About CDPath

Individual person icon.

Individualized
Risk Profile

For potentially developing serious complications within 3 years1,2

A validated laboratory developed test delivered through a blood sample.*

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

Innovative light bulb icon.

Innovative, Validated CD Prognostic Tool

Combining clinical, serologic, and genetic data1,2

Delivers individualized insights into Crohn's disease patients' potential risk for developing serious complications within 3 years.

Combines clinical information with serologic and genetic data from a blood test.

No cost icon.

No Cost

For eligible patients1

CDPATH will be provided free of charge to patients who meet CDPATH clinical eligibility criteria and are on commercial health plans or uninsured.

Patient's blood draw must be taken at a participating location.

The CDPATH process

Designed to be convenient and easy to use in your practice1

Order a free test kit

Have your patient's blood sample collected at a participating location and sent to the lab for analysis

Receive your patient's individualized risk profile

Discuss the risk profile with your patient

Tool to support shared decision-making for a more personalized approach to Crohn’s disease management1-3‡

*The CDPATH risk assessment tool was developed and validated by Prometheus Laboratories Inc., a partner of Takeda, and has received conditional approval from the New York State Department of Health (NYS DoH) as an LDT. Test results are provided via Prometheus Laboratories Inc. to physicians.1

The cost of the blood draw, CDPATH, and shipping will be covered when participating draw sites or services are utilized. Participating locations for required blood draw include Quest Diagnostic Patient Service Centers, Prometheus-contracted phlebotomy sites, and mobile phlebotomy services. Only the cost of CDPATH and blood sample shipping will be covered if the blood draw is completed in a physician’s office and it is shipped to the processing laboratory with the provided shipping label.

HCPs should not rely primarily on the risk predictions from CDPATH to make a clinical diagnosis or treatment decision regarding an individual patient.

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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Personalized prognostic tool

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

Photo of Dr. Corey Siegel

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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.

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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. 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.

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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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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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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-6722v1.0 03/22
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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