Biomecite’s IBD Diagnostic Tool to Be Evaluated in Proof of Concept Study

Biomecite’s IBD Diagnostic Tool to Be Evaluated in Proof of Concept Study

Biomecite Diagnostics, LLC, a medical diagnostics company, recently announced that it is enrolling patients for a proof of concept study whose goal is to assess the accuracy of a new diagnostic technology for inflammatory bowel disease (IBD).

Biomecite’s IBD diagnostic tool is based on a microbiome signature technology developed at the University of Maryland, Baltimore. It explores the differences in the microbiome (bacterial population) found in the human gut in order to determine whether patients suffering from gastrointestinal problems have IBD, and also allows the discrimination between two IBD types, ulcerative colitis and Crohn’s disease. This proof of concept study is being performed in collaboration with the CSSi Life Sciences in Glen Burnie, Maryland, a company providing specialized regulatory and clinical support.

The diagnosis of IBD, including ulcerative colitis and Crohn’s disease, can represent a challenge, and healthcare providers rely mainly on clinical symptoms and invasive procedures such as colonoscopies and biopsies to reach a diagnosis.

Microbiome-based diagnostics is a field in rapid expansion. The Biomecite’s IBD diagnostic tool is included in this type of diagnostics as it relies on the analysis of signature genetic DNA sequences collected directly from stool samples of patients. The fact that DNA-sequencing technologies are increasingly cost-effective as also helped in the expansion of this type of diagnostic tool.

The company believes that its IBD stool-based diagnostic test will offer primary care physicians and gastroenterologists a new, non-invasive, easily automatable, cost effective, and accurate diagnostic within days after the fecal microbiota test. Importantly, this tool causes no discomfort or risk to the patient, and could help tens of millions of individuals worldwide.

“This proof of concept study is a critical milestone for Biomecite,” said the Chief Executive Officer of Biomecite Diagnostics, Gerard Eldering, MBA, in a press release. “If successful, the study will enable the company to raise capital to pursue critical regulatory studies and bring this important diagnostic tool to market.”

According to the Crohn’s and Colitis Foundation of America (CCFA), approximately 1.6 million people in the United States are affected by IBD, with around 70,000 new cases being diagnosed every year. IBD is estimated to affect five million people worldwide.