XIAMEN, March 30, 2026 -- AmoyDx Diagnostics Co., Ltd. (AmoyDx), a leading oncology companion diagnostics company, and HUTCHMED, a leading biopharmaceutical company based in China, today jointly announced that the Human c-Met Gene Amplification Detection Kit (Fluorescence In Situ Hybridization, FISH) has been granted approval by the National Medical Products Administration (NMPA) of China as a companion diagnostic for savolitinib. The approved product is the world's first FISH-based companion diagnostic assay authorized for the detection of MET gene amplification. Its approval represents a significant milestone advancing the precision diagnosis and treatment of non-small cell lung cancer (NSCLC) with MET amplification.
MET gene amplification is recognized as one of the key mechanisms of acquired resistance in patients with EGFR-mutant NSCLC following treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). Notably, the development and regulatory filing of this companion diagnostic were conducted in parallel with savolitinib's pivotal clinical trial, the SACHI study, providing physicians with a highly reliable testing tool for the precise identification of MET-amplified patients.
The approval of this companion diagnostic assay will enable more accurate identification of patients who may benefit from targeted combination therapies, thereby supporting more precise and effective clinical decision-making.
“We are delighted that AmoyDx c-Met Gene Amplification Detection Kit has been approved as a companion diagnostic for savolitinib. AmoyDx worked closely with HUTCHMED to enable the co-development of FISH CDx assay. This collaboration underscores our commitment to breaking barriers to precision medicine and enhancing cancer care. We believe that this approval will significantly impact the treatment landscape for lung cancer patients with MET gene Amplification in China.” said Dr. Li-Mou Zheng, Founder and Chairman of AmoyDx.
“We are pleased to collaborate with AmoyDx in advancing the integration of precision diagnostics and treatment, empowering innovative drug development, and ultimately benefiting more cancer patients. The approval of this MET FISH companion diagnostic provides a precise and efficient testing solution for patients with MET amplification in China, significantly improving the accurate identification of those patients who may benefit from treatment.” said Mr. Johnathan. Lee, Executive Vice President, Chief Medical Officer of HUTCHMED.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch‑med.com.
About Amoy Diagnostics Co., Ltd.
Amoy Diagnostics Co., Ltd. (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 https://www.amoydiagnostics.com/ or follow us at LinkedIn.
MET gene amplification is recognized as one of the key mechanisms of acquired resistance in patients with EGFR-mutant NSCLC following treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). Notably, the development and regulatory filing of this companion diagnostic were conducted in parallel with savolitinib's pivotal clinical trial, the SACHI study, providing physicians with a highly reliable testing tool for the precise identification of MET-amplified patients.
The approval of this companion diagnostic assay will enable more accurate identification of patients who may benefit from targeted combination therapies, thereby supporting more precise and effective clinical decision-making.
“We are delighted that AmoyDx c-Met Gene Amplification Detection Kit has been approved as a companion diagnostic for savolitinib. AmoyDx worked closely with HUTCHMED to enable the co-development of FISH CDx assay. This collaboration underscores our commitment to breaking barriers to precision medicine and enhancing cancer care. We believe that this approval will significantly impact the treatment landscape for lung cancer patients with MET gene Amplification in China.” said Dr. Li-Mou Zheng, Founder and Chairman of AmoyDx.
“We are pleased to collaborate with AmoyDx in advancing the integration of precision diagnostics and treatment, empowering innovative drug development, and ultimately benefiting more cancer patients. The approval of this MET FISH companion diagnostic provides a precise and efficient testing solution for patients with MET amplification in China, significantly improving the accurate identification of those patients who may benefit from treatment.” said Mr. Johnathan. Lee, Executive Vice President, Chief Medical Officer of HUTCHMED.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch‑med.com.
About Amoy Diagnostics Co., Ltd.
Amoy Diagnostics Co., Ltd. (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 https://www.amoydiagnostics.com/ or follow us at LinkedIn.
AmoyDx® PIK3CA Mutation Detection Kit Approved as a Companion Diagnostic for Risovalisib in Japan
Next
Subscribe
to our
newsletter