By Fineline Cube 
Amoy Diagnostics Co., Ltd. (“AmoyDx”) have secured approval from the China National Medical Products Administration (NMPA) for the AmoyDx Pan Lung Cancer PCR (PLC) Panel. This milestone reflects the successful completion of a pivotal, concurrent clinical study that paired the diagnostic reagent with KRAS G12C inhibitor garsorasib, brought to market by Chia Tai Tianqing Pharmaceutical Group (CTTQ).
A Precision Tool for Non‑Small Cell Lung Cancer
The PLC Panel—leveraging state‑of‑the‑art PCR technology—simultaneously detects activating mutations across 11 key driver genes (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, NTRK3). This breadth of coverage not only streamlines genetic profiling but also pinpoints patients whose tumors harbor the clinically actionable KRAS G12C alteration.
First‑In‑China KRAS G12C Companion Diagnostic
China’s first KRAS G12C companion diagnostic product offers a new precision‑diagnosis and treatment paradigm for non‑small cell lung cancer (NSCLC) patients. Coupled with garsorasib—CTTQ’s licensed KRAS G12C inhibitor (approved November 8, 2024)—the PLC Panel supports a matched‑therapy approach that is rapidly adopted across China, Japan, and Europe.
Market Impact and Strategic Positioning
AmoyDx’s PLC Panel has already achieved marketing approval in Japan and Europe, reinforcing its cross‑regional credibility. Riken Genesis’ collaboration with AmoyDx expands its diagnostic footprint while positioning both firms favorably for potential co‑development and distribution deals in emerging precision‑medicine markets.-Fineline Info & Tech