CDI Receives MDEL in Canada for Non-Invasive Diagnostic Breath Tests for Patients with Small Intestinal Bacterial Overgrowth and Other Functional Gastrointestinal Disorders

Commonwealth Diagnostics International, Inc. (CDI), the leader in hydrogen and methane breath testing^® for functional gastrointestinal disorders, announces its entry into the Canadian healthcare market. CDI will offer its state-of-the-art, non-invasive, functional GI diagnostic tests to the approximately five million Canadians afflicted with Irritable Bowel Syndrome (IBS)¹, and millions of other patients suffering from functional gastrointestinal disorders such as Small Intestinal Bacterial Overgrowth (SIBO) and carbohydrate malabsorption disorders. This announcement comes following CDI’s attainment of a Medical Device Establishment License (MDEL) from Health Canada, and in conjunction with a sponsored webinar hosted by Canadian dietician Andrea Hardy, RD, which was attended by more than 400 Canadian healthcare providers.

The growing body of research regarding whole-body health impacts of SIBO, as well as the recent publication of the North American Consensus on Breath Testing,² a cooperative publication by 17 world-leading clinician-scientists which identifies industry-leading protocols for using hydrogen breath testing to diagnose SIBO, represent a growing shift toward early detection of SIBO with patient-friendly, non-invasive diagnostic breath tests, saving both time and resources for patients and providers.

SIBO is the accumulation of excessive amounts of bacteria in the small intestine characterized by at least 100,000 bacteria per mL of fluid. SIBO harms both the structure and function of the small bowel. It may significantly interfere with digestion of food and absorption of nutrients, primarily by damaging the cells lining the small bowel. The main symptoms of SIBO include bloating, abdominal pain, diarrhea and/or constipation, and flatulence.

CDI’s entry into Canada improves the options available to both patients who are suffering from gastrointestinal disorders and healthcare providers challenged with diagnosing, managing, and treating the patients’ conditions. CDI’s easy-to-use diagnostic products can be used by patients in the comfort of their own home and results are delivered 24 hours after specimens are received at its CLIA-certified laboratory for analysis. Commonwealth Diagnostics welcomes patients and providers in Canada to experience the CDI difference!

To find out more about CDI, please visit the company website, www.CommDX.com or call (888) 258-5966.

About Commonwealth Diagnostics

Commonwealth Diagnostics International, Inc. (CDI) is a global diagnostics service provider, independent clinical laboratory, and ISO13485 certified medical technology company founded on the value-centric principle that efficient and early diagnosis of common gastrointestinal ailments results in preventative healthcare, empowered providers and patients, better patient outcomes, and robust cost savings for the healthcare delivery system. CDI operates out of a new CLIA laboratory in Salem, Massachusetts, and specializes in providing innovative diagnostic products and services that support healthcare providers and their patients in the detection and management of some of the most common gastrointestinal disorders, including: hydrogen and methane breath testing for small intestinal bacterial overgrowth (SIBO) and carbohydrate malabsorption, an ELISA blood test (IBSchek™) for Irritable Bowel Syndrome (IBS), and AbStats™, an easy-to-use, non-invasive, 510(k) cleared digestive telemetry and sensory system.

CDI focuses on creating simple, accessible, and innovative approaches to diagnostic modalities while leading in categories of quality, accuracy, and scientific and clinical integrity. CDI is committed to be the “go-to” player in functional GI diagnostics, both in the delivery of our current test portfolio and in our commitment to contributing to research and development in the field. For more information, please email us at inquiries@CommDX.com or visit our website at www.CommDX.com.

References:

[1] Fedorak RN, Vanner SJ, Paterson WG, Bridges RJ. Canadian Digestive Health Foundation Public Impact Series 3: Irritable bowel syndrome in Canada. Incidence, prevalence, and direct and indirect economic impact. Canadian Journal of Gastroenterology. 2012;26(5):252-256.

[2] Rezaie, Ali, et al. “Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus.” The American Journal of Gastroenterology, vol. 112, no. 5, 2017, pp. 775–784., doi:10.1038/ajg.2017.46.

Contacts

CDI
Lisa Richard
VP, Corporate Affairs
978-619-2246
LRichard@CommDX.com
or
Alexandra Connors
VP, Organizational Development
978-219-2123
AConnors@CommDX.com