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Amoy Diagnostics’ AiHuiJie Lung Cancer Companion Diagnostic Receives NMPA Approval
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AiHuiJie, a companion diagnostic (CDx) reagent designed for lung cancer. This PCR-based product is capable of detecting 11 key driver…
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Amoy Diagnostics’ APACE Receives Japanese Approval as Companion Diagnostic for MET-Inhibiting Therapies
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a Chinese diagnostics company, has announced that it has received two new indication approvals in Japan for its APACE (also known as PCR-11 gene product), a multi-target rapid screening product designed for lung cancer detection. The product is now approved as a companion…
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Amoy Diagnostics Partners with Servier to Develop Companion Diagnostic Reagent for IDH Mutations in China
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has entered into a partnership with French pharmaceutical company Servier to co-develop a companion diagnostic (CDx) reagent in China. This reagent is designed for detecting mutations in the isocitrate dehydrogenase (IDH) 1 and 2 genes. The product will complement Servier’s vorasidenib, which…
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Amoy Diagnostics Teams Up with Boehringer Ingelheim for CDx Developmen
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in China’s tumor precision medicine space, has entered into a strategic collaboration with Germany’s Boehringer Ingelheim to advance the development of companion diagnostics (CDx). The partnership is aimed at identifying non-small cell lung cancer (NSCLC) patients who are most likely…
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Amoy Diagnostics Receives NMPA Approval for MSI Detection Kit as Companion Diagnostic for Immunotherapy
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis,…
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Amoy Diagnostics and AstraZeneca Expand Collaboration on Companion Diagnostic Development
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has announced a new cooperation agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN), focusing on the development of a companion diagnostic (CDx). This collaboration builds upon a global strategic master collaboration agreement that was first signed at the end of 2021.…
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Amoy Diagnostics and AstraZeneca Expand Partnership for Companion Diagnostic Development
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has announced an additional cooperation agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN), focusing on the development of a companion diagnostic (CDx). This collaboration builds upon a global strategic master collaboration agreement that was first signed at the end of 2021.…
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Eli Lilly Partners with AmoyDx and Burning Rock for Retevmo Companion Diagnostics
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The 5th China International Import Expo (CIIE) saw US-based Eli Lilly (NYSE: LLY) announce a partnership with China-based Amoy Diagnostics Co., Ltd (AmoyDx) and Burning Rock Biotech Ltd (NASDAQ: BNR). The collaboration aims to enhance the development of companion diagnostics (CDx) for Retevmo (selpercatinib), the world’s first highly-selective RET kinase…
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BeiGene Partners with Amoy Diagnostics for Companion Diagnostics Development
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has entered into a partnership with compatriot firm Amoy Diagnostics Co., Ltd (AmoyDx). The collaboration allows AmoyDx’s HER2 gene IHC (immunohistochemistry) and FISH (fluorescence in situ hybridization) detection kits to support BeiGene’s filings for its drugs as companion diagnostics (CDx).…
