First Walgreens, Now House Calls: The Increasingly Bizarre Predicament of DTC Genetic Testing

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.

Maybe it's all part of FDA's strategy to confuse and frighten the target of its investigation: First OIVD Director Alberto Gutierrez has said that the FDA had begun to monitor DTC genetic tests "carefully" before Pathway had ever expressed plans to sell its kit in Walgreens. But in the same breath he said "[t]he fact is that Pathway's bold move to make themselves noticed achieved its end and brought them to our attention [emphasis added]."

Around that time an agency spokesperson said the FDA bared its teeth at Pathway because the company "moved outside of the currently sanctioned boundaries for lab-developed tests." But one week later another FDA spokeswoman, this time Erica Jefferson, told Reuters that the agency is examining various genetic tests in part to determine if a doctor is involved in helping patients understand the results.

Meantime, in his letter to Pathway last week, James Woods, deputy director of Patient Safety and Product Quality at OIVD, said the agency launched its investigation because it has been "unable to identify" any FDA clearance or approval number for its DTC test.

There are other reasons why OIVD desperately needs a DTC genetic-testing game plan. And if its strategy includes all of the above then the agency has an obligation to let us know that it does. Until then DTC genetic companies and their investors, partners, customers, and rivals continue to swing in the wind.

Although I firmly believe that most congressional investigations, and especially hearings, belong under the big tent, I think this House committee deserves some credit for the same reason the FDA deserves criticism. Don't get me wrong: a Congressional investigation of DTC genetic test makers is silly at best and damaging to the nascent industry at worst.

But there's an ounce of credit due Waxman and his crew. Unlike the FDA, they have provided the three DTC companies with a relatively detailed list of the points it intends to investigate. They want the companies to describe their currently available tests (i.e., whether they are disease-predisposition or pharmacogenomic in nature); to disclose their policies toward genetic counselors; to provide scientific evidence supporting the accuracy and validity of the tests; to show how it processes and stores customer samples; and to show how the tests are in compliance with FDA regulations.

This last one is a bit cheeky since the companies have been operating all along under the belief that their tests do not need to be regulated.

In any event, it's prize time, and the prize for understatement of the week (I know it's only Thursday) should go to Vorhaus, who says the DTC genetic-testing landscape "has certainly shifted dramatically."

As for what happens next, Vorhaus, who is the resident lawyer on the DTC story, says it's "anybody’s guess." One thing's for sure: "Nobody at any DTC genetic testing company … is going to be getting much sleep over the next few weeks."