#United States #Abbott #Abbott Park #Colorectal Cancer #Cologuard Plus

Cologuard Plus® Gains CE Mark Approval in Europe

Abbott has made significant strides in the field of healthcare with its latest product, Cologuard Plus®. Recently, Abbott announced that this non-invasive DNA screening test has received the CE Mark, marking a major regulatory milestone under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). This development is crucial as it paves the way for the introduction of Cologuard Plus in select European markets, depending on local healthcare systems and operational readiness.

Understanding Cologuard Plus

Cologuard Plus is designed to detect both colorectal cancer and advanced precancerous lesions using a non-invasive method based on stool samples. Unlike traditional screening methods, this test does not require bowel preparation, dietary restrictions, or sedation. It analyzes DNA and blood markers found in the stool that are associated with colorectal cancer, thus offering a practical screening option that patients can perform at home.

The CE Mark is anticipated to facilitate the availability of Cologuard Plus across various European countries. However, the introduction schedule will vary based on regional healthcare frameworks and reimbursement pathways. Jake Orville, Abbott's Senior Vice President for Oncology Diagnostics, stated, "Early detection is one of our most powerful tools in the fight against colorectal cancer, but it only works if people participate. Cologuard has transformed colorectal cancer screening in the United States by providing an effective and convenient option for patients. With Cologuard Plus, we have harnessed that expertise to deliver even higher performance. Receiving the CE Mark is a critical step toward making this option available to more people and addressing unmet screening needs across Europe."

The Impact of Colorectal Cancer in Europe

Colorectal cancer is among the most diagnosed cancers in Europe, with approximately 538,000 new cases reported in 2022 alone. Within the EU, this type of cancer accounted for over 356,000 new diagnoses, constituting about 13% of all new cancer diagnoses. Despite the challenges associated with colorectal cancer, participation rates in early screening vary significantly across Europe. In 2022, only 42% of individuals in the target age group from EU countries that provided data participated in colorectal cancer screenings over the previous two years.

Dr. Cesare Hassan, a Professor of Gastroenterology at Humanitas University in Milan, Italy, emphasized the importance of increasing participation in early detection programs. He noted, "Colorectal cancer remains a significant public health challenge in Europe, and boosting participation in early detection programs is a vital step in addressing this issue. Expanding access to accurate and non-invasive screening options that people are willing to complete could help identify more cases of cancer at earlier stages and detect advanced precancerous lesions before they progress."

How Cologuard Plus Works

Cologuard Plus employs a simple home collection method for stool samples. The test assesses various DNA and blood markers linked to colorectal cancer and advanced precancerous lesions. The ease of use is a significant advantage, as patients do not require any prior bowel preparation, dietary changes, sedation, or time off work to take the test.

Clinical Performance Highlights

The clinical efficacy of Cologuard Plus was demonstrated in the pivotal BLUE-C study, which was a prospective multicenter trial involving over 20,000 participants—the largest study of its kind for colorectal cancer screening. Key findings from the BLUE-C study include:

• - A sensitivity of 95% for detecting colorectal cancer with a specificity of 94% among the population tested.
• - A sensitivity of 43% for detecting advanced precancerous lesions.
• - A sensitivity of 74% for high-grade dysplasia, which has the highest likelihood of progressing to cancer.
• - A reduction of false positive results by up to 40% compared to the original Cologuard test.

The Future of Cologuard Plus

Cologuard Plus builds upon the foundation laid by Cologuard, which was first introduced in the U.S. in 2014 and has since been used for over 23 million screenings. With improvements in clinical performance and laboratory processes, Cologuard Plus represents a significant step forward in colorectal cancer detection. It is crucial for adults aged 45 and older who are at average risk for colorectal cancer.

A positive result from Cologuard Plus may indicate the presence of colorectal cancer or advanced precancerous lesions, and a follow-up colonoscopy is necessary. Cologuard Plus is not a substitute for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

As Abbott continues to lead in innovative health solutions, the release of Cologuard Plus is anticipated to enhance early detection landscape, making strides against colorectal cancer across Europe.

About Abbott

Abbott is a global healthcare leader dedicated to helping people live life to the fullest at all stages of life. With a portfolio of innovative technologies, Abbott encompasses diagnostics, medical devices, nutrition, and branded generic pharmaceuticals. With 122,000 employees in over 160 countries, Abbott is committed to advancing the wellbeing of people worldwide.