The platform uses viral DNA markers to monitor for cancer recurrence in patients with hepatocellular carcinoma.

TCM Biotech has received Food and Drug Administration (FDA) Breakthrough Device Designation for CatCHimera, a liquid biopsy platform designed to monitor minimal residual disease (MRD) in patients with hepatocellular carcinoma.

The platform uses hepatitis B virus (HBV)–host genome integration junctions as tumor-specific circulating biomarkers for post-curative treatment monitoring, rather than the somatic mutations typically used in other assays. This approach is mechanistically distinct from circulating tumor DNA (ctDNA) MRD assays currently in the FDA pipeline, which rely on somatic single nucleotide variants and indels, TCM Biotech says in a release.

Published and presented clinical data 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

CatCHimera leverages the fact that HBV integration sites are unique to the tumor clones of each patient. This enables a tumor-informed MRD signal using capture next-generation sequencing and droplet digital PCR without the need for mutation calling.

Hepatocellular carcinoma remains a significant challenge in the MRD landscape, as no other ctDNA MRD platform has yet pursued breakthrough designation for liver cancer, the company says in a release. Hepatocellular carcinoma is the third leading cause of cancer death globally and has a five-year recurrence rate of more than 50% after surgical resection. Approximately 296 million chronic HBV carriers worldwide define the potential addressable population for this technology.

The platform was developed in collaboration with a research group at National Taiwan University and is protected by patents in the US, EU, Singapore, and China. TCM Biotech’s molecular diagnostics laboratory operates under Taiwan Food and Drug Administration laboratory developed test accreditation.

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