Navigenics., a leading personal genomics company, announced today that the New York State Department of Health has issued Navigenics a clinical laboratory permit and approved the offering of the company’s Navigenics® Health Compass service to New York State residents.
The permit makes Navigenics the first personalized genomics service to be licensed as a clinical laboratory by the State of New York.
The permit, issued on December 7, gives Navigenics approval for its CLIA-certified clinical laboratory to process saliva samples originating in the State of New York for the purposes of genetic testing. The permit acknowledges that the State’s Clinical Laboratory Evaluation Program found the validation data for Navigenics’ test acceptable and clarifies the regulatory framework that Navigenics will operate under in New York moving forward.
“As the primary institution responsible for ensuring quality oriented, accurate and reliable clinical laboratory testing for the citizens of New York State it is vital that we examine genetic testing services with the same scrutiny as other clinical tests,” said Michele Caggana, Sc.D., FACMG, Head of the Genetic Testing Section of the Clinical Laboratory Reference System. “Our priority is to ensure that New York residents whose physicians order services from Navigenics do so within the assurance of quality and technical reliability that our scrutiny provides, and we are satisfied that Navigenics has met the State’s requirements for approval.”
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 nascent industry’s innovative technologies and services.
“We are very proud of our collaborative interaction with the New York State Department of Health throughout this process,” said Douglas S. Harrington, M.D., Navigenics Laboratory Director. “The State’s licensing inspection program and regulatory framework are extremely rigorous. To be the first personal genomics service provider to receive approval is truly a testament to our best-in-class approach to the science, validation and clinical laboratory operations behind our individualized genetic testing.”
Navigenics’ genetic testing services will be made available to New York state residents later this year. For more information on the Navigenics service and New York orders, please contact Member Service by phone at (866) 522-1585 or by email at .