MONMOUTH JUNCTION, N.J., March 8, 2016 /PRNewswire-iReach/ -- Biotranex, LLC is pleased to announce the availability of two new assay methodologies for measuring the inhibition of the bile salt export protein (BSEP) and the multidrug resistance protein 3 (MDR3) liver transporters. Drug-induced liver injury (DILI) encompasses a spectrum of toxicities ranging from mild biochemical abnormalities to acute liver failure, and in some cases the need for a liver transplant. DILI is responsible for the withdrawal of several marketed drugs as well as the necessity for FDA black box warning labels. Preclinical animal models are poor predictors of DILI in human subjects. A major cause of DILI and cholestasis is the inhibition of either or both human BSEP and MDR3 hepatic transporters. Therefore, it is critical to accurately determine the inhibition potential for drug candidates of these human hepatic transport proteins.
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BSEPcyteTM and MDR3cyteTM are patent-pending assays that offer significant advantages over other currently available methodologies. They are both physiologically relevant hepatocyte-based systems that allow measurement of drug candidate inhibition of human BSEP and MDR3, provide for cross-species studies, and offer the ability to investigate the effect of drug metabolism on inhibition; both assays are also run without radioactive reagents.
The BSEPcyteTM and MDR3cyteTM assays employ a platform using suspensions of human and animal hepatocytes in a 96-well plate format with liquid chromatography-mass spectrometry quantification. Both assays are reproducible, sensitive, flexible, robust, and possess wide dynamic concentration ranges. The assays show excellent correlation with drugs found to inhibit BSEP and MDR3 that may cause human cholestasis and DILI.
“The role that inhibition of liver transporters, including BSEP and MDR3, play in cholestasis and drug-induced liver injury is only now being appreciated by drug developers in the pharmaceutical and biotech industries. We are pleased to introduce these validated BSEPcyteTM and MDR3cyteTM assay methodologies that provide significant physiological and technical advantages over other assays, while being cost competitive,” states Dr. Kan He, President of Biotranex.
About Biotranex, LLC
Biotranex is an innovative biotechnology discovery and service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex also offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852; email: khe@biotranex.com, phone: (732) 230-3062, website: www.biotranex.com.
Media Contact: Kan He, Biotranex LLC, 732-230-3062, khe@biotranex.com
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