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).

VENTANA ALK (D5F3) CDx Assay product details


ALK IHC Biomarker Testing

Interpretation Guide

Package Inserts

Online training for pathologists

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.

Learn more about ALK targeted therapy

Preanalytics impact your results

The VENTANA ALK (D5F3) CDx Assay — The value of a standardized ALK IHC approach

Quality efforts across the world

How should I validate VENTANA ALK (D5F3) CDx Assay?

CAP Guidelines

Why should I use IHC instead of FISH?

Do more with the VENTANA ALK (D5F3) CDx Assay

How does the VENTANA ALK (D5F3) CDx Assay perform?

Package Inserts

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.

BenchMark ULTRA

BenchMark XT

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). 

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