GLEN BURNIE, Md., Oct. 30, 2015 /PRNewswire/ -- Biomecite Diagnostics, LLC announced today patient enrollment into the company's proof of concept study. The study is designed to demonstrate the accuracy of a new diagnostic technology to allow physicians to diagnose Inflammatory Bowel Disease (IBD). This diagnostic tool explores distinct variances in the populations of bacteria or microbiome found in the human gut to further differentiate between Ulcerative Colitis (UC) and Crohn's Disease (CD). This proof of concept study is being conducted in partnership with CSSi Life Sciences in Glen Burnie, Maryland.
Current methods for the initial clinical diagnosis of UC and CD remain challenging. Healthcare providers rely primarily on the use of colonoscopies and biopsies. The Biomecite diagnostic technology relies on the analysis of signature genetic sequences obtained directly from patient stool samples. This state-of-the-art technology belongs to the rapidly expanding field of microbiome-based diagnostics, fueled by the development of increasingly efficient and cost-effective DNA-sequencing technologies.
Current tests for IBD, relying mostly on clinical symptoms and invasive procedures and depending upon the subjective interpretation of the pathology, result in approximately 10 to 15 percent of colitis cases being labeled "indeterminate colitis." The development of a stool-based diagnostic test for IBD will provide a non-invasive, cost effective alternative.
"This proof of concept study is a critical milestone for Biomecite," said Gerard Eldering, M.B.A., Chief Executive Officer of Biomecite Diagnostics, LLC. "If successful, the study will enable the company to raise capital to pursue critical regulatory studies and bring this important diagnostic tool to market."
Biomecite has received commercial support from the Maryland Innovation Initiative (MII) of TEDCO (Technology Development Corporation), an independent Maryland organization that strives to provide entrepreneurial business assistance and seed funding for the development of startup companies in Maryland's innovation economy.
About Biomecite Diagnostics, LLC
Biomecite Diagnostics, LLC is a development-stage medical diagnostics company commercializing an IBD diagnostic tool based on a microbiome signature technology developed at the University of Maryland, Baltimore. The company was founded in 2014 and received initial seed funding in 2015.
CSSi LifeSciences™ provides fully integrated, specialized regulatory and clinical services to support the entire pharmaceutical and medical device lifecycle. With global expertise, CSSi LifeSciences™ has been a key partner in the development of more than 500 drugs, biologics, medical devices and in-vitro diagnostics.
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SOURCE Biomecite Diagnostics, LLC