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New York Gives Green Light to Navigenics' Genetic Testing

NEW YORK (GenomeWeb News) – Navigenics has received a license to offer its personal genomics services to residents of New York State, the firm said today.

The New York State Department of Health has granted Navigenics a clinical laboratory permit and has said that the company may offer its Health Compass service to state residents.

The approval will enable the company to process saliva samples originating in New York using its CLIA-certified lab.

Specifically, the permit means that the state's Clinical Laboratory Evaluation Program found that the company's validation data is acceptable and that it has clarified the regulatory framework that covers such companies.

New York said last summer that it planned to regulate companies offering educational information about genetic risk as clinical laboratories, although direct-to-consumer firms had argued that their services provided different types of information than regular lab tests.

"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," Michele Caggana, head of the Genetic Testing Section of the Clinical Laboratory Reference System, said in a statement.

"The State’s licensing inspection program and regulatory framework are extremely rigorous," Navigenics' Laboratory Director Douglass Harrington said in a statement.

The company said its testing service will be available to New York residents this year.