What are biomarkers / bio-indicator compounds?
Definition of the term “biomarker”
In 1998, the American National Institutes of Health (NIH) defined the term as “a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.” In the 2006 Critical Path Opportunities List published by the American Food and Drug Administration (FDA), the use of bio markers was advocated for use in the narrowing down of trial registrants with high drug responsiveness for the rationalization of clinical trials.
The important role of biomarkers
Biomarkers assist clinicians when carrying out:
- Evaluation of disease risk
- Early noninvasive screening and diagnosis
- Disease stratification
- Evaluation of prognostic implications and responsiveness to therapeutic intervention
L-FABP as a biomarker
Conventional development of therapeutic drugs for renal disease has used the eGFR (estimated glomerular filtration rate) converted from the serum creatinine level as an index of renal function degeneracy, But the dose response from therapeutic intervention is considered insufficient in terms of clinical evaluation, and is one of the causes of why clinical trials of therapeutic drugs for renal disease are difficult. In recent years, and after fierce competition in various countries in the search for, research into and development of new biomarkers based on the results of research into proteomics, a number of urinary biomarkers, including L-FABP, which was developed by our company, have been adopted in America as measurement items for large scale clinical trials. We believe that use of the L-FABP biomarker has increased expectations for the creation of new therapeutic drugs for AKI (acute kidney injury) and CKD (chronic kidney disease), as well as broader applications (effect expansion) for existing medicines. There seems to be great interest in Japan in a genome biomarker that is assumed to be a main cancer marker, and it is our hope that urinary biomarkers can be used in clinical trial optimization and disease management in the future.