Inflammatory Bowel Disease

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Proven test performance, validated by the numbers1

The Monitr® Crohn’s Disease Test features a proprietary Endoscopic Healing Index (EHI) Score—ranging from 0 to 100—that was developed and validated using endoscopy-paired serum samples from 195 adult Crohn’s disease (CD) patients from a US-based tertiary care center.

Within the Monitr validation cohort patient profile:

  • 77% of patients had a history of biologic medication treatment
  • Median duration of CD was over 10 years
  • 46% of patients had a history of inflammatory bowel disease (IBD)-related surgery

Optimal thresholds identified1

Optimal EHI thresholds were identified to maximize sensitivity and specificity for ruling in—and ruling out—endoscopically active disease, including*:

  • At an EHI cutoff of 20, the sensitivity is 83% for ruling out endoscopically active disease, with a specificity of 37% predictive value for identifying patients in remission or with mild endoscopic disease
  • At an EHI cutoff of 50, the specificity is 88% for ruling in endoscopically active disease, with a sensitivity of 30%
  • As EHI cutoffs increase from 20 to 50, specificity steadily increases, indicating a higher likelihood of active disease

EHI performance vs other biomarkers1

In the validation, EHI performance was compared to clinically relevant C-reactive protein (CRP) and fecal calprotectin (FC) cutoffs in a subcohort of 81 adult CD patients.

Sensitivity

92_EHI_20

for ruling out endoscopically active disease

63_CRP_3
75_FC_50

Specificity

91_EHI_50

for ruling in endoscopically active disease

73_CRP_5
100_FC_250

The EHI demonstrated consistent performance across disease locations and disease behaviors.1

Additional results

In a separate and distinct cohort of 116 adult CD patients from a multisite clinical trial, EHI performance was compared to clinically relevant CRP and FC cutoffs. In this cohort patient profile:

  • Patients were biologic naïve
  • Median CD history was < 1 year
  • 10% of patients had a history of IBD-related surgery

Sensitivity

96_EHI_20

for ruling out endoscopically active disease

60_CRP_3
100_FC_50

Specificity

100_EHI_50

for ruling in endoscopically active disease

97_CRP_5
89_FC_250

Measure, monitor, and track endoscopic disease activity with 1 simple serum test. Get the Monitr Test Requisition Form

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*The EHI was validated using endoscopy-paired serum samples from 195 adult CD patients from a US-based tertiary care center. Validation cohort included patients with a longer-term disease duration who may have failed more than 1 biologic or had IBD-related surgeries. The EHI Score is intended to aid in the assessment of endoscopic disease activity in adult CD patients in conjunction with clinical evaluation performed by a healthcare professional. The Monitr test is not intended to diagnose CD.

†Endoscopically active disease defined as Crohn’s Disease Endoscopic Index of Severity (CDEIS) ≥ 3, Simple Endoscopic Score for Crohn’s Disease (SES-CD) > 2, or SES-CD = 2 (if only 1 intestinal segment had a score of 2 and scores of 0 in remaining segments).

References

1. D’Haens G, Kelly O, Battat R, et al. Development and validation of a test to monitor endoscopic activity in patients with Crohn’s disease based on serum levels of proteins. Gastroenterology. 2020;158(3):515-526.e10.