HelioLiver: AI-Powered Blood Test for Early Hepatocellular Carcinoma Detection

Helio Genomics launched HelioLiver, an AI-powered, multi-analyte, CLIA laboratory-developed blood test for early detection of hepatocellular carcinoma (HCC), the most common form of liver cancer. HelioLiver combines cell-free DNA methylation patterns, established serum protein tumor markers (AFP, AFP-L3%, and des-gamma-carboxy prothrombin), and patient demographics in proprietary machine-learning algorithms. In the 1,968-patient prospective CLiMB trial, HelioLiver achieved approximately four times greater sensitivity for Stage I HCC than standard-of-care ultrasound, with early-stage sensitivity of roughly 75-85% versus ultrasound's ~47%. Liver cancer incidence in the U.S. is forecast to reach ~42,340 new cases and ~30,980 deaths in 2026 with only ~20% five-year survival overall, so early-stage detection (when tumors are still within Milan criteria) is critical: five-year survival can exceed 60-70%. HelioLiver is now commercially available nationwide to high-risk populations (cirrhosis, chronic hepatitis) and is accessible through Quest Diagnostics' 7,700+ U.S. patient service centers, with Medicare reimbursement of $662 per test under CPT 0333U. In May 2026 Helio announced a strategic commercial partnership with Syneos Health, which is deploying its AI-driven Kinetic platform and a hybrid human-and-AI medical-science-liaison field force to engage gastroenterologists, hepatologists, and other liver-disease providers, accelerating nationwide adoption. The rollout also serves as a CRO-led commercialization template for multi-cancer early detection (MCED) diagnostics. (Irvine, California, USA — nationwide rollout) Cross-reference: The Syneos Health AI-driven Kinetic platform and hybrid AI+human MSL field force described in this use case (use case c0b22088-6130-4e2e-94d9-ce2c47624d4d, Syneos Health) is the commercial deployment channel for HelioLiver's nationwide rollout to gastroenterologists and hepatologists.