FDA Breakthrough for First Viral-Integration MRD Liquid Biopsy in HCC -- New ctDNA Biomarker Class

TAIPEI and CHINO, Calif., April 21, 2026 /PRNewswire/ -- TCM Biotech (TPEx: 4169) has received FDA Breakthrough Device Designation for CatCHimera, a liquid biopsy MRD platform for hepatocellular carcinoma (HCC) that uses HBV–host genome integration junctions — rather than somatic mutations — as tumor-specific circulating biomarkers for post-curative treatment monitoring.

This approach is mechanistically distinct from ctDNA MRD assays currently in the BDD pipeline, which rely on somatic SNVs/indels. CatCHimera leverages the fact that HBV integration sites are unique to each patient's tumor clones, enabling a tumor-informed MRD signal using capture-NGS and ddPCR without mutation calling.

Published and presented clinical data (Hepatology; Cellular and Molecular Gastroenterology and Hepatology; AASLD 2023) include:

• vh-DNA detected in 98% of pre-surgical plasma; detection limit ~1.5 cm
• 158-day mean lead time over CT for recurrence detection
• NPV 92%, PPV 71% for post-operative recurrence
• Combined with AFP + PIVKA-II: 95.8% sensitivity, 95.5% specificity
• Sensitivity superior to AFP alone for tumors <5 cm

HCC remains a blind spot in the MRD landscape — no ctDNA MRD platform has yet pursued BDD for liver cancer, despite HCC being the third leading cause of cancer death globally and having >50% five-year recurrence after resection. Approximately 296 million chronic HBV carriers worldwide define the potential addressable population.

The platform was developed in collaboration with Academician Pei-Jer Chen's group at National Taiwan University and is protected by multi-country patents (US, EU, Singapore, China). TCM's molecular diagnostics laboratory operates under Taiwan Food and Drug Administration (TFDA) LDT accreditation.

SOURCE TCM Biotech