Collaborative efforts between academia, industry and regulators are yielding promising results to accelerate the discovery of new biomarkers.
In the latest issue of Nature Biotechnology, a team of research scientists describes the validation of seven specific urine biomarkers that detect kidney damage. This is work that has come out of the Predictive Safety Testing Consortium, which was formed in response to the FDA’s 2004 Critical Path Initiative.
It is an exciting example of collaborative efforts between academia, industry and regulators that are yielding promising results.
The kidney filters significant quantities of blood plasma each day and can be easily damaged by buildup of toxins. To measure kidney injury, traditionally scientists have had to resort to examining tissue samples via microscopy – a model that is not practical for human studies – or use markers such as serum creatinine and blood urea nitrogen, which are not very specific.
One of the seven new biomarkers, KIM-1, is both more specific and more sensitive. This particular biomarker spikes nearly 50-fold after kidney damage from known nephrotoxins. Additionally, the other new biomarkers have been proven to be more sensitive in different regions of the kidney, and could provide complementary ways of assessing toxicity.