maker, plans to sell its gene test kits on May 14 at Walgreen Co. retail stores, making it the first U.S. drug store chain to put such tests in the local pharmacy.

The company said the test aims to help people assess their risk for inherited diseases.

Pathway's test offers to provide customers information on their ability to respond to drugs and their risk of developing various diseases and passing conditions on to their children.

(Agencies)

Editor: Bi Mingxin

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