Xiamen, China — December 29, 2025 — Amoy Diagnostics Co., Ltd. (“AmoyDx”) announced that its “BRCA1/BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing)” has been approved by the National Medical Products Administration (NMPA) as a companion diagnostic (CDx) for AKEEGA® (niraparib tosylate and abiraterone acetate tablets). The kit can reliably detect single-nucleotide variants (SNVs), insertion/deletion mutations (InDels), and homozygous deletions (HD) in the BRCA1/2 genes from prostate cancer patients, providing critical support for clinical treatment decisions.
Previously, in October 2024, Johnson & Johnson announced that AKEEGA® was approved by the NMPA for use in combination with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are positive for germline and/or somatic BRCA gene alterations.
The approvals of AKEEGA® and its primary CDx kit demonstrated the successful collaboration between a global pharmaceutical innovator and a leading domestic precision diagnostic enterprise in China. This milestone established a complete “diagnosis–treatment integration” solution based on BRCA1/2 biomarkers in the field of prostate cancer in China. Following the drug's approval, the approval of this CDx provides this patient population with a clear pathway from precise testing to matched therapy, which will help advance the standardization of their clinical pathways in China.
The newly approved kit is intended for the qualitative detection of BRCA1/2 gene mutations in FFPE tissue samples from prostate cancer patients. As the first NMPA-approved CDx kit for prostate cancer in China, it serves not only as the "precision key" for guiding patient selection for therapy of AKEEGA®, but will also promote the clinical adoption of molecular biomarker testing in prostate cancer, facilitating broader implementation of personalized treatment strategies.
About Amoy Diagnostics Co., Ltd.
AmoyDx is a leading company in the field of precision oncology diagnostics, committed to continuous medical innovation. The company delivers high-quality, regulatory-compliant companion diagnostic products and services, enabling patients to access 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 millions 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.
Previously, in October 2024, Johnson & Johnson announced that AKEEGA® was approved by the NMPA for use in combination with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are positive for germline and/or somatic BRCA gene alterations.
The approvals of AKEEGA® and its primary CDx kit demonstrated the successful collaboration between a global pharmaceutical innovator and a leading domestic precision diagnostic enterprise in China. This milestone established a complete “diagnosis–treatment integration” solution based on BRCA1/2 biomarkers in the field of prostate cancer in China. Following the drug's approval, the approval of this CDx provides this patient population with a clear pathway from precise testing to matched therapy, which will help advance the standardization of their clinical pathways in China.
The newly approved kit is intended for the qualitative detection of BRCA1/2 gene mutations in FFPE tissue samples from prostate cancer patients. As the first NMPA-approved CDx kit for prostate cancer in China, it serves not only as the "precision key" for guiding patient selection for therapy of AKEEGA®, but will also promote the clinical adoption of molecular biomarker testing in prostate cancer, facilitating broader implementation of personalized treatment strategies.
About Amoy Diagnostics Co., Ltd.
AmoyDx is a leading company in the field of precision oncology diagnostics, committed to continuous medical innovation. The company delivers high-quality, regulatory-compliant companion diagnostic products and services, enabling patients to access 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 millions 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 Approved as a Companion Diagnostics for Tabrecta® (Capmatinib) in China
Next
Subscribe
to our
newsletter