Development of commercial gene-expression-based signatures: review of the scientific strategies.

ABSTRACT

Many scientific articles have been published that use gene-expression-based technologies to discriminate a trait of interest, typically a disease subgroup, within a patient population. However, few gene-expression-based signatures have at present reached the market and become a financially and clinically successful product. The technological, scientific and medical challenges, the regulatory environment and the financial considerations are all essential parts of the development process. Here we discuss the scientific aspects of successfully developing a gene-expression-based signature and review the global strategy of six products that made it to the market. We also present a point-to-point guide that should help researchers to successfully develop genomic signatures, thus paving the way towards personalized medicine.