[PDF] Dako Pathology Product Catalog 2018-2019





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Hybridizer Robust FISH and CISH Procedures

Dako FISH Probes. Labeled Cell. Regulatory. Lymphoma Research Markers*. Gene. Type. Status. Code. BCL2 FISH DNA Probe Split Signal.



Catalog Products & Services

173 Split Signal FISH DNA Probes. 180 FISH DNA/PNA Probe Mix Code. Product. Package Size. 24. GC206. Dako Omnis Vial with Mixing Ball.



Dako Pathology Product Catalog 2018-2019

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Education Guide Immunohistochemical Staining Methods Fifth Edition

Composition of a Solid tumor FISH Probe Mixture



Dako Pathology

Product Catalog

2018 - 2019

Agilent is committed to the fight against cancer. Leveraging our tremendous strength within pathology, genomics and companion diagnostics enables us to serve you, our pathology customers, with a full breadth of workflow solutions for routine diagnostics. At the same time, we are in a unique position to accelerate the adoption of new groundbreaking technologies from a research into a clinical setting. These new solutions further address critical issues in bringing robust and timely diagnosis to patients. We want to be your dedicated partner that can offer a broad product portfolio of products and the promise of exciting new technologies, with an ever-increasing ability to provide you with solutions that positively affect patient diagnosis and ultimately patient treatment. We are committed to meet your lab's needs, both today and tomorrow. It is this ability to drive innovation and implement game-changing technologies into a diagnostic setting which makes us truly unique. And as we continually develop new and compliant solutions, collaborating with key pathology labs, our pharma partners and leading academic institutions from around the world, we will work together with you to continue to develop technologies which will advance the diagnosis and treatment of cancer. We are here for you and your laboratory, and will continue to do our best to be first choice as a laboratory partner in clinical research and diagnostics, so that together we can provide patients with trusted answers.

2Table of Contents

New Dako La b Contro l

Solutions

Advanced Staining Solutions

20 Dako Omnis Solution for IHC and ISH

35 Autostainer Link Solution for IHC

55 Autostainer Plus for IHC

63 Antibodies and Controls

126 Visualization Systems

137 Ancillaries for IHC

140La beling Systems

pharmDx Solution HER2 TOP2A

Molecular Pathology

HER2

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Table of Contents (continued)

H&E Solution

Special Stains Solution

Dako Acadmy

Service and Support

General Product Information

Indexes

Distribution

Flow Cytometry and Specific Proteins

flow cytometry specific proteins. flow cytometry specific proteins

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New N ew Products

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The stains above are of NSCLC specimens stained with PD-L1 IHC 22C3 phar mDx, Code SK006. pharmDx Solution

PD-L1 IHC 22C3 pharmDx*

For in vitro diagnostic use. PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone

22C3 intended for use in the detection of PD-L1 protein in formalin-

xed, parafn-embedded (FFPE) non-small cell lung cancer (NSCLC), uroth elial carcinoma and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab). See the

KEYTRUDA

product label for expression cutoff values guiding therapy in

specic clinical circumstances.PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying urothelial

carcinoma patients for treatment with KEYTRUDA (pembrolizumab).

See the KEYTRUDA

product label for specic clinical circumstances guiding PD-L1 testing. PD-L1 IHC 22C3 pharmDx may be used to determine PD-L1 status in melanoma patients being considered for treatment. *PD-L1 IHC 22C3 pharmDx is not available in all countries and indications for use may vary by country. 6 The stains above are of non-squamous NSCLC specimens stained with PD-L1

IHC 28-8 pharmDx, Code SK005.

pharmDx Solution (continued)

PD-L1 IHC 28-8 pharmDx*

For in vitro diagnostic use. PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone

28-8 intended for use in the detection of PD-L1 protein in formalin-

xed, parafn-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is dened as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity, as dened by the specic tumor indication staining interpretation guidelines. PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non- squamous NSCLC and SCCHN may be associated with enhanced survival from OPDIVO (nivolumab). PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO

.PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in melanoma may be used as an aid in the assessment of patients for whom OPDIVO

(nivolumab) and YERVOY (ipilimumab) combination treatment is being considered. For details on staining interpretation and relevant clinical cut offs by indication, refer to the product insert and indication-specic PD-L1 IHC

28-8 pharmDx Interpretation Manuals.

*PD-L1 IHC 28-8 pharmDx is not available in all countries and indications for use may vary by country. 7

Melanoma. Stained with Anti-Melan-A.

Hodgkin's lymphoma. Stained with Anti-B-Cell-Specic Activator Protein. Adenocarcinoma of the lung. Stained with Anti-Cytokeratin 7.

Advanced Staining Solutions

Dako Omnis Solution for IHC and ISHHRP Magenta enables you to fully capitalize upon continuous workow on Dako Omnis HRP Magenta enables your lab to integrate 'red' stains into the ro utine IHC workow. You can now have two complementary colors in one workow with just one extra vial, and your lab can load any patient c ase at any time. Load a complete patient case and save time on sorting and/or batching. This gives your lab increased exibility and shortens time to complet ion of patient cases that include 'red' stains. In addition, HRP Magenta slides can be coverslipped with non-aqueous mounting medium, allowing a complete workow alignment with routine

(DAB) slides, saving hands-on time for your technical specialists.HRP Magenta offers a crisp, clear contrast

As a contrast to hematoxylin and pigmentation in tissue, the high-intens ity staining and color nuance make HRP Magenta offer excellent complemen- tary color for your stains.

Code ProductPackage Size

GV900 EnVision FLEX HRP Magenta, High pH

(Dako Omnis) 60 tests

GV925 EnVision FLEX HRP Magenta Substrate

Chromogen System (Dako Omnis) 150 tests

Why is HRP Magenta unique?

HRP Magenta is a unique Agilent invention. Derived from a well-known chromogen used for many years in other industries, the molecule has been chemically modied to t perfectly into HRP-based visualization on Dako Omnis. The stable structure of HRP Magenta offers: A clear transparent color that also makes HRP Magenta ideal for image analysis

Stains that can be permanently mounted

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Diffuse large B-cell lymphoma. Stained with FLEX Anti-CD19. Hodgkin"s lymphoma. Stained with FLEX Anti-CD57.

Advanced Staining Solutions (continued)

New Antibodies Added to the Dako Omnis FLEX

Ready-to-Use (RTU) Portfolio

High-quality lymphatic tissue FLEX RTU antibodies CD19 and CD57 are amongst the most recent additions to the portfolio.

NEW FLEX Ready-to-Use Antibodies for Dako Omnis

Code SourceProductPackage Size

GA611 Mouse mAbActin (Smooth Muscle), Clone 1A460 tests, 12 mL

GA656 Mouse mAbCD19, Clone LE-CD1960 tests, 12 mL

GA602 Mouse mAbCD30, Clone Ber-H260 tests, 12 mL

GA647 Mouse mAbCD57, Clone TB0160 tests, 12 mL

GA629 Mouse mAbEpithelial Membrane Antigen (EMA), Clone E2960 tests, 12 mL

GA512 Rabbit pAbIgG60 tests, 12 mL

GA513 Rabbit pAbIgM60 tests, 12 mL

GA058 Mouse mAbInhibin , Clone R160 tests, 12 mL

GA067 Mouse mAbMyogenin, Clone F5D60 tests, 12 mL

GA662 Mouse mAbp63, Clone DAK-p6360 tests, 12 mL

GA660 Mouse mAbSynaptophysin, Clone DAK-SYNAP60 tests, 12 mL

H&E Solution

New Flexible H&E Staining Intensities

Two new sets of reagents for Dako CoverStainer provide you with the staining intensity that your lab prefers, combined with the unmatched proven consistency and high-quality staining of Dako CoverStainer. The validated and customizable protocols ensure that your lab's individual needs are met, with ease. The Dako Reagent Management System and Dako Ready-to-Use H&E reagents provide you with consistent staining of up to 3,000 slides or 5-days usage, whichever comes rst. H&E is the most widely used diagnostic test in the pathology lab, so consistently stained slides at the intensity you prefer are a necessity for fast and easy reading.Ready-to-Use H&E Reagents

Code ProductProtocol

CS700 Dako HematoxylinDako H&E Staining

CS701 Dako EosinDako H&E Staining

CS702 Dako Bluing BufferDako H&E Staining

CS709 Dako Harris HematoxylinDako Progressive Staining CS711 Dako Modied Eosin YDako Progressive Staining

CS702 Dako Bluing BufferDako Progressive Staining

CS708 Dako Gill's 3 HematoxylinDako Regressive Staining CS710 Dako Eosin Y Phloxine BDako Regressive Staining CS707 Dako Differentiation SolutionDako Regressive Staining

CS702 Dako Bluing Buffer Dako Regressive Staining

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EBER RNA CISH

(Dako Omnis)EBER RNA CISH (Dako Omnis)

Epstein-Barr virus infected

cells detected in small intestineEpstein-Barr virus infected cells detected in lymph node

RNA CISH on Dako Omnis.

Lambda mRNA CISH

(Dako Omnis)Kappa mRNA CISH (Dako Omnis)

Lambda light chain mRNA

detected in lymph nodeKappa light chain mRNA detected in same lymph node

Example of abnormal Kappa: Lambda ratio

Molecular Pathology

EBER, Kappa and Lambda, Positive Control RNA

CISH Probes for Dako Omnis

EBER RNA CISH (Dako Omnis) is intended for the detection of Epstein-Ba rr Virus (EBV) RNA by chromogenic in situ hybridization (CISH) on Dako Omnis and is recommended to be used on formalin-xed, parafn- embedded (FFPE) tissue specimens. Positive staining is indicative of l atent

EBV infection.

Kappa and Lambda mRNA CISH (Dako Omnis) is intended for the detec- tion of Kappa and Lambda mRNA by chromogenic in situ hybridization (CISH) on Dako Omnis and is recommended to be used on formalin-xed parafn-embedded (FFPE) tissue specimens. Positive Control RNA CISH (Dako Omnis) is intended for the evaluation of RNA quality by chromogenic in situ hybridization (CISH) on Dako Omnis and is recommended to be used on formalin-xed, parafn-embedded

(FFPE) tissue specimens.Anti-FITC-AP CISH Accessory Kit (Dako Omnis) is intended for the detection of FITC-labeled in situ hybridization (ISH) probes following

hybridization to formalin-xed, parafn-embedded tissue specimens onboard Dako Omnis. The CISH probes and associated detection reagents enable the auto- mated chromogenic visualization of Epstein-Barr Virus (EBV) RNA and Kappa and Lambda mRNA expression on formalin-xed, parafn- embedded (FFPE) tissue samples. The probes combine Agilent's oligonucleotide-based technology and formamide-free IQFISH hybridization buffer. IQFISH hybridization buffer is a unique, fast hybridization technology that enables CISH results in abo ut

5 hours. The CISH probes come ready-to-use in Dako Omnis vials.

Combining these advancements with the fully automated Dako Omnis provides same-day, hands-free staining. With the short CISH protocol and high slide and reagent capacity, Dako Omnis processes CISH and FISH slides in an IHC-like turnaround time - fast and with high quali ty.

CISH Probes for Dako Omnis

CodeProductPackage Size

G111701-2EBER RNA CISH (Dako Omnis)*20 tests, 2 mL G111700-2Kappa and Lambda mRNA CISH (Dako Omnis)*20 tests, 2 mL G111702-2Positive Control RNA CISH (Dako Omnis)*20 tests, 2 mL K589911-2Anti-FITC-AP CISH Accessory Kit Dako Omnis* 40 tests * Manufactured in Cedar Creek, Texas 10

Breast carcinoma stained with HER2 IQFISH pharmDx. Left: Staining visualized with a double lter (Red/

Green). Right: Image color merged with DAPI (Red/

Green/DAPI). Tumor cells show

HER2 gene amplication. Get brighter signals with IQFISH and dramatically reduce diagnosis turna round time Less repeat testing than with traditional probes saves time and reduces cost Dramatically reduces diagnostic turnaround time from 18 hours to 4 hours IQFISH Fast Hybridization Buffer is non-toxic, which prevents exposure o f lab personnel to toxic formamide

Molecular Pathology (continued)

HER2

IQFISH pharmDx for Dako Omnis

HER2 IQFISH pharmDx (Dako Omnis) is the hybridization probe for the automated direct uorescence in situ hybridization (FISH) assay onb oard Dako Omnis instruments and is, together with accessory reagent devices, designed to quantitatively determine HER2 gene amplica- tion in formalin-xed, parafn-embedded (FFPE) breast cancer tis sue specimens and FFPE specimens from patients with adenocarcinoma of the stomach including gastro-esophageal junction. HER2 IQFISH pharmDx is indicated in adjunction to HercepTest in the assessment of patients for whom Herceptin™ (trastuzumab) treatment isquotesdbs_dbs25.pdfusesText_31
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