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Thermo Fisher's newer sequencing test for lung cancer, companion to sunvozertinib for EGFR exon 20 insertions and to sevabertinib for HER2 mutations.
Life Technologies' (Thermo Fisher Scientific) Oncomine Dx Express Test was approved on 2 July 2025 (PMA P240040) as the companion diagnostic for sunvozertinib in non-small-cell lung cancer with EGFR exon 20 insertions. A supplement on 9 September 2026 added sevabertinib for HER2 (ERBB2) activating mutations: single-nucleotide variants in exons 18 to 21 of the kinase domain and exon 20 insertions. It is a separate device from the older Oncomine Dx Target Test.
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Companion diagnostic for sunvozertinib in NSCLC with EGFR exon 20 insertions |
| US | 2026 | Companion diagnostic for sevabertinib in NSCLC with HER2 activating mutations |
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Query for this drug: (TITLE:"Oncomine Dx Express Test" OR ABSTRACT:"Oncomine Dx Express Test") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Oncomine Dx Express Test, not a curated reading list.
Shares Companion diagnostic, Next-generation sequencing (NGS), Companion diagnostics, EGFR and the tag test.
Shares Companion diagnostic, Next-generation sequencing (NGS), Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics, EGFR and the tag test.
Shares Companion diagnostic, Companion diagnostics, EGFR, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostic, Companion diagnostics, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostic, Companion diagnostics, HER2 and the tag test.
Shares Companion diagnostic, Companion diagnostics, HER2 and the tag test.
Shares Companion diagnostic, Next-generation sequencing (NGS), Companion diagnostics and the tag test.
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