EpiStem Ltd's Biomarker Division Gains GCLP Accreditation
Published: Jun 07, 2010
MANCHESTER, UNITED KINGDOM--(Marketwire - June 07, 2010) - Epistem plc (LSE: EHP), the UK biotechnology company, has 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".
Notes to Editors:
Epistem is a biotechnology company commercialising its expertise in epithelial stem cells in the areas of oncology, gastrointestinal diseases and dermatological applications. Epistem develops innovative therapeutics and biomarkers and provides contract research services to drug development companies. The Group's expertise is focused on the regulation of adult stem cells located in epithelial tissue, which includes the gastrointestinal tract, skin, hair follicles, breast and prostate. Epistem does not conduct research in the areas of embryonic stem cells or stem cell transplantation. The Company was originally formed in 2000 and this year celebrates its 10 year anniversary.
Epistem operates three distinct business divisions, Contract Research Services, Novel Therapies and Biomarkers. The Biomarker division provides services to drug development companies using its cDNA amplification technology and expertise in gene expression analysis. In addition to the service offering, Epistem has recently marketed RNA-Amp™ kits, a new generation of amplification kits enabling the amplification of small amounts of (or degraded) starting materials. The Company also offers publically available or proprietary biomarker panels to well known disease pathways that could be used to measure drug-induced gene expression change during treatment. Changes in gene expression can be detected within hours and at low levels of chemotherapy or radiation. The highly sensitive biomarker technology is based for the analysis of mRNA extracted from small amounts of blood, hair or tissue to accurately measure gene expression changes in response to drug treatment
Dr. Danielle Hargreaves
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