SALEM, Mass.--(BUSINESS WIRE)--Commonwealth Diagnostics International (CDI), Inc., an international diagnostic service provider specializing in functional gastrointestinal disorders, recently announced the commercial re-launch of IBSchek™, the first clinically validated blood test for diarrhea-predominant and mixed-type Irritable Bowel Syndrome (IBS-D, IBS-M). CDI will officially re-launch IBSchek to the gastroenterology community at Digestive Disease Week in Washington, DC in June 2018. CDI is a registered exhibitor at the Walter E. Washington Convention Center, Booth #919.
IBSchek is a simple blood test that identifies the presence of two antibodies, anti-CdtB and anti-vinculin, which data have shown to be indicative of diarrhea-predominant IBS (IBS-D) and mixed-type IBS (IBS-M).1 As a part of the re-launch, CDI has announced that the IBSchek key biomarkers, anti-CdtB and anti-vinculin, are now included in the Rome Foundation’s official Rome IV Clinical Decision Toolkit. Additionally, 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 aimed at further enhancing the clinical application and utility of these important biomarkers. CDI is also in the process of continuing to establish new commercial partnerships and distribution networks to assist in the expansion and scale of IBSchek in the United States.
“We are excited to announce the availability of IBSchek, and to continue to play our part in assisting the GI community to better-identify and treat the significant portion of the US and global population of IBS sufferers searching for a diagnosis,” said Craig S. Strasnick, President and CEO at CDI. “At CDI, we view new solutions such as IBSchek as a representation of our unwavering commitment and dedication to providing innovative and cost-effective solutions to debilitating functional GI illness for our healthcare providers and their patients in the United States and around the world.”
In addition to the re-launch of IBSchek, Commonwealth Diagnostics is also proud to announce the expansion of their test menu to include a serum-based ELISA test panel for Celiac Disease, which includes anti-human Tissue Transglutaminase (tTG) and deamidated gliadin peptide (DGP) IgA and IgG antibodies. This test is a valuable addition to the test portfolio due to the similar symptomology between Celiac and IBS patients, especially in the IBS subtypes of diarrhea predominant and mixed symptoms. “We believe that using both IBSchek and the CDI Celiac Panel together will further direct clinicians towards the potential cause of their patients’ symptoms, which may ultimately lead to a more effective course of treatment through a clearer diagnosis,” said Brianna Cassidy, PhD, Chief Science Officer at CDI. CDI will begin accepting diagnostic samples for Celiac testing in June 2018.
IBSchek is a proprietary blood test for IBS based on the scientific findings of Mark Pimentel, MD, and his team of gastrointestinal experts at Cedars-Sinai Medical Center in Los Angeles. Dr. Pimentel and his team 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 IBS. The test utilizes a proprietary, ELISA-based blood test. IBSchek requires just 3 mL of blood, which can be drawn in any healthcare provider’s office, phlebotomy center, or via CDI’s at-home mobile phlebotomy network. The blood specimen is sent to CDI for analysis and results are reported back within 24 hours of receipt. For more details please visit www.CommDX.com.
About IBS and Small Intestinal Bacterial Overgrowth (SIBO)
IBS is a common gastrointestinal disorder accompanied by symptoms such as bloating, intermittent abdominal discomfort, diarrhea, and constipation. The exact cause of IBS is unknown.5 IBS 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.
Treatments are available to help manage the symptoms of IBS, but there is no known cure.5 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.6
The symptoms of IBS are similar to those experienced by patients with SIBO.7 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.
About Commonwealth Diagnostics
Commonwealth Diagnostics International (CDI), Inc., was founded on the principle that preventative healthcare, including early detection and diagnosis of disease, results in expedited treatment, better patient outcomes, and robust cost savings for the healthcare delivery system. Operating out of a newly constructed laboratory in Salem, MA, CDI is an international diagnostic service provider, CLIA-certified independent clinical laboratory, and ISO 13485 medical device manufacturer specializing in innovative diagnostic products that assist physicians and patients with the diagnosis and management of some of the world’s most common sources of digestive distress and functional gastrointestinal disorders, including: hydrogen (H2)/methane (CH4) breath testing for Small Intestinal Bacterial Overgrowth (SIBO) and carbohydrate malabsorption, IBSchek for IBS-D/M; and AbStats™, an easy-to-use, noninvasive, and reliable digestive telemetry and sensory system. CDI focuses on creating customized operational solutions to diagnostic technologies that drive accessibility and simplicity in lieu of outdated, expensive, invasive, and inaccessible diagnostic modalities. CDI’s entire portfolio of tests can be utilized either at home or with one simple trip to the physician. CDI’s laboratory specializes in customized gas chromatography, ELISA, and isotope-ratio mass spectrometry solutions. Additional company information can be found at www.CommDX.com.
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.
2) Rezaie A et al: Assessment of Anti-vinculin and Anti-cytolethal Distending Toxin B Antibodies in Subtypes of Irritable Bowel Syndrome. Dig Dis Sci. 2017;62:1480–1485.
3) Pourmorady J et al. The Utility of Measuring Anti-Cytolethal Distending Toxin B and AntiVinculin Antibodies in a Tertiary Care Motility Practice: A Free Range Experience. Gastroenterology. 2016; 4 (Suppl 1): S-230.
4) Schmulson M et al. Clinical experience with the use of anti-CdtB and anti-vinculin antibodies in patients with diarrhea in Mexico. Rev Gastroenterol Mex. 2016; 81:236-239.
5) Irritable bowel syndrome: symptoms. Mayo Clinic website. http://www.mayoclinic.org/diseases-conditions/irritable-bowel-syndrome/basics/symptoms/con-20024578. Accessed May 5, 2017.
6) Facts about IBS. International Foundation for Functional Gastrointestinal Disorders website. http://www.aboutibs.org/facts-about-ibs.html. Accessed May 5, 2017.
7) Gut bacteria and IBS. International Foundation for Functional Gastrointestinal Disorders website. https://aboutibs.org/gut-bacteria-and-ibs.html. Accessed July 12, 2017.