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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,…
