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BRAF V600 Mutation-Melanoma
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Methodology
Real-time PCR
Specimen Requirements
Formalin-fixed paraffin-embedded block or 4 unstained slides at 5µ
CPT Codes
83907, 83891, 83892(2), 83898, 83896(2), 88381, 83914, 83912-26
Highlights
- Approximately 60% of melanomas harbor activating mutations in BRAF V600E as identified by the cobas® 4800 test.1
- A small molecule, ZELBORAF™ (Vemurafenib), targets BRAF V600E mutations showing efficacy in metastatic melanoma.
- The cobas 4800 V600 BRAF mutation test was used in the pivotal trials of ZELBORAF.
- Patients with BRAF V600 mutation-positive melanoma as detected by the cobas 4800 test showed dramatic results with ZELBORAF.
- Confirmation of BRAF V600E mutation-positive melanoma, as detected by the cobas 4800 FDA-approved test, is required for patients to qualify for ZELBORAF therapy because these are the only patients studied and for whom benefit is known.3
- The cobas 4800 test is the first and only FDA-approved diagnostic test to help identify patients with the BRAF V600E mutation.2
Indications for Use
The cobas 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.2
Clinical Indications
ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by the cobas 4800 FDA-approved test. ZELBORAF is not recommended for use in patients with wild-type BRAF melanoma.3
Clinical Significance
Metastatic melanoma has a poor prognosis, with the median survival for patients with stage IV melanoma ranging from 8 to 18 months after diagnosis, depending on the substage. ZELBORAF is a potent inhibitor of mutated BRAF. It has marked antitumor effects against melanoma cell lines with the BRAF V600E mutation but not against cells with wild-type BRAF. ZELBORAF is associated with a relative reduction of 63% in the risk of death and of 74% in the risk of tumor progression in patients with previously untreated, unresectable stage IIIC or stage IV melanoma with the BRAF V600E mutation.1
Turnaround Time
5-7 days
References
- Chapman, P.B., Hauschild, A., Robert, C., Haanen, J.B., Ascierto, P., Larkin, J., Dummer, R., et al. (2011). Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation. The New England Journal of Medicine, 1-10. doi:10.1056/NEJMoa1103782.
- Cobas® 4800 V600 Mutation Test (package insert). Roche Molecular Systems, Inc., Branchburg, NJ; February 2011.
- Zelboraf (package insert). Genentech USA, Inc., South San Francisco, CA; August 2011.
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