Genetic testing has been making headlines recently, but not just for the promise it holds for boosting health. Instead, regulatory issues in the state of California have been at the forefront of the news. State health officials recently sent letters to more than a dozen genetic testing firms, including Navigenics, asking each to stop providing services to customers.
At issue is whether genetic testing companies adhere to California’s clinical laboratory licensing laws. Here at Navigenics, we believe we do, and we will work diligently with both state and federal regulatory agencies to clarify any misunderstandings.
Navigenics wholeheartedly agrees with the California Department of Public Health that laboratories performing genetic testing in California, or labs testing any samples originating from California, must be licensed by the state. We also agree that such tests must be ordered and test results received by a California licensed physician. These commitments prompted us, from the beginning, to build our service accordingly.
All of our laboratory testing is performed at Affymetrix, a laboratory that is not only located and licensed in California, but is certified under the Clinical Laboratory Improvement Amendments, or CLIA. This certification means that the lab adheres to strict government standards for quality and accuracy. All tests conducted through Navigenics are ordered by a California-licensed physician. In our industry, we are also one of the few companies to provide a team of certified Genetic Counselors to help members interpret their test results.
On a broader level, however, we do share a concern with a number of other parties about the current policy gap that exists—both at the federal and the state levels—regarding the regulation of genetics information services.
We share the state’s commitment to protecting the public from false or misleading information. We believe that the current regulatory questions demonstrate that policies need to be updated. Our laws and standards should reflect the new paradigm of health risk communication enabled by the genomic revolution.
To this end, Navigenics announced its own public standards-setting effort on the very same day that we launched our first service.
Under the leadership of the Personalized Medicine Coalition, we are working in collaboration with diverse thought leaders and other industry partners to suggest frameworks for regulation and best practices in this emerging industry. Our work will culminate in a public meeting on December 4th in Washington D.C.
We are also contributing to a review of this area by the federal government, having met directly with officials from the Food and Drug Administration while they are advancing their guidance process for genomic assays. We also met with officials from the U.S. Department of Health and Human Services in the context of their Personalized Health Care Initiative. In fact, HHS (and their advisory group, the Secretary’s Advisory Council on Genetics Health and Society) will be hosting a consumer genetics testing summit in two weeks. Dietrich Stephan, our Chief Science Officer and one of our co-founders, and Mari Baker, our president and CEO, will be testifying before the committee.
We believe that our industry needs a strong set of updated guidelines, given how many new consumer genomics companies with a variety of approaches have been established over the past year. Our interest in these guidelines also reflects our own commitment to the importance of balancing consumer protections with the exciting and innovative potential of genomics to improve health.