FDA Approves New Test to Help Diagnose IBD, Show it is Different from IBS

FDA Approves New Test to Help Diagnose IBD, Show it is Different from IBS

Inova Diagnostics, a developer of autoimmune diagnostics, announced that the U.S. Food and Drug Administration has cleared QUANTA Lite Calprotectin Extended Range, an assay to diagnose  inflammatory bowel disease (IBD) and to help differentiate IBD from irritable bowel syndrome (IBS).

QUANTA Lite is a quantitative enzyme-linked immunosorbent assay (ELISA) designed to detect concentrations of fecal calprotectin to aid in the diagnosis of IBDs, in particular Crohn’s disease and ulcerative colitis. The technology also is capable of differentiating IBD from IBS, which is a non-inflammatory “functional disorder,” meaning that its symptoms don’t have an identifiable cause.

“We are very pleased to launch this high-performing assay to meet the increasing demand from laboratories worldwide,” said Michael Mahler, PhD, Inova’s vice president of research and development, in a press release. Mahler said he believes QUANTA Lite offers a broader analytical measuring range compared to other FDA-approved assays. “Gastrointestinal pain is a common reason for seeking medical attention. Inaccurate diagnosis at the screening level can contribute to unnecessary procedures and increased healthcare costs. QUANTA Lite Calprotectin Extended Range can improve care while helping reduce costs,” Mahler said.

“Fecal calprotectin has revolutionized my clinical practice in two specific areas. First, calprotectin measurements during patients’ diagnostic work-up, particularly when the diagnosis could be either IBS or IBD, provide direction and important information prior to endoscopic evaluations. Second, calprotectin follow-up testing in IBD patients supports a patient-centered, proactive approach to disease management, allowing accurate detection of indolent and often-missed inflammation,” said KT Park, MD, chair of clinical care and quality at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Park also is co-director of Stanford Children’s IBD Center at Stanford University in California.

“The improvements in quantitative range represented by Inova Diagnostics’ new, FDA-cleared assay is an update to the clinicians’ tool kit for decision-making,” Park said.

Inova Diagnostics launched QUANTA Lite in June 2014. The first announcement arrived after a recent recommendation from the National Institute for Health and Care Excellence (NICE) confirmed the benefits of fecal calprotectin testing and increased awareness of its importance to patients and healthcare systems worldwide.

“Looking at the available evidence, we found that fecal calprotectin testing is a good way to distinguish between IBD and IBS,” Carole Longson, PhD, the director of the Centre for Health Technology Evaluation at NICE at the time, said in 2014. “It will reduce both the time spent searching for a diagnosis and the numbers of invasive procedures such as colonoscopy.”