BANGALORE, India, June 9, 2014 /PRNewswire/ --
Clinigene International Ltd, a subsidiary of Syngene International Ltd, India's leading Contract Research Services provider, today announced that it has launched a cholesterol efflux assay to support global aspirants developing cholesterol lowering drugs. This biomarker assay is a cell based assay for assessing the ATP-binding cassette A1 (ABCA1) specific cholesterol efflux capacity in human serum samples.
Speaking on this occasion, Dr. Aparna Kasinath, Head of the Bioanalytical Laboratory, said "Atherosclerotic cardiovascular diseases are the major causes of morbidity and mortality worldwide. Globally, an enormous amount of research effort has been invested into improving the current understanding of molecular pathways that control HDL-C. Biopharma companies are exploring new therapeutic approaches that impact HDL-C. These novel therapies require a better understanding of the functional properties of the HDL particle. Cholesterol efflux capacity through the ABCA1 transporter is so far the best understood functional property of HDL with substantial supportive clinical evidence". "While there are a limited number of alternative Cholesterol Efflux assays in the market, Clinigene's assay is superior in reproducibility and throughput, and therefore better suited for regulated analysis of samples from large scale clinical trials" Dr Kasinath continued.
"Clinigene operates a CAP-accredited central lab and GLP-compliant Bioanalytical laboratory for small and large molecule therapeutics and has deep expertise in GLP validation of cell based assays and regulated analysis of samples from large scale, multi-site clinical trials. In developing this assay we collaborated with our US based partner Pacific Biomarkers to produce a cost effective, high-throughput, and highly reproducible efflux assay that was subsequently GLP validated and used for assaying samples from a few global clinical trials. This cholesterol efflux assay is now available for regulated bioanalysis of study samples from early to late phase drug-development clinical trials for drugs affecting the lipoprotein metabolism" she added.
About Clinigene International Limited
Clinigene is India's leading clinical research organization that provides trial management, Clinical & Bioanalytical Lab services and Data Management services for Phase 1-4 clinical trials (Know more - http://www.clinigeneintl.com )
About Pacific Biomarkers (PBI)
Established in 1989, PBI provides biomarker laboratory services and contract research services to support pharmaceutical and diagnostic manufacturers conducting human clinical trial research (Know more - http://www.pacbio.com)
Clinigene International Ltd.
SOURCE Clinigene International Limited