Pathvysion her2 dna probe kit

Manufactured by Abbott

Sourced in United States, Israel

The PathVysion HER2 DNA Probe Kit is a laboratory diagnostic tool used for the detection and quantification of the HER2 gene in human breast cancer tissue samples. The kit utilizes fluorescence in situ hybridization (FISH) technology to provide accurate and reliable results for HER2 gene status assessment, which is a crucial factor in determining appropriate treatment options for breast cancer patients.

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80 protocols using pathvysion her2 dna probe kit

HER2 Status Determination by FISH and SISH

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Fluorescence in‐situ hybridisation (FISH, n = 32, PathVysion HER2 DNA Probe Kit; Abbott Molecular, Abbott Park, IL, USA) and/or bright‐field dual‐colour silver in‐situ hybridisation (SISH, n = 126, INFORM HER2 Dual ISH DNA Probe Cocktail; Ventana) assays were performed following the manufacturer's recommendations.
ISH was evaluated according to current guidelines, calculating the HER2/CEP17 ratio and the average HER2 copy number in 20–40 cells.2 ISH‐positive: ratio ≥2.0 with HER2 ≥4.0, or ratio <2.0 with HER2 ≥6.0 by two observers with FISH and SISH. ISH‐negative: ratio <2.0 with HER2 <4.0, ratio ≥2.0 with HER2 <4.0 by two observers with FISH and SISH, or ratio <2.0 with HER2 ≥4.0/<6.0 by two observers with FISH and SISH (this last category was ‘equivocal’ before the recent guideline update).1, 2

Koopman T., Buikema H.J., Hollema H., de Bock G.H, & van der Vegt B. (2019). What is the added value of digital image analysis of HER2 immunohistochemistry in breast cancer in clinical practice? A study with multiple platforms. Histopathology, 74(6), 917-924.

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Standardized HER2 Evaluation in Cancer

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For immunohistochemical HER2 determination, sections were incubated with the rabbit monoclonal primary antibody VENTANA anti-HER2/neu (4B5) (Ventana, Tucson, AZ, USA). Evaluation of IHC stains was performed by an experienced pathologist (P.B.), and scored according to the Manufacturer’s specifications [13 ]. FISH reaction was performed with PathVysion HER2 DNA Probe Kit (Abbott Molecular) according to the Manufacturer’s instructions. Analysis of HER2/CEP17 signals was done on ten areas selected by an experienced pathologist (L.V.C. and C.B.) and automatically acquired and read by the Imager MetaSystem (Zeiss) (http://www.metasystems-international.com), properly equipped, through PathVysionV2 classifier (FDA approved). Automatic reading of each case was verified with Isis software (Zeiss). Heterogeneous cases³ were counted on the Isis images. Cases were FISH scored according to ASCO/CAP 2013 guidelines and BICE AIOM/SIAPEC 2014 consensus recommendations [14 , 15 (link)].

Zoppoli G., Garuti A., Cirmena G., di Cantogno L.V., Botta C., Gallo M., Ferraioli D., Carminati E., Baccini P., Curto M., Fregatti P., Isnaldi E., Lia M., Murialdo R., Friedman D., Sapino A, & Ballestrero A. (2017). Her2 assessment using quantitative reverse transcriptase polymerase chain reaction reliably identifies Her2 overexpression without amplification in breast cancer cases. Journal of Translational Medicine, 15, 91.

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FISH-Based HER2 Testing in Breast Cancer

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Fluorescence in situ hybridization (FISH) was performed on FFPE specimens using the PathVysion HER2 DNA Probe Kit (Abbott Molecular Inc.), with 20 nuclei scored for each tissue specimen. The HER2 gene probe was a dual-color probe targeting the HER2 gene (SpectrumOrange) on chromosome 17 (SpectrumGreen). Washes were performed and slides were counterstained with 4’, 6-diamidino-2-phenylindole (phenylindole (DAPI) anti-fade solution before being analyzed under a fluorescence microscope.
Results interpretation (HER2 testing guideline in breast cancer, 2014 edition, China): Signals from 20 non-overlapping nuclei in representative fields were enumerated for the HER2 and CEP17 numbers, and the results were scored as the ratio of HER2 to CEP17 signal numbers. Positive results were defined as ratios of at least 2.0 or ratios less than 2.0, with an average HER2 copy number of 6.0 signals or more per cell. Equivocal results were considered as ratios less than 2.0, with an average HER2 copy number between 4.0 and 6.0 signals per cell. Negative results were defined as ratios less than 2.0, with an average HER2 copy number of than 4.0 signals per cell.

Lian J., Xu E.W., Xi Y.F., Wang H.W., Bu P., Wang J.F, & Wang L.X. (2020). Clinical-Pathologic Analysis of Breast Cancer With PIK3CA Mutations in Chinese Women. Technology in Cancer Research & Treatment, 19, 1533033820950832.

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HER2 Gene Copy Number Evaluation

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HER2 gene copy number was evaluated using the PathVysion HER2 DNA Probe kit (Abbott Molecular, Des Plaines, IL/ Inter Medico, Markham, Canada). The deparaffinized 4-μm section was immersed in 0.2N HCl for 20 minutes. The Slide was placed in pretreatment solution at 98 °C for 30 minutes and then proteaseized at 37 °C for 5 minutes. Slides were hybridized with a PathVysion HER2 DNA probe mixture containing HER2 DNA probe (labeled with spectrum red) and CEP17 DNA probe (labeled with spectrum green) (Fig. 1). The CEP17 DNA probe allows correction of HER2 gene copy number relative to the copy number of chromosome 17. Slide glass cover slip was applied and sealed with rubber. The slides were then denatured at 74 °C for 2 minutes and hybridized overnight at 37 °C in a humidified hybridization chamber (ThermoBrite, Abbott Vysis, Downers Grove, IL). The nest day, the slides were washed in a post-hybridization buffer at 73.5 °C for 2 minutes and dried in the dark. The nuclei were then subsequently counterstained with 10 μL of 4′,6-diamidino-2-phenylin-dole (DAPI). Slides were stored in the dark at 4 °C until signal enumeration.

Choi J.H., Jeon C.W., Kim Y.O, & Jung S. (2020). Pathological complete response to neoadjuvant trastuzumab and pertuzumab therapy is related to human epidermal growth factor receptor 2 (HER2) amplification level in HER2-amplified breast cancer. Medicine, 99(46), e23053.

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Dual-Probe FISH Assay for HER2 and CEP17

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A dual‐probe fluorescence in situ hybridization (FISH) assay for HER2 and chromosome enumeration probe 17 (CEP17) was carried out using a PathVysion HER2 DNA probe kit (Abbott Molecular Inc., Des Plaines, IL, USA) according to the manufacturer's protocol. Tumor nuclei were counterstained with 4′,6‐diamidino‐2‐phenylindole (DAPI) (Abbott Molecular Inc., Des Plaines, IL, USA) after hybridization. The HER2 and CEP17 signals per nucleus were recorded. The results from 20 interphase nuclei from invasive carcinomatous cells were reported as the ratio of total HER2 signals to total CEP17 signals. HER2 testing was eventually interpreted as amplification or no‐amplification according to the updated American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline for breast carcinoma (2018) [23].

Shi H., Shao Y., Lu W, & Lu B. (2020). An analysis of HER2 amplification in cervical adenocarcinoma: correlation with clinical outcomes and the International Endocervical Adenocarcinoma Criteria and Classification. The Journal of Pathology: Clinical Research, 7(1), 86-95.

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HER2 FISH Analysis in Breast Cancer

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The FISH analysis with the CEN17 probe was performed at our institution using the dual-color Vysis FDA-approved PathVysion HER2 DNA Probe Kit (Abbott Molecular, Des Plaines, IL). The signals for the HER2 gene and CEN17 were visualized under a fluorescence microscope using appropriate filters. The average numbers of HER2 and CEN17 signals per cell were recorded for at least 50 cells, and the HER2/CEN17 ratio was calculated for each case. The results were interpreted by specialized molecular pathologists and signed out by case pathologists with a specialization in breast pathology.

Hartage R., Li A.C., Hammond S, & Parwani A.V. (2020). A Validation Study of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry Digital Imaging Analysis and its Correlation with Human Epidermal Growth Factor Receptor 2 Fluorescence In situ Hybridization Results in Breast Carcinoma. Journal of Pathology Informatics, 11, 2.

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HER2 Gene Amplification Analysis by FISH

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FISH analysis was performed using the PathVysion HER2 DNA Probe Kit (Abbott Molecular Inc, Des Plaines, IL, USA), according to the manufacturer’s protocols. FISH signal assessment was performed by visual counting using an epifluorescence microscope (BX53F; Olympus, Tokyo, Japan). At least 50 tumor cells per case with a minimum of one signal for the HER2 gene and centromere 17 were randomly selected, and the mean HER2 and centromere 17 count was calculated. Amplification was defined as a HER2/CEP17 ratio of ≥2.2 in 20 tumor nuclei. The equivocal cases (ratio: 1.8 to 2.2) were recounted in at least 20 nonoverlapping nuclei of different tumor cells at a second target area, and a new HER2/CEP17 ratio was recalculated.

Dong Z., Kong L., Wan Z., Zhu F., Zhong M., Lv Y., Zhao P, & Shi H. (2019). Somatic mutation profiling and HER2 status in KRAS-positive Chinese colorectal cancer patients. Scientific Reports, 9, 16894.

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HER-2/neu Gene FISH Assay

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A PathVysion HER-2 DNA probe kit was purchased from Vysis Inc. (Abbott Molecular, Inc.). A fluorescence microscope (Bx51; Olympus Corporation) was used to view the FISH staining. The HER-2/neu gene FISH test was performed on the tumor tissue according to the instructions and requirements of the kit.

Zhu X., Xu X., Zhang B., Dong Y., Gong S., Gong T., Zhang F, & Jin C. (2022). Individualized therapy based on the combination of mini-PDX and NGS for a patient with metastatic AFP-producing and HER-2 amplified gastric cancer. Oncology Letters, 24(5), 411.

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Immunohistochemical Biomarker Detection in Breast Cancer

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Estrogen and progesterone receptor detection was performed on formalin fixed, paraffin embedded tumor tissue using an enzyme immunoassay provided by Ventana Medical Systems (Tucson, Arizona). These tests were performed and reported according to the previously published Guidelines for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer[30 (link)]. HER2 status was determined by either immunohistochemistry (IHC) (Ventana Medical Systems) or FISH. HER2 gene amplification status by FISH was determined using the PathVysion HER-2 DNA probe kit (Abbott Molecular). All samples were deemed adequate for testing based on ASCO and CAP guidelines[31 (link)]. Amplification status was determined by calculating the ratio of HER2 to chromosome 17 centromere probe signals. A ratio less than 1.8 represented a normal result, while a ratio greater than 2.2 represented a positive gene amplification. A ratio between 1.8 and 2.2 was considered equivocal. We considered a patient to be HER2 positive if the result by IHC was 3+ and FISH was either not done or equivocal, or if FISH was positive. A patient was considered to be HER2 negative if the result by IHC was 0 or 1+ and FISH was equivocal or not done, or if FISH was negative with any IHC result.

Abramson V.G., Lloyd M.C., Ballinger T., Sanders M.E., Du L., Lai D., Su Z., Mayer I., Levy M., LaFrance D.R., Vnencak-Jones C.L., Shyr Y., Dahlman K.B., Pao W, & Arteaga C.L. (2014). Characterization of breast cancers with PI3K mutations in an academic practice setting using SNaPshot profiling. Breast cancer research and treatment, 145(2), 389-399.

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HER2 FISH Assay for Tumor Heterogeneity

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HER2 FISH was performed on 23 tumors with available archival tissue using an FDA-approved HER2 dual-probe FISH assay [HER2 IQFISH pharmDx (Dako, Glostrup, Denmark) or PathVysion HER2 DNA Probe Kit (Vysis, Abbott Molecular, Des Plaines, IL, USA)]. HER2 (red) and chromosome enumeration probe 17 (CEP17; green) signals were enumerated in at least 20 tumor cell nuclei by two independent observers (KAD, DSR). HER2 amplification by FISH was defined as HER2/CEP17 ratio of ≥ 2.0. The entire section was assessed for heterogeneity both independently of and in conjunction with HER2 immunohistochemical staining pattern. Areas with low/absent HER2 immunohistochemical staining (0/1+) were scored separately from areas with moderate/high intensity staining (2+/3+) for tumors in which these areas are spatially distinct. For cases in which spatial separation of cells with variable HER2 expression was not feasible, an overall FISH score was determined.

Ross D.S., Devereaux K.A., Jin C., Lin D.Y., Zhang Y., Marra A., Makker V., Weigelt B., Ellenson L.H, & Chui M.H. (2021). Histopathologic features and molecular genetic landscape of HER2-amplified endometrial carcinomas. Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 35(7), 962-971.

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