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"Value": "BACKGROUND INFORMATION#1 CE-IVD
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody (VENTANA ROS1 (SP384) antibody) is a rabbit monoclonal antibody produced against the ROS1 protein, a receptor tyrosine kinase of the insulin receptor family.1,2,3,4,5 The ROS1 gene is susceptible to chromosomal rearrangements.1,2,3,4,5 These chromosomal rearrangements result in a portion of ROS1, including the kinase domain, to be fused with one of several currently known partner genes.1,2,3,4,5,6 The resulting overexpression of these novel ROS1 rearranged proteins has been demonstrated to promote tumorigenesis in a variety of cancers including non-small cell lung cancer (NSCLC).1,2,3,4,5,6 ROS1 immunohistochemistry (IHC) can detect wild-type and rearranged ROS1 proteins and thus determination of ROS1 gene rearrangement status is not possible by ROS1 IHC alone.1,2,3,4,5 Therefore, tissues that exhibit ROS1 expression by IHC should be further characterized by a molecular and/or cytogenetic method.7,8,9
The detection of ROS1 protein by IHC with the VENTANA ROS1 (SP384) antibody may be used to aid in the identification of non-small cell lung cancer (NSCLC) with ROS1 expression for further characterization by a molecular and/or cytogenetic method. The staining pattern is mainly cytoplasmic and rarely membranous and nuclear.
1. Rossi G, Jocolle G, Conti A, et al. Detection of ROS1 Rearrangement in Non-Small Cell Lung Cancer: Current and Future Perspectives. Lung Cancer (Auckl). 2017;8:45-55.
2. Bubendorf L, Buttner R, Al-Dayel F, et al. Testing for ROS1 in Non-Small Cell Lung Cancer: A Review with Recommendations. Virchows Arch. 2016;469(5):489-503.
3. Gainor JF, Shaw AT. Novel Targets in Non-Small Cell Lung Cancer: ROS1 and RET Fusions. Oncologist. 2013;18(7):865-875.
4. Lin JJ, Shaw AT. Recent Advances in Targeting ROS1 in Lung Cancer. J Thorac Oncol. 2017;12(11):1611-1625.
5. Davies KD, Doebele RC. Molecular Pathways: ROS1 Fusion Proteins in Cancer. Clin Cancer Res. 2013;19(15):4040-4045.
6. Varella-Garcia M, Yoshida A. ROS1 Testing with FISH. IASLC Atlas of ALK and ROS1 Testing in Lung Cancer. Ed. Tsao M, Ed. Hirsch F, Ed. Yatabe Y. 2nd Edition. Aurora, CO, USA. Editorial Rx Press; 2016. 55-61. Print.
7. D. Planchard, S. Popat, K. Kerr, et al. ESMO Clinical Practice Metastatic NSCLC Guidelines for Diagnosis, Treatment and Follow Up. Ann Oncol. 2019.
8. Wu YL, Planchard D, Lu S, et al. Pan-Asian Adapted Clinical Practice Guidelines for the Management of Patients with Metastatic Non-Small-Cell Lung Cancer: A CSCOESMO Initiative Endorsed by JSMO, KSMO, MOS, SSO and TOS. Ann Oncol. 2019;30(2):171-210.
9. Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors: Guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346.
BACKGROUND INFORMATION#2 not for US and China
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody (VENTANA ROS1 (SP384) antibody) is a rabbit monoclonal antibody produced against the ROS1 protein, a receptor tyrosine kinase of the insulin receptor family. The ROS1 gene is activated by chromosomal rearrangements. These chromosomal rearrangements result in a portion of ROS1, including the kinase domain, fused with 1 of 27 currently known partner genes.1 The resulting overexpression of ROS1 has been demonstrated to promote tumorigenesis in a variety of cancers.2-6
1. Varella-Garcia M, Yoshida A. ROS1 Testing with FISH. IASLC Atlas of ALK andROS1 Testing in Lung Cancer. Ed. Tsao M, Ed. Hirsch F, Ed. Yatabe Y. 2ndEdition. Aurora, CO, USA. Editorial Rx Press; 2016. 55-61. Print.
2. Charest A, Lane K, McMahon K, et al. Fusion of FIG to the receptor tyrosine kinaseROS in a glioblastoma with an interstitial del(6)(q21q21). Genes ChromosomesCancer 2003;37:58-71.
3. Rikova K, Guo A, Zeng Q, et al. Global survey of phosphotyrosine signalingidentifies oncogenic kinases in lung cancer. Cell 2007;131:1190-120.
4. Lee J, Lee SE, Kang SY, et al. Identification of ROS1 rearrangement in gastricadenocarcinoma. Cancer 2013;119:1627-1635.
5. Gu TL, Deng X, Huang F, et al. Survey of tyrosine kinase signaling reveals ROSkinase fusions in human cholangiocarcinoma. PLoS One 2011;6:e15640-e15640.
6. Birch AH, Arcand SL, Oros KK, et al. Chromosome 3 anomalies investigated bygenome wide SNP analysis of benign, low malignant potential and low gradeovarian serous tumours. PLoS One 2011;6:e28250-e28250.
BACKGROUND INFORMATION#3 US
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody (VENTANA ROS1 (SP384) antibody) is a rabbit monoclonal antibody produced against the ROS1 protein, a receptor tyrosine kinase of the insulin receptor family. The ROS1 gene is activated by chromosomal rearrangements. These chromosomal rearrangements result in a portion of ROS1, including the kinase domain, fused with 1 of 27 currently known partner genes.1 The resulting overexpression of ROS1 has been demonstrated to promote tumorigenesis in a variety of cancers.2-6
1. Varella-Garcia M, Yoshida A. ROS1 Testing with FISH. IASLC Atlas of ALK and ROS1 Testing in Lung Cancer. Ed. Tsao M, Ed. Hirsch F, Ed. Yatabe Y. 2nd Edition. Aurora, CO, USA. Editorial Rx Press; 2016. 55-61. Print.
2. Charest A, Lane K, McMahon K, et al. Fusion of FIG to the receptor tyrosine kinase ROS in a glioblastoma with an interstitial del(6)(q21q21). Genes Chromosomes Cancer 2003;37:58-71.
3. Rikova K, Guo A, Zeng Q, et al. Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell 2007;131:1190-120.
4. Lee J, Lee SE, Kang SY, et al. Identification of ROS1 rearrangement in gastric adenocarcinoma. Cancer 2013;119:1627-1635.
5. Gu TL, Deng X, Huang F, et al. Survey of tyrosine kinase signaling reveals ROS kinase fusions in human cholangiocarcinoma. PLoS One 2011;6:e15640-e15640.
6. Birch AH, Arcand SL, Oros KK, et al. Chromosome 3 anomalies investigated by genome wide SNP analysis of benign, low malignant potential and low grade ovarian serous tumours. PLoS One 2011;6:e28250-e28250.",
"Language": "en",
"Country": "XG",
"Code": "Background Information"
},
{
"Name": "Product Purpose",
"Value": "VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the qualitative detection of ROS1 protein in formalin-fixed, paraffin-embedded tissue stained with VENTANA BenchMark IHC/ISH instruments.
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"
}
]
}
}
]
}