VENTANA® ALK (D5F3) CDx Assay

US-FDA

IVD For in vitro diagnostic use.
VENTANA ALK (D5F3) CDx Assay
Identifying ALK+ NSCLC patients for targeted treatment

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.

About the VENTANA ALK (D5F3) CDx Assay
  • VENTANA ALK (D5F3) CDx 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 VENTANA ALK (D5F3) CDx Assay
Available therapies

XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) and LORBRENA® (lorlatinib) 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.1,3,7

  • 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
  • LORBRENA (lorlatinib) is indicated for the treatment of patients with anaplastic lymphoma kinase (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 alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease
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) CDx 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, ALECENSA or LORBRENA8,9,10,11,12

Shown: comparison of VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amp vs. FISH testing for determining ALK status

ALK ISH and FISH assays compared

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

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VENTANA ALK (D5F3) CDx 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) CDx Assay with OptiView DAB Detection and Amplification ALK FISH

Scoring process
  • 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
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.

Roche ALK lung cancer algorithm

References

  1. XALKORI® (crizotinib) [package insert], New York, NY: Pfizer; 2012.
  2. 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: https://globocan.iarc.fr [accessed March 2023].
  3. ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2016.
  4. ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech; 2017.
  5. World Health Organization. International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Lyon, France https://globocan.iarc.fr [accessed March 2014]
  6. Lung Cancer Survival Rates and Prognosis. National Cancer Institute at the National Institutes of Health. Bethesda, MD. http://www.cancer.gov [accessed March 2023]
  7. 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 [accessed March 2023]
  8. 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.
  9. 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.
  10.  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 Modern Pathology (2013) 26, 1545–1553; doi:10.1038/modpathol.2013.87; published online 7 June 2013.
  11. 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
  12. LORBRENA (lorlatinb)[package insert], New York, New York: Pfizer; 2020

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