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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"
}
]
}
}
]
}
