Xiamen China, September 6, 2024 – Amoy Diagnostics Co., Ltd., (“AmoyDx”) recently announced that the China National Medical Products Administration (NMPA) has approved its AmoyDx® Pan Lung Cancer PCR Panel (the “AmoyDx PLC Panel”) for use in identifying EGFR, ALK, ROS1, and METex14 skipping mutations in non-small cell lung cancer (NSCLC) patients.
On September 13, the AmoyDx companion diagnostic assay targeting METex14 skipping mutation, developed based on AmoyDx PLC Panel, secured approval from NMPA as a companion diagnostic for Haiyitan® (gumarontinib) to identify locally advanced or metastatic NSCLC patients with METex14 skipping mutation.
With the approvals, the AmoyDx PLC panel now can be used as companion diagnostic for the following therapies in China:
Lung cancer remains the most prevalent and deadliest cancer in China with an estimated 4.8 million new cases and 2.5 million new deaths occurred in 2022*. The NMPA approval of the AmoyDx PLC Panel provides a critical tool to combat this significant health burden by enabling accurate detection of key genetic mutations, facilitating personalized treatment plans, and improving patient survival rates across China.
*Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, Volume 4, Issue 1, 2024
About Amoy Diagnostics
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, LinkedIn, and X.
For media inquiries, please contact:
Robson Ee
Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
On September 13, the AmoyDx companion diagnostic assay targeting METex14 skipping mutation, developed based on AmoyDx PLC Panel, secured approval from NMPA as a companion diagnostic for Haiyitan® (gumarontinib) to identify locally advanced or metastatic NSCLC patients with METex14 skipping mutation.
With the approvals, the AmoyDx PLC panel now can be used as companion diagnostic for the following therapies in China:
| Mutations / Fusions | Targeted Therapies |
| EGFR exon 19, L858R | Erlotinib, Osimertinib |
| EGFR T790M | Osimertinib |
| ALK | Crizotinib |
| ROS1 | Crizotinib |
| METex14 skipping | Gumarontinib, Tepotinib |
Lung cancer remains the most prevalent and deadliest cancer in China with an estimated 4.8 million new cases and 2.5 million new deaths occurred in 2022*. The NMPA approval of the AmoyDx PLC Panel provides a critical tool to combat this significant health burden by enabling accurate detection of key genetic mutations, facilitating personalized treatment plans, and improving patient survival rates across China.
*Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, Volume 4, Issue 1, 2024
About Amoy Diagnostics
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, LinkedIn, and X.
For media inquiries, please contact:
Robson Ee
Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
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