Abbott’s Cologuard Plus, a non-invasive, stool-based colorectal cancer screening test, has received the CE Mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), paving the way for its introduction in select European markets.
The test is designed to detect colorectal cancer and advanced precancerous lesions in adults aged 45 years and older who are at average risk of developing the disease.
Cologuard Plus uses a stool sample collected by patients at home to analyse multiple DNA markers and occult blood associated with colorectal cancer and advanced precancerous lesions. The sample collection process does not require bowel preparation, dietary changes or sedation, allowing patients to complete the test without taking time away from work or other daily activities.
Abbott plans to introduce Cologuard Plus in select European markets, with availability varying by country depending on local healthcare pathways, reimbursement and operational readiness.
“Screening is one of the most powerful tools we have in the fight against colorectal cancer, but it only works when people complete it,” said Jake Orville, senior vice president of Abbott’s cancer diagnostics business.
He added that Cologuard Plus builds on the experience of the original Cologuard test in the United States, offering improved clinical performance.
Clinical performance of Cologuard Plus
Cologuard Plus was evaluated in BLUE-C, a prospective, multicentre clinical study involving more than 20,000 participants. In the US screening population, the test demonstrated 95% sensitivity for colorectal cancer detection at 94% specificity. It also showed 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia, a type of precancerous lesion associated with a higher risk of progression to cancer.
The test demonstrated up to a 40% reduction in false-positive results compared with the original Cologuard test. Findings from the BLUE-C study were published in the New England Journal of Medicine.
Cologuard Plus incorporates novel biomarkers and improvements to laboratory processes and sample stability, building on more than a decade of experience with the original test.
Developed in collaboration with Mayo Clinic, Cologuard and Cologuard Plus are non-invasive, stool-based screening tests that detect DNA markers associated with colorectal neoplasia and occult blood in stool.
A positive Cologuard Plus result may indicate colorectal cancer or advanced precancerous lesions and should be followed by a colonoscopy. Abbott noted that the test is not intended to replace diagnostic colonoscopy or surveillance colonoscopy for high-risk individuals.
The original Cologuard test was launched in the US in 2014 and has been used for more than 23 million screenings. Cologuard Plus builds on this experience with enhanced clinical performance and improvements to the testing process.
Colorectal cancer burden in Europe
Colorectal cancer is among the most commonly diagnosed cancers in Europe. According to data cited by Abbott, approximately 538,000 people across Europe were diagnosed with the disease in 2022. Within the European Union, colorectal cancer accounted for more than 356,000 new cases, representing approximately 13% of all new cancer diagnoses.
Screening can help detect colorectal cancer at an earlier stage, when treatment may be more effective, and identify certain precancerous lesions before they progress to cancer. However, participation in colorectal cancer screening varies considerably across Europe.
In 2022, an average of 42% of people in the target age group across reporting EU countries had participated in colorectal cancer screening within the previous two years.
“Colorectal cancer remains a major public-health challenge in Europe, and increasing participation in screening is an important part of addressing it,” said Dr Cesare Hassan, Full Professor of Gastroenterology at Humanitas University, Milan, Italy.
He added that expanding access to accurate, non-invasive screening options that people are willing to complete could help identify more cancers earlier and detect advanced precancerous lesions before they progress.
