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Inform her2 dual ish dna probe assay

Manufactured by Roche

The INFORM HER2 Dual ISH DNA Probe Assay is a laboratory diagnostic tool for the detection of the HER2 gene in human breast cancer tissue samples. It utilizes in situ hybridization technology to visualize and quantify the HER2 gene status within the tested samples.

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2 protocols using inform her2 dual ish dna probe assay

1

Quantitative HER2 Amplification Assessment

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The INFORM HER2 Dual ISH DNA Probe Assay was used on 5-μm sections using the BenchMark XT Staining Platform (Ventana Medical Systems). All samples were processed following the FDA-approved protocol. Samples with >70% of the cells with a DM (small dispersed dots distributed throughout the nucleus) or HSR (tightly clustered dots in discrete regions of the nucleus) patterns were classified accordingly. Cases not falling into these categories because of the presence of both HSR and DM patterns in the same sample were classified as mixed; for example, samples with 40% and 60% of cells with DM and HSR patterns, respectively, were classified as mixed while samples with 20% and 80% of cells with DM and HSR patterns, respectively, were classified as HSR (see text for details). Two teams including certified pathologists led by V. P. and R. M. blindly assessed the pattern of HER2 amplification in the series of samples from patients treated with neoadjuvant trastuzumab. The pattern of amplification in the series of samples from patients treated with adjuvant trastuzumab was assessed by V. P. The HER2/centromere 17 probe signal ratio was determined based on the quantification of 20 cells in at least two different fields, as recommended in ASCO/CAP 2013 guideline [11 (link)].
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2

HER2 Gene Amplification Evaluation by DISH

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DISH was performed with a BenchMark XT Staining Platform (Ventana Medical Systems, Tucson, AZ) using an INFORM HER2 Dual ISH DNA Probe Assay and 4-μm tissue sections. The kit contains two DNA probes, the Inform® ErbB2 DNA Probe (labeled with black) and the Inform® Chromosome 17 Probe (CEP17) (labeled with red). DISH signals were observed using a conventional light microscope. The HER2/CEP17 ratio was assessed using the scoring criteria of fluorescence in situ hybridization (FISH) for breast cancer [9 (link)]. The HER2 and CEP17 signals were counted in 20 tumor cell nuclei in two different areas. HER2 gene amplification was quantitatively assessed by evaluating the HER2/CEP17 ratio and the average number of HER2 signals in each cell. The designation “amplified” was assigned if the HER2/CEP17 ratio was ≥2.0 or if the HER2/CEP17 ratio was < 2.0 but the average number of HER2 signals in each cell was ≥6.0. Conversely, the designation “not amplified” was assigned if the HER2/CEP17 ratio was < 2.0 and the average number of HER2 signals was < 4.0. When a case had a HER2/CEP17 signal count ratio of < 2.0 and an average number of HER2 signals per cell of ≥4.0 and < 6.0, signals were counted in another 20 nuclei, and the result was determined in a total of 40 tumor cell nuclei.
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