Antibodies for immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) probes and labor drive the cost of testing for anaplastic lymphoma kinase (ALK) mutations in lung cancer patients. Given the increasing availability of molecularly targeted therapies and the accompanying reliance on genetic mutational analysis, laboratories need to identify the most cost-effective testing approach for their setting, say the authors of a study published Jan. 6 in Diagnostics. Professional society guidelines support testing for ALK mutations. Many studies have evaluated the inter-test concordance between FISH, the standard method to directly detect ALK rearrangements, and IHC, which detects aberrant proteins resulting from rearrangements. But, little attention has been given to comparing the testing strategies in terms of cost and workflow for laboratories. The researchers developed a cost-impact model that compared four alternative testing strategies—IHC only, FISH only, IHC pre-screen followed by FISH confirmation, and parallel testing with both IHC and FISH. Key model inputs were derived from a review of the literature and interviews. U.S. IHC and FISH reimbursement rates were based on the Medicare physician fee schedule. Given variance in European markets, the average payment on a per test basis was determined from laboratory interviews. Ten laboratories were interviewed (three in the […]