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SBH Diagnostics has developed a novel, rapid blood test for Sjogren's Syndrome
(Natick, MA) June 1, 2013. SBH Diagnostics, Inc. announced today the development of a novel blood test for Sjogren's syndrome. SBH Diagnostics test is called EASy-Sjogren's (Early, Accurate and Sensitive). Up to now there has been no single test that can be used to make a definitive diagnosis of Sjögren's Syndrome in its early stages. The EASy-Sjogren's Test is designed to provide results within 72 hours of receipt of a blood sample.
Sjögren's syndrome affects up to 4 million people in the United States, 90% of those affected are women. Patients with this autoimmune disease, which targets and destroys exocrine glands such as the tear (lacrimal) and salivary glands, often experience the classic symptoms of severe dry mouth and/or eyes, increasing the risk of infection or damage to these organs (e.g. corneal scarring, dental decay, gingivitis). Patients may also exhibit systemic complications, such as disabling fatigue, joint pain and stiffness, or dysfunction of the heart, blood vessels, lung, liver, nerves, or kidney.
Existing Sjögren's syndrome diagnosis is currently based on a combination of symptoms, blood tests, tissue studies (e.g., salivary gland punch biopsy), and physical exam. Sjögren's syndrome is often initially mistaken for another condition or simply goes undiagnosed. The Sjögren's Syndrome Foundation estimates that the average time from onset of symptoms to diagnosis is 6.5 years.
Our EASy-Sjogren's test is based upon quantifying altered Post Translational Modifications (PTMs - phosphorylations) of selected proteins from patients with Sjogren's syndrome. These altered PTMs are a result of the genetic lesions associated directly with Sjogren's syndrome. SBH Diagnostics utilizes an automated IEF-Western Blot detection system to accurately and reproducibly quantify these altered proteins.
SBH Diagnostics will develop and commercialize the Sjogren's syndrome test under CLIA regulation and will offer it to clinicians, and pharmaceutical and biotechnology companies that desire more accurate Sjögren's Syndrome diagnosis, clinical trials management, and pre-clinical therapeutic development.
CLIA (Clinical Laboratory Improvement Amendments) is a lab testing quality standard that was first established in 1988, and became part of the Federal Register in 1992. CLIA laboratory-developed tests are most frequently brought to market in order to satisfy a testing niche which is not served by a commercially available test.
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 has a unique model to develop, validate and commercialize tests in Oncology, Inflammation, vaccines and other disease states for entrance to the US and Canadian markets.
For further information, please contact:
Thayer White, PhD
CEO & CSO
2 Mercer Road
Natick, MA 01760
General information about SBH Diagnostics may be found at:
Please click here for representative Sjogren's data.