Exact Sciences Announces Breakthrough Results from Landmark Study Demonstrating Superior Early Detection of Liver Cancer with Blood-Based Surveillance Test
Oncoguard® Liver blood test delivers seven times greater sensitivity for very early-stage hepatocellular carcinoma (HCC) versus standard of care
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
Exact 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's Oncoguard® Liver blood test delivers superior early-stage and overall sensitivity for hepatocellular carcinoma (HCC) — the most common form of liver cancer — compared to the current standard of care.1,2
These findings 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, underscoring the Oncoguard Liver test's potential to transform liver cancer surveillance for at-risk populations. The company intends to submit the data for publication in a peer-reviewed journal.
"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," 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 is a game changer that could make liver cancer screening more accessible, equitable, and effective for millions of at-risk patients."
Setting the new benchmark in liver cancer surveillance
The 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
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%).1 Milan criteria are a set of guidelines that describe eligibility for curative liver transplant.3†
- Very early-stage HCC sensitivity: 64% for Oncoguard Liver vs 9% for ultrasound1
- Early-stage HCC sensitivity: 77% for Oncoguard Liver vs 36% for ultrasound1
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.1-3
The Oncoguard Liver test also demonstrated a specificity of 82% in the ALTUS study,1 exceeding the threshold established by experts for clinical utility.4
"These new data from the ALTUS study show that we can reliably detect liver cancer earlier, which is key to improving outcomes," said Dr. Paul Limburg, chief medical officer, screening at Exact Sciences. "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."
Transforming surveillance for a growing and underserved population
Hepatocellular carcinoma is among the fastest-growing causes of cancer-related deaths in the United States.5-7 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 Patients diagnosed at early stages of HCC experience 12 times greater survival rates than those diagnosed with distant disease,6 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
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 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
*The Liver Meeting® and AASLD are registered trademarks of the American Association for the Study of Liver Diseases. |
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†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. |
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References |
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| 1. | John B, Camardo M, Singal A. Performance of a multi-target blood test versus ultrasound in detecting hepatocellular carcinoma: results from the ALTUS prospective study. Presented at: The Liver Meeting®, American Association for the Study of Liver Disease (AASLD); November 11, 2025; Washington, DC. |
| 2. | Singal A, Llovet J, Yarchoan M et al. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology 2023; 78(6):1922-1965. doi: 10.1097/HEP.0000000000000466 |
| 3. | Mazzaferro V, Regalia E, Doci S et al. Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis. New Engl J Med. 1996 Mar 14;334(11):693-699. doi: 10.1056/NEJM199603143341104 |
| 4. | Singal A, Quirk L, Boike J et al. Value of HCC surveillance in a landscape of emerging surveillance options: perspectives of a multi-stakeholder modified Delphi panel. Hepatology. 2025;82(3):794-809. doi:10.1097/HEP.0000000000001203. |
| 5. | Siegel RL, Kratzer T, et al. Global cancer statistics 2025: CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871 |
| 6. | American Cancer Society. Cancer facts and figures. Accessed October 28, 2025. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf |
| 7. | Rahib L. Wehner MR, Matrisian LM, Nead KT. Estimated projection of US cancer incidence and death to 2040. JAMA Netw Open. 2021;4(4):e214708. doi: 10.1001/jamanetworkopen.2021.4708. |
| 8. | Wolf E, Rich NE, Marrero JA et al. Use of hepatocellular carcinoma surveillance in patients with cirrhosis: a systematic review and meta-analysis. Hepatology. 2020. doi: https://doi.org/10.1002/hep.31309 |
| 9. | Esfeh JM, Hajifathalian K, Ansari-Gilani K. Sensitivity of ultrasound in detecting hepatocellular carcinoma in obese patients compared to explant pathology as the gold standard. Clin Mol Hepatol. 2020;26(1):54-59. doi:10.3350/cmh.2019.0039 |
| 10. | Samolyova, ML, Mehta N, Roberts JP, et al. Predictors of ultrasound failure to detect hepatocellular carcinoma. Liver Transpl. 2018;24(9):1171-1177. doi:10.1002/lt.25202. |
About the Oncoguard® Liver test
The Oncoguard Liver test is a laboratory-developed, blood-based assay for hepatocellular carcinoma (HCC) surveillance among patients at high risk, including those with cirrhosis or chronic liver disease. Built on Exact Sciences' proprietary LQAS PCR technology, the test was developed in collaboration with Mayo Clinic and designed for broad, real-world applicability.
About Exact Sciences
A leading provider of cancer screening and diagnostic tests, Exact Sciences (NASDAQ:EXAS) helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company's growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like the Cancerguard® test for multi-cancer early detection and the Oncodetect® test for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit ExactSciences.com, follow @ExactSciences on X, or connect on LinkedIn and Facebook.
NOTE: Exact Sciences, Cologuard, Cancerguard, Oncodetect, and Oncoguard Liver are trademarks of Exact Sciences Corporation. The Cologuard test and Cologuard Plus test are only available in the U.S.
Forward-looking statement
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.
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