BENEFIT APPLICATION
Subject to the terms and conditions of the applicable benefit contract, PathFinderTG®, PancraGEN®, and BarreGEN® are not eligible for payment under the medical benefits of the Company’s commercial products because the service is considered experimental/investigational and, therefore, not covered.
Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Patented diagnostic tests (e.g., PancraGEN™) are available only through Interpace Diagnostics (formerly RedPath Integrated Pathology, (although the former name may still be used in the marketplace) under the auspices of the Clinical Laboratory Improvement Amendments. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.