NEW YORK (360Dx) – Gemelli Biotech today announced a deal by which Advanced Medical German (AMG) will distribute its diagnostic blood test for irritable bowel syndrome.
Gemelli said that AMG, which is based in Kuwait, will begin distributing the test, IBS-smart, starting in the spring of 2019 in parts of the Middle East and North Africa, including Kuwait, United Arab Emirates, Qatar, Saudi Arabia, Egypt, and Turkey, among others.
Financial and other terms of the deal were not disclosed.
The ELISA blood test measures antibodies elevated in patients with post-infectious IBS.
Gemelli said it launched the test at the annual American College of Gastroenterology conference in Philadelphia, Pennsylvania, in October 2018, and made it available as a kit-based system for use by physicians in the US.
The firm developed the test in partnership with Los Angeles, California-based Cedars-Sinai Medical Center's Medically Associated Science and Technology Program using technology that it exclusively licensed from Cedars-Sinai, which discovered the test's biomarkers.
The test consists of two biomarkers for IBS — anti-vinculin and anti-cytolethal distending toxin B (CdtB) — which implicate gastroenteritis and/or food poisoning as the root causes of IBS, Gemelli said.
The noninvasive diagnostic tool is capable of ruling in IBS with up to 98 percent certainty and has greater than 90 percent specificity in distinguishing IBS from inflammatory bowel disease, the firm said.
Citing a review of twelve studies in the Journal of Health Informatics in Developing Countries, Gemelli said that the prevalence of IBS in the Arabian countries could be as high as 31 percent.
A cost analysis published in Clinical Therapeutics showed that, by preventing the need for unnecessary, invasive procedures, antibody blood testing for IBS could save health systems more than $500 per patient, Gemelli said.
Gemelli CEO Matt Mitcho said that the collaboration with AMG marks the beginning of its international expansion. He said that an IBS biomarker study conducted at Cedars-Sinai is being replicated in other countries and recently in Mexico and Korea.
IBS is the most common diagnosis by gastroenterologists and affects 40 million Americans, Gemelli said.