Exact Sciences plans ‘transformative year’ with 3 cancer test debuts

Title

Exact Sciences Ushers in ‘Transformative Year’ with Launch of Three Innovative Cancer Tests in 2025

Keywords

Exact Sciences
Cancer screening
Cologuard Plus
Oncodetect
Cancerguard EX
Multi-cancer detection
Molecular residual disease (MRD)
Colorectal cancer
ctDNA
Cancer diagnostics
2025 medical innovation

Key Facts

Exact Sciences is embarking on what it calls a "transformative year" in 2025 by launching three major new cancer detection tests to broaden its impact in oncology.

- The company launched two new tests:

* - Cologuard Plus™:*
An FDA-approved, noninvasive, at-home colorectal cancer screening test for average-risk adults 45+, showing 95% sensitivity and 94% specificity—the most accurate noninvasive CRC screening reported to date. It is covered by Medicare and is expected to significantly reduce unnecessary follow-up colonoscopies compared to its predecessor3 4.

* - Oncodetect™:*
A molecular residual disease (MRD) test for detecting circulating tumor DNA (ctDNA) variants, designed to find minimal residual disease after colon cancer treatment. In the Alpha-CORRECT study, it reached 78% sensitivity post-surgery and 91% sensitivity during surveillance, with high specificity, positioning Exact Sciences as a leader in the growing MRD market2 4 5.
- A third test, Cancerguard™ EX, a laboratory-developed multi-cancer screening test, is on track for launch in the second half of 2025, further expanding Exact Sciences’ footprint in early cancer detection1.
- The launches are prompting Exact Sciences to raise its financial outlook for 2025, reflecting expectations for increased adoption and revenue growth.
- These innovations reinforce Exact Sciences' leadership in the cancer screening industry, powered by extensive clinical validation and efforts to enhance patient access and outcomes4 5.