By Kirell Lakhman
An influential House committee yesterday launched an investigation into 23andMe, Navigenics, and Pathway Genomics, and has asked the companies to hand over certain documents by June 4.
The House Energy and Commerce Committee asked the consumer genetic-testing vendors to provide information about their tests' accuracy and how the companies analyze their results, among other details.
In three nearly-identical letters sent to the companies Wednesday, Committee Chairman Rep. Henry Waxman and three other legislators supported their decision to investigate the companies by citing "concern from the scientific community regarding the accuracy of test results.”
The letters were sent to Pathway CEO James Plante; Navigenics chief Vance Vanier; and 23andMe president Anne Wojcicki. Waxman is a prominent California Democrat. All three companies are based in California.
It wasn't immediately clear whether the officials would have to testify before the committee.
Apparently Navigenics has "already talked with staff on the House committee and would respond to its request for information." It has also been in contact with the FDA for more than three years and said it "believes its services comply with all existing federal and state regulations."
23andMe said it would comply with the committee's request, and that it has had "several conversations with the FDA," including a meeting that took place before the company launched its test in late 2007. "We continue to welcome dialogue with the agency," the company said.
Robert Blodgett, a Pathway spokesman, didn’t have an immediate comment on the lawmakers’ letter.
Icing on the Cake
News of the House committee's action comes two weeks after the FDA said it would investigate Pathway's tests and that it had in fact been investigating other DTC genetic-test companies on the sly for some time.
The FDA's very public action caused Walgreens and CVS, two national pharmacy chains, to shelve plans to sell Pathway's starter kits in their stores. Walgreens was to have begun selling the kits last Friday, while CVS was to put them on its shelves in August.
The committee's action, which Dan Vorhaus at Genomics Law Report calls the "first publicly reported Congressional investigation into the current generation of DTC genetic-testing companies," represents a bright Maraschino cherry planted atop the FDA's seemingly uncoordinated and contradictory investigation into Pathway.