Risk Immune®

Determine risk of anti-TNF immunogenicity before initiating anti-TNF therapy in IBD patients.

RiskImmune™ is a laboratory-developed test that may help identify patients at greater risk of anti-TNF antibody (ADAb) formation and could aid your therapeutic decision making.

This blood-based genetic test identifies if an IBD patient is a variant carrier of  HLADQA1*05 (rs2097432), a single nucleotide polymorphism that has been associated with:

  • A 2-fold increased risk of developing antibodies to infliximab or antibodies to adalimumab1
    • Regardless of concomitant immunomodulator use and the drug type1,*
  • A 7-fold increased risk of developing antibodies to infliximab2,†
    • Associated with a 2-fold increase in loss of response to infliximab2,†
    • Variant carriers were 2 times more likely to discontinue infliximab therapy2,†

RiskImmune can help you optimize IBD patient care from the start
Variant carriers2,*:

  • Had a significantly increased risk of infliximab ADAb formation versus nonvariant carriers—even when adjusted for age, sex, weight, dose, and coimmunosuppression
  • Were at an increased risk of infliximab loss of response and had a higher rate of infliximab discontinuation versus nonvariant carriers

Get ahead of the impact of immunogenicity with RiskImmune.

  • Helps you understand an IBD patient’s risk of developing immunogenicity to infliximab or adalimumab

  • Aids in being proactive with treatment choices and therapeutic drug monitoring

TNF = tumor necrosis factor; IBD = inflammatory bowel disease.
* Based on the Personalising Anti-TNF Therapy in Crohn’s Disease (PANTS) clinical study, which included a discovery cohort of 1240 biologic-naïve patients with Crohn’s disease starting infliximab or adalimumab and a replication cohort of 178 patients with IBD. The PANTS study only included subjects of European descent, 40% of whom carry the risk allele. Immunogenicity was defined as an antidrug antibody concentration of ≥ 10 AU/mL, irrespective of drug level, at 1 or more time points.
Based on a separate retrospective study of 262 IBD patients on infliximab therapy of which 40% identified as variant carriers.
According to HLADQA1*05>G genotype from a Cox proportional hazard model. Data were adjusted for age, sex, weight, infliximab dose, and coimmunosuppression with an immunomodulator (azathioprine or methotrexate). The 95% confidence intervals are represented by blue (HLADQA1*05 wild type) and red (HLADQA1*05 variant) shading.

References:

  1. Sazonovs A, Kennedy NA, Moutsianas L, et al; PANTS Consortium. HLA-DQA1*05 carriage associated with development of anti-drug antibodies to infliximab and adalimumab in patients with Crohn’s disease. Gastroenterology. 2020;158(1):189-199.
  2. Wilson A, Peel C, Wang Q, Pananos AD, Kim RB. HLADQA1*05 genotype predicts anti-drug antibody formation and loss of response during infliximab therapy for inflammatory bowel disease. Aliment Pharmacol Ther. 2020;51(3):356-363.

RiskImmune is a laboratory-developed test that was developed and validated under federal Clinical Laboratory Improvement Amendments (CLIA) laboratory guidelines, and is performed exclusively by Prometheus Laboratories Inc.
It has not been cleared or approved by the US FDA. The test is used for clinical purposes and should not be regarded as investigational or for research. Prometheus Laboratories Inc is certified under 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.

7C4 Diagnostic Test

Measures 7α-hydroxy-4-cholesten-3-one (7C4) levels to help determine if bile acid malabsorption (BAM) may be the underlying cause of patients’ gastrointestinal-related symptoms.

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®

Combines serologic, genetic, and inflammation markers to help differentiate IBD vs non-IBD and ulcerative colitis vs Crohn’s disease.

The PROMETHEUS® IBD sgi Diagnostic® is the 4th-generation IBD diagnostic test and the first and only test to combine serologic, genetic, and inflammation markers in the proprietary Smart Diagnostic Algorithm for added diagnostic clarity. This test aids healthcare providers in differentiating IBD vs non-IBD and CD vs UC in one comprehensive blood test. This assay includes 9 serological markers including the proprietary anti-Fla-X, anti-A4-Fla2, anti-CBir1, anti-OMPC, and DNAse-sensitive pANCA that helps identify patients with IBD and utilizes Smart Diagnostic Algorithm Technology to improve the predictive accuracy. Genetic susceptibility influences immune responses and this assay includes evaluation of ATG16L1, STAT3, NKX2-3, and ECM1. Inflammatory markers include VEGF, ICAM, VCAM, CRP, SAA. While most other labs only offer assay values, PROMETHEUS® IBD sgi Diagnostic® provides added clarity in diagnosing IBD, UC, and CD.


Sample insurance correspondence for PROMETHEUS® IBD sgi Diagnostic®

References:

Chidlow, Jr., Shukla, Grisham et al. Pathogenic angiogenesis in IBD and experimental colitis: new ideas and therapeutic avenues. American Journal of Physiology.Gastrointestinal and Liver Physiology. 2007;293:G5-G18.

Cummings, Cooney, Pathan et al. Confirmation of the role of ATG16L1 as a Crohn’s disease susceptibility gene. Inflammatory Bowel Diseases. 2007;13:941-946.

Henriksen, Jahnsen, Lygren et al. C-reactive protein: a predictive factor and marker of inflammation in inflammatory bowel disease. Results from a prospective population-based study. Gut. 2008;57:1518-1523.

Meggyesi, Kiss, Koszarska et al. NKX2-3 and IRGM variants are associated with disease susceptibility to IBD in Eastern European patients. World J.Gastroenterol. 2010;16:5233-5240.

Sandborn, Loftus, Colombel, et al. Evaluation of serologic disease markers in a population-based cohort of patients with ulcerative colitis and Crohn’s disease. Inflammatory Bowel Diseases. 2001; 7:192-201.

Schoepfer, Schaffer, Mueller et al. Phenotypic associations of Crohn’s disease with antibodies to flagellins A4-Fla2 and Fla-X, ASCA, p-ANCA, PAB, and NOD2 mutations in a Swiss Cohort. Inflammatory Bowel Diseases. 2009;15:1358-1367.

Targan, Landers, Yang et al. Antibodies to CBir1 flagellin define a unique response that is associated independently with complicated Crohn’s disease. Gastroenterology. 2005;128:2020-2028.

Thompson, Lees. Genetics of ulcerative colitis. Inflammatory.Bowel Diseases. 2011;17:831-848.

Lees, Satsangi. Genetics of inflammatory bowel disease: implications for disease pathogenesis and natural history. Expert Rev.Gastroenterol.Hepatol. 2009;3:513-534.

Monitr™

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.