On May 26, 2025, the plasma-based version of AmoyDx® Essential NGS Panel (Reversible Terminator Sequencing Method) was approved by the National Medical Products Administration (NMPA) as the primary companion diagnostic (CDx) for RYBREVANT® (amivantamab-injection), developed by Johnson & Johnson, for the detection of EGFR exon 20 insertion mutations (EGFR exon20ins) in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). On April 8, the tissue-based version of the same panel was approved for the same indication. With this latest regulatory milestone, the AmoyDx® Essential NGS Panel becomes the first primary NGS-based CDx capable of detecting both tissue and plasma samples in China, meeting diverse clinical demands for sample flexibility, precision treatment selection, and dynamic disease monitoring.
Driving Innovation in CDx – A New Industry Benchmark
• China’s first CDx approved for both tissue and plasma samples: Bridging this regulatory gap and marking the advent of the "multi-specimen era" in NGS-based companion diagnostics.
• First CDx approval in both lung and colorectal cancers: Initially approved in 2018, pioneering cross-cancer companion diagnostics in China.
• Broadest gene coverage among approved NGS CDx products: Covers ten major driver genes - EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET - making it the NGS CDx product with the largest number of approved genes currently on the market in China.
With the high sensitivity and accuracy of the AmoyDx® Essential NGS Panel, physicians can reliably and comprehensively identify patients eligible for targeted therapies, ensuring patients benefit from truly personalized medicine.
The approval of both tissue- and plasma-based CDx under this indication also underscores the growing maturity of Chinese CDx companies in liquid biopsy development, clinical translation, and regulatory compliance.
About the AmoyDx® Essential NGS Panel
The AmoyDx® Essential NGS Panel is a high-throughput sequencing assay based on Reversible Terminator Sequencing (RTS) technology. It is designed to detect mutations in 10 key driver genes in NSCLC and colorectal cancer (CRC): EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET.
Previously, EGFR, ALK, ROS1, and KRAS were approved as CDx biomarkers in tissue samples for various targeted therapies. With this latest dual approval for RYBREVANT®, the panel further strengthens AmoyDx’s leadership position in the lung cancer CDx space and highlights its global capabilities in collaborative development and clinical innovation.
About Amoy Diagnostics Co., Ltd.
AmoyDx is a leading company in the field of precision oncology diagnostics, committed to continuous medical innovation. The company provides high-quality, regulatory-compliant companion diagnostic products and services, enabling patients to benefit from truly personalized cancer care.
AmoyDx holds several prestigious accreditations, including National Enterprise Technology Center, “Little Giant” Enterprise of Specialization and Innovation, Single Champion of Manufacturing, Postdoctoral Research Station, and Demonstration Center for Gene Testing Technologies. Its proprietary technology platforms - ADx-ARMS®, Super-ARMS®, ddCapture®, and ADx-HANDLE® - are protected by patents in China, the United States, Europe, and Japan.
The company has received the Second Prize of the National Science and Technology Progress Award and the China Patent Silver Award, with product lines covering key indications across major tumor types. Several products remain without domestic equivalents and have been approved for marketing in Japan, South Korea, and the European Union, with some included in Japanese and Korean reimbursement systems - marking milestones in the internationalization of China’s cancer diagnostics industry.
Today, AmoyDx’s products and services are used in dozens of countries and regions worldwide, benefiting hundreds of thousands of cancer patients annually. Through partnerships with leading pharmaceutical companies, AmoyDx continues to drive innovation at the source, establishing itself as a globally recognized Chinese brand in the field of companion diagnostics.
Driving Innovation in CDx – A New Industry Benchmark
• China’s first CDx approved for both tissue and plasma samples: Bridging this regulatory gap and marking the advent of the "multi-specimen era" in NGS-based companion diagnostics.
• First CDx approval in both lung and colorectal cancers: Initially approved in 2018, pioneering cross-cancer companion diagnostics in China.
• Broadest gene coverage among approved NGS CDx products: Covers ten major driver genes - EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET - making it the NGS CDx product with the largest number of approved genes currently on the market in China.
With the high sensitivity and accuracy of the AmoyDx® Essential NGS Panel, physicians can reliably and comprehensively identify patients eligible for targeted therapies, ensuring patients benefit from truly personalized medicine.
The approval of both tissue- and plasma-based CDx under this indication also underscores the growing maturity of Chinese CDx companies in liquid biopsy development, clinical translation, and regulatory compliance.
About the AmoyDx® Essential NGS Panel
The AmoyDx® Essential NGS Panel is a high-throughput sequencing assay based on Reversible Terminator Sequencing (RTS) technology. It is designed to detect mutations in 10 key driver genes in NSCLC and colorectal cancer (CRC): EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET.
Previously, EGFR, ALK, ROS1, and KRAS were approved as CDx biomarkers in tissue samples for various targeted therapies. With this latest dual approval for RYBREVANT®, the panel further strengthens AmoyDx’s leadership position in the lung cancer CDx space and highlights its global capabilities in collaborative development and clinical innovation.
About Amoy Diagnostics Co., Ltd.
AmoyDx is a leading company in the field of precision oncology diagnostics, committed to continuous medical innovation. The company provides high-quality, regulatory-compliant companion diagnostic products and services, enabling patients to benefit from truly personalized cancer care.
AmoyDx holds several prestigious accreditations, including National Enterprise Technology Center, “Little Giant” Enterprise of Specialization and Innovation, Single Champion of Manufacturing, Postdoctoral Research Station, and Demonstration Center for Gene Testing Technologies. Its proprietary technology platforms - ADx-ARMS®, Super-ARMS®, ddCapture®, and ADx-HANDLE® - are protected by patents in China, the United States, Europe, and Japan.
The company has received the Second Prize of the National Science and Technology Progress Award and the China Patent Silver Award, with product lines covering key indications across major tumor types. Several products remain without domestic equivalents and have been approved for marketing in Japan, South Korea, and the European Union, with some included in Japanese and Korean reimbursement systems - marking milestones in the internationalization of China’s cancer diagnostics industry.
Today, AmoyDx’s products and services are used in dozens of countries and regions worldwide, benefiting hundreds of thousands of cancer patients annually. Through partnerships with leading pharmaceutical companies, AmoyDx continues to drive innovation at the source, establishing itself as a globally recognized Chinese brand in the field of companion diagnostics.
AmoyDx® Essential NGS Panel Approved as Companion Diagnostic for RYBREVANT® (Amivantamab Injection) in China for EGFR Exon 20 Insertion Mutations in NSCLC
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