Epistem plc announced today that their Biomarker Division has been awarded Good Clinical Laboratory Practice (GCLP) accreditation status. The Biomarker Division conducts gene expression analysis to support clinical drug development programs within pharmaceutical and biotechnology organisations, with an increasing focus on providing valuable biomarker information that can be used in diagnostic applications.
For use in tissue and sample preparation, Epistem has developed a proprietary cDNA amplification technique which enables gene expression information to be provided from very small (or degraded) biological samples such as formalin-fixed, paraffin-embedded (FFPE) tissue, laser captured microdissected (LCM) samples, single plucked hairs, fractionated blood cells and pinch biopsies. Epistem also provides ‘off the shelf’ and proprietary panels of biomarkers targeting known oncology and disease specific biological pathways. Epistem has pioneered a technique to provide and interpret gene expression information from single plucked hairs, working with drug development companies globally to support biomarker programmes which translate from preclinical proof of concept to clinical phases.
GCLP accreditation now enables Epistem to support the later stage clinical phases of drug development assuring customers that all studies will be conducted to GCLP quality standards set by the British Association of Research Quality Assurance. GCLP status demonstrates that the Biomarker Division operates to a standard that assures the reliability, quality and integrity of the work and results generated.
Lydia Meyer-Turkson, Vice President of the Biomarker Division commented, “Accreditation strengthens our clinical biomarker capabilities enabling us to support regulatory submissions from partners who use our technology and expertise globally”