# Abbott Secures European Regulatory Clearance for Cologuard Plus Cancer Test

- URL: https://stocks.freetheai.org/news/abbott-secures-european-regulatory-clearance-for-cologuard-plus-cancer-test-16c38a
- Published: 2026-10-20T06:00:00Z
- Category: company_news; sentiment: bullish; impact: medium
- Symbols: [NYSE:ABT](https://stocks.freetheai.org/symbols/NYSE-ABT)
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Abbott Laboratories (ABT) secured a CE Mark under European Union regulations for its Cologuard Plus noninvasive colorectal cancer test. The regulatory milestone allows the healthcare company to prepare for commercial launch across select European countries, expanding access to stool-based DNA screening for adults aged 45 and older.

Colorectal cancer is a major health challenge in Europe, accounting for over 356,000 new diagnoses across the European Union in 2022. Cologuard Plus offers an at-home screening option that requires no dietary changes, sedation, or bowel preparation. In clinical trials, the updated test demonstrated 95% sensitivity in detecting colorectal cancer and reduced false-positive results by up to 40% compared to the original version.

Abbott plans to introduce Cologuard Plus in targeted European markets, though regional launch timelines will depend on country-specific healthcare processes, reimbursement decisions, and operational setup. Shares of Abbott Laboratories were down 0.79% at $104.10 following the announcement.

## Key points

- Abbott Laboratories received a CE Mark in Europe for its noninvasive Cologuard Plus colorectal cancer screening test.
- The test demonstrated 95% sensitivity for colorectal cancer detection and up to a 40% reduction in false-positive results compared to the original test.
- Commercial availability across select European markets will vary based on local reimbursement and healthcare integration timelines.
- Colorectal cancer accounted for over 356,000 new cancer diagnoses within the European Union in 2022.

## Questions and answers

### What is Cologuard Plus?

Cologuard Plus is a noninvasive, stool-based DNA screening test designed to detect colorectal cancer and advanced precancerous lesions in adults aged 45 and older using a sample collected at home.

### Did Abbott receive approval for Cologuard Plus in Europe?

Yes, Abbott earned a CE Mark under the European Union's In Vitro Diagnostic Medical Devices Regulation, clearing the test for introduction in select European markets.

### How accurate is the Cologuard Plus test?

In clinical trials, Cologuard Plus achieved 95% sensitivity for detecting colorectal cancer at 94% specificity, while reducing false-positive results by up to 40% compared to the original Cologuard test.