Xiamen China, September 30th, 2024 – Amoy Diagnostics (“AmoyDx”) today announced that the AmoyDx® HRD Complete Panel has been accepted into the Special Review Procedure for Innovative Medical Devices by the China National Medical Products Administration (NMPA). This significant milestone positions the panel as the first domestically developed kit for homologous recombination deficiency (HRD) detection to enter this expedited regulatory pathway. It also marks AmoyDx’s third product to receive the “Innovative Medical Device” designation, reaffirming our ongoing commitment to delivering cutting-edge solutions in precision oncology.
HRD is increasingly recognized as a critical biomarker for guiding PARP inhibitor (PARPi) therapies, particularly for patients with ovarian and other solid tumors. Global clinical guidelines have acknowledged the importance of accurately detecting HRD status in optimizing treatment outcomes. With the ability to identify HRD-positive patients, the performance of AmoyDx® HRD Complete Panel has been rigorously evaluated by pharmaceutical leaders, oncologists and pathology experts.
The panel is designed to detect key HRR gene alterations (including BRCA1/2) and to assess HRD status using AmoyDx proprietary ADx-GSS® Algorithm - which has passed non-infringement assessments by multinational pharmaceutical companies, breaking the monopoly of foreign companies. Paired with the AmoyDx HANDLE® technology, the panel streamlines the workflow, makes NGS as easy as PCR and shortens the turnaround time from sample to report within 3 days, addressing clinical needs and facilitating in-hospital testing. Its acceptance into the NMPA’s Special Review Procedure is a testament to the panel’s innovative design, robust clinical validation, and its potential to address an urgent medical need in China.
AmoyDx has been at the forefront of developing reliable diagnostic tools that guide PARPi therapies. From the pioneering AmoyDx® BRCA Pro Panel to the newly recognized HRD Complete Panel, the company offers a comprehensive portfolio addressing the precision diagnostics needs for a variety of cancers, including breast, ovarian, prostate, and pancreatic cancers.
The NMPA's Special Review Procedure for Innovative Medical Devices is a fast-track regulatory process intended to expedite the approval of breakthrough medical technologies that demonstrate significant clinical value and address unmet medical needs. AmoyDx’s achievement in entering this pathway highlights its leadership in the field of molecular diagnostics and its commitment to advancing cancer care in China and beyond.
About Amoy Diagnostic
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
Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
HRD is increasingly recognized as a critical biomarker for guiding PARP inhibitor (PARPi) therapies, particularly for patients with ovarian and other solid tumors. Global clinical guidelines have acknowledged the importance of accurately detecting HRD status in optimizing treatment outcomes. With the ability to identify HRD-positive patients, the performance of AmoyDx® HRD Complete Panel has been rigorously evaluated by pharmaceutical leaders, oncologists and pathology experts.
The panel is designed to detect key HRR gene alterations (including BRCA1/2) and to assess HRD status using AmoyDx proprietary ADx-GSS® Algorithm - which has passed non-infringement assessments by multinational pharmaceutical companies, breaking the monopoly of foreign companies. Paired with the AmoyDx HANDLE® technology, the panel streamlines the workflow, makes NGS as easy as PCR and shortens the turnaround time from sample to report within 3 days, addressing clinical needs and facilitating in-hospital testing. Its acceptance into the NMPA’s Special Review Procedure is a testament to the panel’s innovative design, robust clinical validation, and its potential to address an urgent medical need in China.
AmoyDx has been at the forefront of developing reliable diagnostic tools that guide PARPi therapies. From the pioneering AmoyDx® BRCA Pro Panel to the newly recognized HRD Complete Panel, the company offers a comprehensive portfolio addressing the precision diagnostics needs for a variety of cancers, including breast, ovarian, prostate, and pancreatic cancers.
The NMPA's Special Review Procedure for Innovative Medical Devices is a fast-track regulatory process intended to expedite the approval of breakthrough medical technologies that demonstrate significant clinical value and address unmet medical needs. AmoyDx’s achievement in entering this pathway highlights its leadership in the field of molecular diagnostics and its commitment to advancing cancer care in China and beyond.
About Amoy Diagnostic
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
Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
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