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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 reagents1.

ALK targeted therapy1,2

  • 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.3,4,5,6

  • XALKORI (crizotinib) is indicated for the treatment of patients with ALK positive metastatic NSCLC and other kinases3
  • 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, crizotinib4
  • 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, crizotinib5
  • 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 disease6

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.7,8,9,10

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.” 2

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.” 2

  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.11,12,13

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    References

    1. VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody [package insert], Indianapolis, IN; Roche, 2022
    2. 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.
    3. XALKORI® (crizotinib) [package insert], New York, NY: Pfizer; 2022.
    4. ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2021.
    5. ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech; 2021.
    6. LORVIQUA (lorlatinib) [package insert]. Bruxxels: Pfizer Europe MA EEIG; 2022.  
    7. Zhou J, Zhao J, Sun K, Wang B, Wang L, et al. Accurate and Economical Detection of ALK Positive Lung Adenocarcinoma with Semiquantitative Immunohistochemical Screening. PLoS ONE (2014) 9(3): e92828. doi:10.1371/journal.pone.0092828.
    8. Ling Shan, Fang Lian, Lei Guo, Xin Yang, Jianming Ying and Dongmei Lin. Combination of conventional immunohistochemistry and qRT-PCR to detect ALK rearrangement. Diagnostic Pathology 2014, 9:3. doi:10.1186/1746-1596-9-3.
    9. Ying, J.; Guo, L.; Qiu, T.; Shan, L.; Ling, Y.; Liu, X.; Lu, N. Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma. Annals of Oncology. 24(10):2589-2593, October 2
    10. Mok T, Peters S, Camidge DR. Patients with ALK IHC-positive/fish-negative NSCLC benefit from ALK TKI treatment: response data from the global ALEX trial. Presented at: the IASLC 18th World Conference on Lung Cancer; October 15-18;
      Yokohama, Japan. Poster MA 07.01
    11. Ferlay, J., Soerjomataram, I., Ervik, M., Dikshit, R., Eser, S., Mathers, C., Rebelo, M., Parkin, D.M., Forman, D., Bray, F. (2012). GLOBOCAN v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 Lyon, France: International Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr (last accessed March 2016).
    12. World Health Organization. International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Lyon, France http://globocan.iarc.fr/ Default.aspx. Accessed August 1, 2014.
    13. Lung Cancer Survival Rates and Prognosis. National Cancer Institute at the National Institutes of Health. Bethesda, MD. http://www.cancer.gov/cancertopics/types/lung/cancer-survival-prognosis Accessed August 1, 2014.

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      Technical Documents

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      Document repository
      IVD For in vitro diagnostic use.
      PD-L1 SP142 Assay
      VENTANA® PD-L1 (SP142) Assay CE-IVD VENTANA PD-L1 (SP142) Assay is intended for the immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tumor tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark IHC/ISH instrument.
      IVD For in vitro diagnostic use.
      VENTANA PD-L1 (SP263) Assay, non-small cell lung cancer (NSCLC), urothelial carcinoma, bladder cancer
      VENTANA® PD-L1 (SP263) Assay CE-IVD VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), urothelial carcinoma (UC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.
      VENTANA anti-ALK (D5F3), lung carcinoma
      VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (CE IVD)
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