Crohn’s Prognostic
Evaluate the probability of disease progression in a Crohn’s disease patient by providing a personal serogenetic profile.
The PROMETHEUS® Crohn’s Prognostic combines proprietary serologic (anti-CBir1, anti-OMPC, DNAse sensitive pANCA) and genetic (NOD2 variants SNPs 8,12,13) markers in an innovative blood test that quantifies a patients individual probability of developing disease complications over time. The objective information from the test may allow physicians to stratify patients, assist in optimizing management strategies and may be used in risk/benefit discussions.
Sample insurance correspondence for PROMETHEUS® Crohn’s Prognostic
IBD sgi Diagnostic®
The only IBD test of its kind that uses pattern recognition to assess 17 assay results, including proprietary biomarkers anti-CBir1, anti-OmpC, anti-FlaX, anti-A4-Fla2, and DNAse-sensitive pANCA
Provides greater diagnostic and prognostic clarity,1 and aids in*:
- Identifying IBD vs non-IBD
- Differentiating CD vs UC
- Assessing a patient’s risk for more aggressive disease
- Determining your therapeutic management approach (eg, treat-to-target/tight control) based on objective evidence of inflammation and an actionable risk assessment
Combination of biomarkers with Smart Diagnostic Algorithm increases diagnostic accuracy*
Sample insurance correspondence for PROMETHEUS® IBD sgi Diagnostic®
- Test Requisition Form
- Prior Authorization Request
- Letter to Request Coverage – Patient
- Letter of Appeal – Patient
- Letter of Appeal – Physician
- Letter of Medical Necessity
References:
1. Plevy S, Silverberg MS, Lockton S, et al. Combined serological, genetic, and inflammatory markers differentiate non-IBD, Crohn’s disease, and ulcerative colitis patients. Inflamm Bowel Dis. 2013;19(6):1139-1148.
CD = Crohn’s disease; UC = Ulcerative colitis.
*Compared to individual biomarkers alone.
Monitr™
Measure, monitor, and track endoscopic disease activity over time in your adult CD patients
Learn more www.monitrcd.com »
Helps you noninvasively assess CD endoscopic activity and therapeutic response
| Feature | Benefit |
|---|---|
| Proprietary algorithm specific to endoscopic healing and unique combination of 13 biomarkers | Provides a noninvasive assessment of endoscopic disease activity, regardless of disease location, disease behavior, or current therapy Higher sensitivity and specificity than clinically relevant C-reactive protein (CRP) scores1,3 Similar sensitivity and specificity to clinically relevant fecal calprotectin scores1 |
| Provides a quantitative Endoscopic Healing Index Score2 ranging from 0 to 100 | Plotted score provides a patient’s current status of endoscopic disease activity |
| Goes beyond inflammatory biomarkers | Evaluates multiple mucosal damage and repair processes to create a composite Endoscopic Healing Index Score, regardless of disease location |
| Track a patient’s Endoscopic Healing Index Scores over the course of treatment | Test report allows tracking of multiple test results over time |
Monitr helps you:
- Establish a baseline measurement of disease activity at initial presentation
- Track and assess disease activity and response to therapeutic management
- Optimize treatment management decisions
- Evaluate if treatment changes may be appropriateCounsel patients about therapeutic management goals
- Reinforce importance of patient compliance to continue therapy
References:
- 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.
- The PROMETHEUS® MonitrTM Crohn’s Disease Test was validated using endoscopy-paired serum samples from 195 adult CD patients. The Endoscopic Healing Index Score is intended to aid in the assessment of endoscopic disease activity in adult Crohn’s disease patients in conjunction with clinical evaluation performed by a healthcare professional. The MonitrTM test is not intended to diagnose CD.
- Significantly fewer false-negative results compared to clinically relevant CRP scores. EHI cutoffs of 20 and 50 showed higher sensitivity (sens.) and specificity (spec.) than clinically relevant CRP scores of 3 mg/L (sens. = 63%, spec. = 64%) and 5 mg/L (sens. = 42%, spec. = 73%), respectively.
CD = Crohn’s disease
Monitr is a laboratory-developed test that was developed and validated under Federal CLIA laboratory guidelines, and is performed exclusively by Prometheus Laboratories Inc.