Commonwealth Diagnostics International, Inc. (CDI), a specialized clinical diagnostics service provider, independent CLIA-certified laboratory, and medical technology company focused on the early detection and diagnosis of functional gastrointestinal disorders, announced today several strategic updates, including the official re-launch of IBSchek® – its first-in-kind blood test to rule in Irritable Bowel Syndrome – in the United States, enhancements to its hydrogen and methane breath testing services, international expansion benchmarks, and key additions to the Leadership Team to guide the company’s future growth plans.
“Today’s announcements represent another mission-critical step in the evolution of CDI as we continue to deploy our growth strategy in a meaningful way,” said Craig S. Strasnick, President and CEO at CDI. “They also come at an inflection point for our company, and these organizational updates give CDI the infrastructure and support it needs to accelerate the execution of our long-term plan while also optimizing our in-market operating activities and ensuring that we are continually positioning ourselves to materialize the value of our growth prospects through a disciplined yet ambitious focus on technological innovation, clinical program development, key market product introductions, and overall organizational flexibility.”
The organizational updates announced today include the elevation of Gray W. Rifkin, Esq. to Chief Operating Officer of the company, overseeing the day-to-day operations and continuing to lead business development, strategy, legal, and corporate governance functions. In addition, Brianna Cassidy, PhD has joined CDI as the company’s Chief Science Officer, managing all research and development initiatives as well as new assay development programs. Roy Peake, PhD has joined CDI as Laboratory Director, responsible for the oversight and implementation of all quality assurance programs, regulatory inspections, and compliance submissions.
In January of this year, CDI’s state-of-the-art laboratory obtained ISO 13485 certification for medical device manufacturing and CLIA certification as an independent clinical laboratory. In the coming months, CDI plans to release health economic data showing cost savings associated with the use of hydrogen and methane breath testing as a diagnostic tool vs the exclusionary diagnostic pathway.
Expanding product offerings outside of the United States has been a key focus for 2018. CDI recently obtained a Medical Device Establishment License from Health Canada, expanding distribution capabilities into the Canadian market as of April 3rd, 2018. Additionally, CDI continues to broaden its footprint oversees. CDI’s joint venture, Functional Gut Diagnostics, which was launched in conjunction with the Functional Gut Clinic last year, has recently expanded its clinical and commercial capacities and operations in the United Kingdom. CDI also continues to grow its global IP portfolio with 73 registered patents in the EU.
Finally, CDI is excited to officially re-launch IBSchek in the United States at Digestive Disease Week (DDW) in Washington, DC in June 2018. IBSchek is the first clinically validated blood test for diarrhea-predominant and mixed-symptom (diarrhea and constipation) Irritable Bowel Syndrome (IBS-D, IBS-M). IBSchek is based on the scientific findings of Mark Pimentel, MD, and his team of gastrointestinal experts at Cedars-Sinai Medical Center in Los Angeles who conducted a 2500+ patient clinical trial which showed that anti-vinculin and anti-CdtB are effective biomarkers for the diagnosis of diarrhea-predominant or mixed-symptom IBS1. IBSchek key biomarkers are now included in the Rome Foundation’s official Rome IV Clinical Decision Toolkit. CDI continues to work with its medical advisory board, key opinion leaders, and leading healthcare institutions around the globe to conduct revalidation studies and clinical research projects. CDI is also in the process of establishing new commercial partnerships and distribution networks to assist in expanding the scale of IBSchek in the United States.
1) Pimentel M, Morales W, Rezaie A, Marsh E, Lembo A, Mirocha J, et al. (2015) “Development and Validation of a biomarker for DiarrheaPredominant Irritable Bowel Syndrome in Human Subjects”. PLoS ONE. 2015;10: e0126438.