Oncoguard Liver test demonstrates seven times greater sensitivity for very early-stage hepatocellular carcinoma compared to ultrasound surveillance.
Exact Sciences Corp announced results from the ALTUS study showing its Oncoguard Liver blood test achieved significantly higher sensitivity for detecting early-stage hepatocellular carcinoma compared to standard ultrasound surveillance.
The prospective, head-to-head trial enrolled more than 3,000 participants across community practices, Veterans Affairs, and academic centers. The Oncoguard Liver test detected three times more cancers defined as early-stage by Milan criteria compared to ultrasound (67% vs 22%), representing a seven-fold improvement in detecting liver cancers when they remain eligible for potentially curative options such as resection or transplant. Milan criteria are a set of guidelines that describe eligibility for curative liver transplant.
- Very early-stage hepatocellular carcinoma sensitivity: 64% for Oncoguard Liver vs 9% for ultrasound
- Early-stage hepatocellular carcinoma sensitivity: 77% for Oncoguard Liver vs 36% for ultrasound
The test also demonstrated 82% specificity in the ALTUS study, exceeding thresholds established by experts for clinical utility.
“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,” says 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, in a release. “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.”
Addressing Growing Clinical Need
Hepatocellular carcinoma ranks among the fastest-growing causes of cancer-related deaths in the US. 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 hepatocellular carcinoma experience 12 times greater survival rates than those diagnosed with distant disease, yet fewer than 30% of eligible individuals participate in regular surveillance recommended by the American Association for the Study of Liver Diseases for people with specific risk factors, such as chronic liver disease or cirrhosis.
Multiomics Technology Platform
The 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’ proprietary PCR technology designed for accuracy, scalability, and broad clinical access.
The test meets consensus thresholds for blood-based surveillance and overcomes key barriers associated with ultrasound imaging, particularly in populations affected by obesity or other factors that limit image quality.
“These new data from the ALTUS study show that we can reliably detect liver cancer earlier, which is key to improving outcomes,” says Dr Paul Limburg, chief medical officer, screening at Exact Sciences, in a release. “With 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.”
The findings will be presented as late-breaking data at the American Association for the Study of Liver Diseases The Liver Meeting on Nov 11. The company intends to submit the data for publication in a peer-reviewed journal.
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