Gene Expression Detection Assay for Cancer Clinical Use

Narrandes, Shavira; Xu, Wayne

In addition to the above proposed guidelines, developing an assay into clinical use must pass stringent Clinical Laboratory Improvement Amendments (CLIA) standards and a College of American Pathology certification. Diagnostic tests can result in large costs due to demonstrating improved patient mortality outcomes through replicated and randomized clinical trials. 5 The cost of an assay, then, is an important parameter in experimental design and should be minimized for the desire to translate results into clinical use. Medical costs are increasing in the current healthcare system as cures are being sought for all illnesses and the general population ages and increases in life expectancy, resulting in more money being put towards the elderly population's care and medical costs. Cost-effectiveness studies may be performed on an assay to determine its economic utility for a consumer's and society's well-being. 6, 128 New biomarkers may undergo cost-utility studies measured in sum of money per quality adjusted life year (QALY) gained, where the ratio of the cost of a test to its benefits in the number of years gained is taken. $50 000 USD per QALY gained is considered the upper-limit for cost-effectiveness. 126 In addition to the necessity of developing an assay with low cost, the FDA guidelines for approval must be met. Once FDA-approved, it is then up to clinicians to accept and employ the assay. 6