FOR IMMEDIATE DISTRIBUTION
SBH Diagnostics receives High-Complexity-CLIA Certification for our Natick, Massachusetts Lab
(Natick, MA) January 19, 2014. SBH Diagnostics announced receipt for CLIA certification and will offer the highly anticipated Picosensitive C-Peptide and Glucagon Assays in the US and Canada for diagnostic testing.
C-peptide has been used as a surrogate marker for insulin secretion in research and clinical diagnostics for many years.
The Picosensitive Assay called CPEP3, (exclusive Diagnostic-Use license from Mercodia, SA), is highly specific, precise and offers a low measuring range, not available with any other C-peptide assay on the market today. This assay allows many diabetic patients who may have been characterized as C-peptide negative based on the use of standard (less sensitive) methods to have their C-peptide levels accurately measured and this knowledge may affect treatment plans, inclusion in clinical trials, etc.
The value of this C-peptide assay has been highlighted by various groups including AACC publications (Clinical Laboratory News and Clinical Laboratory Strategies) and several publications by the Faustman Lab at MGH. The Pico 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 also lead to intervention therapies to mitigate diabetes complications.
SBH Diagnostics will include the Picosensitive Assay 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 and therapeutics.
"With CLIA certification, SBH Diagnostics now has the capacity to provide comprehensive solutions for clients working in clinical environments," stated Raphael Nir, President, SBH Diagnostics, Inc. "We are committed to providing clinical researchers, physicians, and patients with C-peptide testing results that ultimately lead to better diagnoses and more effective treatments. Because we deliver validated tests through our own CLIA laboratory, our partners have the ability to test clinical samples in a CLIA-certified setting, with appropriate standard operating procedures, Quality Management Systems, and robust documentation. The company's laboratory operates under Good Laboratory Practice, and all personnel follow strict confidentiality guidelines and undergo a rigorous training program including Health Insurance Portablilty and Accountability Act (HIPAA) practices".
SBH Diagnostics (SBHD) is an innovative Contract Research Organization and CLIA Lab dedicated to providing accurate and reproducible biomarker analysis services. We are focused on the commercialization of Laboratory Developed Tests (LDTs). In the SBH Diagnostics portfolio under CLIA auspices are the Pico-molar C-Peptide test, the highly-specific Glucagon Test and the EASy-Sjogren's test using the Automatic Simple Western process. SBHD is located in Natick, MA and is associated with SBH Sciences and GlycoZym.
Mercodia AB 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 to all major international markets and provides a professional scientific support system to develop novel applications for existing products and unique diagnostics for emerging markets. Mercodia has demonstrated compliance with "International Organization for Standardization (ISO) in 13485:2003, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes".
For further information, please contact:
Marvin A. Collin, Vice President
General information about SBH Diagnostics may be found at:
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