Complements the RBM Rat Kidney Panel developed in conjunction with the Critical Path Initiative
AUSTIN (January 15, 2009) — Rules-Based Medicine, Inc. (RBM), the world’s leading multiplexed biomarker testing laboratory, today announced the launch of its Human Kidney Multi-Analyte Profile (MAP), a cost-effective biomarker testing service designed to aid pharmaceutical and biotechnology companies in their efforts to improve drug development through better understanding of drug toxicity. The Human Kidney MAP will be used in clinical trials to reveal early signs and locations of drug-induced kidney damage, known as renal toxicity or nephrotoxicity, thereby guiding important decisions on lead compounds and dosage.
“The Human Kidney MAP is an important response to the FDA’s Critical Path Initiative, which highlighted the need for new tools to better understand the safety profile of new drugs,” said Craig Benson, RBM president and chief executive officer. “By providing a quantitative and predictive multiplexed biomarker test for renal toxicity, we will help our customers improve safety, mitigate risk, and reduce costs associated with drug development.”
RBM’s Human Kidney MAP utilizes a multiplexed panel of 16 biomarkers to detect early renal damage and pinpoint the location within the kidney. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) recently decided to accept data related to certain biomarkers of kidney damage as part of the drug approval process in conjunction with new safety initiatives. Historically, regulatory agencies have required drug companies to provide results of blood urea nitrogen (BUN) and serum creatinine tests as indicators of kidney damage. Studies, however, suggest these tests detect only late signs of kidney damage and provide no information on the location of damage.
The Human Kidney MAP was developed using a translational medicine approach. In 2008, RBM commercialized a Rat Kidney MAP based on an ambitious study directed by Novartis as part of one of the first Cooperative Research and Development Agreements (CRADA) granted under the FDA’s Critical Path Initiative. The data and assays were subsequently shared with the Predictive Safety Testing Consortium. The Human Kidney MAP contains many of the same biomarkers and is designed to detect general signs of kidney damage. Drugs in circulation are concentrated up to 1000-fold in the kidney compared to plasma, magnifying the potential for renal toxicity of any drug.
Kidney damage also occurs in connection with diseases such as diabetes, hypertension, and autoimmune conditions, among others. RBM has established and is seeking additional collaborations with leading academic and pharmaceutical researchers to develop diagnostic applications based on the Human Kidney MAP.
About Rules-Based Medicine
Rules-Based Medicine (RBM) provides comprehensive protein biomarker products and services centered on its Multi-Analyte Profiling (MAP) technology. Its service platform (RodentMAP® and HumanMAP®) provides pre-clinical and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of proteins cost-effectively in multiple species, and from a small sample volume. The Company also offers innovative and proprietary ex vivo testing systems such as TruCulture®, the first fully-closed, reproducible whole blood culture system. RBM is actively developing multiplex diagnostic tests to detect the presence of complex diseases and conditions in areas of unmet medical need such as neuropsychiatry, nephrology, immunology and cardiology. More information about RBM is located at www.rbmmaps.com.