Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Inflammatory Bowel Disease Diagnostic Receives FDA Approval

XTALKS VITALS NEWS

IBD

The clinical diagnostic could help differentiate IBD from the closely-related irritable bowel syndrome (IBS).

Share this!

November 17, 2016 | by Sarah Hand, M.Sc.

The US Food and Drug Administration (FDA) has approved Inova Diagnostics’ assay, QUANTA Lite Calprotectin Extended Range, to help physicians diagnose inflammatory bowel disease (IBD). The clinical diagnostic could help differentiate IBD from the closely-related irritable bowel syndrome (IBS).

“We are very pleased to launch this high performing assay to meet the increasing demand from laboratories worldwide,” said Dr. Michael Mahler, Vice President of Research and Development for Inova Diagnostics. “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.”

By measuring calprotectin levels, physicians can determine the best treatment option from a patient suffering from a gastrointestinal disorder. Inova’s QUANTA Lite Calprotectin Extended Range using a quantitative enzyme linked immunosorbent assay (ELISA) to accurately detect calprotectin.



When used in combination with other clinical and laboratory tests, the diagnostic could help in the diagnosis of IBD, including Crohn’s disease and ulcerative colitis. Compared to other FDA-approved assays, QUANTA Lite Calprotectin Extended Range can detect a broader range of calprotectin levels.

“Fecal calprotectin has revolutionized my clinical practice in two specific areas,” said Dr. KT Park, Chair of Clinical Care and Quality, NASPGHAN and Co-Director, Stanford Children's IBD Center at Stanford University School of Medicine. “First, calprotectin measurements during patients' diagnostic workup, 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. The improvements in quantitative range represented by Inova Diagnostics' new, FDA cleared assay is an update to the clinicians' toolkit for decision-making.”


Keywords: IBD, Diagnostic, FDA


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
IBS Patients Taking Viberzi May Be at Increased Risk of Pancreatitis

March 22, 2017 - According to a recent drug safety communication issued by the US Food and Drug Administration (FDA), patients with irritable bowel syndrome (IBS) with diarrhea should not be treated using Viberzi (eluxadoline), if they do not have a gallbladder.

Featured In: Drug Safety News


PTC to Acquire Marathon’s Recently Approved Duchenne Muscular Dystrophy Drug

March 17, 2017 - Amid a drug pricing controversy, PTC Therapeutics has agreed to buy Marathon Pharmaceuticals’ Duchenne muscular dystrophy (DMD) drug, Emflaza.

Featured In: Pharmaceutical News


Memphis Meats Produces World’s First Poultry from Animal Cells

March 17, 2017 - Silicon Valley-based food manufacturing company, Memphis Meats, has produced the world’s first “clean poultry” by growing chicken and duck cells outside the animals.

Featured In: Food News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

REGISTER FOR THESE WEBINARS

How to Improve the Speed and Efficiency of Your Clinical Trials


High Performance Computing for High Content Screening - A Case Study


The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review


Treatment of Psoriasis: Improvements Through Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.