Xiamen, China – February 20, 2025 – Amoy Diagnostics Co., Ltd. (AmoyDx), a leading innovator in molecular diagnostics, announced today that its AmoyDx® PD-L1 (E1L3N) assay has obtained approval from China’s National Medical Products Administration (NMPA) as a companion diagnostic (CDx) for detecting PD-L1 expression in FFPE tissue sections of gastric adenocarcinoma / gastroesophageal adenocarcinoma (GA/GEA), aiding in the identification of patients eligible for treatment with sugemalimab in combination with chemotherapy.
This milestone follows its previous NMPA approval as a CDx for the first-line treatment of pembrolizumab (anti-PD-1) in non-small cell lung cancer (NSCLC), making it China’s first and only domestically developed PD-L1 CDx with dual-cancer indications—a major step forward in advancing personalized cancer treatment.
Key Highlights:
✅ Expanded Indication: Now approved for detecting PD-L1 expression in FFPE GA/GEA tissue samples, supporting sugemalimab in combination with chemotherapy treatment decisions in China.
✅ Exclusive Status: The only NMPA-approved PD-L1 CDx for GA/GEA testing in China.
✅ Dual Indications: The first domestically developed PD-L1 CDx for both NSCLC and GA/GEA in China.
✅ Expert Recognition: Recommended as a preferred PD-L1 assay in the Chinese Expert Consensus on NSCLC PD-L1 Testing, highlighting its clinical reliability and technical performance.
✅ Future Pipeline: Additional multi-cancer CDx registrations are underway to further expand precision medicine applications.
Gastric cancer remains a major global health challenge, with China accounting for nearly 40% of all cases worldwide. GA/GEA, in particular, presents significant treatment hurdles, and the approval of sugemalimab + chemotherapy alongside the AmoyDx PD-L1 CDx provides new hope for patients by enabling more precise and effective immunotherapy selection.
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 or follow us at LinkedIn, and X.
For media inquiries, please contact:
Robson Ee
Senior Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
This milestone follows its previous NMPA approval as a CDx for the first-line treatment of pembrolizumab (anti-PD-1) in non-small cell lung cancer (NSCLC), making it China’s first and only domestically developed PD-L1 CDx with dual-cancer indications—a major step forward in advancing personalized cancer treatment.
Key Highlights:
✅ Expanded Indication: Now approved for detecting PD-L1 expression in FFPE GA/GEA tissue samples, supporting sugemalimab in combination with chemotherapy treatment decisions in China.
✅ Exclusive Status: The only NMPA-approved PD-L1 CDx for GA/GEA testing in China.
✅ Dual Indications: The first domestically developed PD-L1 CDx for both NSCLC and GA/GEA in China.
✅ Expert Recognition: Recommended as a preferred PD-L1 assay in the Chinese Expert Consensus on NSCLC PD-L1 Testing, highlighting its clinical reliability and technical performance.
✅ Future Pipeline: Additional multi-cancer CDx registrations are underway to further expand precision medicine applications.
Gastric cancer remains a major global health challenge, with China accounting for nearly 40% of all cases worldwide. GA/GEA, in particular, presents significant treatment hurdles, and the approval of sugemalimab + chemotherapy alongside the AmoyDx PD-L1 CDx provides new hope for patients by enabling more precise and effective immunotherapy selection.
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 or follow us at LinkedIn, and X.
For media inquiries, please contact:
Robson Ee
Senior Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
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