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A sequencing test that confirms KRAS is unmutated before cetuximab or panitumumab in bowel cancer, and finds common EGFR mutations in lung cancer.
Pillar Biosciences' ONCO/Reveal Dx Lung & Colon Cancer Assay was approved on 30 July 2021 (PMA P200011). In colorectal cancer it identifies KRAS wild-type tumours (no mutation in codons 12 and 13) for cetuximab or panitumumab. In non-small-cell lung cancer it carries a group claim: EGFR exon 19 deletions or L858R for any tyrosine kinase inhibitor the FDA has approved for that use, which the FDA list names as erlotinib, osimertinib, gefitinib, afatinib, dacomitinib and lazertinib (as part of a combination).
| Region | Year | Indication |
|---|---|---|
| US | 2021 | KRAS wild-type for cetuximab or panitumumab in colorectal cancer; EGFR exon 19 deletion or L858R for approved EGFR inhibitors in NSCLC (group labelling) |
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Query for this drug: (TITLE:"ONCO/Reveal Dx Lung and Colon Cancer Assay" OR ABSTRACT:"ONCO/Reveal Dx Lung and Colon Cancer Assay" OR TITLE:"ONCO" OR ABSTRACT:"ONCO" OR TITLE:"Reveal Dx Lung & Colon Cancer Assay" OR ABSTRACT:"Reveal Dx Lung & Colon Cancer Assay" OR TITLE:"ONCO/Reveal Dx Lung & Colon Cancer Assay" OR ABSTRACT:"ONCO/Reveal Dx Lung & Colon Cancer Assay" OR TITLE:"O/RDx-LCCA" OR ABSTRACT:"O/RDx-LCCA") 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 ONCO/Reveal Dx Lung and Colon Cancer Assay, not a curated reading list.
Shares Panitumumab, Companion diagnostic, Companion diagnostics, Cetuximab and the tag test.
Shares RAS wild-type (extended KRAS and NRAS testing), Panitumumab, Companion diagnostic, Companion diagnostics and the tag test.
Shares Afatinib, RAS wild-type (extended KRAS and NRAS testing), Panitumumab, Companion diagnostic and the tag test.
Shares Erlotinib, Companion diagnostic, Companion diagnostics, Osimertinib and the tag test.
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, Next-generation sequencing (NGS), Companion diagnostics, EGFR and the tag test.
Shares Companion diagnostic, Companion diagnostics, Non-small-cell lung cancer and the tag test.
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