It is not entirely certain at present which biomarkers of kidney injury most adequately detect subclinical kidney injury in patients receiving nephrotoxic agents. Moreover, the difference in responsiveness of promising candidate biomarkers to injury based on previous impairment of kidney function (patients in various stages of chronic kidney disease) is unexplored.

Our ambition is to bring about transformation in liver drug safety through its life cycle from its early development through clinical trials to its use in routine clinical practice.  The state of the art is merely diagnostic and does not confidently inform on prognosis for the patient or the mechanism driving the injury.

Acute pancreatitis, caused by drugs or other factors, is a serious condition, can progress rapidly, and can be fatal. Current biomarkers are not precise at disease onset and have limited predictive ability of prognosis or to grade impending hazard for appropriate ameliorative action.

Vascular injury has no gold standard biomarkers and thus remains an area of unmet medical need from a safety, diagnostic and efficacy biomarker perspective.  This proposal will establish circulating biomarkers based on shared histomorphologic outcomes rather than on mechanism of injury to identify, characterize, and/or monitor DIVI, as well as to diagnose and monitor disease state and progression of vasculitides (systemic or localized) and response to treatment in clinical trials.

Neurotoxicity causes significant morbidity and can sometimes be fatal. Thus, there is a critical need for sensitive biomarkers predictive of neurotoxicity that can be readily translated to clinical trials. However, up to now there are no qualified fluid-based biomarkers for early detection of CNS injury.

Circulating miRNAs have received recent attention as biomarkers with enormous potential for application in clinical diagnostics or drug development. However, we have seen little progress in this area in terms of translation from research into clinical or commercial applications. The reasons for this disappointing output of clinically-relevant miRNA biomarkers can be attributed to the general challenges that we face during biomarker discovery, validation, and qualification.

The “gold standard” in clinical protein analysis is the sandwich immunoassay. Here, high specificity and sensitivity is provided based on the specific interaction of a capture and a detector antibody with the protein of interest. However, sandwich immunoassays rely on the availability of antibodies. SIGNATOPE has developed a hybrid assay technology using antibodies for enrichment and mass spectrometry as read-out.