About CDPath

Powered by a novel algorithm that analyzes predictive variables1,2

CDPATH's advanced algorithm distills specific patient characteristics, serologic factors, and a genetic factor into a personalized risk profile. These key inputs are known to be good predictors for a diagnosed adult patient's potential risk of developing serious Crohn’s disease complications within 3 years. These include bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).

Patient
Characteristics

Time from diagnosis
Establishes eligibility for CDPATH test and provides a baseline hazard function

Disease location
Can help determine the likelihood of serious complications occurring

Serologic
Factors
  • ASCA IgA ELISA
  • ASCA IgG ELISA
  • pANCA IFA
  • Anti-CBir1 IgG ELISA

Measures of antibodies in the blood that may predict disease course

Genetic
Factor

NOD2 SNP13 (1007fs)
May identify the likelihood of developing serious Crohn's-related complications.

CDPATH Personalized Predictive Results

ASCA=anti-Saccharomyces cerevisiae antibodies; CBir1=anti-flagellin; ELISA=enzyme-linked immunosorbent assay; IFA= Immunofluorescence Assay; IgA=immunoglobulin A; IgG=immunoglobulin G; NOD2=nucleotide-binding oligomerization domain 2; pANCA=perinuclear anti-neutrophil antibody; SNP=single-nucleotide polymorphism

Easy-to-present graphical results empower shared decision-making

CDPATH generates results that graphically depict whether a patient is at low, medium, or high risk of developing serious Crohn’s disease complications including bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty). This unique visual approach helps patients better understand their disease and individual risk profile, which may promote more proactive collaboration around disease management.

Complex clinical data displayed in a single, personalized graph1

Predicted risk of serious complications from Crohn’s disease over 3 years2*
Sample curves for low-, medium-, high-risk patients

Graphical example of low risk of serious Crohn's disease complications over 3 years. Graphical example of medium risk of serious Crohn's disease complications over 3 years. Graphical example of high risk of Serious Crohn's disease complications over 3 years.

Actual charts will vary based on each individual patient's results.

*Serious Crohn's disease complications are defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).

One part of the overall picture

CDPATH results provide one piece of information. The results are prognostic, but not conclusive, nor are they guaranteed. You should not rely primarily on the results from CDPATH to make a clinical diagnosis or treatment. CDPATH is not affiliated with any Crohn’s disease treatments. Results are intended to be used in combination with your clinical assessments to facilitate discussions with your patients regarding their Crohn’s disease management.1,3

HCP and Patient Portrayals

What CDPATH could mean for Crohn’s disease patients

Hear more from Dr. Corey Siegel about what CDPATH could mean for patients.

Shared decision-making is a key component to a patient-centric management approach. Helping patients have a better understanding of their underlying disease can help them take a more proactive role in their Crohn's disease management."– Corey Siegel, MD, MS

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CDPATH logo

Personalized prognostic tool

What CDPATH Could Mean for Crohn’s Disease Patients with Dr. Corey Siegel

Photo of Dr. Corey Siegel

[On screen]

What CDPATH Could Mean for Crohn’s Disease Patients

Corey Siegel, M.D.

Co-Founder, MiTest Health

Initial Co-Creator, CDPATH

Co-Director of the IBD Center at the Dartmouth-Hitchcock Medical Center

Dr. Siegel is a paid consultant for Takeda

Photo of Dr. Corey Siegel

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What does this mean for Patients?

We need to better understand the individual potential risk for CD related serious complications1

Line graph showing hypothetical progression of Crohn’s disease over time.

The above image is a hypothetical representation of a potential CD disease course.2,3 Individual CD patient time from diagnosis to experiencing potential complications and types of complications may vary

Note: Concept established in rheumatoid arthritis; further evidence in IBD is needed; Adapted from Pariente et al, 2011.

We need to Partner with Patients4

Line drawing of doctor and patient shaking hands.

CDPATH is here5!

Predicted Risk of Complications from Crohn’s Disease Over 3 Years (Example Report)

Line graph showing a hypothetical patient’s predicted risk of complications from Crohn’s disease over 3 years.

CDPATH is intended to be used in combination with your clinical assessment and supports a personalized approach to CD management4,5

CDAI=Crohn’s Disease Activity Index; CDEIS=Crohn’s Disease Endoscopic Index of Severity; CRP=C-reactive protein; IBD=inflammatory bowel disease.

The Lémann index is a tool under evaluation designed to assess bowel damage with respect to cumulative damage, progression of damage, and identification of patients at risk of damage progression and determination of treatment response.8

1. Lichtenstein GR, Loftus EV, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27; published online 27 March 2018. Accessed May 2021. 2. Pariente B, Cosnes J, Danese S, et al. Inflamm Bowel Dis. 2011;17(6):1415-1422. 3. Colombel J-F, Narula N, Peyrin-Biroulet L. Gastroenterology. 2017;152(2):351-361.e5. 4. Siegel CA, Lofland JH, Naim A, et al. Dig Dis Sci. 2015;60(9):2636-2645. 5. Data on file. Takeda Pharmaceuticals USA, Inc.

CDPATH is only validated in, and can only be performed on, adult Crohn’s disease patients (≥18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication, defined as any fistulas or strictures in the bowels or non-perianal (area other than in or around the anus) surgery (removal of portions of small and/or large intestine or repair of strictures).

Due to the nature of clinical testing, there are limitations to consider for CDPATH. See CDPATH.com for more information.

[Audio]

So at the end of the day, what does this mean for patients?

In my opinion, it means that we need to better understand the individual potential risk for Crohn’s disease–related serious complications.

We need to partner with patients in a way that they understand, using tools that are clear.

The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda, and has received approval from the New York State Department of Health (NYS DoH) as a Laboratory Developed Test (LDT). Test results are provided via Prometheus Laboratories Inc. to physicians.

[Audio]

CDPATH allows us to do just that for adult Crohn’s disease patients 18 years or older who are within 10 years of diagnosis and have yet to experience serious complications.3

We can now use CDPATH to better understand a patient’s individualized potential risk of serious complications within 3 years.

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The CDPATH results can be shared with patients to help facilitate shared decision-making discussions between patients and providers for a more personalized approach for their care management.

Healthcare Providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient. CDPATH should only be considered an additional piece of information in combination with a doctor’s evaluation of a patient’s CD.

[Audio]

CDPATH is intended to be used in combination with your clinical assessment, and providers should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient.2,3

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CDPATH logo

Personalized prognostic tool

For more information, contact Client Services at 1-877-556-8766 or ask your CDPATH representatives.

Hours of Operation:

Monday-Friday

6:00 am-4:30 pm PST

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TERMS AND CONDITIONS:   CDPATH is only validated in, and can only be run on, adult Crohn’s disease patients (≥18 years old) diagnosed within the past ten (10) years, who have not experienced a Crohn’s disease complication such as blockages, strictures, or fistulas. Beneficiaries of any state or federal health insurance program (including, but not limited to, Medicare, Medicaid, Department of Veterans  Affairs, Coast Guard, Public Health Service, or Department of Defense) are excluded from participating in this program. No insurance claims should be collected or processed, and no charges should be billed to the patient for CDPATH and shipping. Takeda has made arrangements with the processing laboratory to directly cover these charges. Void where prohibited by law. Takeda reserves the right to change or end CDPATH at any time without notice, and other terms and conditions may apply. This test cannot be substituted for or combined with any other test and is only offered for a one-time use.

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CDPATH logo

Personalized prognostic tool

Up Next

Development, Validation, and Limitations of the CDPATH Model

CDPATH™ is a trademark of Takeda Pharmaceuticals U.S.A., Inc.

©2022 Takeda Pharmaceuticals U.S.A., Inc.

All rights reserved. Contact CDPATH Client Services at 1-877-556-8766.

US-NON-6722v2.0 08/22

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Shared decision-making is a key component to a patient-centric management approach. Helping patients have a better understanding of their underlying disease can help them take a more proactive role in their Crohn's disease management."– Corey Siegel, MD, MS

Eligibility & Cost