Xiamen and Hong Kong, January 14, 2022 -- Amoy Diagnostics Co., Ltd., (“AmoyDx”) and PREMIA Holdings (HK) Limited (“PREMIA”) today announced the commercial launch of the AmoyDx® Pan Lung Cancer PCR Panel (the “PLC Panel”) in Japan as a reimbursed companion diagnostic for multiple anti-cancer agents. AmoyDx is the inventor and manufacturer and PREMIA the developer of the PLC Panel in Japan.
“We are extremely pleased to announce this significant milestone. This is the first time in Japan that a multiplex companion diagnostic, using real-time PCR, has been approved and covered by insurance. We are also aggressively pursuing marketing applications worldwide, including Asia, the EU, Latin America and the United States,” said both Li-Mou Zheng, Ph.D., Founder and Chief Executive Officer of AmoyDx and Wenn Sun, Ph.D., Founder and President of PREMIA.
About the PLC Panel: The PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes). In Japan, the PLC Panel has received approval for five driver genes (EGFR, ALK, ROS1, BRAF, and MET exon 14 skipping) for ten associated targeted therapies in Non-Small Cell Lung Cancer (NSCLC). Due to its high sensitivity, short turnaround time (TAT) and ease of use, the PLC Panel is expected to contribute to the planning of early treatment strategies and the expansion of treatment opportunities for NSCLC patients.
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685): Amoy Diagnostics Co., Ltd. is a pioneer and global leading company in the field of molecular diagnostics for precision oncology, focusing on companion diagnostics product development and commercialization. AmoyDx has a portfolio with more than twenty products approved by China’s NMPA, the EU regulatory authorities, Japan’s MHLW, South Korea’s MFDS, etc. Patients in more than 60 countries are benefiting from AmoyDx products. With multiple technological platforms and full capability for companion diagnostics product development and commercialization, AmoyDx has become an important diagnostics partner for many pharmaceutical companies around the globe. For more information, please visit www.amoydiagnostics.com.
About PREMIA: PREMIA offers an integrated platform for the development of innovative oncology therapies and diagnostics in Asia, the fastest growing market for the pharmaceutical industry. PREMIA through its affiliate, Precision Medicine Asia, manages Japan’s nationwide clinical-genomic lung cancer registry, the only such database in Asia. The registry currently includes more than 13,000 patients and allows an efficient patient identification process for clinical trial enrollment through participation by more than 200 hospitals in Japan and Taiwan, with the expected addition of hospitals in Southeast Asia during 2022. For more information, please visit www.premia-inc.com
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