Challenges in the commercialization of array-based tests

Abstract

Since the advent of array-based molecular diagnostics early in the last decade, the tests have faced a number of challenges, including an evolving regulatory environment, costs associated with developing a test and bringing it through a regulatory clearance process, costs associated with the technology itself, both the assay kits and the underlying platforms, hesitance from insurers to reimburse tests, questions about the clinical utility of the new assays, community awareness of the tests' benefits, and competition from other technology platforms. While there are many obstacles to achieving success, array-based tests used in constitutional cytogenetics have been widely adopted and are now considered the standard of care. Revenues for other tests continue to grow, though not in line with earlier predictions. This chapter examines the challenges associated with bringing an array-based test to market and how they have been overcome.