Molecular Probes Introducing 14 new probes

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1 Molecular Probes Introducing 14 new probes

2 Gene and Chromosome Probes Dual Colour ISH INFORM HER2 Dual ISH DNA Probe Cocktail Assay Product Part Number INFORM HER2 Dual ISH DNA Probe Cocktail tests ultraview SISH DNP Detection Kit tests ultraview Red ISH DIG Detection Kit tests HybReady dispenses ultraview Silver Wash II L HER2 Dual ISH 3-in-1 Xenograft Slides slides Interpretation Guide Please contact your local representative The INFORM HER2 Dual ISH DNA Probe Cocktail is designed to quantitatively detect amplification by light microscopy of the HER2 gene via two colour chromogenic in situ hybridisation (ISH) in formalin-fixed, paraffin-embedded tissue specimens of human breast cancer and gastric cancer, including the gastro-oesophageal junction, following staining on VENTANA BenchMark instruments (BenchMark GX, BenchMark LT/XT, The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information and proper controls. This reagent is intended for in vitro diagnostic () use. HER2 clusters and Chr17 60X, amplified HER2 and Chr17 60X, non-amplified INFORM IGF1R Probe Assay Product Part Number INFORM IGF1R DNP Probe tests INFORM Chromosome 15 DIG Probe tests ultraview SISH DNP Detection Kit tests ultraview Red ISH DIG Detection Kit tests HybReady dispenses ultraview Silver Wash II L IGF1R ISH Xenograft Slides slides The INFORM IGF1R DNP Probe and INFORM Chromosome 15 DIG Probe are designed to quantitatively detect amplification by light microscopy of the IGF1R gene via two colour chromogenic in situ hybridisation (ISH) in formalin-fixed, paraffin-embedded human tissue specimens, following staining on VENTANA BenchMark instruments (BenchMark GX, BenchMark LT/XT, Genomic gain of IGF1R is associated with non-small cell lung cancer (NSCLC). The IGF1R gene is located on chromosome 15 (15q26.3) and encodes the insulin-like growth factor-1 receptor protein. This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information and proper controls. This reagent is intended for in vitro diagnostic () use.

3 DNP Labelled Gene Probes EGFR DNP Probe NEW Part Number One 1.25 ml vial of EGFR DNP Probe contains approximately 40 μg/ml of the probe labelled with DNP Chromosome 7 DIG Probe The EGFR DNP Probe is designed to hybridise to an approximately 955 Kb region of Chromosome 7 that includes the EGFR gene in FGFR1 DNP Probe NEW Part Number One 1.25 ml vial of FGFR1 DNP Probe contains approximately 40 μg/ml of the probe labelled with DNP Chromosome 8 DIG Probe The FGFR1 DNP Probe is designed to hybridise to an approximately 505 Kb region of chromosome 8 that includes the FGFR1 gene in MDM2 DNP Probe NEW Part Number One 1.25 ml vial of MDM2 DNP Probe contains approximately 40 μg/ml of the probe labelled with DNP Chromosome 12 DIG Probe The MDM2 DNP Probe is designed to hybridise to an approximately 628 Kb region of chromosome 12 that includes the MDM2 gene in formalin-fixed, paraffin-embedded human tissue specimens following staining on VENTANA BenchMark instruments (BenchMark MET DNP Probe NEW Part Number One 1.25 ml vial of MET DNP Probe contains approximately 40 μg/ml of the probe labelled with DNP Chromosome 7 DIG Probe The MET DNP Probe is designed to hybridise to an approximately 506 Kb region of chromosome 7 that includes the MET gene in MYC DNP Probe NEW Part Number One 1.25 ml vial of MYC DNP Probe contains approximately 40 μg/ml of the probe labelled with DNP Chromosome 8 DIG Probe The MYC DNP Probe is designed to hybridise to an approximately 496 Kb region of chromosome 8 that includes the MYC gene in VENTANA part number in black, Roche item number in blue.

4 DNP Labelled Gene Probes (cont.) PIK3CA DNP Probe NEW Part Number One 1.25 ml vial of PIK3CA DNP Probe, contains approximately 40 μg/ml of the probe labelled with DNP Chromosome 3 DIG Probe The PIK3CA DNP Probe is designed to hybridise to an approximately 766 Kb region of chromosome 3 that includes the PIK3CA gene in PTEN DNP Probe NEW Part Number One 1.25 ml vial of PTEN DNP Probe contains approximately 40 μg/ml of the probe labelled with DNP, Chromosome 10 DIG Probe The PTEN DNP Probe is designed to hybridise to an approximately 360 Kb region of chromosome 10 that includes the PTEN gene in TOP2A DNP Probe NEW Part Number One 1.25 ml vial of TOP2A DNP Probe contains approximately 40 μg/ml of the probe labelled with DNP Chromosome 17 DIG Probe The TOP2A DNP Probe is designed to hybridise to an approximately 500 Kb region of chromosome 17 that includes the TOP2A gene in DIG Labelled Chromosome Probes Chromosome 3 DIG Probe NEW Part Number One 1.25 ml vial of Chromosome 3 DIG Probe contains approximately 3.5 μg/ml of the probe labelled The Chromosome 3 DIG Probe is designed to hybridise to the centromeric region of chromosome 3 in formalin-fixed, paraffinembedded Chromosome 7 DIG Probe NEW Part Number One 1.25 ml vial of Chromosome 7 DIG Probe contains approximately 8 μg/ml of the probe labelled The Chromosome 7 DIG Probe is designed to hybridise to the centromeric region of chromosome 7 in formalin-fixed, paraffinembedded VENTANA part number in black, Roche item number in blue.

5 DIG Labelled Chromosome Probes (cont.) Chromosome 8 DIG Probe NEW Part Number One 1.25 ml vial of Chromosome 8 DIG Probe contains approximately 4 μg/ml of the probe labelled The Chromosome 8 DIG Probe is designed to hybridise to the centromeric region of chromosome 8 in formalin-fixed, paraffinembedded Chromosome 10 DIG Probe NEW Part Number One 1.25 ml vial of Chromosome 10 DIG Probe contains approximately 4 μg/ml of the probe labelled The Chromosome 10 DIG Probe is designed to hybridise to the centromeric region of chromosome 10 in formalin-fixed, paraffinembedded Chromosome 12 DIG Probe NEW Part Number One 1.25 ml vial of Chromosome 12 DIG Probe contains approximately 3 μg/ml of the probe labelled The Chromosome 12 DIG Probe is designed to hybridise to the centromeric region of chromosome 12 in formalin-fixed, paraffinembedded Chromosome 17 DIG Probe NEW Part Number One 1.25 ml vial of Chromosome 17 DIG Probe contains approximately 2.5 μg/ml of the probe labelled The Chromosome 17 DIG Probe is designed to hybridise to the centromeric region of chromosome 17 in formalin-fixed, paraffinembedded

6 EBER, Kappa, and Lambda Probes INFORM EBER Probe Part Number To be used with ISH iview Blue Detection Kit EBER Positive Specimen Slides INFORM EBER Probe is a fluorescein-labelled oligonucleotide probe intended to identify cells expressing Epstein-Barr encoded RNA (EBER) in sections of formalin-fixed, paraffin-embedded tissue using ISH iview Blue Detection Kit and other reagents on the VENTANA BenchMark instruments (BenchMark GX, BenchMark LT/XT, INFORM EBER Probe specifically hybridises to EBER RNA transcripts. Positive results aid in the identification of cells infected with Epstein-Barr virus. INFORM Kappa Probe Part Number To be used with ISH iview Blue Detection Kit Kappa Positive Specimen Slides INFORM Kappa Probe is a fluorescein-labelled oligonucleotide probe intended to detect cytoplasmic mrna for kappa immunoglobulin light chain in formalin-fixed, paraffin-embedded tissue samples using ISH iview Blue Detection Kit and other reagents on the VENTANA BenchMark instruments (BenchMark GX, BenchMark LT/XT, INFORM Kappa Probe is typically used in conjunction with the INFORM Lambda Probe for lambda immunoglobulin light chain. The combined assays assist distinction between polyclonal (kappa positive, lambda positive mrna) proliferations associated with benign reactive plasma cell and B-cell lymphoid proliferations; and monoclonal (either kappa positive and lambda negative or kappa negative and lambda positive) proliferations associated with neoplastic plasma cell and B-cell lymphoid proliferations. INFORM Lambda Probe Part Number To be used with ISH iview Blue Detection Kit Lambda Positive Specimen Slides INFORM Lambda Probe is a fluorescein-labelled oligonucleotide probe intended to detect cytoplasmic mrna for lambda immunoglobulin light chain in formalin-fixed, paraffin-embedded tissue samples using ISH iview Blue Detection Kit and other reagents on the VENTANA BenchMark instruments (BenchMark GX, BenchMark LT/XT, INFORM Lambda Probe is typically used in conjunction with the INFORM Kappa Probe for kappa immunoglobulin light chain. The combined assays assist distinction between polyclonal (kappa positive, lambda positive mrna) proliferations associated with benign reactive plasma cell and B-cell lymphoid proliferations; and monoclonal (either kappa positive and lambda negative or kappa negative and lambda positive) proliferations associated with neoplastic plasma cell and B-cell lymphoid proliferations. VENTANA part number in black, Roche item number in blue.

7 HPV Probes INFORM HPV II Family 6 Probe (B) Part Number To be used with ISH iview Blue Plus Detection Kit HPV Family 6 Control Slides INFORM HPV II Family 6 (B) contains a cocktail of labelled human papillomavirus (HPV) genomic probes. The probe cocktail has demonstrated positive hybridisation to the following low risk genotypes: 6 and 11. INFORM HPV II Family 6 (B) Probe is to be used in conjunction with ISH iview Blue Plus Detection Kit and other reagents to stain formalin-fixed, paraffin-embedded tissue on the VENTANA BenchMark instruments (BenchMark GX, BenchMark LT/ XT, INFORM HPV III Family 16 Probe (B) Part Number To be used with ISH iview Blue Plus Detection Kit HPV 3 in 1 System Control Slides INFORM HPV III Family 16 (B) contains a cocktail of labelled human papillomavirus (HPV) genomic probes. The intended targets are the common genital HPV genotypes found to be associated with cervical cancer. The probe cocktail has demonstrated positive hybridisation to the following genotypes: 16, 18, 31, 33, 35, 45, 51, 52, 56, 58 and 66. INFORM HPV III Family 16 (B) Probe is to be used in conjunction with ISH iview Blue Plus Detection Kit and other reagents to stain formalin-fixed, paraffin-embedded tissue on the VENTANA BenchMark instruments (BenchMark GX, BenchMark LT/XT,

8 Roche Diagnostics (Schweiz) AG Industriestrasse 7 CH-6343 Rotkreuz Switzerland Tel: +41 (0) Ventana Medical Systems, Inc. and Roche Diagnostics International Ltd VENTANA, the VENTANA logo, BenchMark, INFORM, and ultraview are trademarks of Roche. E3052_0812C VENTANA Empowering Innovation

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