On April 8, 2025, the AmoyDx® Essential NGS Panel was approved as the companion diagnostic for RYBREVANT®, supporting clinical treatment decisions through reliable detection of EGFR exon 20 insertion mutations.
Prior to this, on February 8, 2025, Johnson & Johnson’s RYBREVANT® was granted NMPA approval in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring confirmed EGFR exon 20 insertion mutations.
The sequential approvals of RYBREVANT® and its original companion diagnostic represent a strong and successful collaboration between a global pharmaceutical innovator and a leading Chinese precision diagnostics company. This milestone further accelerates the integration of EGFR exon 20 insertion-targeted therapies into routine clinical practices in China and strengthens the path toward precision oncology.
The AmoyDx® Essential NGS Panel is designed for the qualitative detection of key oncogenic driver mutations in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). It covers ten clinically relevant genes: EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET. Among these, EGFR, ALK, ROS1, and KRAS have already been approved as companion diagnostic markers for multiple targeted therapies. With this latest approval, the kit now includes multiple EGFR biomarkers under companion diagnostic labeling, further advancing comprehensive tumor molecular profiling and individualized treatment strategies.
About AmoyDx
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.
Prior to this, on February 8, 2025, Johnson & Johnson’s RYBREVANT® was granted NMPA approval in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring confirmed EGFR exon 20 insertion mutations.
The sequential approvals of RYBREVANT® and its original companion diagnostic represent a strong and successful collaboration between a global pharmaceutical innovator and a leading Chinese precision diagnostics company. This milestone further accelerates the integration of EGFR exon 20 insertion-targeted therapies into routine clinical practices in China and strengthens the path toward precision oncology.
The AmoyDx® Essential NGS Panel is designed for the qualitative detection of key oncogenic driver mutations in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). It covers ten clinically relevant genes: EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET. Among these, EGFR, ALK, ROS1, and KRAS have already been approved as companion diagnostic markers for multiple targeted therapies. With this latest approval, the kit now includes multiple EGFR biomarkers under companion diagnostic labeling, further advancing comprehensive tumor molecular profiling and individualized treatment strategies.
About AmoyDx
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® Pan Lung Cancer PCR Panel submission for regulatory approval in Japan for the additional indication of Amivantamab plus Lazertinib combination therapy
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