COMMONWEALTH DIAGNOSTICS ANNOUNCES U.S. LAUNCH AND NEW GLOBAL DEVELOPMENTS

Commonwealth Diagnostics International (CDI), Inc., an international diagnostic service provider specializing in functional gastrointestinal disorders, recently announced the re-launch and integration of its customer-centric, gastroenterology-focused diagnostic testing business in the United States, including its hydrogen and methane breath testing portfolio for Small Intestinal Bacterial Overgrowth (SIBO) and carbohydrate malabsorption. This announcement comes after CDI generated positive momentum and recognition at the American Gastroenterological Association’s Digestive Disease Week (DDW) 2017 Annual Meeting, where CDI announced new data from three studies that provide evidence to support improved testing methods for the diagnosis of Irritable Bowel Syndrome (IBS) and other common digestive disturbances.^1-3

“This is an exciting time for CDI as we are able to return to our heritage and deliver our industry-leading model of service and simplicity to our healthcare providers throughout the United States,” said Craig S. Strasnick, President and CEO at CDI. “These new developments will allow CDI to focus on our current portfolio of diagnostic tests in the U.S., while also introducing new technologies that will help to facilitate the diagnosis of gastrointestinal disorders in the future as we advance our growing R&D program across a broad spectrum of GI health areas.”

This announcement comes as CDI takes steps to provide expanded offerings to patients in the US and globally. Some recent notable developments include:

• CDI has adopted the North American Consensus Standards on hydrogen and methane breath testing. These consensus standards, which were arrived at by 17 world renowned clinician-scientists, help to standardize the indications, preparation, performance, and interpretation of hydrogen and methane breath testing in clinical practice and research.⁴
• CDI has received ISO 13485 Certification and CE Marking for its hydrogen and methane breath testing kits, allowing for their introduction into European markets.

• CDI has entered into a series of international joint ventures and commercial partnerships to make its diagnostic products and services available in the United States, Latin America, the United Kingdom (UK), and Switzerland. CDI is also planning for continued market expansion into Australia in 2018.⁵
• In the United Kingdom, CDI and the Functional Gut Clinic have come together to establish a new joint venture, Functional Gut Diagnostics, a premier functional GI-focused diagnostic company that will offer CDI’s entire suite of products in the greater UK region, as well as significantly expand CDI’s R&D activities and clinical trial capabilities.
• In Switzerland, CDI has entered into a commercial partnership with UniLabs, a multinational laboratory with a presence in 11 European countries, to distribute IBSchek™, CDI’s proprietary blood test for IBS-D/M.
• CDI has recently published new health economic studies showing significant cost savings to the healthcare system when using IBSchek^TM, CDI’s proprietary blood test for IBS with predominant diarrhea or of mixed/alternating type (IBS-D/M).⁶
• CDI has entered into a development and commercial partnership agreement with Alpha Logic, Inc., a medical device company that has recently received 510(k) clearance for AbStats™, a new cutting-edge acoustic gastrointestinal monitoring system.
• CDI has entered into a commercial partnership with My Total Health, a cloud-based healthcare data ecosystem that allows real-time patient symptoms to be captured and transmitted to healthcare providers, including its GI-focused platform, MyGiHealth™.
• CDI has recently sponsored The Rome Foundation in its efforts to guide clinicians and investigators in the understanding and care of patients with functional gastrointestinal disorders (FGIDs), including Irritable Bowel Syndrome. The Rome Foundation is an independent not-for-profit organization that works with high-impact medical professionals across the globe to generate scientific data and educational information to assist in the diagnosis and treatment of FGIDs and improve the lives of patients suffering from them.

“Our company understands that millions of people worldwide are continuing to struggle with these increasingly prevalent GI disturbances and we are committed to continuing to expand the breadth and scope of our services to all of these patients around the world,” Strasnick continued. “We see both a responsibility and opportunity to positively impact the lives of millions of people in the U.S. and abroad, and we look forward to providing our patients and healthcare providers with innovative and cost-effective solutions to help facilitate the diagnosis of Small Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome, as well as many other common sources of gastrointestinal disorders.”

IBS, a common gastrointestinal disorder accompanied by symptoms such as bloating, intermittent abdominal discomfort, diarrhea, and constipation, is often difficult for healthcare providers to diagnose. Frequently, IBS is diagnosed by a process of exclusion, meaning patients are diagnosed after numerous tests and after excluding all other conditions. These testing methods can be invasive, expensive, and time-consuming.

“I have had the opportunity to work with CDI’s management team and portfolio of products for several years, as I diagnose and treat patients with various GI disorders. I am glad to know the company’s diagnostic products and services are now available to the patients I am seeing at my local practice,” said Brennan Spiegel, MD, MSHS, Director, Health Services Research in Academic Affairs and Clinical Transformation at Cedars-Sinai. “I am excited to follow the new advances and contributions CDI can make to the GI patient and research community.”

CDI re-launched its domestic operations the week of August 21, 2017, with additional launch activities and announcements coming at the American College of Gastroenterology (ACG) Annual Meeting, October 13–18, 2017, in Orlando, FL.

About IBS and Small Intestinal Bacterial Overgrowth (SIBO)

IBS is a functional gastrointestinal disorder that is associated with bloating, chronic abdominal pain and cramping, and changes in bowel frequency and form. Diarrhea and constipation are common symptoms associated with IBS. The exact cause of IBS is unknown.⁷ Treatments are available to help manage the symptoms of IBS, but there is no known cure.⁷ It is estimated that IBS affects between 25 and 45 million people in the United States and is the most commonly diagnosed functional gastrointestinal disorder.⁸

The symptoms of IBS are similar to those experienced by patients with SIBO.⁹ SIBO occurs when an increased number and/or type of bacteria proliferate in the upper gastrointestinal tract, resulting in patient symptoms such as bloating, pain, abdominal discomfort, watery diarrhea, dyspepsia, and weight loss. CDI offers proprietary hydrogen and methane breath tests to assist patients and providers in diagnosing SIBO.

 

References:

1 Almario CV, Noah BD, Jusufagic A,Lew D, Spiegel B. At what price and accuracy are IBS-D biomarkers cost-saving in clinical practice? [abstract]. Gastroenterology. 2017; 152(5)(suppl):S118-S119. Abstract 516.

2 Lin E, Chua KS, Pichetshote N, et al. Measurement of hydrogen sulfide during breath testing correlates to patient symptoms [abstract]. Gastroenterology. 2017;152(5)(suppl):S205-S206. Abstract 1102.

3 Parodi G, Morales W, Park SC, et al. Cytolethal distending toxin B (CdtB) exposure alone is sufficient to precipitate autoimmunity and changes to the small intestinal microbiome in a rat model of post-infectious IBS [abstract]. Gastroenterology. 2017;152(5)(suppl):S621. Abstract Su1991.

4 Rezaie A, Buresi M, Lembo A, et al. Hydrogen and methane-based breath testing in gastrointestinal disorders: the North American Consensus. Am J Gastroenterol. 2017;112(5):775-784.

5 For additional information about these strategic partnerships, or to inquire about how to work with CDI in the global markets, please contact the company directly.

6 Rinde H, Holtorf A, Riceberg LJ. The Economic Impact for Self-Insured Employers in the USA from Early Diagnosis of Diarrhea Dominated or Mixed Irritable Bowel Syndrome (IBS-D/M) Using a Novel IBS Diagnostic Blood Panel. Poster presented at ISPOR 22nd Annual International Meeting; May 2017.

7 Irritable bowel syndrome: symptoms. Mayo Clinic website. http://www.mayoclinic.org/diseases-conditions/irritable-bowel-syndrome/basics/symptoms/con-20024578. Accessed May 5, 2017.

8 Facts about IBS. International Foundation for Functional Gastrointestinal Disorders website. http://www.aboutibs.org/facts-about-ibs.html. Accessed May 5, 2017.

9 Gut bacteria and IBS. International Foundation for Functional Gastrointestinal Disorders website.

https://aboutibs.org/gut-bacteria-and-ibs.html. Accessed July 12, 2017.