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NY State Regulating DTC Genomics Firms as Labs

NEW YORK (GenomeWeb News) - Despite claims by direct-to-consumer genomics companies that they should not be regulated as clinical laboratories because they provide educational information about genetic risk, the New York State Department of Health is regulating such facilities as laboratories, according to a state health official.

"We believe it's consistent to say that these entities that will obtain raw data from the analytical testing facility, and generate a report that would go to the ordering practitioner, are a laboratory," Ann Willey, director of the New York State Department of Health Office of Laboratory Policy, said at a meeting of the HHS Secretary's Advisory Committee on Genetics, Health, and Society last week in Washington, DC.

"We consider these data-management facilities no different than laboratories," Willey added in her presentation updating the advisory committee on New York's stance on DTC consumer genomics firms.

Willey's comments come nearly one year after the New York State Department of Health sent letters to 23 consumer genomics and genetic testing firms saying they must obtain a permit and that a state-licensed physician must order the tests.

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. The US Food and Drug Administration has said it is watching the burgeoning industry closely, but has yet to issue federal guidance on the sector.

New York State regulations for laboratories operating within the state are considered within the industry to be more stringent than CLIA. According to industry observers, New York regulators' thinking on DTC genetic testing can have broad impact on the regulations in other states. To date, however, the state's Department of Health has not disclosed much detail regarding its thinking in this area.

In the absence of federal guidelines on DTC genetic testing, many consumer genomics companies have argued that they should not be regulated as providers of medical tests because the genetic risk information they sell to consumers is for education only and not meant to be used to make medical decisions.

However, one of these shops, 23andMe, recently began offering BRCA testing for hereditary breast and ovarian cancer — a test that most physicians believe carries serious clinical implications. Another consumer genomics firm, Navigenics, began marketing a version of its service to doctors in an effort to incorporate genetic risk data into individuals' annual physical exams.

Currently, New York State law requires that all laboratories testing human specimens must first obtain a permit in order to operate in the state. The law also states that labs can only order tests at the request of a state-licensed physician, who is not employed or financially compensated by the company that will perform the test.

Several of the consumer genomics firms working in states that allow DTC marketing of genetic tests employ physicians licensed in that state to order tests for their customers. This practice violates anti-kickback statues in New York restricting labs from offering physicians who order tests monetary payments or other kinds of incentives.

Willey also stressed during her talk that New York's statutes governing how labs may test human specimens also apply to companies collecting samples within the state's geographic borders.

This has implications for 23andMe's highly publicized "spit party" last year, in which the company collected saliva samples from celebrities in order to raise awareness of its genetic-screening service.

"We have told 23andMe repeatedly that without a NY license, any samples collected in the state have to be destroyed. We've been assured that this has been done," Willey said. "Of course, we've not confirmed that the samples have been incinerated."

A more comprehensive version of this article appears in this week's issue of Pharmacogenomics Reporter.

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