WASHINGTON Federal scrutiny over at-home genetic testing continues to snowball in the wake of an abortive plan by one testing kit supplier to sell the products through the nation’s two largest drug store chains. Both chains, Walgreens and CVS/pharmacy, last week temporarily suspended their plans to begin offering kits produced by Pathway Genomics Corp. after the Food and Drug Administration raised concerns about the efficacy and approval procedure for the test.
In the latest development, the House Energy and Commerce Committee has begun looking into personal genetic testing kits sold online, according to a report Wednesday from Dow Jones news service. The committee and its chairman, California Democratic Rep. Henry Waxman, are asking Pathway and two other kit makers, 23andMe Inc. and Navigenics Inc., to provide information about the test and the accuracy of its results, Dow Jones reports.
All three companies sell the saliva-based kits online, and provide lab analysis of the results for a fee. But press reports last week about Pathway’s plan to sell the kits at retail triggered new attention from the FDA, which announced that the kits aren’t FDA-approved. Concerns raised by the agency prompted both Walgreens and CVS to suspend plans to sell the products until those issues were resolved.
Pathway has claimed that the test kits don’t fall under FDA approval requirements, but said it is working with the agency to resolve the issue.