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The BRAF test for melanoma approved as companion to vemurafenib in 2011 and to cobimetinib with vemurafenib in 2016.
Roche Molecular Systems' cobas 4800 BRAF V600 Mutation Test was approved on 17 August 2011 (PMA P110020) as the companion diagnostic for vemurafenib in BRAF V600E melanoma. A supplement on 7 November 2016 added cobimetinib with vemurafenib for V600E or V600K melanoma.
Detects BRAF V600 mutations in DNA from melanoma tissue. Connects to BRAF.
| Region | Year | Indication |
|---|---|---|
| US | 2011 | Companion diagnostic for vemurafenib in BRAF V600E melanoma |
| US | 2016 | Companion diagnostic for cobimetinib with vemurafenib (V600E or V600K) |
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Query for this drug: (TITLE:"cobas 4800 BRAF V600 Mutation Test" OR ABSTRACT:"cobas 4800 BRAF V600 Mutation 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 cobas 4800 BRAF V600 Mutation Test, not a curated reading list.
Shares Companion diagnostic, Companion diagnostics, Roche / Genentech and the tag test.
Shares Companion diagnostic, Companion diagnostics, Roche / Genentech and the tag test.
Shares Companion diagnostic, Companion diagnostics, Roche / Genentech and the tag test.
Shares Companion diagnostic, Companion diagnostics, Roche / Genentech and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics, Roche / Genentech and the tag test.
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