VENTANA ALK (D5F3) CDx Assay
ALK (D5F3) Assay and Detection with Amplification vs. FISH
Technical benefits of IHC testing
ALK FISH can present technical challenges in evaluating patient results and offers the potential for false negatives. Recent studies indicate that the ALK (D5F3) Assay stained with OptiView DAB Detection and Amplification (OptiView DAB Detection and Amp) is sensitive and specific for determination of ALK status, and a better alternative to ALK FISH. There are reports of ALK IHC-positive, FISH-negative patients benefitting from treatment with XALKORI or ZYKADIA.1, 2, 3
Figure 1. Comparison of ALK (D5F3) Assay stained with OptiView DAB Detection and Amp vs. FISH testing for ALK mutation
|ALK (D5F3) Assay with OptiView DAB Detection and Amp||ALK FISH|
|Easy to score||
|Faster turnaround times||
|Bright field vs.
1. Zhou J, Zhao J, Sun K, Wang B, Wang L, et al. Accurate and Economical Detection of ALK Positive Lung Adenocarcinoma with Semiquantitative Immunohistochemical Screening. PLoS ONE (2014) 9(3): e92828. doi:10.1371/journal.pone.0092828.
2. Ling Shan, Fang Lian, Lei Guo, Xin Yang, Jianming Ying and Dongmei Lin. Combination of conventional immunohistochemistry and qRT-PCR to detect ALK rearrangement. Diagnostic Pathology 2014, 9:3. doi:10.1186/1746-1596-9-3.
3. Ying, J.; Guo, L.; Qiu, T.; Shan, L.; Ling, Y.; Liu, X.; Lu, N. Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma. Annals of Oncology. 24(10):2589-2593, October 2 Modern Pathology (2013) 26, 1545–1553; doi:10.1038/modpathol.2013.87; published online 7 June 2013.
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