| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
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†
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."
Posted In: EXAS
