Exact Sciences announces results from ALTUS study

Exact Sciences (EXAS) announced pivotal clinical validation results from the ALTUS study. 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 – the most common form of liver cancer – compared to the current standard of care. These findings will be presented as late-breaking data at the American Association for the Study of Liver Diseases The Liver Meeting on November 11. The company intends to submit the data for publication in a peer-reviewed journal. The Oncoguard Liver test achieved its primary endpoint, detecting three times more cancers defined as early-stage by Milan criteria compared to ultrasound. Milan criteria are a set of guidelines that describe eligibility for curative liver transplant. 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. 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. The Oncoguard Liver test also demonstrated a specificity of 82% in the ALTUS study, exceeding the threshold established by experts for clinical utility.