When searching the Test Catalog, tests displaying the icon and text ‘New York Approved’ are approved or conditionally approved by New York State and do not require a Single-Use Permit. Please note that for carrier/targeted variant tests, the approval status depends on whether the gene is in an approved GeneDx single-gene or multi-gene test. In addition, carrier/targeted testing for any gene is automatically approved for relatives of existing GeneDx patients. In all other situations, GeneDx will complete the Single-Use Permit application and submit it to the NYS Department of Health for approval upon receipt of the sample and test order.
Additional information regarding Single Use Permits is available at: https://www.wadsworth.org/regulatory/clep/clinical-labs/single-use-permits