As Congress Investigates DTC Genomics Market, Firms Vow Cooperation

This article has been updated to include comments from Pathway Genomics.

Originally published May 19.

By Turna Ray

Pathway's attempt to market genetic tests at retail stores Walgreens and CVS/Caremark has not only invited regulatory scrutiny from the US Food and Drug Administration, but now it has raised eyebrows at 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. The committee has sent letters to Pathway Genomics, 23andMe, and Navigenics requesting information about their services.

Decode Genetics, the Icelandic based 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 following the company's announcement that it would begin selling its personal genomics service at Walgreens. The company's test assesses people's predisposition for disease, gauges their pharmcogenomic drug responses, and conducts pre-pregnancy genetic testing (PGx Reporter 05/19/10).

In its letter to the three firms, the committee requests information on several aspects of the tests they sell directly to consumers, including the specific diseases and drugs for which the service provides 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 regulations.

The requested information, which includes documentation 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 held that it has the authority to regulate these services. In comments to 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 has been in discussions with players in the DTC genomics industry.

"The field of genetics and personalized genetic testing is a relatively new science that has developed rapidly over the last several years under limited FDA oversight," Pathway said in a statement. "During that same time there has been a robust conversation between scientists and experts from the genetics industry, the FDA, and Congress about whether updated regulations are needed, and the appropriate role that government should have in oversight of this new science."

Pathway briefly enumerated the aspects of its service that it feels fall in line with existing regulatory guidelines under the Centers for Medicare & Medicaid Services' Clinical Laboratory Improvement Amendment. In addition to operating a CLIA-certified laboratory licensed in California, Pathway highlighted that its customers are provided unlimited access to the company's board certified genetic counselors and physicians.

"We are confident that our services are both safe and of the highest quality," Pathway said.

However, the prospect of FDA regulation, and now a Congressional probe, certainly has made Pathway's would-be retail partners nervous. After receiving FDA's letter, Walgreens backed out of its plans with Pathway to market its genetic testing service 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 light of the regulatory uproar around DTC genetic testing, some DTC genomics firms are taking steps to clarify their marketing strategies while others are backing away from the DTC label.

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 it "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 this statement after receiving the letter from the House committee: “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.”

In the meantime, Counsyl, a firm that began marketing a microarray-based genetic carrier test directly to consumers last year, has decided to modify its strategy.

Balaji Srinivasan, Counsyl's chief technology officer, told Pharmacogenomics Reporter sister publication In Sequence this week that the company phased out direct-to-consumer testing earlier this month in favor of an online booking system that requires a doctor's order. The system lets consumers make their own test appointment at a clinic and provide their own billing information, but the results go directly to the physician for interpretation.

Regulation of DTC consumer genomics firms is a new and evolving area for state and federal regulation. Most states have limited or no guidelines on DTC marketing of genetic tests. However, California and New York in 2008 sent letters to several DTC firms restricting their practices. Maryland also does not allow DTC marketing of genetic tests (PGx Reporter 06/25/08).

The large players in the DTC genomic industry have indicated they would welcome federal guidelines as opposed to navigating state regulations on a state by state basis.

"We share the responsibility with Congress and the FDA to ensure public safety," Pathway said. "We look forward to working collaboratively with them as any new regulations or guidelines are considered for developing public health policy."