Incorporate gene signature profiling into routine molecular testing

• Incorporate gene signature profiling into routine molecular testing
• Assay development and validation are complex in gene signature profiling.
• Effort in determining clinical validity can be too large for a single institution.
• Collaboration among institutions can bring gene signature based test to fruition.

The success of gene and gene expression profiling, such as the Oncotype DX® test for breast cancer patients, demonstrates that as technology becomes more sophisticated molecular diagnostics will continue to play a more important role in disease management in the future. Such promises have been and continue to be enabled by advances in real-time PCR, microarray detection platforms and next generation sequencing technologies. Practical adoption of new technologies into routine clinical care, however, has not always been a smooth ride. Challenges lie on several fronts: establishment of clinical validity in large scale patient population, mechanisms of incorporating molecular tests into standard care, and keeping up with the pace of ever changing technologies in regulated clinical laboratories, just to name a few. This review's goals are to educate, to stimulate discussion and to provoke efforts to build consensus, share resources, and establish standards in order to realize the promises of genomic technologies for routine patient care.