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VENTANA® anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody

CE-IVD

IVD For in vitro diagnostic use.
VENTANA<sup>®</sup> anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody

Identifying ALK+ NSCLC patients for targeted treatment

The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody empowers your lab to provide timely results with a four-and-one-half hour run time using fully automated, ready-to-use reagents.

ALK targeted therapy

  • VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody* 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 VENTANA anti-ALK (D5F3) Assay

* VENTANA ALK (D5F3) Assay

Non-small cell lung cancer (NSCLC)

XALKORI® (crizotinib), ZYKADIA® and ALECENSA® (alectinib) and lorlatinib are clinically effective and CE Marked 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, 7

  • 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, crizotinib3
  • 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, crizotinib7
  • Lorlatinib is indicated for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease12

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 VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amplification 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. 8,9,10,11

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

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VENTANA 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 fine-needle aspirations (FNA) to predict tumor response and survival to crizotinib for patients with advanced NSCLC.” 7

In one study, van der Wekken et al. “…found that dichotomous ALK-IHC is superior to ALK-FISH on small biopsies and fine-needle aspirations (FNA) to predict tumor response and survival to crizotinib for patients with advanced NSCLC.” 7

  VENTANA ALK (D5F3) Assay with OptiView DAB Detection and Amplification
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
  • 4.5 hours, fully automated
  • Routine IHC testing
  • 12+ hours, semi-automated
  • Typically batch or send-out testing
Brightfield vs. fluorescent
staining
  • Standard brightfield microscope
  • Fully archivable results
  • Full visibility of tumor morphology
  • Requires a fluorescent 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.

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Overview

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