Challenges in the Commercialization of Array-Based Tests

Chapter

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.

Keywords

Initial Public Offering Molecular Diagnostics Genomic Health Affymetrix Platform Regulatory Clearance 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  1. 1.BioArray News, GenomeWeb LLCNew YorkUSA

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