November 7, 2025 — Leads & Copy —
Exact Sciences Corp. (NASDAQ: EXAS) has announced pivotal clinical validation results from the ALTUS study, demonstrating that its Oncoguard® Liver blood test delivers superior early-stage and overall sensitivity for hepatocellular carcinoma (HCC) compared to the current standard of care.
The findings from the prospective, head-to-head trial (NCT: 05064553) will be presented as late-breaking data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®* on November 11, 2025. The company intends to submit the data for publication in a peer-reviewed journal.
Dr. Binu John, principal investigator for the ALTUS trial, associate professor at the University of Miami Miller School of Medicine, and chief of gastroenterology and hepatology at the Miami VA, stated that a highly sensitive blood-based alternative like Oncoguard Liver is a game changer that could make liver cancer screening more accessible, equitable, and effective for millions of at-risk patients. He noted that ultrasound surveillance has been the standard for liver cancer screening for decades, but it’s limited by image quality and inconsistent follow up, resulting in low detection rates and poor adherence.
The ALTUS study is the largest prospective, real-world trial of a blood test for liver cancer surveillance in the United States, with more than 3,000 participants enrolled across community practices, Veterans Affairs, and academic centers, representing the racial and ethnic diversity of high-risk patient populations.
The Oncoguard Liver test achieved its primary endpoint, detecting three times more cancers defined as early-stage by Milan criteria compared to ultrasound (67% vs 22%). Milan criteria are a set of guidelines that describe eligibility for curative liver transplant.
The study also demonstrated:
* Very early-stage HCC sensitivity: 64% for Oncoguard Liver vs 9% for ultrasound
* Early-stage HCC sensitivity: 77% for Oncoguard Liver vs 36% for ultrasound
These findings demonstrate a seven-fold improvement in detecting liver cancers when they are most treatable and remain eligible for potentially curative options such as resection or transplant.
The Oncoguard Liver test also demonstrated a specificity of 82% in the ALTUS study, exceeding the threshold established by experts for clinical utility.
Dr. Paul Limburg, chief medical officer, screening at Exact Sciences, said that these new data from the ALTUS study show that we can reliably detect liver cancer earlier, which is key to improving outcomes. He added that with Cologuard, the company has already seen what is possible, with more than 20 million tests completed and thousands of colorectal cancers prevented through early detection, and the Oncoguard Liver test builds on that success, applying the same science-driven approach to another cancer in which finding disease early can help save lives.
Hepatocellular carcinoma is among the fastest-growing causes of cancer-related deaths in the United States. By 2040, liver cancer is expected to become the third-leading cause of cancer death, with more than 40,000 new cases and 30,000 deaths annually. Patients diagnosed at early stages of HCC experience 12 times greater survival rates than those diagnosed with distant disease, yet fewer than 30% of eligible individuals participate in regular surveillance, which is recommended by AASLD for people with specific risk factors, such as chronic liver disease or cirrhosis.
The Oncoguard Liver test is a blood-based multiomics assay developed in collaboration with Mayo Clinic, combining DNA methylation and protein markers to detect molecular signatures associated with liver cancer, using Exact Sciences’ proprietary PCR technology designed for accuracy, scalability, and broad clinical access.
The ALTUS study confirms that the Oncoguard Liver test meets consensus thresholds for blood-based surveillance established in 2025 and overcomes key barriers associated with ultrasound imaging, particularly in populations affected by obesity or other factors that limit image quality.
*The Liver Meeting® and AASLD are registered trademarks of the American Association for the Study of Liver Diseases.
†Milan Criteria: Defines early-stage liver cancer as a single tumor ≤ 5 cm in diameter or up to three tumors each ≤ 3 cm in diameter, confined to the liver. Patients meeting these criteria may be eligible for curative surgery or transplant.
References are available in the original press release.
Contact:
Investor Relations: Erik Denk, investorrelations@exactsciences.com
Media Relations: Kate Boyce, news@exactsciences.com
Source: Exact Sciences Corp.
