Complements the RBM Rat Kidney Panel developed in conjunction with the Critical Path Initiative
AUSTIN, Texas, Jan. 15 /PRNewswire/ -- 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 translatio
|SOURCE Rules-Based Medicine, Inc.|
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