COMPANION DIAGNOSTICS Instant Quality FISH Instant Quality FISH. The name says it all.
IQ: Instant Quality every time. Breast carcinoma stained with : Triple filter showing Blue DAPI colors nuclei, FITC filter Green dots (Centromere 17) and Texas red filter red dots (HER2 gene) Dako s new IQFISH hybridization buffer is revolutionizing cancer diagnostics The cutting-edge IQFISH* hybridization buffer, introduced by Dako, reduces diagnostic test turnaround time from ~18 hours to less than 4 hours. It enables pathology labs for the first time to run DNA-based hybridization assays quickly, with distinct and higher fluorescent signal intensity compared to traditional FISH assays. This ability represents a major advance for pathologists, oncologists and ultimately for patients. An additional benefit of the IQFISH hybridization buffer is that it avoids the use of toxic formamide eliminating concerns for pregnant laboratory technicians and does not require a fume hood during use. is the first FDA-approved product that uses the revolutionary IQFISH hybridization buffer. Top quality stains, combined with diagnostic certainty, speed and safety. That s real progress. * Patent pending
In summary, the 1-day HER2 IQFISH approach is a potent method for the determination of HER2 status offering some relevant advances further to the short incubation time, including enhanced tissue integrity and preserved fluorescent signal intensity when compared with the conventional HER2 FISH kit. All these features make fluorescence detection more competitive in the area of light microscopy-based in-situ hybridization approaches. Hegyi et al. Appl Immunohistochem Mol Morphol, 2013. Timeline for IQFISH procedure Hours 0 2 4 6 8 10 12 14 16 18 New hybridization buffer with 1.5 hours hybridization 1.5 hours Traditional formamidebased buffer with 14-20 hours hybridization 14-20 hours hybridization Deparaffinization Digestion Hybridization Mounting Heat pre-treatment Denaturation Stringent wash
IQFISH: Setting new standards for quality and speed. Quantitatively determines HER2 gene amplification Identifies patients with breast or gastric cancer likely to benefit from Herceptin (trastuzumab) treatment Identifies patients with breast cancer likely to benefit from PERJETA (pertuzumab) and KADCYLA (ado-trastuzumabemtansine) treatment Outstanding concordance to HER2 FISH pharmdx Source: Internal validation studies as referenced in the package insert for the kit GASTRIC CANCER HER2 IQFISH pharmdx BREAST CANCER HER2 IQFISH pharmdx HER2 FISH pharmdx Amplified Non-amplified Total Amplified 62 1 63 Non-amplified 1 75 76 Total 63 76 139 Concordance: 98.6% Concordance: 99.2% HER2 FISH pharmdx Amplified Non-amplified Total Amplified 60 1 61 Non-amplified 0 60 60 Total 60 61 121 Outstanding concordance to PathVysion Source: Rüschoff. ECP Symposia, 2012. BREAST CANCER PathVysion HER2 IQFISH pharmdx Concordance: 100% Amplified Non-amplified Total Amplified 25 0 25 Non-amplified 0 109 109 Total 25 109 134
IQFISH provided excellent quality signals without any background staining. As a rule, DAPI stain and red and green signals were brighter with IQFISH than with FISH. The highly concordant data support IQFISH as a useful alternative to FISH, allowing reliable assessment of HER2 status. Use of this method could lead to reporting of HER2 status to the oncologist within a day. Franchet et al. Histopathology, 2013. When it comes to cancer diagnostics providing the right diagnosis to the right patient on time is everything: Top quality: Fast: Accurate: Non-toxic: Brilliant colors and pin-sharp stainings enhance visualization of morphology to help pathologists identify cancer cells more easily. Crisp, clear signals make counting remarkably accurate, easy and fast. Hybridization takes only 1 to 2 hours with IQFISH hybridization buffer. Enhanced staining quality and a total turnaround time of less than 4 hours from dewax to counting. The ultimate combination of quality and speed. The robust kit delivers accurate results with high concordance to other FDA-approved FISH assays. Protect the health and safety of your lab personnel by eliminating their exposure to formamide, a known carcinogen which can cause harm to the unborn child. IQFISH hybridization buffer is free from formamide making it a safer choice for your staff and the environment.
kit includes: Dual-target probe mix (HER2/CEN-17) Pre-treatment solution Pepsin, ready-to-use Pepsin diluent Stringent wash buffer Wash buffer Fluorescence mounting medium, with DAPI Coverslip sealant Product Name Targets Indication Code HER2/CEN-17 Breast/Gastric K5731 Dako Breast Panel Dako pharmdx kits for breast tissue Dako Gastric Panel Dako pharmdx kits for gastric tissue Product HER2 CISH pharmdx ER/PR pharmdx HercepTest Targets HER2/CEN-17 HER2/CEN-17 ER/PR HER2 Product HercepTest Targets HER2/CEN-17 HER2 Dako FLEX RTU Antibodies for breast tissue Dako FLEX RTU Antibodies for gastrointestinal tract BCL2 Oncoprotein Caldesmon CD31, Endothelial Cell CD34 Class II Cytokeratin 8/18 E-Cadherin Epithelial Membrane Antigen Estrogen Receptor α Gross Cystic Disease Fluid Protein-15 NEW Ki-67 Antigen Mammaglobin Muscle Actin Myosin Heavy Chain, Smooth Muscle p53 Protein Progesterone Receptor S100 Smooth Muscle Actin Beta-Catenin Calretinin CD45, Leucocyte Common Antigen CDX2 Desmin E-Cadherin MUC2 MUC5AC MutL Protein Homolog 1 MutS Protein Homolog 2 MutS Protein Homolog 6 Neurofilament Protein Neuron-Specific Enolase p53 Protein Podoplanin Postmeiotic Segregation Increased 2 S100 Smooth Muscle Actin Villin Vimentin
In this study, we used the IQFISH technique. The hybridization time is 90 120 min for IQFISH assay, so it is faster and efficient. Also, this protocol yields very distinct signals. As an additional benefit, the buffers are non-toxic. Pala et al. Pathol Res Pract, 2013.
US only Relentless in our commitment to fighting cancer. Together. References: Franchet C, Filleron T, Cayre A, Mounie E, Penault-Llorca F, Jacquemier J, et al. Instant-quality fluorescence in-situ hybridization as a new tool for HER2 testing in breast cancer: a comparative study. Histopathol. 2014;64:274-83. Hegyi K, Lonborg C, Monus A, Mehes G. One-Day FISH Approach for the High-Speed Determination of HER2 Gene Copy Status in Breast Carcinoma. Appl. Immunohistochem. Mol. Morphol. 2013;21:567-71. Pala EE, Bayol U, Ozguzer A, Akman O. HER2 status in gastric cancer: A comparison of two novel in-situ hybridization methods (IQFISH and dual color SISH) and two immunohistochemistry methods (A0485 and HercepTest ). Pathol. Res. Pract. 2013;209:548-54. Rüschoff J. In-situ Hybridization Results in 3½ Hours - Performance evaluation and clinical perspectives. Symposia at ECP 2012. www.dako.com Corporate Headquarters Denmark +45 44 85 95 00 Australia +61 3 9357 0892 Austria +43 1 408 43 34 0 Canada +1 905 335 3256 China +86 21 3612 7091 France +33 1 64 53 61 44 Germany +49 40 69 69 470 Japan +81 3 5802 7211 Korea +82 2 402 6775 Poland +48 58 661 1879 Spain +34 93 499 05 06 United Kingdom +44 (0)1 353 66 99 11 United States of America +1 805 566 6655 www.dako.com Represented in more than 100 countries Belgium +32 (0) 16 38 72 20 Brazil +55 11 50708300 Denmark +45 44 85 97 56 Finland +358 9 348 73 950 Ireland +353 1 479 0568 Italy +39 02 58 078 1 The Netherlands +31 20 42 11 100 Norway +47 23 14 05 40 Sweden +46 8 556 20 600 Switzerland +41 41 760 11 66 29051 21FEB14