Commercialisation of Biomarker Tests for Mental Illnesses: Advances and Obstacles

Abstract

Substantial strides have been made in the field of biomarker research for mental illnesses over the past few decades. However, no US FDA-cleared blood-based biomarker tests have been translated into routine clinical practice. Here, we review the challenges associated with commercialisation of research findings and discuss how these challenges can impede scientific impact and progress. Overall evidence indicates that a lack of research funding and poor reproducibility of findings were the most important obstacles to commercialization of biomarker tests. Fraud, pre-analytical and analytical limitations, and inappropriate statistical analysis are major contributors to poor reproducibility. Increasingly, these issues are acknowledged and actions are being taken to improve data validity, raising the hope that robust biomarker tests will become available in the foreseeable future. Substantial advances have been made in the field of biomarker research for mental illnesses.However, no FDA-cleared blood-based biomarker tests have been translated into clinical applications.A personal account of challenges associated with commercialisation of research findings is reported.The major obstacles and challenges encountered in the field are briefly discussed.