Analytical and Clinical Validation of the Oncomine Dx Target Test to Assess HER2 Mutation Status in Tumor Tissue Samples From Patients With Non-Small Cell Lung Cancer Treated With Trastuzumab Deruxtecan in the DESTINY-Lung01 and DESTINY-Lung02 Studies.

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Title: Analytical and Clinical Validation of the Oncomine Dx Target Test to Assess HER2 Mutation Status in Tumor Tissue Samples From Patients With Non-Small Cell Lung Cancer Treated With Trastuzumab Deruxtecan in the DESTINY-Lung01 and DESTINY-Lung02 Studies.
Authors: Qi Z; From Global Companion Diagnostics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Qi, Feng, Khambata-Ford)., Ha T; Research & Development, Thermo Fisher Scientific, Carlsbad, California (Ha, Velasco Roth)., Feng W; From Global Companion Diagnostics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Qi, Feng, Khambata-Ford)., Karnoub M; Biostatistics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Karnoub)., Pereira K; Global Oncology R&D, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Pereira)., Shiga R; Global Oncology R&D, Daiichi Sankyo, Co, Ltd, Shinagawa, Japan (Shiga)., Smit EF; the Faculty of Medicine Division 2 Pulmonary Diseases, Leiden University Medical Center, Leiden, The Netherlands (Smit)., Goto Y; the Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan (Y Goto, K Goto)., De Langen AJ; the Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands (De Langen)., Goto K; the Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan (Y Goto, K Goto)., Velasco Roth AM; Research & Development, Thermo Fisher Scientific, Carlsbad, California (Ha, Velasco Roth)., Khambata-Ford S; From Global Companion Diagnostics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Qi, Feng, Khambata-Ford).
Source: Archives of pathology & laboratory medicine [Arch Pathol Lab Med] 2025 Jun 01; Vol. 149 (6), pp. 542-549.
Publication Type: Journal Article; Validation Study
Journal Info: Publisher: College of American Pathologists Country of Publication: United States NLM ID: 7607091 Publication Model: Print Cited Medium: Internet ISSN: 1543-2165 (Electronic) Linking ISSN: 00039985 NLM ISO Abbreviation: Arch Pathol Lab Med Subsets: MEDLINE
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  Data: Analytical and Clinical Validation of the Oncomine Dx Target Test to Assess HER2 Mutation Status in Tumor Tissue Samples From Patients With Non-Small Cell Lung Cancer Treated With Trastuzumab Deruxtecan in the DESTINY-Lung01 and DESTINY-Lung02 Studies.
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  Data: <searchLink fieldCode="AU" term="%22Qi+Z%22">Qi Z</searchLink>; From Global Companion Diagnostics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Qi, Feng, Khambata-Ford).<br /><searchLink fieldCode="AU" term="%22Ha+T%22">Ha T</searchLink>; Research & Development, Thermo Fisher Scientific, Carlsbad, California (Ha, Velasco Roth).<br /><searchLink fieldCode="AU" term="%22Feng+W%22">Feng W</searchLink>; From Global Companion Diagnostics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Qi, Feng, Khambata-Ford).<br /><searchLink fieldCode="AU" term="%22Karnoub+M%22">Karnoub M</searchLink>; Biostatistics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Karnoub).<br /><searchLink fieldCode="AU" term="%22Pereira+K%22">Pereira K</searchLink>; Global Oncology R&D, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Pereira).<br /><searchLink fieldCode="AU" term="%22Shiga+R%22">Shiga R</searchLink>; Global Oncology R&D, Daiichi Sankyo, Co, Ltd, Shinagawa, Japan (Shiga).<br /><searchLink fieldCode="AU" term="%22Smit+EF%22">Smit EF</searchLink>; the Faculty of Medicine Division 2 Pulmonary Diseases, Leiden University Medical Center, Leiden, The Netherlands (Smit).<br /><searchLink fieldCode="AU" term="%22Goto+Y%22">Goto Y</searchLink>; the Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan (Y Goto, K Goto).<br /><searchLink fieldCode="AU" term="%22De+Langen+AJ%22">De Langen AJ</searchLink>; the Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands (De Langen).<br /><searchLink fieldCode="AU" term="%22Goto+K%22">Goto K</searchLink>; the Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan (Y Goto, K Goto).<br /><searchLink fieldCode="AU" term="%22Velasco+Roth+AM%22">Velasco Roth AM</searchLink>; Research & Development, Thermo Fisher Scientific, Carlsbad, California (Ha, Velasco Roth).<br /><searchLink fieldCode="AU" term="%22Khambata-Ford+S%22">Khambata-Ford S</searchLink>; From Global Companion Diagnostics, Daiichi Sankyo, Inc, Basking Ridge, New Jersey (Qi, Feng, Khambata-Ford).
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