Abbott Receives CE Mark for Cologuard Plus in Europe
The DNA-based stool test for colorectal cancer screening has gained regulatory approval for use in European markets.
Updated on Oct. 20, 2026 in Cancer
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Abbott has secured the CE Mark for its Cologuard Plus colorectal cancer screening test under the European Union's regulatory framework. The stool-based test is designed to detect cancer and precancerous lesions in adults aged 45 and older without needing sedation.
Why it matters
The introduction of the test provides a non-invasive screening alternative for European patients as authorities aim to increase diagnostic participation. Colorectal cancer remains a major public health concern, accounting for a significant portion of annual cancer diagnoses across the region.
The clinical validation for the test was based on the BLUE-C study which included more than 20,000 participants. This new screening option enters a market where colorectal cancer screening participation averaged 42% in 2022.
The players
Abbott
Abbott is a global medical device and healthcare company that produces diagnostic, cardiovascular, and neuromodulation products.
The details
Patients can collect a stool sample at home to analyze DNA markers and blood associated with cancer and precancerous lesions. The diagnostic process avoids the need for bowel preparation or dietary restrictions common with other screening methods.
Timeline
The original Cologuard test launched in the United States in 2014.
Colorectal cancer data for Europe was reported in 2022.
The Cologuard Plus test received its CE Mark on October 20, 2026.
The Big Picture
This development follows the rigorous safety and performance requirements established by the European Union's In Vitro Diagnostic Medical Devices Regulation. The test reflects a broader shift toward integrating molecular diagnostics into standard non-invasive cancer screening protocols.
Patients at average risk aged 45 and older will gain access to a screening option that eliminates the need for invasive procedures or sedation. This at-home collection method may lower barriers to screening for individuals who previously avoided traditional diagnostic protocols.
The takeaway
Advancements in non-invasive DNA stool testing are creating more accessible options for early cancer detection. Patients should consult with their healthcare providers to determine if this screening method is appropriate based on their personal health history and risk factors.
Further reading
Learn more about the latest innovations in Cancer diagnostics and screenings.
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