Recent news in the personal genomics industry has prompted interest in how we work with state and federal regulators. At Navigenics, this interest is always appreciated. Since starting our company, we’ve sought to work closely with regulators, and consider this approach as one of our founding principles.
Navigenics has an established history of working closely with state and federal regulators:
- Navigenics has helped lead the effort to set industry standards for personal genomic testing services in cooperation with the Personalized Medicine Coalition and other industry organizations.
- Navigenics has consistently been a leader in encouraging collaboration and dialogue with regulatory authorities – at both the state and federal levels – to ensure compliance and develop standards for the industry’s innovative technologies and services.
- The New York State Department of Health issued Navigenics a clinical laboratory permit in January 2010, making Navigenics the first personalized genomics service ever to be licensed as a clinical laboratory by the State of New York. To date, we are the only personal genomics company permitted to offer its services in New York.
- Navigenics was granted a license by the State of California’s Department of Public Health in 2008 to provide genetic laboratory testing services to customers within the state.
- When Navigenics launched its personal genome service more two years ago, we issued a 10-point proposal for a set of industry standards to ensure the integrity of this new field of science and health and safeguard consumers.
- We highlighted the need for these principles again last year when we helped the Personalized Medicine Coalition convene a meeting on standards for personal genomics services.
- Navigenics has met with the FDA half a dozen times to discuss its services and the potential standards that could apply to the industry, with its first meetings dating back to 2007.
- We operate consistent with HIPAA practices and build them into our infrastructure.
To learn more about our work with regulators, see our press releases.
We appreciate and support the FDA’s mission and role in helping achieve the promise of personalized medicine. We believe our services comply with all existing federal and state regulations, and look forward to continuing our dialogue with the FDA to ensure transparency and the optimal use of genetic information as it applies to personalized medicine.
Our mission is to improve health outcomes across the population by providing clinically actionable genetic insights, and we believe that a healthcare professional should be an integral part of that process. We remain committed to providing support for individuals and their physicians at every step in the personal genetic analysis process – at no additional cost. We are the only company with a staff team of board-certified genetic counselors with years of experience specializing in personal genomics, and we have made physician education and clinical integration a fundamental focus of our service.
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