New Serum Test Is First to Measure and Monitor Mucosal Healing in Crohn’s Disease

16 October 2017

SAN DIEGO, CA., October 16, 2017 – Prometheus Laboratories Inc. introduces a comprehensive new serum test that measures and monitors mucosal healing status in Crohn’s disease patients. The new test—PROMETHEUS® Monitr™ Crohn’s Disease—is the first of its kind, providing a valuable, noninvasive tool for patient management.

Crohn’s disease has traditionally been difficult to monitor because the only available diagnostic tools have been colonoscopy and endoscopy, both of which are invasive, expensive, and challenging for the patient. Additionally, symptoms do not necessarily correlate to the amount of inflammation present. Monitr™ gives the physician a high degree of flexibility for assessing mucosal disease; the test can be used as an adjunct to endoscopy or by itself, between endoscopies, allowing for more frequent, noninvasive monitoring.

“Our goal is to see patients achieve mucosal healing, or significant improvements in mucosal health,” said Marla Dubinsky, M.D., Chief of Pediatric Gastroenterology and Hepatology and Co-director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine, Mount Sinai. “To do that, we really need an objective way to view snapshots of the mucosa without frequent scoping. The more noninvasive biomarkers we can assay to objectively evaluate the mucosa, the better off patients will be.”

The clinical validation of the Monitr test demonstrated high accuracy and concordance rates with endoscopically visualized mucosal disease activity in adult Crohn’s disease patients, regardless of the anatomical disease location or selected treatment regimens. Monitr will allow healthcare providers to more easily evaluate Crohn’s disease patients who have suspected active disease in difficult-to-reach locations, such as the small bowel. The test can be performed with or without endoscopy, making it convenient for both the healthcare provider and the patient. Every Monitr test report provides a single objective Mucosal Healing Index Score that can be used to assess and track disease activity over time.

“Monitr is a powerful patient counseling tool that addresses an unmet need. It can help healthcare providers discuss difficult treatment decisions with their patients,” said Warren Cresswell, General Manager and Head of Diagnostics at Prometheus Laboratories Inc. “Monitr represents our continued focus and commitment to helping improve patient care through innovation and testing excellence.”

Prometheus is presenting Monitr clinical validation and test performance data during the 2017 American College of Gastroenterology (ACG) conference, October 13-18, in Orlando, FL.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is expanding product development to oncology testing. The company complements its proprietary diagnostic testing services with therapeutic products. By integrating therapeutics and diagnostics, Prometheus provides physicians with more targeted solutions to optimize care for their patients. Prometheus became part of Nestlé Health Science in 2011. For more information about Prometheus, please visit www.prometheuslabs.com.

PROMETHEUS, the Link Design, For the person in every patient, and Monitr are trademarks or registered trademarks of Société des Produits Nestlé S.A. Vevey, Switzerland.

- Prometheus Press release