Brief history of biomarkers

In 1998, the biomarker is defined by the National Institutes of Health (NIH) as “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.” In 2006, the use of Biomarkers was recommended in Critical Path Opportunities List which was published by Food and Drug Administration (FDA), in order to target patients who have high drug sensitivity among clinical trial registrants for rationalization of clinical trial.

Biomarkers and Diagnostics

Biomarkers are used in the research and the clinical practice for following activities:

• Evaluation of disease risk
• Noninvasive screening and diagnosis in early stage of disease
• Disease risk stratification
• Reactivity evaluation for prediction of prognosis and treatment intervention

L-FABP, a renal biomarker

In conventional development of renal disease therapeutic drug, eGFR (estimated glomerular filtration rate) which is converted by serum creatinine level, is applied and considered as an indicator of renal function. However, the reaction in evaluating dose-response during drug intervention shows this indicator insufficient hence this is one of the causes of the difficulty in clinical trial of renal disease therapeutic drugs. In recent year, after the research and development of new biomarkers based on the results of proteomics and intense competitions between countries, many urinary biomarkers are found and some including L-FABP discovered by our company are adopted for large-scale clinical trials in US.
We believe that use of our discovery, L-FABP, would enhance the possibility in the new drug developments targeting AKI (acute kidney injury) and CKD (chronic kidney disease), the expansion of the adaptation of existing drugs. In Japan, there is great interest in genomic biomarkers which are mainly focused on cancers but we are expecting that the urinary biomarkers could be used in clinical trial for the treatment optimization and disease management in the future.