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."

"Amoy Diagnostics Co., Ltd...today announces that it has entered into a new collaboration agreement with AstraZeneca...Based on the agreement, the AmoyDx® Essential NGS panel, developed by AmoyDx, will be used as a companion diagnostic of ENHERTU® to identify HER2 (ERBB2) mutations in patients with non-small cell lung cancer (NSCLC)....This new agreement further expands the cooperation between the companies with projects in prostate, breast cancer and ovarian cancer ongoing."

"Chinese diagnostics firm Amoy Diagnostics said...that it has entered into a collaboration agreement with AstraZeneca to advance its AmoyDx HRD Complete Panel as a companion diagnostic for the pharma firm's PARP inhibitor Lynparza (olaparib)."

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') today 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 RET fusion-positive non-small cell lung cancer ('NSCLC'), for selpercatinib capsules 40 mg and 80 mg. The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics."

"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 Amgen’s LUMAKRAS® (sotorasib), for patients with KRAS G12C-mutated, unresectable, advanced and/or recurrent non-small-cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy."

"Several key researches supported by Amoy Diagnostics were presented at WCLC 2022...EP16.03-033...Structure-based classification of Chinese patients with non-canonical EGFR-mutant Non–Small Cell Lung Cancer..."

"Amoy Diagnostics and Roche Pharma China reached a strategic cooperation to jointly promote the development of an open, cooperative and innovative medical and health ecosystem and provide patients with more accurate digital medical solutions. This coupled with the July 29th approval of Roche’s Rozlytrek (Entrectinib, a selective tyrosine kinase inhibitor to treat patients with NTRK-fusions positive solid tumours) in China will allow both companies to work jointly to establish a precise and treatment path and maximize the benefits for NTRK-fusion positive patients."

"A study presented at the IASLC World Conference on Lung Cancer 2022 in Vienna disclosed the clinically relevant intertumoral heterogeneity of non-small cell lung cancer (NSCLC) driven by MET exon 14 skipping (METex14 skipping)...All the samples were subjected to targeted RNA sequencing using the AmoyDx® Master Panel consisting of 2660 onco-immunology genes."

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA')...announced that the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') had been approved by the Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC) for Rozlytrek®...The AmoyDx® PLC Panel has received approval for five driver genes (EGFR, ALK, ROS1, BRAF, and MET exon 14 skipping) for eleven associated targeted therapies in NSCLC."

"Alercell® announced...that it has started the distribution of AmoyDx ROS1 Gene Fusion Detection Kit. Part of the master AmoyDx distribution agreement signed last month...The AmoyDx® ROS1 Gene Fusions Detection Kit is a real-time PCR assay for qualitative detection of 14 ROS1 gene fusions in human total RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissues in NSCLC patients."

"Alercell® announced today that it has entered into a master distribution agreement with Amoy Diagnostics Co., Ltd (AmoyDx)...The master distribution agreement enables Alercell® to introduce to the United States market several innovative DNA sequencing cancer tests...The first tests to be introduced under the Agreement include: Pan Lung Cancer PCR Panel, EML4-ALK Fusion Gene Detection Kit, BRCA Pro Panel, and the Human Papillomavirus (HPV) Genotyping Detection Kit. These molecular diagnostic tests are all introduced as RUOs (Research Use Only) and are the most advanced next generation DNA sequencing tests in various fields to tackle, Lung Cancer, Breast Cancer , Ovarian Cancer and Cervical Cancer screening."

"Riken Genesis Co., Ltd...Amoy Diagnostics Co., Ltd...Precision Medicine Asia Co., Ltd...announced that in April 2022, AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel'), an in vitro diagnostic reagent for multiple antineoplastic agents, was filed in Japan as a companion diagnostic for Retevmo (selpercatinib)...The aim of this application is to obtain approval as a companion diagnostic for RET fusion-positive non-small cell lung cancer (“NSCLC”), for Retevmo capsules 40 mg and 80 mg (common name: selpercatinib) marketed by Eli Lilly Japan K.K."

"Amoy Diagnostics Co., Ltd...announces that it has entered into a Master Collaboration Agreement (Agreement) with AstraZeneca...The master collaboration agreement enables the Parties to collaborate in the development and commercialization of AmoyDx assays that may cover any type of indication or biomarker for companion diagnostic (CDx) use with AstraZeneca medicines globally....The first projects to be initiated under the Agreement include the co-development of a CDx to identify prostate cancer patients with Homologous Recombination Repair (HRR) gene mutations in China, the EU and Japan, and a CDx to identify breast cancer patients with BRCA gene mutations in the EU for Lynparza^® (olaparib) monotherapy."

"Amoy Diagnostics Co., Ltd...and HUTCHMED (China) Limited...announced the signing of a strategic cooperation agreement in the companion diagnostic field. The agreement will enable the two sides to jointly promote the development of molecular diagnostics in Osimertinib/Savolitinib Combo treatment for NSCLC in the Chinese market."

"Amoy Diagnostics Co., Ltd...announced that China’s National Medical Products Administration (NMPA) recently granted Approval to AmoyDx® PD-L1 Expression Detection Kit (IHC) for guiding the first-line treatment of Pembrolizumab in non-small cell lung cancer patients."

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') today announced that an application for partial revision of manufacturing and marketing approval for AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel'), an in vitro diagnostic reagent for multiple antineoplastic agents, was submitted in February 2022...The aim of the Application for Partial Change is to obtain approval as a companion diagnostic for ROS1 fusion genes, for the anti-tumor agent/tyrosine kinase inhibitor Rozlytrek® capsules 100 mg and 200 mg (common name: Entrectinib), marketed by Chugai Pharmaceutical Co., Ltd."

"Amoy Diagnostics Co., Ltd...and the French pharmaceutical group Pierre Fabre announced that the companies have entered into a collaboration to develop Companion Diagnostic (CDx) kits in China, supporting encorafenib and binimetinib marketing authorization applications...AmoyDx will provide Pierre Fabre with kits to detect BRAF mutation in tumor samples. These Companion Diagnostics (CDx) candidate kits are currently being validated in two clinical studies in China, to demonstrate they are correctly selecting the right patients for optimized use of treatment with encorafenib +/- binimetinib."

"Amoy Diagnostics Co., Ltd...today announced that the AmoyDx Pan Lung Cancer PCR Panel (the 'PLC Panel') has been adopted by Takeda Pharmaceutical Company Limited in Japan as one of the companion diagnostics for Brigatinib, its tyrosine kinase inhibitor for identifying ALK+ patients with non-small cell lung cancer (NSCLC)."

"Amoy Diagnostics Co., Ltd and PREMIA Holdings (HK) Limited...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."

"Amoy Diagnostics Co., Ltd....recently signed a Memorandum of Understanding (MoU) on strategic collaboration with The Janssen Pharmaceutical Companies of Johnson & Johnson...AmoyDx will further empower patients to use management of the whole course of disease and, while improving the accessibility of concomitant diagnosis and accelerating patient reimbursement, it will further optimize the diagnosis of Janssen’s key target therapeutic areas including lung cancer and urothelial cancer."