VENTANA ALK (D5F3) CDx Assay

VENTANA ALK (D5F3) CDx Assay
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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.
 

Benefits of IHC Testing
  • ALK (D5F3) Assay stained with OptiView DAB Detection and Amplification detects the ALK protein that is the target of therapy
  • Clinical guidelines recommend rapid turnaround for earlier targeted therapies
  • ALK has comparable sensitivity and specificity relative to FISH
  • Make more immediate treatment decisions for advanced NSCLC patients by using the ALK (D5F3) Assay
  • XALKORI® (crizotinib) ZYKADIA® (ceritinib) and ALECENSA® (alectinib) are clinically effective and FDA approved for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved testing method for ALK.1, 3
  • XALKORI® (crizotinib) is indicated for the treatment of patients with ALK positive metastatic NSCLC and other kinases¹
  • ZYKADIA® (ceritinib) is indicated for the treatment of patients with ALK-positive metastatic NSCLC who have had no previous treatment, or who have progressed on, or who are intolerant to, crizotinib.2
  • ALECENSA® (alectinib) is indicated for the treatment of patients with ALK-positive metastatic NSCLC who have had no previous treatment, or who have progressed on, or who are intolerant to, crizotinib.3

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.

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®, ZYKADIA® or ALECENSA®.

ALK (D5F3) Assay and detection with amplification vs. FISH

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ALK (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

Easy to score
  • Binary (+/-) scoring
  • Any strong positive staining in any number of cells is positive for ALK
  • Requires a dual color scoring algorithm
  • Requires 50 enumerable cells and specific cutoff ratios to be calculated
Faster turnaround times
  • 41/2 hours, fully automated
  • Routine IHC testing
  • 12+ hours, semi-automated
  • Typically batch or send-out testing
Bright field vs. flourescent staining
  • Standard brightfield microscope
  • Fully archivable results
  • Full visibility of tumor morphology
  • Requires a flourescent microscope
  • Staining and signal fade over time
  • Loss of tissue morphology
Testing for lung cancer

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.

ALK-testing

 

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.