By Radha Krishnan, Chief Pathologist and Senior Medical Director and Jacqueline Coleman, Scientific Advisor, Molecular and Targeted Genetics Testing, Q2 Solutions
In today’s challenging economic environment, it is more important than ever for a drug manufacturer to predict the successful outcome of a clinical trial. It is now proven that clinical trials incorporating biomarker selection have a greater probability of success across all stages of clinical development.
Incorporating biomarkers to measure genetic mutations can contribute to a reduction in failure rate of clinical trials by:
The Precision Medicine initiative was launched by President Obama in 2015 with the ultimate goal of “moving the U.S. into an era where medical treatment can be tailored to each patient.” This personalized approach to medicine will be a driving force in drug development, which is demonstrated by techniques already in practice such as immunotherapy and immuno-oncology. Demands for increasingly complex laboratory testing in this field are expected to continue into the future, and so is the requirement for assessable, predictive biomarkers as our understanding of the tumor microenvironment grows.
Companion diagnostics are vital to support the advancement of precision medicine through the use of predictive, prognostic and early response biomarkers. These diagnostics utilize technologies in molecular pathology such as molecular genetic amplification and sequencing, genetic probes, biochips, microfluidics, biosensors, molecular labels, microarrays, and fluorescent in-situhybridization (FISH).