Following the launch of two new cancer tests—plus a third planned for before the end of 2025—Exact Sciences is nudging up its financial expectations for what it says will be a transformative year.
The company started rolling out its Cologuard Plus test in late March, after obtaining FDA approval and Medicare coverage, as a long-awaited update to its flagship colorectal cancer screening kit that’s enjoyed more than 10 years on the market.
Exact Sciences has said that the addition of new genetic biomarkers to the home stool DNA test have cut its false-positive rate while maintaining its sensitivity in detecting tumors and advanced precancerous polyps.
Then, just last week, the company began offering Oncodetect, a circulating tumor DNA blood test designed to track minimal residual disease and cancer recurrence across multiple types of solid tumors.
The test tracks up to 200 genetic variants matched with the patient’s tumor, offering high sensitivity in capturing the evidence of cancer cells left over following surgery and other therapies. The company said it expects to receive a Medicare reimbursement decision covering its use in colon cancer by the end of June.
“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,” Exact Sciences CEO Kevin Conroy said in a statement. “With growing momentum in our commercial organization and improved profitability, we raised our full-year outlook and continue to build a foundation for sustained, long-term growth.”
For 2025, the company bumped up its previously predicted annual revenue ballpark by $40 million, while slightly narrowing the range to between $3.07 billion and $3.12 billion. That would result in 12% year-over-year growth—including 14% in the company’s $2.4 billion screening business and 5% in its $690 million precision oncology division.
Though the launches of Cologuard Plus and Oncodetect had little to no impact on Exact Sciences’ first-quarter earnings, the company logged an 11% gain in revenue compared to 2024, with total sales of $707 million.
Screening revenue, primarily from its current Cologuard test, amounted to $540 million and was up 14%—while precision oncology grew 2%, adding $167 million from its Oncotype DX and therapy selection catalog. The company’s net loss came to $101 million.
Looking ahead, the company said that it’s “on track” to debut Cancerguard EX, a blood test designed to screen for multiple cancers, in the second half of this year.
Aiming to compete with early detection tests like Grail’s Galleri, Cancerguard measures DNA methylation as well as protein biomarkers. In a previous clinical study, it delivered 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.
The company said Cancerguard is planned to tap into a standardized, imaging-based diagnostic pathway for confirmatory follow-up procedures.