JAPAN – Japanese biopharmaceutical company Takeda, in partnership with US-based diagnostics company Prometheus Laboratories, has rolled out the CDPATH program in the US.

CDPATH is a personalized prognostic test that leverages blood tests that predicts the risk of developing severe complications related to Crohn’s Disease (CD).

Crohn’s disease is a type of inflammatory bowel disease that can affect any part of the gastrointestinal tract.

Symptoms may include abdominal pain, diarrhea, weight loss, and fatigue. Crohn’s disease is thought to be caused by a combination of genetic and environmental factors.

There is no cure for Crohn’s disease, but treatment can help manage symptoms.

The new tool is used alongside clinical evaluation by a physician to predict the risk of an adult patient developing serious CD-related complications.

These complications can include internal penetrating disease, strictures in the bowel, or non-perianal surgery.

The test is intended for adults at least 18 years old who have been diagnosed with Crohn’s disease during the past 10 years and who have not experienced serious complications.

CDPath is used with a blood sample and integrates serologic biomarkers and genetic marker status with a patient’s Crohn’s disease characteristics to predict a low, medium, or high risk for developing serious complications during the next three years.

The test enables the patients with CD to partner with their physicians to figure out a personalized disease management plan, said Takeda.

Free CDPATH test for eligible patients

The test will also be provided to eligible patients free of cost to support shared decision-making between physicians and patients.

Takeda Pharmaceuticals USA gastroenterology business unit head Gamze Yüceland said: “Offering CDPATH at no cost to eligible patients with CD will help deliver an innovative tool to the community that can help inform and personalize CD management.”

The test was developed through a collaboration among Takeda, Prometheus, and MiTest Health. Prometheus has received approval from the New York State Department of Health to market CDPath as a laboratory-developed test.

Prometheus examined the model and will be the processing laboratory for the CDPATH program. Takeda will be responsible for providing the CDPATH test to US-based physicians.

Prometheus is a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory and serves as the processing laboratory for the CDPATH program.

The Crohn’s disease market is expected to grow at a CAGR of 7.6% from 2018 to 2026. The global Crohn’s disease market was valued at US$4.9 billion in 2018 and is projected to reach US$8.1 billion by 2026.

Other than Takeda, other pharmaceutical companies in the Crohn’s disease market are AbbVie, Janssen Biotech, Pfizer, and UCB. These companies hold a combined market share of over 80%.

Notable trends in Crohn’s disease market include rising preference to symptomatic medications and therapeutic over surgery and the emergence and improvement of better drugs in this market, which is due to substantial money being spent by manufacturers on research and development.

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