Commonwealth Diagnostics Presents Evidence To Support Improved Testing Methods To Facilitate Diagnosis Of Irritable Bowel Syndrome

SALEM, Mass.--(BUSINESS WIRE)--Commonwealth Diagnostics International, Inc. (CDI), announced today findings from three studies presented at the Digestive Disease Week (DDW) Annual Meeting 2017 in Chicago, IL. Given the prevalence of Irritable Bowel Syndrome (IBS), there is an interest in gaining a better understanding of the disease and available diagnostic testing methods. Through the three studies shared at DDW, CDI provided new insights linking IBSchek^TM to issues related to IBS-D (Irritable Bowel Syndrome with Diarrhea) testing methods.

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.

IBSchek is considered to be the only reliable blood test for the diagnosis of IBS-D and is predictive of an IBS-D diagnosis based on the presence of 2 antibodies – anti-cytolethal distending toxin B (CdtB) and anti-vinculin. IBSchek allows healthcare providers to quickly and confidently diagnose IBS-D, as these biomarkers can accurately differentiate IBS from other causes of diarrhea without excessive investigation.

“DDW is the world’s largest gathering of gastroenterologists, and we are pleased to present new scientific data at this meeting that will contribute to a better understanding of IBS-D,” said Craig S. Strasnick, president and CEO at CDI. “Through the three studies showcased at DDW, we hope to generate dialogue between patients, healthcare providers, and payers about the value of leveraging less invasive testing methods that can quickly and confidently diagnose this common disease.”

Studies presented at DDW include these by Dr. Mark Pimentel, of Cedars-Sinai:

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: Results from this study support that CdtB is an important factor in the development of functional changes after gastroenteritis. Many cases of IBS begin after a bout of acute gastroenteritis. This study suggests that the presence of two specific antibodies (CdtB and anti-vinculin) can be highly predictive of an IBS-D diagnosis, and these biomarkers can accurately differentiate IBS from other causes of diarrhea. ¹

Measurement of hydrogen sulfide (H₂S) during breath testing correlates to patient symptoms: This study provided evidence that H₂S appears to be important in predicting clinical symptoms of small intestinal bacterial overgrowth (SIBO), particularly diarrhea and fatigue. Additionally, increased levels of H₂S may correlate to increased severity of symptoms.²

An additional study, also done in partnership with Cedars-Sinai, will be presented to explore the cost-effectiveness of IBS-D testing:

The Cost-Effectiveness of Laboratory Biomarkers for Irritable Bowel Syndrome with Diarrhea: A Framework for Payers: This study helped determine the cost savings—both direct and indirect—to the patient and healthcare system from receiving a faster IBS-D diagnosis. Additionally, the study provides a framework for payers to evaluate the return on investment of implementing IBS-D biomarkers of varying accuracy and cost.³

“As a gastroenterologist, it is helpful to evaluate this diverse data, as it provides insights into a variety of issues related to IBS-D testing,” said Mark Pimentel, MD, principal investigator and Executive Director, MAST Program (Medically Associated Science and Technology), Cedars-Sinai. “In particular, I am intrigued by the studies that explored various biomarkers and how these biomarkers specifically affect symptoms and can point to underlying IBS-D disease. The ability to effectively and quickly diagnose an IBS-D patient is essential, as we know this is a disease that can significantly affect a patient’s quality of life.”

Brennan Spiegel, MD, MSHS, Director, Health Services Research in Academic Affairs and Clinical Transformation at Cedars-Sinai, believes the new testing is a great benefit to patients, and noted, “Although IBS is the most common disease managed by gastroenterologists, it can still be surprisingly difficult to diagnose because other conditions can present with the same symptoms. With the increasing development of biomarkers to help clinicians distinguish IBS from other conditions, it’s important to measure the cost-effectiveness of these new blood tests.”

IBSchek is marketed internationally by CDI. Cedars-Sinai has entered into an exclusive license agreement with CDI for several patent applications covering the blood tests to detect both anti-CdtB and anti-vinculin antibodies in the diagnosis of irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), developed by Mark Pimentel, MD.

About IBSchek

IBSchek is a simple ELISA-based blood test that is highly predictive of an IBS-D diagnosis based on the presence of 2 antibodies – anti-CdtB and anti-vinculin. IBSchek is considered to be the only quick and reliable blood test for the diagnosis of IBS-D. With IBSchek, IBS-D may no longer be a diagnosis of exclusion and healthcare providers can now confidently diagnose certain mechanisms of IBS without excessive investigation. Additional information about IBSchek can be found at www.CommDx.com.

About IBS

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, and the exact cause is unknown.⁴ Treatments are available to help manage the symptoms of IBS⁴, but there is no known cure. It is estimated that IBS affects between 25 and 45 million people in the United States⁵ and is the most commonly diagnosed functional GI disorder.

About Commonwealth Diagnostics

Commonwealth Diagnostics International, Inc. is an international diagnostic service provider specializing in cutting-edge diagnostic products that assist physicians and patients with the diagnosis of some of the common sources of digestive distress and functional gastrointestinal disorders. CDI’s current diagnostic portfolio (excluding R&D) specializes in customized Gas Chromatography, ELISA, and Isotope-Ratio Mass Spectrometry solutions. CDI partners internationally with some of the most reputable and preeminent diagnostic service providers, medical and health technology companies, life sciences and biotechnology organizations, academic and research institutions, and public health consortiums in the world. The company is headquartered in Salem, MA, and additional company information can be found at www.CommDx.com.

About Cedars-Sinai

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars-Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow’s health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

References:

1. Pimentel, Mark, 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. Presented at Digestive Disease Week, May 6-9, 2017; Chicago, IL.
2. Pimentel, Mark, et al. Measurement of hydrogen sulfide during breath testing correlates to patient symptoms. Presented at Digestive Disease Week, May 6-9, 2017; Chicago, IL.
3. Spiegel, Brennan, et al. The Cost-Effectiveness of Laboratory Biomarkers for Irritable Bowel Syndrome with Diarrhea: A Framework for Payers. Presented at Digestive Disease Week, May 6-9, 2017; Chicago, IL.
4. Irritable bowel syndrome: symptoms. Mayo Clinic website. http://www.mayoclinic.org/diseases-conditions/irritable-bowel-syndrome/basics/symptoms/con-20024578 . Accessed on May 5, 2017.
5. About IBS. International Foundation for Functional Gastrointestinal Disorders. http://www.aboutibs.org/facts-about-ibs.html. Accessed on May 5, 2017.