Final Topic Refinement Document - Role of Liquid Biopsy in Detection and Management of Cancer in the Medicare Population

Final Topic Refinement Document - Role of Liquid Biopsy in Detection and Management of Cancer in the Medicare Population Final Topic Refinement Document Role of Liquid Biopsy in Detection and Management of Cancer in the Medicare Population ID: MYOE58 Agency for Healthcare Research and Quality Technology Assessment Program Mayo Clinic Evidence-based Practice Center January 22, 2021 Key Questions (K. [...] The position of the FDA may change in the future as the FDA has issued a discussion paper on LDTs in 2017 but without an enforceable action.1 The CLIA final rules specify that the actual performance characteristics of LDTs must be comparable to their claimed specifications in the following areas: accuracy, precision, reportable range of results, reference intervals (normal ranges), analytical sens. [...] 4 Validity of a medical test: For a medical test such as the liquid biopsy to be used in practice, several conditions are required.7 Pre-analytic factors should be evaluated (i.e., the test needs to conform to technical specifications that relate to the collection, handling and storage of the specimen). [...] The test needs to have sufficient analytic validity (i.e., the test needs to measure the substance of interest in an accurate manner concordant with a gold or reference standard), clinical validity (i.e., the test needs to have diagnostic accuracy in classifying the target population) and clinical utility (i.e., the test needs to demonstrate improvement in patients’ management and outcomes). [...] chemotherapy) Study design • Randomized controlled trial • Longitudinal comparative observational studies 8 Definition of Terms in the context of this topic refinement document Term Definition Liquid biopsy A minimally invasive test done on a sample of blood to look for cancer cells from a tumor that are circulating in the blood or for fragments of tumor- derived DNA that are in the blood.8 Pre-an.