Xiamen, China, September 21, 2026 – TÜV SÜD formally presented Amoy Diagnostics Co., Ltd. (AmoyDx; SZSE: 300685) with China’s first Class C companion diagnostic certificate under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR). The certificate marks another important milestone for Amoy Diagnostics in companion diagnostic development and global regulatory registration, further demonstrating the company’s capabilities in these areas. Ms. Chen Zhaohui, President of TÜV SÜD Greater China, and Dr. Luo Jiemin, General Manager of Amoy Diagnostics, attended the certificate presentation ceremony.
The certified product is an HRD assay independently developed by Amoy Diagnostics. It has obtained EU IVDR certification for use as a companion diagnostic to aid in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a novel hormonal agent and who may be eligible for treatment with olaparib monotherapy.
During the certificate presentation event, senior executives from TÜV SÜD and Amoy Diagnostics held in-depth discussions on companion diagnostic regulatory developments, oncology precision medicine, and future cooperation opportunities. The TÜV SÜD delegation also visited the AmoyDx showroom to learn more about the company’s molecular diagnostics technologies, R&D capabilities, and international precision oncology footprint.
The certificate presentation reflects Amoy Diagnostics’ continued progress in EU IVDR companion diagnostics and marks a new stage in cooperation between the two parties in oncology companion diagnostics. Both parties will continue to deepen cooperation and further strengthen their global regulatory and compliance efforts in precision oncology.
About TÜV SÜD
Founded in 1866, TÜV SÜD has grown into a globally recognized provider of testing, inspection, and certification services, with operations across major markets worldwide. In the healthcare and medical device sector, TÜV SÜD has extensive expertise in regulatory assessment, testing, and certification for medical devices and in vitro diagnostics (IVDs).
TÜV SÜD is one of the world’s leading EU Notified Bodies for medical devices and is designated as a full-scope Notified Body under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). Through its global network of technical and regulatory experts, TÜV SÜD supports medical device and IVD manufacturers in meeting stringent regulatory requirements and achieving global market access.
About Amoy Diagnostics
Amoy Diagnostics Co., Ltd. (AmoyDx) is a leading molecular diagnostics company focused on precision oncology. Through continuous innovation, AmoyDx develops high-quality companion diagnostic products and services to support personalized cancer treatment worldwide.
With proprietary technologies including ADx-ARMS®, Super-ARMS®, ddCapture®, and ADx-HANDLE®, AmoyDx offers comprehensive solutions covering major cancer types and multiple testing platforms. Its products have received regulatory approvals in key international markets, including the European Union, Japan, and South Korea, with selected products included in local reimbursement systems.
AmoyDx also works closely with leading global pharmaceutical companies on companion diagnostic development. Today, AmoyDx products and services are used across dozens of countries and regions, benefiting millions of cancer patients worldwide.
For more information, please visit: www.amoydiagnostics.com
The certified product is an HRD assay independently developed by Amoy Diagnostics. It has obtained EU IVDR certification for use as a companion diagnostic to aid in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a novel hormonal agent and who may be eligible for treatment with olaparib monotherapy.
During the certificate presentation event, senior executives from TÜV SÜD and Amoy Diagnostics held in-depth discussions on companion diagnostic regulatory developments, oncology precision medicine, and future cooperation opportunities. The TÜV SÜD delegation also visited the AmoyDx showroom to learn more about the company’s molecular diagnostics technologies, R&D capabilities, and international precision oncology footprint.
The certificate presentation reflects Amoy Diagnostics’ continued progress in EU IVDR companion diagnostics and marks a new stage in cooperation between the two parties in oncology companion diagnostics. Both parties will continue to deepen cooperation and further strengthen their global regulatory and compliance efforts in precision oncology.
About TÜV SÜD
Founded in 1866, TÜV SÜD has grown into a globally recognized provider of testing, inspection, and certification services, with operations across major markets worldwide. In the healthcare and medical device sector, TÜV SÜD has extensive expertise in regulatory assessment, testing, and certification for medical devices and in vitro diagnostics (IVDs).
TÜV SÜD is one of the world’s leading EU Notified Bodies for medical devices and is designated as a full-scope Notified Body under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). Through its global network of technical and regulatory experts, TÜV SÜD supports medical device and IVD manufacturers in meeting stringent regulatory requirements and achieving global market access.
About Amoy Diagnostics
Amoy Diagnostics Co., Ltd. (AmoyDx) is a leading molecular diagnostics company focused on precision oncology. Through continuous innovation, AmoyDx develops high-quality companion diagnostic products and services to support personalized cancer treatment worldwide.
With proprietary technologies including ADx-ARMS®, Super-ARMS®, ddCapture®, and ADx-HANDLE®, AmoyDx offers comprehensive solutions covering major cancer types and multiple testing platforms. Its products have received regulatory approvals in key international markets, including the European Union, Japan, and South Korea, with selected products included in local reimbursement systems.
AmoyDx also works closely with leading global pharmaceutical companies on companion diagnostic development. Today, AmoyDx products and services are used across dozens of countries and regions, benefiting millions of cancer patients worldwide.
For more information, please visit: www.amoydiagnostics.com
AmoyDx® HRD Complete Panel Receives EU IVDR Certification as Companion Diagnostic for Identification of Patients with Metastatic Castration-Resistant Prostate Cancer
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