COMPANY:

Amoy Diagnostics

"Amoy Diagnostics...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."

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd...and Precision Medicine Asia Co., Ltd...announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel...as a companion diagnostic (CDx) for AUGTYRO® (repotrectinib) for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with ROS1 fusion gene."

"Amoy Diagnostics Co., Ltd...recently announced that the China National Medical Products Administration (NMPA) has approved its AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') for use in identifying EGFR, ALK, ROS1, and METex14 skipping mutations in non-small cell lung cancer (NSCLC) patients."

"Amoy Diagnostics Co., Ltd...announces that its AmoyDx® FGFR2 Break-apart FISH Probe Kit has been approved as a companion diagnostic (CDx) for Eisai’s innovative targeted therapy, Tasurgratinib in Japan. This approval marks a significant milestone in precision oncology, enhancing the treatment options for biliary tract cancer patients with FGFR2 gene fusions."

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd...and Precision Medicine Asia Co., Ltd...announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') as a companion diagnostic for Haiyitan® (gumarontinib), a product of Haihe Biopharma K.K. Haiyitan® in 50 mg tablet form, was approved by MHLW in June 2024 for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations."

"AmoyDx...and Servier...announced...they have entered into a strategic partnership to develop a companion diagnostic test (CDx) in China that detects Isocitrate Dehydrogenase (IDH) 1&2 gene mutations. This test will be developed for vorasidenib, Servier’s investigational dual inhibitor of mutant IDH1 and mutant IDH2 enzymes, for Chinese patients with diffuse IDH-mutant glioma (LGG)."

"Amoy Diagnostics Co., Ltd...announced a collaboration with Boehringer Ingelheim for the development of a Companion Diagnostic (CDx) kit to identify those non-small cell lung cancer (NSCLC) patients who are most likely to benefit from targeted therapy."

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') as a companion diagnostic for TABRECTATM (capmatinib), a product of Novartis AG, Basel, Switzerland which was approved by the Japanese MHLW in June 2020."

"Recently, the 'Chinese Expert Consensus on Clinical Testing standards of PD-L1 Expression Clinical Detection in Non-Small Cell Lung Cancer (2023 Edition)' was officially released in the Chinese Journal of Pathology. It aims to provide better guidance for the standardized use of PD-L1 detection in the clinical diagnosis and treatment process of non-small cell lung cancer (NSCLC). In this updated consensus, the AmoyDx®PD-L1 (E1L3N) assay (NMPA approval number 20223400313) was prioritized as companion diagnostics for Pembrolizumab."

"Cell Signaling Technology...and Amoy Diagnostics Co., Ltd. (AmoyDx)...announced...the expansion of their ongoing partnership for companion diagnostic (CDx) development in China. As the use of precision oncology therapeutics continues to advance in China, the partnership will provide AmoyDx with access to additional, highly validated CST® antibodies against critical CDx targets that will support the development of diagnostic assays used to identify patients for targeted therapeutics."

"AmoyDx announced multiple collaborations with AstraZeneca and Pfizer during the 2023 China International Import Expo (CIIE), held on November 5-10 in Shanghai China. These partnerships aim to jointly promote the development of precision diagnostics and treatment, ultimately benefiting cancer patients."

"National Medical Products Administration (NMPA) granted approval to AmoyDx® Microsatellite Instability (MSI) Detection Kit, making it the first-of-its-kind pan-cancer immunotherapy companion diagnostic kit for market in China."