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Invitae's Lab Gets Permit From NY State Regulator

NEW YORK (GenomeWeb) – Invitae said it has received a clinical lab permit from the New York State Department of Health after completing its Clinical Laboratory Evaluation Program.

Invitae said that it now offers its hereditary cancer, cardiology, and pediatric genetic testing services in all 50 US states. Invitae's clinical lab is also accredited by the College of American Pathologists and certified under the Clinical Laboratory Improvement Amendments.

In a statement, Invitae CEO Randy Scott said the firm "looks forward to working with the New York State Department of Health to expand this license to our other panels in neurology, pediatrics, and other rare diseases while lowering the cost of genetic testing for patients, physicians, and payors in the state of New York."

The NYSDOH is known for having the toughest state lab evaluations in the US, consisting of on-site inspections, proficiency testing, and personnel evaluations. The state regulator recently issued a three-tier, risk-based system for evaluating and approving laboratory-developed tests, and indicated that it will implement the policy sometime this year.

Invitae's lab is accredited by the College of American Pathologists and has certification under Clinical Laboratory Improvement Amendments.