If we think of our bodies as walking, talking ecosystems, it stands to reason that microbial collections may change in response to the foods we eat and places we live. Similarly, disease-related shifts in the human environment are expected to influence our resident microbes, even if those microbes themselves don’t cause the changes.
Investigators and investors are increasingly banking on the possibility that microbes finding safe harbor in human habitats may be useful for detecting disease—from acute infections to chronic inflammatory conditions.
Biomecite’s IBD Diagnostic Tool to Be Evaluated in Proof of Concept Study. Microbiome-based test may lead to a new non-invasive and cost effective way of diagnosis. Read the story in IBD News Today.
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.