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DTC Genomics Targeted by Congressional Investigation

By Turna Ray

NEW YORK (GenomeWeb News) – Pathway Genomics' attempt to market genetic tests at retail stores Walgreens and CVS/Caremark has not only invited regulatory action from the US Food and Drug Administration, but now it has raised eyebrows in the US Congress.

Henry Waxman, chairman of the House Committee on Energy and Commerce, announced today that the committee is investigating direct-to-consumer genomic companies. As part of that investigation, the committee has sent letters to three firms — Pathway Genomics, 23andMe, and Navigenics.

Decode Genetics, the Icelandic molecular diagnostics firm that runs a DTC genomics service in many US states, called DecodeMe, was not sent a letter.

According to a statement posted on the committee website, the letters were prompted by "recent reports that at least one of the companies is seeking to sell personal genetic testing kits in retail locations, despite concern from the scientific community regarding the accuracy of test results."

Congressional action comes after FDA last week sent a letter to Pathway concerning its announcement that pharmacy chain Walgreens would offer the firm's saliva sample collections kits related to its personal genomics service. That service tests people's predisposition for disease, gauges their pharmcogenomic drug responses, and conducts pre-pregnancy genetic testing.

In its letter to these companies, the House committee is requesting information on several aspects of the tests they sell directly to the consumer, including the specific diseases and drugs for which the services provide genomic risk data; policy documents and materials on genetic counseling or physician consultation; data showing the accuracy of the risk predictions delivered by these services; details on policies regarding handling of DNA samples; as well as documents relating to the services' compliance with FDA regulation.

The requested information, which includes documentations from Jan. 1, 2007 to the present, must be submitted to the committee by June 4, according to the letters.

Although the FDA has not issued any formal guidelines specific to DTC genomics firms, it has always said it has the authority to regulate these services. In comments to GenomeWeb Daily News sister publication Pharmacogenomics Reporter last week, Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, said that long before Pathway decided to migrate its service from the internet to store shelves, the agency had been in discussions with players in the DTC genomics industry.

After receiving FDA's letter, Walgreens backed out of its plans with Pathway to sell the kits at its stores. Simultaneously, CVS/Caremark said it had intended to sell Pathway's saliva sample collection kits in a similar deal beginning in August, but now has put those plans on hold until regulatory issues are resolved.

In a blog post last week, Navigenics said that from the inception of the company it has sought "to work closely with regulators." The company pointed out that it has participated with others in the industry and the Personalized Medicine Coalition to set industry standards; agreed to not market its test to consumers but go through doctors in New York, which bans DTC marketing of genetic tests; and has obtained a laboratory license to operate as a DTC firm in California.

After receiving the letter from the House Committee on Energy and Commerce, Navigenics told Pharmacogenomics Reporter that Navigenics "has always followed [its] own policy of transparency and open communication with state and federal governments.

"In fact, we have already proactively engaged in conversations with key stakeholders in Washington this week, including with senior staff at the House Committee on Energy and Commerce a day before this letter was issued," said Amy DuRoss, Navigenics VP of policy and business affairs. "We will be glad to respond to the Committee's requests in a timely fashion, and we look forward to further cooperation with committee members in the future."

Additionally, 23andMe issued a statement after receiving the letter from the House committee, saying, "We will comply with the Committee on Energy and Commerce's request for information. We look forward to sharing information detailing what individuals can learn about their own bodies through personal genetic testing and how our company is facilitating important scientific research in the field."

A more comprehensive version of this article is available on Pharmacogenomics Reporter.