BRAF V600E (VE1)Mouse Monoclonal Primary Antibody

DRAFT

The BRAF V600E (VE1) antibody is the first ready-to-use IVD IHC antibody that empowers you to evaluate the expression of BRAF V600E mutation with clinical confidence using the OptiView DAB IHC Detection Kit.

Colorectal carcinoma positive with BRAF V600E (VE1) IHC with OptiView DAB IHC detection

Papillary thyroid carcinoma positive with BRAF V600E (VE1) IHC with OptiView DAB IHC detection

High sensitivity and specificity 98.9% concordance rate between BRAF V600E (VE1) IHC

and Sanger sequencing1

100% sensitivity and 98.8% specificity in MSI-H colorectal cancers with the BRAF V600E (VE1) antibody1

Single cell-level resolution

Improve turnaround time and efficiency Fast turnaround time compared to existing molecular methods Fully automated, ready-to-use reagents achieve timely results

in your anatomic pathology labs

One test for a variety of cancers Over 95% of all BRAF mutations are of the V600E type2

Detects the BRAF V600E mutant protein in colorectal, thyroid, hairy cell leukaemia and other cancers

Product Specifications

BRAF V600E (VE1) Mouse Monoclonal Primary Antibody (50 tests)Part Number: 790-4855 06918727001 Automation: Optimised for use on all VENTANA BenchMark IHC/ISH staining instrumentsDetection: Optimised with VENTANA OptiView DAB IHC Detection Kit

BRAF V600E (VE1) Antibody

The BRAF V600E (VE1) antibody is a sensitive and specific antibody used for the detection of the BRAF V600E mutation at a single cell level in a variety of cancers.3 V600E is the most common activating mutation of BRAF.2 BRAF V600E is a clinically significant mutation in several cancers, including colorectal, papillary thyroid and hairy cell leukaemia (Table 1).3

BRAF mutations by cancer

Colorectal cancer/Lynch syndrome 98.9% concordance rate between BRAF V600E (VE1) IHC and

Sanger sequencing1

100% sensitivity and 98.8% specificity in MSI-H colorectal cancers with the BRAF V600E (VE1) antibody1

BRAF V600E detection in MLH1-deficient patients1 is used with the MMR panel in the exclusion of Lynch syndrome1

BRAF V600E mutation has been associated with prognostic and predictive implications6

Thyroid papillary cancer The BRAF V600E mutation is associated with diagnosis of

cancer (high specificity) and associated with worse prognosis (higher tumour stage, increased risk of recurrence)5

Hairy cell leukaemia Since the neoplastic cells are often very scant in tissue samples,

diagnosis by other means is typically difficult 7

The BRAF V600E mutation is highly sensitive and specific for this disease process and can aid in making a diagnosis 7

Other CancersRecent studies have shown that using the VE1 antibody in IHC is a specific and sensitive method for detection of BRAF V600E and may be an alternative to molecular testing for the detection of this mutation in NSCLC (non-small cell lung cancer).8 Additional findings show that in diagnosing serous ovarian tumours, especially those low in epithelial content, IHC with the VE1 antibody is a sensitive and specific tool for detection of the BRAF V600E mutation.9 The BRAF V600E (VE1) antibody has also been said to be a promising tool for patient stratification among individuals presenting with brain metastases.10

Cancer % with BRAF mutations

% that are BRAF V600E mutations

Colorectal 5153 >904

Papillary thyroid 40702 >985

Hairy cell leukaemia ~1002 ~1002

Table 1: BRAF mutations & BRAF V600E prevalence by disease state

References

1. Capper D, Voigt A, Bozukova G, et al. BRAF V600E-specific immunohistochemistry for the exclusion of Lynch Syndrome in MSI-H colorectal cancer. Int J Cancer. 2013 Mar 30

2. Capper D, Preusser M, et al. Assessment of BRAF V600E mutation status by immunohistochemistry with a mutation-specific monoclonal antibody. Acta Neuropathol. 2011 Jul; 122(1): 11-9.

3. Pakneshan S, Salajegheh A, Smith RA, et al. Clinicopathological relevance of BRAF mutations in human cancer. Pathology. 2013 Jun; 45(5): 346-356.

4. Sharma S. BRAF Mutation Testing in Colorectal Cancer. Arch Pathol Lab Med. 2010; 134: 1225-1228.

5. Bullock M, ONeill C, Chou A, et al. Utilization of a MAB for BRAF V600E detection in papillary thyroid carcinoma. Endocrine-Related Cancer. 2012; 19: 779-784.

6. Affloter K, Samowitz W, Tripp S, et al. BRAF V600E Mutation detection by immunohistochemistry in colorectal carcinoma. Genes, Chromosomes & Cancer. 2013 Aug; 52(8):748-52

7. Andrulis M, Penzel R. Application of a BRAF V600E mutation-specific antibody for the diagnosis of hairy cell leukemia. Am J. Surg Pathol. 2012 Dec; 36(12): 1796-1800

8. Llie M, Long E, Hofman V, et al. Diagnostic value of immunohistochemistry for the detection of the BRAF V600E mutation in primary lung adenocarcinoma Caucasian patients. Ann Oncol. 2013 Mar; 24(3): 742-8.

9. Bosmuller H, Fischer A, et al. Detection of the BRAF V600E mutation in serous ovarian tumors: a comparative analysis of immunohistochemistry with a mutation-specific monoclonal antibody and allele-specific PCR. Human Pathology. 2013 Mar. 44(3): 329-335.

10. Preusser M, Capper D, et al. Brain metastases: pathobiology and emerging targeted therapies. Acta Neuropathol. 2011 Oct. 123:205-222

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