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Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Intended Use", "Value": "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. ", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Content", "Value": "VENTANA ALK (D5F3) CDx Assay contains sufficient reagent for 50 tests.

One 5 mL dispenser of VENTANA ALK (D5F3) CDx Assay contains approximately 70 μg of the rabbit monoclonal (D5F3) antibody.

The antibody is diluted in 0.08 M PBS with 3% carrier protein and 0.05% ProClin 300, a preservative.

Total protein concentration of the reagent is approximately 10 mg/mL. Specific antibody concentration is approximately 14 μg/mL.
 ", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Principle", "Value": "VENTANA ALK (D5F3) CDx 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 package inserts (method sheets) for further information.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Background Information", "Value": "VENTANA ALK (D5F3) CDx Assay is a rabbit monoclonal primary antibody produced against the C-terminal region of the anaplastic lymphoma kinase (ALK) protein. The ALK protein is a member of the insulin receptor superfamily of receptor tyrosine kinases.1 ALK is a type I membrane glycoprotein that is normally expressed in the nervous system.2 The ALK gene resides at chromosome 2p23 and is constructed of 2 large introns and 26 exons.1 Molecular pathogenesis involving ALK begins with chromosomal rearrangements that partner the 3′′ coding sequences for the ALK intracellular signaling domain with the 5′ promoter elements and coding sequences of other genes. The 5′ promoter elements and coding sequences drive overexpression and ligand-independent oligomerization of the chimeric proteins, features common in fusion-type protein tyrosine kinase human neoplasms. An inversion within chromosome 2p resulting in the formation of a fusion gene product comprising portions of the echinoderm microtubule associated protein-like 4 (EML4) gene and the ALK gene was discovered in 2007 in NSCLC cell lines and archived clinical specimens.3 A subsequent series of published studies indicated that EML4-ALK inversion events produced at least 9 catalytically active kinase fusion protein variants, each containing the same portion of the ALK C-terminal kinase domain.4-8 As with ALK gene fusions first identified in anaplastic large-cell lymphoma (ALCL), the EML4-ALK fusion protein was shown to have transforming activity. Consistent with this finding, EML4-ALK expression in lung alveolar epithelial cells in transgenic mice has been reported to be a potent oncogenic factor.9

1. Kutok JL, Aster JC, et al. Molecular biology of anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma. J Clin. Onc. 2002;20(17):3691-3702.
2. Iwahara T, et al. Molecular characterization of ALK, a receptor tyrosine kinase expressed specifically in the nervous system. Oncogene. 1997;14:439-49.
3. Soda M, et al. Identification of the transforming EML4−ALK fusion gene in non- small-cell lung cancer. Nature 2007;448(7153)561-66.
4. Inamura K, et al. EML4–ALK fusion is linked to histological characteristics in a subset of lung cancers. J Thorac Oncol. 2008;3(1):13-17.
5. Choi YL, et al. Identification of novel isoforms of the EML4-ALK transforming gene in non-small cell lung cancer. Cancer Res. 2008;68(13):4971-76.
6. Koivunen JP, et al. EML4–ALK fusion gene and efficacy of an ALK kinase inhibitor in lung cancer. Clin Cancer Res. 2008;14(13):4275-83.
7. Shinmura K, et al. EML4−ML4−ALK fusion transcripts, but no NPM-, TPM3−, CLTC−, ATIC−, or TFG-ALK fusion transcripts, in non-small cell lung carcinomas. Lung Cancer. 2008;61:163-9.
8. Takeuchi K, et al. Multiplex reverse transcription−PCR screening for EML4−ALK fusion transcripts. Clin Cancer Res. 2008;14(20):6618−24.
9. Shaw AT, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J Clin Oncol. 2009;27(26):4247-53.", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Product Purpose", "Value": "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. ", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }

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

View Full Table

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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