News & Events

SAN DIEGO, Sept. 14, 2022 /PRNewswire/ -- Prometheus Laboratories Inc. ("Prometheus") today announced its partnership with Takeda Pharmaceutical Company Limited ("Takeda") to nationally launch CDPATH, an innovative prognostic tool for Crohn's disease (CD) patients. CDPATH is a personalized risk assessment tool that can be used in combination with a physician's clinical assessment to evaluate an adult patient's risk for developing serious complications of CD such as bowel strictures, internal penetrating disease, or non-perianal surgery within three years.

The CDPATH test is a result of a collaboration among Prometheus, MiTest Health LLC ("MiTest") and Takeda Pharmaceutical Company Limited ("Takeda"). MiTest defined and established the clinical relevance of the CDPATH model through an independent clinical study. Prometheus, a CLIA certified and CAP accredited laboratory, validated CDPATH and is the processing laboratory for the CDPATH program. Takeda will make CDPATH available for use by US-based physicians and offer the test free of charge to eligible patients, with the goal of supporting shared decision-making between patients and healthcare providers.

"This tool was developed to address a significant unmet need in the management of Crohn's disease," said Dr. Marla Dubinsky, who along with being a Co-inventor and Co-founder of MiTest Health, is also a Professor of Pediatrics and Medicine at the Icahn School of Medicine, Chief of Division of Pediatric Gastroenterology and Co-director of the Mount Sinai Susan and Leonard Feinstein IBD Clinical Center. "With CDPATH, we want to identify patients before they have severe disease and inform discussions with patients about the management of disease."

This partnership with Takeda, a pharmaceutical industry leader in the field of gastroenterology (GI), contributes to the Prometheus mission of enabling precision-guided patient care and improving disease outcomes.

Mike Walther, President of Prometheus Laboratories commented, "We are pleased to partner with Takeda to make CDPATH available to healthcare providers and their patients. Supporting the launch of CDPATH is yet another milestone among our strategic initiatives as we continue to provide innovative clinical lab services to guide care from disease interception through therapeutic optimization and monitoring."

"At Takeda, we are driven by the challenge of making a meaningful difference in the lives of patients with inflammatory bowel disease, and working with partners to provide solutions that can help transform their care," said Gamze Yüceland, Head, Gastroenterology Business Unit, Takeda Pharmaceuticals, U.S.A., Inc. "Offering CDPATH free of charge to eligible CD patients will help deliver an innovative tool to the community that can help inform and personalize CD management."

CDPATH integrates patient-specific serologic markers and genetic marker status, identified via a blood sample, with patient's CD characteristics to help predict a low, medium, and high risk for potentially developing serious CD complications over a three-year period. It is intended to be used in combination with a physician's clinical assessment. Healthcare providers will receive a CDPATH test report with a graphical risk profile that can then be used to facilitate discussions with patients.

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 such as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).

---

CLIA: Clinical Laboratory Improvement Amendments; CAP: College of American Pathology

Dr. Dubinsky is co-founder and equity owner in a MiTest Health, which received a licensing fee from Takeda for CDPATH. Dr. Dubinsky has received compensation from both Takeda Pharmaceutical and Prometheus Laboratories as a consultant.  In addition to Takeda, Dr. Dubinsky also serves as a paid consultant for other pharmaceutical companies that develop and/or manufacture treatments for inflammatory bowel disease (IBD). Dr. Dubinsky is co-founder and equity owner of two start-up companies involved in IBD healthcare, Trellus Health and GoDoRun.

Beneficiaries must be covered by a commercial insurance plan or be uninsured. Those with a state or federal health insurance program (including, but not limited to, Medicare, Medicaid, Department of Veteran's 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 to directly cover these charges.

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. Doctors can decide if this tool is appropriate for individual patients as part of their overall assessment. More information is available at www.CDPATH.com.

Crohn's disease (CD) is a chronic inflammatory disease that affects the gastrointestinal (GI) tract and impacts approximately 780,000 people in the U.S. CD is one of the most common forms of inflammatory bowel disease (IBD) with symptoms of abdominal pain, diarrhea, and weight loss. The disease is usually progressive and has the potential to lead to irreversible and destructive complications, which may require surgery. These complications - including fistulas, abscesses, strictures, and intestinal obstruction - can be common, yet the course of CD is highly variable and difficult to predict.

Prometheus Laboratories is a specialty clinical laboratory which enables precision-guided care in Inflammatory Bowel Disease and other GI disorders.  We discover, develop and commercialize testing services that help clinicians improve outcomes across the patient journey, from disease interception and stratification, to therapy selection, optimization and monitoring. For more information, please visit https://prometheuslabs.com and engage with us on LinkedIn.

SOURCE Prometheus Laboratories, Inc.