Exact Sciences' Blood Test Shows Seven-Fold Improvement in Early Liver Cancer Detection Over Standard Ultrasound
核心洞察
The ALTUS study, the largest prospective trial of a blood test for liver cancer (搜索) surveillance in the U.S., demonstrated that Oncoguard Liver (搜索) detected three times more early-stage hepatocellular carcinomas than ultrasound (67% vs 22%).
The blood test achieved seven times greater sensitivity for very early-stage liver cancer (搜索) compared to standard ultrasound (64% vs 9%), with 82% specificity exceeding clinical utility benchmarks.
Results address critical gaps in liver cancer (搜索) screening, where fewer than 30% of eligible patients participate in regular surveillance despite liver cancer being among the fastest-growing causes of cancer deaths in the United States.
Exact Sciences Corp (搜索). has announced breakthrough results from its landmark ALTUS study, demonstrating that the company's Oncoguard Liver (搜索) blood test significantly outperforms standard ultrasound in detecting early-stage hepatocellular carcinoma (搜索) (HCC), the most common form of liver cancer (搜索). The findings, which will be presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting on November 11, 2025, represent a potential paradigm shift in liver cancer surveillance.
Superior Detection Performance in Largest U.S. Trial
The ALTUS study enrolled more than 3,000 participants across community practices, Veterans Affairs, and academic centers, making it the largest prospective, real-world trial of a blood test for liver cancer (搜索) surveillance in the United States. The trial was designed to reflect the racial and ethnic diversity of high-risk patient populations.
The Oncoguard Liver (搜索) 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 guidelines that describe eligibility for curative liver transplant, making early detection crucial for treatment options.
The most striking results emerged in very early-stage disease detection, where the blood test demonstrated a seven-fold improvement over ultrasound:
- 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
The test also demonstrated 82% specificity, exceeding the threshold established by experts for clinical utility.
Addressing Critical Surveillance Gaps
"Ultrasound surveillance has been the standard for liver cancer (搜索) screening for decades, but it's limited by image quality and inconsistent follow up, resulting in low detection rates and poor adherence," 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. "A highly sensitive blood-based alternative like Oncoguard Liver (搜索) is a game changer that could make liver cancer screening more accessible, equitable, and effective for millions of at-risk patients."
The findings address a significant clinical need, as hepatocellular carcinoma (搜索) is among the fastest-growing causes of cancer-related deaths in the United States. By 2040, liver cancer (搜索) is expected to become the third-leading cause of cancer death, with more than 40,000 new cases and 30,000 deaths annually. Despite patients diagnosed at early stages experiencing 12 times greater survival rates than those diagnosed with distant disease, fewer than 30% of eligible individuals participate in regular surveillance recommended by AASLD for people with specific risk factors, such as chronic liver disease (搜索) or cirrhosis (搜索).
Multiomics Technology Platform
The Oncoguard Liver (搜索) test is a blood-based multiomics assay developed in collaboration with Mayo Clinic. It combines DNA methylation (搜索) and protein markers (搜索) to detect molecular signatures associated with liver cancer (搜索), using Exact Sciences' proprietary PCR technology designed for accuracy, scalability, and broad clinical access.
"These new data from the ALTUS study show that we can reliably detect liver cancer (搜索) earlier, which is key to improving outcomes," said Dr. Paul Limburg, chief medical officer, screening at Exact Sciences. "With Cologuard (搜索), 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 (搜索) test builds on that success, applying the same science-driven approach to another cancer in which finding disease early can help save lives."
Clinical Impact and Implementation
The ALTUS study confirms that the Oncoguard Liver (搜索) 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 ability to detect liver cancers when they remain eligible for potentially curative options such as resection or transplant represents a significant advancement in patient care. The company intends to submit the data for publication in a peer-reviewed journal following the AASLD presentation.