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VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffinembedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), or ALECENSA® (alectinib). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (IVD) use.
References
1. XALKORI® (crizotinib) [package insert], New York, NY: Pfizer; 2012.
2. ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2016.
3. ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech; 2017.
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®, ZYKADIA® or ALECENSA®.
ALK (D5F3) Assay and detection with amplification vs. FISH
View Full TableALK (D5F3) Assay and detection with amplification vs. FISH
In one study, van der Wekken et al. “…found that Dichotomous ALK-IHC is superior to ALK-FISH on small biopsies and FNA to predict tumor response and survival to crizotinib for advanced NSCLC patients.”
VENTANA ALK (D5F3) Assay with OptiView DAB Detection and Amp |
ALK FISH |
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Easy to score |
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Faster turnaround times |
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Bright field vs. flourescent staining |
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Clinical guidelines recommend routine testing for genetic mutations in all adenocarcinomas, including ALK EML4 gene rearrangement. Testing is recommended immediately after establishing histology and is required prior to initiating targeted therapy for a patient. The current approved methods for testing include IHC and FISH.
References
1. van der Wekken et al Dichotomous ALK-IHC is a better predictor for ALK inhibition outcome than traditional ALK-FISH in advanced non-small cell lung cancer, Clinical Cancer Research, 2017. Available at http://clincancerres.aacrjournals.org/content/early/2017/02/09/1078-0432. CCR-16-1631.