Second-Generation Blood Test for Irritable Bowel Syndrome Validated as Providing Most Conclusive Diagnosis of Inclusion for IBS

Gemelli Biotech, in partnership with the Medically Associated Science and Technology (MAST) program at Cedars-Sinai, announced new findings that validate a second-generation diagnostic blood test for irritable bowel syndrome (IBS) as the most accurate ever.

Available commercially as is-smart™, the test could provide physicians with the most conclusive data currently attainable for ruling in IBS. Primarily applicable to patients with a diarrheal component to their symptoms, the test could serve up to two-thirds of the 45 million Americans suffering from IBS.

After over a decade of uncovering the pathophysiology of post-infectious IBS, researchers at Cedars-Sinai validated the antibodies anti-CdtB and anti-vinculin as highly specific biomarkers measurable in blood. This innovative blood test offered patients the first-ever opportunity to receive a diagnosis of IBS by ruling in the disease, rather than by ruling out other diseases.

Scientists at the Medically Associated Science and Technology program at Cedars-Sinai, in collaboration with Gemelli Biotech, developed a proprietary epitope optimization process that was instrumental to improving the test for its second-generation launch as ibs-smart™. Cedars-Sinai has entered into an exclusive license agreement with Gemelli Biotech for several patent applications covering the blood test technology.

At Digestive Disease Week (DDW 2019) in San Diego, the MAST team reported the results of their validation study. The second-generation blood test is >90% specific in distinguishing patients with IBS from patients with Inflammatory Bowel Disease using each marker. When combined, the post-test probability of IBS is >98%. That means that for the first time, a near certain diagnosis of IBS can be made if both biomarkers are elevated.

Gemelli Biotech is determined to bring ibs-smart™ to physicians worldwide. Physicians in the US can order the test for patients via a kit-based system. The company helps interested patients find local specialists and blood draw labs. Samples are tested in a CLIA-certified lab in Irvine, California. The test is covered at least in part by most insurance providers.

“It’s painful for millions of IBS patients to keep hearing long lists of negative test results that tell them what they don’t have,” says Matt Mitcho, CEO of Gemelli Biotech. “Finally, you can get the most concrete diagnosis that rules in IBS. We’ve heard many stories of patients breaking down in tears of relief when doctors hand them the results of this test.”

Dr. Mark Pimentel, Executive Director of the MAST program, as well as a practicing gastroenterologist and co-founder of Gemelli Biotech, believes the greater diagnostic accuracy is meaningful to patients and doctors alike. “As a physician, I want to know what is causing the disease in my patient, and I want to know as efficiently as possible. This test tells me that my patient has IBS and I can get to the desired therapy without undue testing.”

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