US-based Biomecite Diagnostics has started enrolling patients in its proof of concept study, which is designed to show the accuracy of a new diagnostic technology to allow physicians to diagnose inflammatory bowel disease (IBD).
The diagnostic technology 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).
The company is conducting the proof of concept study in partnership with CSSi Life Sciences in Glen Burnie, Maryland.
Existing methods for initial clinical diagnosis of UC and CD are challenging. Healthcare providers rely mainly on the use of colonoscopies and biopsies.
The diagnostic technology relies on the analysis of signature genetic sequences obtained directly from patient stool samples.
It belongs to the field of microbiome-based diagnostics, fuelled by the development of efficient and cost-effective DNA sequencing technologies.
Current tests for IBD rely on clinical symptoms and invasive procedures, and depending on the subjective interpretation of the pathology, result in 10%-15% of colitis cases being labelled 'indeterminate colitis'.
The company noted the development of a stool-based diagnostic test for IBD will provide a non-invasive, cost-effective alternative.
Biomecite Diagnostics CEO Gerard Eldering said: "This proof of concept study is a critical milestone for Biomecite.
"If successful, the study will enable the company to raise capital to pursue critical regulatory studies and bring this important diagnostic tool to market."
The company received commercial support from the Maryland Innovation Initiative (MII) of Technology Development Corporation (TEDCO), an independent Maryland organisation.
TEDCO offers entrepreneurial business assistance and seed funding for the development of startup companies in Maryland.
Biomecite commercialises an IBD diagnostic tool based on a microbiome signature technology developed at the University of Maryland.
CSSi LifeSciences offers fully integrated, specialised regulatory and clinical services to support the pharmaceutical and medical device lifecycle.