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AmoyDx, HaiHe aim for CDx
October 2020
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XIAMEN, China—Amoy Diagnostics Co. Ltd. (AmoyDx) and HaiHe Pharmaceutical have inked an agreement for the development of a companion diagnostic test to support HaiHe's novel MET inhibitor glumetinib. Per the agreement, AmoyDx will develop and register the AmoyDx Pan Lung Cancer PCR Panel (9-in-1 Plus) in Japan in order to get PMDA approval for an intended use as a c-MET exon14 skipping companion diagnostic for glumetinib in non-small cell lung cancer.
 
“We announce with great excitement this co-development collaboration for the Japan market,” stated Dr. Li-Mou Zheng, founder and CEO of AmoyDx. “AmoyDx has a strong pipeline of diagnostic products for precision medicines, as well as successful CDx development experience in Japan. Exploiting our test to help guide treatment decisions will address a high unmet medical need from patients. AmoyDx is a trusted partner with the expertise in R&D, regulatory affairs and commercialization for co-development of companion diagnostic.”

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