Revolutionizing GI Diagnostics with Precision

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Measure & monitor mucosal healing changes over time

Learn more www.monitrcd.com »

Provides unique combination of 13 biomarkers to assess mucosal healing in adult Crohn’s disease patients.

  • Comprehensive: Features a proprietary algorithm specific to mucosal healing and a unique combination of 13 biomarkers to evaluate multiple mucosal damage and repair processes, regardless of disease location
  • Quantitative: Every test report provides a single objective Mucosal Healing Index Score that is consistent with severity of disease (remission – mild to moderate – severe)* – Scores can be tracked over time to assess response to therapeutic management
  • Actionable: Provides valuable information beyond endoscopy, biopsy, or inflammatory biomarkers
  • Flexible: Can be used any time and during any type of treatment

Well-characterized serum samples (N = 748) from 396 adult CD patients were utilized for the development and validation of the Mucosal Healing Index algorithm.1-3

Samples were divided into training and validation sets, to provide a Mucosal Healing Index Score that ranges from 0 to 100, and biomarkers were mathematically modeled against endoscopic disease severity (CDEIS or Simple Endoscopic Score-CD [SES-CD]).

* In a study where 748 serum samples from 396 CD patients were divided into 2 cohorts: 335 samples from 278 patients were used to develop the Mucosal Healing Index (biomarker expression was modeled against endoscopic scoring CDEIS or SES-CD) and 412 samples from 118 CD patients were analyzed with endoscopic scoring for independent validation.1

90% concordance rate with endoscopically visualized mucosal inflammation2

† In a study where 748 serum samples from 396 CD patients were retrospectively analyzed. Remission was defined as CDEIS < 3 and mild endoscopic disease was defined as CDEIS 3-8. Endoscopic evidence of active disease was defined as CDEIS ≥ 3. Specimens that fell within Mucosal Healing Index (MHI) range 41-49 had an observed 78% probability of active disease.

Helps you:

  • Establish a baseline measurement at initial presentation
  • Assess disease activity and response to therapeutic management
  • Optimize your treatment plan
  • Counsel patients about therapeutic management goals
  • Reinforce importance of patient compliance to continue therapy

References:

  1. Vermeire S, D’Haens G, Hale M, et al. A novel serum test to describe the mucosal healing state by disease location in Crohn’s disease patients. Accepted for presentation at: World Congress of Gastroenterology; October 13-18, 2017; Orlando, FL.
  2. Kelly OB, Silverberg MS, Dulai PD, et al. Development and validation of a multi-marker serum test for the assessment of mucosal healing in Crohn’s disease patients. Accepted for presentation at: World Congress of Gastroenterology; October 13-18, 2017; Orlando, FL.
  3. Data on file. Prometheus Laboratories, Inc.

Monitr is a laboratory-developed test that was developed and validated under Federal CLIA laboratory guidelines, and is performed exclusively by Prometheus Laboratories Inc.

  • These tests have not been cleared or approved by the US FDA. The tests are used for clinical purposes and should not be regarded as investigational or for research. Prometheus Biosciences is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity clinical laboratory testing and is accredited by the College of American Pathologists (CAP).
  • This material is provided for general information purposes only as an educational service for healthcare physicians and their patients. It is not intended as a substitute for medical advice and/or consultation with a physician.