LOS ANGELES, Oct. 10, 2018 /PRNewswire/ -- Gemelli Biotech™, a specialty biotechnology company focused on developing novel diagnostics and therapeutics for the human microbiome, announced the commercial availability of ibs-smart™, a second-generation blood test for Irritable Bowel Syndrome (IBS). ibs-smart™ offers an advancement in the specificity and accuracy of measuring two antibodies (anti-CdtB and anti-vinculin) in diagnosing Diarrhea Predominant and Mixed-Type IBS (IBS-D and IBS-M).
With 40 million Americans affected, IBS is the most common diagnosis by gastroenterologists, and a top-ten diagnosis made by primary care physicians. Patients suffer from IBS symptoms for an average of 6 years before finally being diagnosed in part because physicians have operated for decades without a biomarker for this disease. Instead, they have had to rely on a diagnosis using an exclusionary approach which is invasive for patients and expensive.
"When you diagnose a patient with IBS through a process of elimination, it takes a serious toll on the patient, financially and emotionally," says Dr. Mark Pimentel, MD FRCPC, Executive Director of the Medically Associated Science and Technology (MAST) program at Cedars-Sinai and co-founder of Gemelli Biotech. "If we apply that old approach across forty million people, that's a huge economic burden on the healthcare system overall. We can now avoid conducting complicated and expensive tests to rule out other diseases, and simply 'rule in' IBS"
A prevailing theory is that a subset of IBS cases start after having food poisoning. Cytolethal distending toxin B (CdtB) is commonly found in bacteria that cause food poisoning. Dr. Pimentel led the groundbreaking research at Cedars-Sinai in Los Angeles that discovered that levels of two antibodies, anti-CdtB and anti-vinculin, were elevated in patients with IBS-D and IBS-M.
Pimentel and his team have continued to innovate their patented technology for antibody testing. "As our scientific understanding of post-infectious IBS and its antibody biomarkers has advanced, we've continued to advance the technology used to test the blood for these substances," says Pimentel. For example, our ability to manage and measure anti-CdtB has improved through epitope optimization, which has significantly increased the test's likelihood ratio and overall accuracy." This technology has been exclusively licensed by Cedars-Sinai to Gemelli Biotech, the makers of ibs-smart™.
"A blood test for IBS is a paradigm shift in IBS diagnostics, which will impact millions of people," says Matt Mitcho, Gemelli Biotech's CEO. "Replacing the traditional path of invasive, expensive procedures from CT scans to multiple colonoscopies with a simple blood test allows for a faster diagnosis. A faster diagnosis most importantly means a faster path to treatment and reduced costs." The results of the ibs-smart™ test are available within 48 hours. A positive result indicates that a patient has IBS-D with a positive predictive value of greater than 90%.
ibs-smart™ and the science on which it is founded not only provides the fastest and simplest path to an IBS diagnosis, but also reaffirms the organic nature of IBS. Dr. Pimentel says, "For decades, patients with IBS were told that it was just in their heads. We are finally seeing the global perspective on IBS shift as we continue to better understand its underlying pathophysiology. That's good news for patients and doctors alike."
More information is available at: www.ibssmart.com
ibs-smart™ is the second-generation blood test for Irritable Bowel Syndrome (IBS) and offers an advancement in the specificity and accuracy of data available to help doctors diagnose Diarrhea Predominant and Mixed-Type IBS (IBS-D and IBS-M).
ibs-smart™ tests a patient's blood for anti-CtdB and anti-vinculin, two known biomarkers of post-infectious IBS-D and IBS-M. The test has been developed by Gemelli Biotech and uses patented technology exclusively licensed from Cedars-Sinai, where the biomarkers for IBS were first discovered.
About Gemelli Biotech
Gemelli Biotech is a specialty biotechnology company that strives to achieve a thriving global family of healthy individuals by unlocking the potential of the microbiome. Gemelli's mission is to support the discovery of novel diagnostics and therapeutics for the human microbiome by bringing biotechnology innovations to market in a fiscally responsible and socially conscious way.
Gemelli Biotech is proud to partner closely with Cedars-Sinai in Los Angeles, ranked by US News and World Report as one of the top ten hospitals in the nation. The Medically Associated Science and Technology (MAST) program at Cedars-Sinai is dedicated to the development of lab tests, drugs and devices to diagnose and treat patients and works closely with Gemelli.
Dr. Mark Pimentel is Cofounder of Gemelli Biotech and has equity interest in the company.
SOURCE Gemelli Biotech