TCM Biotech announced on March 17 that its proprietary liquid biopsy platform, CatCHimera, has been awarded Breakthrough Device Designation (BDD) by the US FDA. The technology is designed for post-operative monitoring and recurrence detection of HBV-related Hepatocellular Carcinoma (HCC).

• Technological Edge: CatCHimera detects virus-host chimeric DNA (vh-DNA) as a tumor-specific biomarker. Clinical data shows it can detect recurrence an average of 158 days earlier than CT scans, with a negative predictive value (NPV) of 92%. Its limit of detection reaches tumors as small as 1.5 cm, significantly outperforming traditional AFP tests.
• Regulatory Advantages: The BDD status grants TCM Biotech priority review and intensive interaction with high-level FDA officials. It also qualifies the platform for certain US Medicare reimbursement programs, lowering barriers to entry into the world’s largest healthcare market.
• Global Strategy: HCC is the third leading cause of cancer death globally, with over a 50% recurrence rate within five years of surgery. CEO Arthur Wang noted that TCM Biotech is now actively seeking international partnerships and licensing deals to expand the platform's global influence.

Resource: 泰宗CatCHimera獲美FDA突破性醫材認定 肝癌液態活檢搶進國際