New diagnostics speed drug development

New accurate and powerful in vitro diagnostics could hasten future drug development. Pacific Biomarkers’ Timothy Carlson and Amar Sethi explain how.

Evidence is accumulating that several novel biomarkers will become powerful clinical tools in detection of treatment-induced acute kidney injury (AKI) and in the diagnosis of impaired kidney function in future.¹ The US Food and Drug Administration’s Critical Path Initiative (CPI),² launched in 2004, has inspired a biomarker programme³ with the aim of identifying biomarkers useful for the assessment of drug-induced toxicity for drugs that are in development.

The biomarkers qualified in this programme would, following detailed analytical validations, be used in clinical trials with the ultimate goal of being accurate and powerful in vitro diagnostics (IVDs) that could replace or augment less sensitive existing tests. Current costs associated with drug development from discovery to final approval have been estimated to be US$1bn (€720m) or more.⁴

Drug-induced organ toxicity accounts for 30% of all drugs that fail prior to reaching the market;⁵ the sooner this toxicity is discovered, the sooner further development costs can be curtailed, enabling drug developers to focus on other, safer drugs.

Early diagnosis of drug-induced organ toxicity during drug development would not only reduce the cost associated with development, but also avert injury to future and current patients involved in clinical trials. Thus, the appropriate acute organ injury biomarker panel has the potential to detect organ-specific toxic drug effects that are currently being missed in clinical trials.

This kind of timely detection of early organ injury in clinical trials could potentially reduce the time needed for drug development by a number of years. Accomplishing this might also reduce overall healthcare costs if drug-induced organ injury can be diagnosed early enough to avoid severe and costly complications in patients taking the drug after its approval.