For in vitro diagnostic use. Cytoplasm Others ALK D5F3 VENTANA IVD ALK positive tissue VENTANA® anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody RTD001189 CE-IVD Rabbit D5F3 06 679 072 001 6 679 072 001 06679072001 6679072001 06679072001 ALK (D5F3) VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody 04015630984831 Reagents, kits 790-4794 50 tests Not Available true VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (NSCLC) tissue stained on a BenchMark IHC/ISH instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib), or lorlatinib. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic (IVD) use. en VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (NSCLC) tissue stained on a BenchMark IHC/ISH instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib), ALUNBRIG® (brigatinib) or lorlatinib.This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This antibody is intended for in vitro diagnostic (IVD) use. en VENTANA anti-ALK (D5F3) assay is a rabbit monoclonal primary antibody that binds to ALK in paraffin-embedded tissue sections. The specific antibody can be visualized using OptiView DAB IHC Detection Kit (Cat. No. 760-700 / 06396500001) followed by the OptiView Amplification Kit (Cat. No. 760-099 / 06396518001 (50 test) or 860-099 / 06718663001 (250 test)). Refer to the appropriate OptiView DAB IHC Detection Kit and OptiView Amplification Kit method sheets for further information. en

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

CE-IVD

IVD

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 therapy^1,2

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

	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

VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody [package insert], Indianapolis, IN; Roche, 2022
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.
XALKORI® (crizotinib) [package insert], New York, NY: Pfizer; 2022.
ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2021.
ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech; 2021.
LORVIQUA (lorlatinib) [package insert]. Bruxxels: Pfizer Europe MA EEIG; 2022.
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
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
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).
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/cancertopics/types/lung/cancer-survival-prognosis Accessed August 1, 2014.

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