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Abbott Wins European Regulatory Clearance for Cologuard Plus Screening Test

BullishMedium impact
ABT$102.45 −1.55%

Healthcare company Abbott Laboratories (ABT) secured CE Mark clearance under European Union In Vitro Diagnostic Regulation rules for Cologuard Plus. The noninvasive stool DNA screening test detects colorectal cancer and advanced precancers, supported by clinical performance data from the BLUE-C study published in the New England Journal of Medicine. Abbott shares traded down 0.79% at $104.10 following the news.

The regulatory clearance expands the screening test's potential market beyond its existing footprint in the United States. Offering a convenient home stool DNA test could lift screening uptake compared to colonoscopies. Broader detection capabilities for cancer and precancers may also increase clinical utility and adoption.

Abbott plans to introduce the test in select European markets. Investors will watch for country-by-country launch timelines and reimbursement decisions, which will be key catalysts for commercial rollout and adoption metrics.

Key points

  • Abbott Laboratories received CE Mark clearance under EU IVDR for its Cologuard Plus stool DNA screening test.
  • The noninvasive test targets colorectal cancer and advanced precancer using data from the BLUE-C study.
  • The regulatory win enables planned product rollouts in select European markets.
  • Country-level launch timelines and commercial adoption will depend on local reimbursement pathways.

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Questions and answers

What regulatory approval did Abbott receive in Europe?

Abbott obtained CE Mark clearance under EU In Vitro Diagnostic Regulation rules for its Cologuard Plus colorectal cancer screening test.

How does Cologuard Plus test for colorectal cancer?

Cologuard Plus is a noninvasive home stool DNA test that screens for both colorectal cancer and advanced precancer.

When will Cologuard Plus launch in European countries?

Abbott plans to launch the test in select European markets, with the exact timing dependent on country-specific regulatory pathways and reimbursement decisions.