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Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Background Information", "Value": "The anaplastic lymphoma kinase (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.4,5,6,7,8 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, 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):4971-6.
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-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": "Intended Use", "Value": "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.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Content", "Value": "VENTANA anti-ALK (D5F3) assay contains sufficient reagent for 50 tests.

One 5 mL dispenser of VENTANA anti-ALK (D5F3) assay contains approximately 70 μg of the rabbit monoclonal (D5F3) antibody.

The antibody is diluted in PBS with carrier protein and 0.05% ProClin 300, a preservative.
Specific antibody concentration is approximately 14 μg/mL.
VENTANA anti-ALK (D5F3) assay is a recombinant rabbit monoclonal antibody produced as purified cell culture supernatant.
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody Interpretation Guide for Non-Small Cell Lung Carcinoma (NSCLC) (P/N 1011879).

Refer to the appropriate VENTANA detection kit method sheet for detailed descriptions of: Principle of the Procedure, Material and Methods, Specimen Collection and Preparation for Analysis, Quality Control Procedures, Troubleshooting, Interpretation of Results, and Limitations.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Principle", "Value": "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.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Product Purpose", "Value": "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.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }

VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody

790-4794

IVD For in vitro diagnostic use.
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody

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