VENTANA ALK (D5F3) CDx Assay
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 VENTANA ALK (D5F3) CDx Assay empowers your lab to provide timely results with a four and one half hour run time using fully automated, ready-to-use reagents.
ALK Testing with Roche Diagnostics
VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib).
ALK Targeted Therapy
Confidence begins with knowing your IHC/ISH diagnostic solution is clinically sound, technically strong and designed to improve the future for you and your patients.
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How should I validate VENTANA ALK (D5F3) CDx Assay?
Why should I use IHC instead of FISH?
How does the VENTANA ALK (D5F3) CDx Assay perform?
How do I compare my VENTANA ALK (D5F3) CDx Assay performance?
The power of VENTANA ALK (D5F3) CDx Assay in your laboratory
The VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amplification is approved to identify patients eligible for treatment with XALKORI. IHC is a routine testing method in a majority of pathology laboratories and an economical option to more expensive and labor-intensive molecular testing techniques.
Related articles and other resources
- Marchetti et al. ALK Protein Analysis by IHC Staining after Recent Regulatory Changes: A Comparison of Two Widely Used Approaches, Revision of the Literature, and a New Testing Algorithm. Journal of Thoracic Oncology 9.12 (2015).
- Lim C, et al. Biomarker testing and time to treatment decision in patients with advanced nonsmall-cell lung cancer. Ann Oncol (2015)doi: 10.1093/annonc/mdv208.
- Lindeman N, et al. Molecular testing guidelines for selection of lung cancer patients for EGFR and ALK Tyrosine Kinase Inhibitors. Journal of Thoracic Oncology. 8 (2013): 823-859.
- von Laffert, Maximilian, et al. Multicenter ALK testing in non—small-cell lung cancer: results of a round robin test. Journal of Thoracic Oncology 9.10 (2014): 1464-1469.
- Tsao MS et al. IASLC atlas of ALK testing in lung cancer.
- CAP. Principles of Analytic Validation of Immunohistochemical Assays Frequently Asked Questions (FAQs).