SBH Diagnostics signs exclusive license to offer the CPEP3 Assay in their CLIA-certified lab
(Natick, MA) April 2, 2013.SBH Diagnostics, Inc. announced the signing of an exclusive licensing agreement with Mercodia AB, allowing them to offer the highly anticipated CPEP3 in the US and Canada for diagnostic testing.
C-peptide is a standard measure of pancreatic beta cell function and is used to assess the health of patients, especially those with diabetes. The CPEP3 test is highly specific, precise and offers a low Picomolar measuring range, an advantage not found with any other C-peptide assay on the market today. The ultrasensitive aspects of the CPEP3 Assay are important so as to provide a test that is highly quantitative and reliable with specificity and sensitivity that provides predictive results and minimal cross reactivity.
Various groups, including the AACC (American Association for Clinical Chemistry) and Dr. Denise Faustman, Massachusetts General, Boston MA, have highlighted the value of this assay in several peer-reviewed publications. The CPEP3 assay not only has important potential implications for patients and clinicians, it also allows for changes in inclusion criteria and monitoring during trials that assess treatments targeting those with long-term Type 1 diabetes. This can lead to interventional therapies to mitigate the life-threatening complications of diabetes.
SBH Diagnostics will include the CPEP3 in their CLIA Lab test portfolio, making it available to clinicians in addition to those conducting clinical trials and companies involved with diabetes diagnosis, management, therapeutics and devices.
SBH Diagnostics (www.sbhdiagnostics.com) is an innovative CLIA lab that is a joint-venture between SBH Sciences (www.sbhsciences.com) and GlycoZym USA (www.glycozym.com) focused on the commercialization of Laboratory Developed Tests (LDTs). Combining the laboratory disciplines and expertise of SBH Sciences with the patented biomarker technology of GlycoZym, SBH Diagnostics provides a CLIA Lab development model called EVOCC; a test is Evaluated, Validated, Optimized, Commercialized and Certified under CLIA and CAP auspices.
Mercodia AB (www.mercodia.com) is a Swedish biotech company focusing on the development of high quality immunoassays within the field of metabolic disorders. Mercodia is a world-leading supplier and provides a professional scientific support system to develop novel applications for existing products and unique diagnostics for emerging markets.
For further information, please contact:
Marvin A. Collin,
Vice President Business Development
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