Exact Sciences reported that its Oncoguard Liver blood test achieved a 67% sensitivity for very early‑stage hepatocellular carcinoma (HCC) and an 82% specificity in the ALTUS study, compared with a 22% sensitivity for the current standard of care ultrasound. The study enrolled more than 3,000 high‑risk patients across community practices, Veterans Affairs sites, and academic centers, demonstrating the test’s performance in a real‑world, diverse population.
The Oncoguard Liver assay is a multi‑omics platform developed in partnership with Mayo Clinic that combines DNA methylation signatures with protein biomarkers. The seven‑fold increase in early‑stage detection relative to ultrasound represents a substantial improvement over imaging, which is limited by operator variability and inconsistent follow‑up. By detecting cancer at a stage when curative therapies are more likely to succeed, the test could improve patient outcomes and reduce the need for invasive procedures.
Liver cancer is projected to become the third‑leading cause of cancer death in the United States by 2040, underscoring the growing market opportunity. A non‑invasive, highly sensitive test could accelerate adoption of surveillance guidelines, increase adherence among at‑risk populations, and position Exact Sciences as a leader in a rapidly expanding diagnostic niche.
Exact Sciences’ Q3 2025 earnings beat analyst expectations, with revenue of $851 million versus an estimate of $810 million and an adjusted EPS of $0.24 versus a consensus loss of $0.13. The company raised its full‑year 2025 revenue guidance to $3.22‑$3.235 billion and adjusted EBITDA guidance to $470‑$480 million, reflecting confidence in continued demand for its screening products. The screening segment grew 22% year‑over‑year to $666 million, driven by strong uptake of Cologuard and the launch of Cologuard Plus, while the precision oncology segment grew 12% to $183 million.
Dr. Paul Limburg, Chief Medical Officer for Screening, said the data “show that we can reliably detect liver cancer earlier, which is key to improving outcomes.” Dr. Binu John, principal investigator of the ALTUS trial, added that a highly sensitive blood‑based alternative “could make liver cancer screening more accessible, equitable, and effective for millions of at‑risk patients.”
Exact Sciences plans to present the full ALTUS data at the American Association for the Study of Liver Diseases (AASLD) meeting on November 11, 2025, and intends to engage with regulators for potential market launch. The company’s portfolio expansion beyond colorectal cancer screening signals a broader strategy to capture high‑growth diagnostic markets.
The Oncoguard Liver test represents a significant innovation milestone for Exact Sciences, diversifying its revenue streams and reinforcing its position as a pioneer in non‑invasive cancer diagnostics. The combination of strong clinical performance, a growing market for liver cancer surveillance, and robust financial results positions the company for continued growth in the coming years.
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