Announcing the Release of a Novel Tool for the Assessment of Porcine Islet Functionality: the Mercodia Porcine C-peptide ELISA
Winston Salem, NC, November 10, 2011 --(PR.com)-- Mercodia announced the release of their new Porcine C-Peptide ELISA at the recent Cell Transplant Society (CTS) and International Xenotransplantation Association (IXA) meeting in Miami, Florida, October 23-26. This assay provides the type 1 diabetes, and more specifically the islet transplantation, research field a long awaited high quality tool for measuring the islet-specific biomarker.
With human pancreata in such short supply, islets isolated from pigs have provided this field with an efficient and more plentiful option. Furthermore, porcine islet transplantation has resulted in long-term benefits in NHP (non-human primate) models. Since early stages of clinical xenotransplant trials have hinted that the same might be true in humans, having access to more sensitive and precise ways to measure key biomarkers in these unique models is imperative.
Mercodia's new Porcine C-Peptide ELISA offers scientists a way to detect the biomarker in various xenotransplant models with no cross-reactivity to related proteins such as proinsulin and insulin. In addition, the inclusion of Mercodia's highly efficient, proprietary blocking reagent eliminates non-specific interferences present in various sample matrices. The small sample volume required for this assay also makes it a perfect tool for groups working with smaller animal models and/or wanting to conserve sample volume for multiple analyses.
Nathan Provo, MS (Research Applications Specialist for Mercodia Inc.) presented assay performance data at the recent CTS-IXA meeting. He also points to the importance of including C-peptide determinations in porcine islet trials: "With the IXA establishing porcine C-peptide response as a benchmark for efficacy in pig-to-diabetic NHP models and the FDA recommending that clinical trials of porcine islets be monitored similarly to allogeneic islet trials (for which C-peptide is a recommended secondary endpoint), the Mercodia C-Peptide ELISA offers scientists a high quality method to use."
Mercodia AB is a Swedish biotech company focusing on the development of immunoassays within the field of metabolic disorders. Mercodia is a world-leading supplier to all major international markets, providing a professional scientific support system to develop novel applications for existing products and unique diagnostics for emerging markets.
Mercodia has demonstrated compliance with "ISO 13485:2003, Medical Devices - Quality Management Systems", and also included an extension of ISO 13485:2003 to demonstrate compliance with the "Canadian Medical Device Regulations (CMDR)". The Mercodia Quality System has also implemented practices and procedures that promote compliance with Quality System Regulation (QSR) including current Good Manufacturing Practices (cGMP), as set forth by the FDA.
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