The industry responds

Representatives from the companies manufacturing DTCs emphasized the benefits of genetic testing. David Becker, chief scientific officer of Pathway Genomics, said in his statement, "Empowering consumers with information about their genes holds tremendous promise to promote health and improve lives."


Becker also said that the company believes consumers can understand the benefits of having genetic information and understand that genetics are only part of a healthy life.

Becker explained that Pathway places high importance on ensuring that its testing accurately represents the best scientific literature. He said the reports are constructed using evidence-based standards and markers that have achieved high quality standards of clinical research. Becker also stated that Pathway believes genetic testing companies would benefit from a stable regulatory environment and that in some areas the company could use additional guidance or clarification, including a risk-based classification system for genetic tests; minimum scientific study criteria; standardized definitions for population risk; a list of the strongest effect marker for each condition; standardized labeling and website disclosures; a genetic test registry with required disclosures; mandatory CLIA and CAP certifications; and publicized and standardized compliance procedures.

Dr. Vance Vanier, CEO of Navigenics, Inc., explained that the company believes a health care professional should be an integral part of the personal genetic analysis process and the company has its own team of genetic counselors available to educate and support both health care providers and its customers. Vanier further stated that Navigenics operates in full compliance with all existing state and federal regulations "and is the only consumer genomics company that is approved by state regulators to operate in every state."

Navigenics also welcomes balanced federal oversight, Vanier said, and the company supports the creation of an outside advisory committee to guide the FDA as it determines how to regulate personal genetic testing services.

Finally, Ashley C. Gould, general counsel to 23andMe, Inc. testified that the company wants to better understand the issues involved and that "...23andMe has worked with the Genetics and Public Policy Center at Johns Hopkins University to conduct an independent study of how 23andMe customers understand and use their results. We fully appreciate the concerns that different companies can return different risk predictions, which can happen even when the tests are accurate."

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