ALTUS study is the largest prospective trial of a blood test for liver cancer surveillance in the United States, reflecting the racial and ethnic diversity of high-risk groups<\/i><\/p>\n
MADISON, Wis.–(BUSINESS WIRE<\/a>)– \nThese findings will be presented as late-breaking data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting\u00ae<\/sup>* on November 11, 2025, underscoring the Oncoguard Liver test\u2019s potential to transform liver cancer surveillance for at-risk populations. The company intends to submit the data for publication in a peer-reviewed journal.\n<\/p>\n \n\u201cUltrasound surveillance has been the standard for liver cancer screening for decades, but it\u2019s limited by image quality and inconsistent follow up, resulting in low detection rates and poor adherence,\u201d said 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. \u201cA 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.\u201d\n<\/p>\n Setting the new benchmark in liver cancer surveillance<\/b><\/p>\n \nThe ALTUS study is the largest prospective, real-world trial of a blood test for liver cancer surveillance in the United States. More than 3,000 participants were enrolled across community practices, Veterans Affairs, and academic centers, representing the racial and ethnic diversity of high-risk patient populations.1<\/sup><\/p>\n \nThe 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%).1<\/sup> Milan criteria are a set of guidelines that describe eligibility for curative liver transplant.3\u2020<\/sup><\/p>\n \nThese 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.1-3<\/sup><\/p>\n \nThe Oncoguard Liver test also demonstrated a specificity of 82% in the ALTUS study,1<\/sup> exceeding the threshold established by experts for clinical utility.4<\/sup><\/p>\n \n\u201cThese new data from the ALTUS study show that we can reliably detect liver cancer earlier, which is key to improving outcomes,\u201d said Dr. Paul Limburg, chief medical officer, screening at Exact Sciences. \u201cWith Cologuard, we have already seen what is possible, with more than 20 million tests completed and thousands of colorectal cancers prevented through early detection. 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.\u201d\n<\/p>\n Transforming surveillance for a growing and underserved population<\/b><\/p>\n \nHepatocellular carcinoma is among the fastest-growing causes of cancer-related deaths in the United States.5-7<\/sup> 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.5-7<\/sup> Patients diagnosed at early stages of HCC experience 12 times greater survival rates than those diagnosed with distant disease,6<\/sup> 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.8<\/sup><\/p>\n \nThe Oncoguard Liver test is a blood-based multiomics assay developed in collaboration with Mayo Clinic. It combines DNA methylation and protein markers to detect molecular signatures associated with liver cancer, using Exact Sciences\u2019 proprietary PCR technology designed for accuracy, scalability, and broad clinical access.\n<\/p>\n \nThe 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.9,10<\/sup><\/p>\n
\nExact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced pivotal clinical validation results from the ALTUS study (NCT: 05064553). The prospective, head-to-head trial demonstrated that the company\u2019s Oncoguard\u00ae<\/sup> Liver blood test delivers superior early-stage and overall sensitivity for hepatocellular carcinoma (HCC) \u2014 the most common form of liver cancer \u2014 compared to the current standard of care.1,2<\/sup><\/p>\n\n
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