Translating Cancer Biomarker Discoveries to Clinical Tests: What should be Considered?

Abstract

The use of biomarkers for the diagnosis, prognosis, and monitoring of disease; as well as to guide the choice of therapeutic regimens is predicted to be one of the leading priorities in clinical practice. The sheer complexity of the human cell, including its growth and signaling pathways, has made one of the biggest challenges in the cancer field the identification and characterization of such biomarkers and their translation into informative and reproducible diagnostic/prognostic tests. The increasing amounts of data, generated by experimental methods, challenges researchers to extract biologically applicable information. The authors, who represent academia, industry, and governmental organizations, discuss the current potential of translating cancer biomarker discoveries into suitable clinical tests. This review includes current information based on the latest patents in the cancer biomarker field relating to the different types of biomarkers (genomic, proteomics, epigenetics and microRNAs). It also describes the importance of strong intellectual property protection, current trends in patenting biomarkers, and future intellectual property strategies in the biomarker-related field. Finally, a summary of the recent relevant patentsand primary barriers to the translation of new biomarkers into viable clinical diagnostic tests is presented. Keywords: Accuracy, biomarker discovery, cancer biomarkers, epigenetics, genomics, IP protection, proteomics, miRNA, sensitivity, specificity, PPV, NPV, Bioinformatics, Genomic Biomarkers