Exact Sciences Expands Cancer Test Portfolio, Raises 2025 Revenue Outlook

Exact Sciences, a leader in cancer diagnostics, is poised for a transformative year with the launch of two new cancer tests and plans for a third, prompting an increase in its financial projections for 2025. The company's expanding portfolio aims to revolutionize cancer detection and treatment across multiple tumor types.

Cologuard Plus and Oncodetect: New Additions to Exact Sciences' Arsenal

In late March, Exact Sciences introduced Cologuard Plus, an enhanced version of its flagship colorectal cancer screening kit. The updated test, which received FDA approval and Medicare coverage, incorporates new genetic biomarkers to reduce false-positive rates while maintaining high sensitivity for tumor and advanced precancerous polyp detection.

Following closely, the company launched Oncodetect, a blood-based test designed to track minimal residual disease and cancer recurrence across various solid tumors. This circulating tumor DNA test can monitor up to 200 genetic variants specific to a patient's tumor, offering high sensitivity in detecting residual cancer cells post-treatment. Exact Sciences anticipates a Medicare reimbursement decision for Oncodetect's use in colon cancer by the end of June.

Financial Outlook and Q1 2025 Performance

Buoyed by these developments, Exact Sciences has revised its 2025 revenue forecast upward. The company now projects annual revenue between $3.07 billion and $3.12 billion, representing a $40 million increase from previous estimates and a 12% year-over-year growth. This growth is expected to be driven by a 14% increase in the screening business and a 5% rise in the precision oncology division.

For the first quarter of 2025, Exact Sciences reported total sales of $707 million, an 11% increase compared to the same period in 2024. The screening revenue, primarily from the current Cologuard test, grew by 14% to $540 million, while precision oncology revenue increased by 2% to $167 million. Despite these gains, the company recorded a net loss of $101 million for the quarter.

Looking Ahead: Cancerguard EX on the Horizon

Exact Sciences is not resting on its laurels, with plans to debut Cancerguard EX in the second half of 2025. This multi-cancer screening blood test is designed to compete with early detection tests like Grail's Galleri. Cancerguard EX measures DNA methylation and protein biomarkers, demonstrating promising results in a previous clinical study. The test showed 63.7% sensitivity and 98.5% specificity in detecting cancers of the pancreas, esophagus, liver, lung, stomach, and ovaries – some of the most aggressive tumor types with low five-year survival rates.

Exact Sciences CEO Kevin Conroy emphasized the company's mission, stating, "These additions expand our portfolio and move us closer to our goal of helping to eradicate cancer by preventing it, detecting it earlier, and guiding personalized treatment." As Exact Sciences continues to innovate and expand its product lineup, the company is positioning itself as a key player in the fight against cancer, with a focus on early detection and personalized treatment approaches.