Table 1 Tips for the discovery of true candidate biomarkers at clinical laboratories

Clinically clearly understood

Direct comparison with the existing best practice in the population for which it is intended

Well-characterized clinical specimens for discovery the relevant clinical population

Several factors have to be taken into account when collecting specimens for the studies of new biomarkers, whether for a specific clinical study or for a biobank in order to enable interpretation of results and ensure appropriate matching of patient and health controls

Well-validated discovery platform which is robust and reliable

The use of internal standards for identifying specific components and quality control via proteomic –mass spectrometry and OMICS strategies is critical.

Clinical evidence for the true candidate biomarker

Take into account: (a) which is the association of our candidate-biomarker with the relevant disease, (b) which is the assessment of clinical utility and impact, (c) which are the circumstances where use of the test would be unjustified and (d) Make a rigorous early investigation of the specific pre-analytical factors which might influence interpretation of the resulting data