VENTANA ALK (D5F3) CDx Assay (US FDA)

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.

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

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	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

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

Intended use

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 or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI^® (crizotinib), ZYKADIA^® (ceritinib), ALECENSA^® (alectinib) or LORBRENA^® (lorlatinib).

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.

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References

XALKORI® (crizotinib) [package insert], New York, NY: Pfizer; 2012.
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 (accessed March 2016).
ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2016.
ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech; 2017.
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.
Lung Cancer Survival Rates and Prognosis. National Cancer Institute at the National Institutes of Health. Bethesda, MD. http://www.cancer.gov
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
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.
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.
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.
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
LORBRENA (lorlatinb)[package insert], New York, New York: Pfizer; 2020

VENTANA ALK (D5F3) CDx Assay (US FDA Approved)

Available therapies

Technical benefits of IHC testing

Technical benefits of IHC testing

Testing for lung cancer

Testing for lung cancer

Lung cancer is the leading cause of death

Find out more about the VENTANA ALK (D5F3) CDx Assay

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VENTANA ALK (D5F3) CDx Assay (US FDA Approved)

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