For in vitro diagnostic use. Others HER2 Dual ISH DNA Probe Cocktail VENTANA IVD VENTANA® HER2 Dual ISH DNA Probe Cocktail RTD001251 US-FDA 08 314 365 001 8 314 365 001 08314365001 8314365001 08314365001 VENTANA HER2 DUAL ISH DNA PROBE COCKTAIL VENTANA HER2 Dual ISH DNA Probe Cocktail 07613336158432 Reagents, kits 760-6072 30 tests Not Available true The VENTANA HER2 Dual ISH DNA Probe Cocktail is intended to determine the HER2 gene amplification status by enumeration of the ratio of the HER2 gene to Chromosome 17 by light microscopy. The HER2 and Chromosome 17 probes are detected using the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit by a two-color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast carcinoma and gastroesophageal adenocarcinoma (gastric, gastroesophageal junction and esophageal adenocarcinoma) tissue specimens following staining on a BenchMark ULTRA or BenchMark ULTRA PLUS instrument. The VENTANA HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom the following therapies are being considered, in accordance with the approved therapeutic labeling: • Breast carcinoma patients for whom Herceptin® (trastuzumab) or ENHERTU® (fam-trastuzumab deruxtecan-nxki)a is being considered. • Gastroesophageal adenocarcinomab patients for whom ZIIHERA® (zanidatamab-hrii) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr is being considered. a See the ENHERTU® product label for specific clinical circumstances guiding HER2 testing. b Gastroesophageal adenocarcinoma indication is only approved for use with BenchMark ULTRA Instrument. Test results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (IVD) use. en The VENTANA HER2 Dual ISH DNA Probe Cocktail contains HER2 probes (labeled with the hapten dinitrophenyl or DNP) and Chromosome 17 probes (labeled with the hapten digoxigenin or DIG) formulated in a formamide-based buffer. The probes are designed to detect amplification of the HER2 gene in invasive breast carcinoma and gastroesophageal adenocarcinoma (GEA, i.e. gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal adenocarcinoma). The HER2 DNA Probe is a mixture of oligo probes that spans approximately 300 000 base pairs along the genomic region containing the HER2 gene (also known as ERBB2 and NEU), which is located on human Chromosome 17 (17q12). The Chromosome 17 probe is a mixture of oligo probes that target sequences within the centromeric region and serves as a reference for aneusomy. Copy numbers of both probes are enumerated in tumor nuclei and results are reported as a ratio of HER2/Chromosome 17 to determine HER2 amplification status (HER2/Chromosome 17 ratio ≥ 2.0 is amplified, while a ratio < 2.0 is non-amplified). The VENTANA HER2 Dual ISH DNA Probe Cocktail is optimally formulated for use with VENTANA Silver ISH DNP Detection Kit, VENTANA Red ISH DIG Detection Kit, and accessory reagents on a BenchMark ULTRA or BenchMark ULTRA PLUS instrument. The detection kit contains a primary antibody and an enzyme-labeled secondary antibody conjugated to horseradish peroxidase (HRP) or alkaline phosphatase (AP) which is used as the chromogenic enzyme. During the Dual in situ hybridization (Dual ISH) staining process, DNP and DIG labeled probes are co-hybridized to their respective specific target DNA sequences within the cell nuclei. Detection of the DNP-labeled HER2 probe occurs first, using the VENTANA Silver ISH (SISH) DNP Detection Kit, which contains the following dispensers: mouse anti-DNP primary antibody labeled with hydroxyquinoxaline (HQ), mouse anti-HQ secondary antibody conjugated to horseradish peroxidase (HRP), Chromogen A (Silver A), Chromogen B (Silver B) and Chromogen C (Silver C). Following incubation with the HQ-labeled mouse anti-DNP primary antibody and then mouse anti-HQ HRP secondary antibody conjugate, the SISH reaction occurs. This reaction is driven by the sequential addition of Chromogens A (silver acetate), B (hydroquinone) and C (H2O2). Here, the silver ions (Ag+) are reduced by hydroquinone to metallic silver atoms (Ag0). This reaction is fueled by the substrate for HRP, hydrogen peroxide (Chromogen C). The silver precipitate is deposited in the nuclei and a single copy of the HER2 gene is visualized as a black dot. Figure 1 illustrates the SISH reaction. Following SISH detection for HER2, the DIG-labeled Chromosome 17 probe is detected with the VENTANA Red ISH DIG Detection Kit. This kit includes the following dispensers: mouse anti-DIG primary antibody labeled with nitropyrazole (NP), mouse anti-NP secondary antibody conjugated to Alkaline Phosphatase (AP), pH Enhancer, Naphthol, and Fast Red. Following development of the SISH signal, the slide is incubated with the NP-labeled mouse anti-DIG primary antibody, which binds to the DIG hapten on the Chromosome 17 probe. The anti-hapten primary antibody is detected with the mouse anti-NP conjugated to AP enzyme. The slide is incubated with the pH Enhancer solution, which provides the proper salt components and concentrations and buffered pH for optimal AP enzyme performance. Next, naphthol phosphate is applied, which serves as the substrate for the AP enzyme (AP dephosphorylates naphthol). Fast Red, added to the slide next, combines with the dephosphorylated naphthol to form a red precipitate, which is readily visualized by light microscopy. Figure 2 illustrates the Red ISH reaction. The specimen is then counterstained with Hematoxylin II for interpretation by light microscopy. The staining protocol consists of numerous steps in which reagents are incubated for pre-determined times at specific temperatures. At the end of each incubation step, the BenchMark ULTRA or BenchMark ULTRA PLUS instrument washes the sections to remove unbound material and applies a liquid coverslip which minimizes the evaporation of the aqueous reagents from the slide. Results are interpreted using a light microscope using 20x, 40x, and/or 60x keyives. en

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