Commonwealth announces availability of new ELISA-based blood test to quickly and reliably diagnose IBS

New Diagnostic Test for IBS Can Reduce Frustration, Time and Cost Associated with the Current Practice of Diagnosis by Exclusion Used for an Estimated 40 Million IBS Sufferers

Commonwealth Laboratories, Inc. (“Commonwealth”) announced today the availability of IBSchek™, a new blood test designed to help physicians quickly and reliably diagnose Irritable Bowel Syndrome (IBS). Within 24 hours of receiving the blood specimen, the test identifies the presence of two antibodies - anti-CdtB and anti-vinculin, which recent data have shown to be indicative of diarrhea-prominent IBS. These data, which will be presented during an oral session at Digestive Disease Week^® 2015 in Washington, D.C., show that for the first time ever, researchers have identified an organic biomarker for the diagnosis of IBS. Prior to the introduction of IBSchek™, a diagnosis of IBS was typically made after excluding all other conditions. This often requires multiple costly diagnostic tests over an average of five years to rule out other conditions before coming to a confident diagnosis of IBS.

The study was also published in the peer-reviewed journal, PLOS ONE, on May 13, 2015. IBSchek™ is supported by this statistically significant data from a 180 center, large-scale, randomized clinical trial of 2,681 (IBS n=2,375) patients, comparing those with IBS against patients with Inflammatory Bowel Disease (IBD) and Celiac Disease, as well as healthy controls.

“Data from this study validates our long-held suspicion that IBS is caused by infection, by way of confirming anti-vinculin and anti-CdtB as blood-based biomarkers that provide a differential diagnosis of IBS,” says Mark Pimentel, M.D., FRCPC, Director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai. “This study suggests that IBSchek™ is an important new tool that allows healthcare providers to quickly and accurately diagnose IBS, one of the most challenging gastrointestinal disorders to diagnose.” Cedars-Sinai granted Commonwealth exclusive license rights to the intellectual property vital to the development of IBSchek™.

IBS is the most common gastrointestinal disorder in the U.S., affecting nearly 40 million Americans and approximately 15% of the world’s total population. It is more common in women than in men and the symptoms can be very difficult to diagnose. Until now, it has been unknown whether or not there is a natural cause of IBS. As a result, IBS patients typically consult with more than four healthcare providers before they are diagnosed with the disorder. In addition, up to 70% of people with IBS do not consult their healthcare provider regarding their symptoms, thinking their symptoms are not serious enough, or are caused by secondary factors such as diet, stress, anxiety or depression. This means that many patients are living with IBS without being properly diagnosed. IBSchek™ is a simple enzyme-linked immunosorbent assay (ELISA) based test that aims to change this paradigm. The test can be conducted via standard blood draw in a healthcare provider’s office, with results reported within 24 hours of the patient’s blood specimen being received by Commonwealth for analysis.

“The launch of IBSchek™ is an unprecedented step forward in the diagnosis of IBS. It is an exciting scientific breakthrough that can assist patients and healthcare providers alike in identifying the cause of the disease, as well as provide hope and relief to the millions of Americans who have endured years of frustration and suffering associated with their digestive discomfort” says Craig Strasnick, Chief Operating Officer at Commonwealth. IBSchek™ uniquely addresses the needs of IBS patients with GI discomfort by either confirming an IBS diagnosis, or potentially eliminating it as a cause of symptoms.

If a patient tests positive for IBS with IBSchek™, it means there is a high degree of medical certainty that he or she has Diarrhea-predominant IBS and not another disease, such as IBD (specificity of 91.6%) or celiac disease. Although IBSchek™ is highly predictive of an IBS diagnosis, an inconclusive result with IBSchek™ may not mean that the patient definitively does not have IBS. An inconclusive IBSchek™ result simply may mean that 1) further investigation into the cause of symptoms may need to be conducted 2) the cause of the IBS is attributed to an alternate mechanism outside of the mechanism that IBSchek™ is looking for specifically, or 3) the symptoms may be caused by a disease other than IBS. An inconclusive test may help the physician narrow down the differential diagnosis, helping them get one step closer to a determination as to the cause of symptoms.