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TEST:
AmoyDx® HER2 Mutation Detection Kit

Type:
Laboratory Developed Test
Related tests:
Evidence

News

over1year
Performance of AmoyDx HER2 mutation detection kit and AmoyDx Pan Lung Cancer PCR Panel for detection of com-mon HER2 and/or EGFR mutations (ECP 2022)
In March 2019, AstraZeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (T-DXd; DS-8201)... Detection of rare mutations require sensitive and specific diagnostic assays. AmoyDx HER2 Mutation Detection Kit demonstrated robust performance in detecting representa-tive HER2 indel and single nucleotide variant mutations at low frequencies. The AmoyDx Pan Lung Cancer PCR assay showed similarly robust and sensitive detection of the common HER2 A775_G776insYVMA indel in addition to detecting clinically relevant EGFR mutations.
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KIT (KIT proto-oncogene, receptor tyrosine kinase)
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion • HER-2 V777L • HER-2 exon 20 YVMA insertion • HER-2 A775
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AmoyDx® Pan Lung Cancer PCR Panel • AmoyDx® HER2 Mutation Detection Kit
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Enhertu (fam-trastuzumab deruxtecan-nxki)