Rules-Based Medicine announced this week that it has commercialized a new biomarker panel to aid pharmaceutical and biotech companies evaluate renal toxicity in rats for pre-clinical drug trials.
RBM's Rat Kidney MAP (multi-analyte profile) “measures key biomarkers found in urine that can provide additional information about drug-induced damage to kidney cells,” the company said.
The study leading to the development of new renal safety biomarkers included in RBM’s panel was directed by Novartis through a cooperative research and development agreement granted under the US Food and Drug Administration’s Critical Path Initiative. The data and the assays were shared with the Predictive Safety Testing Consortium, an effort led by the C-Path Institute, involving scientists from 16 institutions, including 13 major pharmaceutical companies.
RBM developed and validated a panel of 12 new biomarkers connected with renal toxicity on 4,000 samples supplied by Novartis from rats dosed with multiple different known kidney toxicities. PSTC’s industry members analyzed the results and determined that RBM’s biomarker panel was effective in choosing the safest drug candidate to move forward from preclinical to late stage trials.
The FDA and the European Medicines Agency recently published reports supporting the use of these biomarker tests for pre-clinical trials.
“Using predictive safety biomarkers in early animal and laboratory studies will improve drug safety screening, help researchers select initial human doses with more accuracy, and provide better monitoring for side effects prior to human clinical trials,” RBM said.