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AN INNOVATIVE TOOL FOR PATIENTS WITH CROHN'S DISEASE

CDPATH is a validated prognostic tool that uses a blood test* to evaluate an adult Crohn's disease (CD) patient's potential risk for developing serious complications within 3 years.1,2

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

Doctor Portrayal

About CDPath

ABOUT CDPATH*

INDIVIDUALIZED
RISK PROFILE

For potentially developing serious complications within 3 years1,2

INNOVATIVE, VALIDATED
CD PROGNOSTIC TOOL

Combining clinical, serologic, and genetic data1,2

NO COST
 

For eligible patients1

A validated laboratory developed test delivered through a blood sample.*
Delivers individualized insights into CD patients' potential risk for developing serious complications within 3 years.
CDPATH will be provided free of charge to patients who meet CDPATH clinical eligibility criteria and are on commercial health plans or uninsured.
Serious complications are defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).*
Combines clinical information with serologic and genetic data from a blood test.
Patient's blood draw must be taken at an HCP's office or participating lab.
Tool to support shared decision-making for a more personalized
approach to Crohn's disease management1-3†

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.

– Dr. Corey Siegel MD, MS

ELIGIBILITY
& COST

ELIGIBILITY & COST

CDPATH is being offered free of charge for eligible patients1

As part of the program, the costs of CDPATH* will be covered as long as patients meet the following eligibility criteria1:

  • Adult CD patients (≥18 years old) diagnosed within the last 10 years
  • Patients on a commercial healthcare plan or uninsured
  • Patients who have not experienced serious CD complications, defined as bowel stricture, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty)
  • Blood draw taken at a physician's office or participating lab

Takeda will cover the following cost based on blood draw location1*

BREAKDOWN OF COSTS COVERED
BLOOD DRAW
LOCATION
CDPATH
TEST
BLOOD
DRAW
BLOOD SAMPLE
SHIPPING (must use shipper provided in the specimen collection kit)
HCP's office
Participating lab*
Participating mobile phlebotomy*
DEVELOPMENT
& VALIDATION

DEVELOPMENT & VALIDATION

CDPATH: A Validated Personalized Prognostic Tool
For more information please click here.
independent
clinical study
1

Defining the model through a calibration cohort in an independent clinical study2

The model was defined using a well-characterized calibration cohort of 243 adult patients (18 years and older) with Crohn's disease diagnosed within the last 10 years to identify statistically significant variables that predicted the potential of serious Crohn's disease-related complications within 3 years*

2

Establishing clinical relevance through a validation cohort in an independent clinical study1,2

A well-characterized adult cohort of 109 Crohn's disease patients who were within 10 years of diagnosis without a previous complication confirmed the clinical relevancy of the model*

laboratory
developed test
3

Developing and validating the laboratory developed test (LDT)1

The model was developed and validated as an LDT using calibration (N=106) and validation (N=32) cohorts of adult Crohn's disease patients within 10 years of diagnosis without a previous complication

The performance of CDPATH showed consistent results

Harrell's C-statistic and P Value for CDPATH Cohorts1,2
  PATIENT
POPULATION
HARRELL'S
C-STATISTIC
P VALUE
independent
clinical study
1

Calibration cohort
(N=243)

0.73 P<0.001
2

Validation cohort
(N=109)

0.73 P<0.001
laboratory
developed test*

Calibration cohort
(N=106)

0.73 P<0.001
3

Validation cohort
(N=32)

0.70 P=0.015

The ability of CDPATH to predict the potential risk of CD-related complications was evaluated using the Harrell's Concordance statistic (C-statistic), a measure used to assess the accuracy of predictive risk models.1,2

  • A value of 0.5 means a prediction that is the same as random chance, and a value of 1 means a perfect prediction4

LIMITATIONS TO CONSIDER: Due to the nature of clinical testing, there are limitations to consider for CDPATH model2:

  1. Testing was conducted with only patients from North America; the results for patients from other regions have not been established.2
  2. Patients were recruited from large referral centers and may not be representative of all CD patients.2
  3. The model was built and validated in CD patients with 15 years as the maximum duration of disease; as such, it is not understood whether the model is applicable for patients with long-standing CD beyond 15 years from diagnosis.2
  4. The validity of the model after the first complication or surgery has not been tested or established; therefore, CDPATH may only be used one time for each patient.1,2

Transforming CDPATH results into an individualized risk profile

Using system dynamics analysis (SDA), the results of the multivariate Cox proportional analyses were transformed into a tool to show patients their individualized risk profile for the potential likelihood of developing a complication over a 3-year period based on a stratification of low, medium, and high probable risk.1,2

The graphs below are examples of patient reports with
low-, medium-, and high-risk profiles, respectively1:

Example of
LOW RISK result
Graphical example of low risk complications from Crohn's Disease
Example of
MEDIUM RISK result
Graphical example of medium risk complications from Crohn's Disease
Example of
HIGH RISK result
Graphical example of high risk complications from Crohn's Disease

Actual charts will vary based on each individual patient's results. To see an actual sample patient test report, click here.

HOW TO
ORDER

HOW TO ORDER

Designed to be convenient and easy to use in your practice1

To order CDPATH, follow these steps:

  • 1 Contact the CDPATH client services line at 1-877-556-8766, or call your Takeda CDPATH contact to obtain the test requisition form and specimen collection kit.
  • 2 Complete ALL required fields on the CDPATH requisition form.
    You can also download the Test Requisition form here.
  • 3 Have your patient’s blood sample collected at your office or a participating lab,* and have it sent to the testing laboratory in the provided shipper. Must include both the completed test requisition form and blood specimen in the CDPATH shipping kit.
  • Should a patient's mobility or geographical location necessitate an at-home blood draw, patients can contact the participating mobile phlebotomy service directly at 1-877-556-8766 to schedule a blood draw at their home or office1
  • The results will be faxed or mailed to your office (at your designation) approximately 7 business days from the date of blood sample collection1
RESOURCES