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Catalog Products & Services

2016

Dear Valued Customer,

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 trusted answers 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. In this years catalog, we are pleased to present several new products, including 15 new FLEX Ready-to-Use antibodies for Dako Omnis, new SureFISH* probes and an IQFISH Panel for Lung Cancer. In addition, we are working closely with several pharma partners to very soon bring you the most important tests in recent cancer treatment history for PD- L1 testing. These products, currently only available in the United States, are the most recent example of our leadership in the diagnostics space, as the first company providing

FDA-approved tests for PD-L1.

We hope you enjoy reading and using the new catalog. 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.

Sincerely,

Christian Sauber

Vice President and General Manager Pathology Division * SureFISH probes are manufactured by Agilent Technologies, Inc. 2

7New Products

10 Presentation of Dako Solutions

14 Experience a new level of lab control and insight

18 Introduction

21 Dako Omnis

23 IHC Ancillaries and Accessories

24 ISH Ancillaries and Accessories

25 pharmDx Kit

26 Primary Antibodies (FLEX Ready-to-Use)

33 Negative Controls (FLEX Ready-to-Use)

34 Visualization Systems (EnVision FLEX)

36 Autostainer Link 48

37 Ancillaries and Accessories

38 PT Link, Instrument and Accessories

39 pharmDx Kits

40 Primary Antibodies (FLEX Ready-to-Use)

53 Negative Controls FLEX Ready-to-Use

53 Visualization Systems (EnVision FLEX)

54 Optional Reagents (EnVision FLEX)

54 Doublestaining System (EnVision DuoFLEX)

55 Ancillaries and Accessories

56 pharmDx Kits (Dako Autostainer)

57 Primary Antibodies (FLEX Ready-to-Use)

60 Negative Controls (FLEX Ready-to-Use)

60 Visualization Systems (EnVision FLEX)

61 Optional Reagents (EnVision FLEX)

62 Visualization Systems

64 Overview of FLEX Ready-to-Use Antibodies

74 Primary Antibodies

119 Antibody Cocktails

121 Multipurpose Antibodies

123 Secondary Antibodies

125 Control Reagents

127 Overview of Dako Visualization Systems

128 Overview of EnVision FLEX and FLEX+ Visualization Systems

130 EnVision FLEX Systems

132 EnVision FLEX Single Reagents

134 EnVision DuoFLEX System

135 EnVision Systems

136 Other Visualization Systems

137 Chromogenic Substrates

137 Blocking Reagents, Buffers, Diluents

138 Counterstains

139 Mounting Media

139 Proteolytic Enzymes

139 Dako Pen, Slides and Pascal Quality Strips

140 Label Printers

141 Slide Labels

145 Introduction

147 c-Kit pharmDx Kits

148 EGFR pharmDx Kits

150 ER/PR pharmDx Kits

152 HercepTest Kits

156HER2 pharmDx Kits

160TOP2A IQFISH pharmDx

Kit

163 Introduction

164 Hybridizer Instrument

165 CISH and FISH Kits

165 Overview of Dako FISH and CISH Kits

166 Dako DuoCISH Kit

167HER2 pharmDx Kits

172 Telomere PNA FISH Kits

173 FISH Probes

173 Split Signal FISH DNA Probes

180 FISH DNA/PNA Probe Mix

181 IQFISH Panel for Lung Cancer

183 SureFISH ALK/RET/ROS1 Probes

184 Labeled Probes and Detection Systems

184 Human Papillomavirus DNA Probes

185 GenPoint Amplified Signal Detection System

3 (continued)

186 Standard Nucleic Acid Detection System

186 PNA Probes and Detection System

187 ISH Ancillaries and Accessories

190 Introduction

191 Dako CoverStainer

192 Coverslipper for Glass Slides

192 Ancillaries and Accessories

196 Introduction

197 Artisan Link Pro Special Staining System

199 Artisan Accessories

200 Artisan Link and Link Pro Special Stains

202 Artisan Special Stains

208 Introduction

209 Training

214 Literature

215 e-Learning

216 Events

218 Introduction

219 Deployment Services

220 Instrument Services

221 Application and Technical Support

222 Instrument Service Agreements

224 Monoclonal Antibodies

224 Polyclonal Antibodies

225 Biotinylated Antibodies

225 Alkaline Phosphatase-Conjugated Antibodies

226 Peroxidase-Conjugated Antibodies

227 Fluorescein-Conjugated Antibodies for Tissue Staining

228 Rhodamine-Conjugated Antibodies for Tissue Staining

230 Alphabetical Index

251 Synonym List

254 Antibody Clone Index

256 Product Code System

257 Product Code Index

276 Dako Sales Offices and Distributors

Reagent Partnership Division provides Dako"s clinical diagnostic products within the area of flow cytometry and

specific proteins. The Division focuses on two business areas:

Retail sales of IVD-approved products within the areas of flow cytometry and specific proteins, including a

broad range of assays for turbidimetry OEM bulk sales and assay development of antibody solutions and kits with special expertise in assay development and validation for turbidimetric platforms To acquire a product catalog for Flow Cytometry and/or Specific Proteins, please contact rpsupport@agilent.com or visit our homepage www.dako.com/index/products.htm.

New in 2016

New Products7

Presentation of Dako Solutions10

6 7

New Products

pharmDx Solution

Advanced Staining Solutions

Dako Omnis Solution for IHC and ISH

FLEX Ready-to-Use Antibodies for Dako Omnis

PageCodeProductPackage Size

ISH Ancillaries and Accessories for Dako Omnis

PageCodeProductPackage Size

8

New Products (continued)

Advanced Staining Solutions

(continued) Autostainer Link Solution for IHCH&E SolutionDako CoverStainer Slide Rack (Code CS119)

PT Link

PageCodeProductPackage Size

PT Link Accessories

PageCodeProductPackage Size

9

New Products (continued)

Molecular Pathology

IQFISH Panel for Lung Cancer

PageCodeProductPackage Size

SureFISH* Probes

PageCodeProductPackage Size

ISH Accessories

PageCodeProductPackage Size

Instrument

connectivity

Get the full picture with Dako Solutions

IHC FISH CISH 10

Autostainer Link

Dako CoverStainer

Artisan Link Pro

DakoLink

workstation

Companion Diagnostics

11

Dako Lab Control Solutions

Experience a new level of lab control and insight14

True Positive ID

14

Dako Lab Control Solutions

Experience a new level of lab control

and insight

The DakoLink and the DakoLink Omnis

DakoLink True Positive ID (TPID)

Dako connectivity for total lab control

DakoLink

15

Advanced Staining Solutions

Introduction18

Dako Omnis Solution for IHC and ISH20

Autostainer Link Solution for IHC 35

Autostainer Plus for IHC 55

Antibodies and Controls 63

Antibody Cocktails 119

Multipurpose Antibodies 121

Secondary Antibodies 123

Control Reagents 125

Visualization Systems 126

Ancillaries for IHC 137

Labeling Systems 140

18

Advanced Staining Solutions

Introduction

Introduction to the

Advanced Staining Solutions

We listened. We responded.

Our commitment to advancing pathology begins with something very simple - listening. By listening carefully to pathologists and lab personnel around the world, we learned that there is growing pressure to: Manage increasing slide volumes with limited personnel and financial resources Process slides faster, to minimize time to diagnosis Cope with fluctuations in workload without sacrificing turnaround time Improve quality control of processes and secure consistency in quality Increase the traceability of patient samples to enable accreditation

Find and retain well-trained, qualified staff

With almost 50 years of dialogue with our customers, We have helped drive scientific advancement and certainty in cancer diagnostics. We remain committed to delivering novel solutions and innovative technologies which support you to meet the challenges of today and tomorrow.

Dako Omnis. Developed by the lab for the lab.

Developed together with pathologists, lab managers and lab technicians from around the world, with the needs of the pathology lab very much in focus. Dako Omnis builds on our reputation for delivering quality reagents and staining solutions that bring certainty to cancer diagnostics.

Dako Omnis provides:

A true automated, walk-away solution

High throughput and overnight capacity

Same-day IHC and ISH provides complete patient case management Unparalleled onboard capacity of temperature-controlled reagents Increased productivity with limited setup and minimal maintenance time Dako Omnis delivers what pathologists, lab managers and technicians are asking for in terms of time, choice and better patient care.

One supplier. Two choices.

With the addition of Dako Omnis, we can now deliver a unique and flexible combination of comprehensive advanced staining solutions. These solutions can be used independently or together, to help you meet the individual needs of your lab, without compromising on quality and consistency results. Speak to your local representative to assess which solution addresses the needs of your lab now and in the future. Dako Omnis is a generation ahead in IHC and ISH. Parallel or batch loading, the choice is yours. With a high throughput and full automation, this is a true walk-away solution. A controlled onboard environment facilitates unattended overnight processing of patient cases. Autostainer Link 48 is a compact, bench-top, open system that delivers the flexibility required in a research and clinical environment. Adaptable to your individual setup, and helps to maximize productivity by the decoupled pre-treatment and the ability to run either large batches of up to 48 IHC slides, or mini batches. 19

Introduction

Advanced Staining Solutions

The Dako FLEX RTU solution

Ensures optimal staining results, slide after slide

Plug and play on Dako advanced staining platforms

FLEX RTU antibodies

EnVision FLEX

visualization system

Validated protocols

20

Advanced Staining Solutions

Dako Omnis Solution for IHC and ISH

Dako Omnis Solution for IHC and ISH

Dako Omnis meets the challenges of the modern pathology lab. It accommodates an increasing number of diverse, advanced staining methods in an increasingly unpredictable working day. Dako Omnis achieves this by automating any advanced staining method using a simple interface with little hands-on time. Lab staff can deliver consistent

IHC and ISH results with minimal training.

Continuous sample loading allows prioritized patient cases to stream seamlessly into an ongoing workflow. With turnaround times of less than four hours for FISH slides, they are ready within the same time frame as IHC slides. Dako Omnis delivers consistent results in IHC and ISH, regardless of operator experience. The system logs operator actions and built-in controls reduce possible human errors.

Dako Omnis gives more time

Process 165 IHC slides in a typical workday, including setting up overnight runs Handle the workload with fewer instruments thanks to an unparalleled capacity Enable faster diagnosis of whole patient cases with same-day IHC and

ISH results

Minimize hands-on time with automation designed for the clinical laboratory Free up lab techs for other tasks thanks to accurate run-time information

Dako Omnis allows greater choice

Choose continuous loading to match patient cases, or load in batches to utilize full through-put capacity Absorb peaks in workload by processing up to 60 slides in unattended overnight runs Eliminate operator waiting time by loading slides and/or reagents anytime, also during runs, while keeping an optimal throughput because runs continue uninterrupted during the loading Ensure transparency by enabling staff to monitor the slide flow from their workstations

Dako Omnis enables better patient care

Get results with ease and greater certainty thanks to the FLEX Ready- to-Use reagents and optimized protocols Increase lab quality and staffing options because Dako Omnis minimizes the risk of human error Facilitate lab accreditation and improve patient safety by automatic tracking and reporting Apply patient case workflow while optimizing capacity utilization thanks to the 5-slide racks Achieve consistent staining conditions with temperature-controlled and humidity-controlled staining chambers alongside temperature- controlled reagent positions 21

Dako Omnis Solution for IHC and ISH

Advanced Staining Solutions

Dako Omnis

Dako Omnis provides

IHC and ISH automated on the same platform

Compensate for increasing fluctuations in workflow

Monitor and control your staining workflow

Manage increasing slide volumes with limited resources

Dako Omnis

C 22

Dako Omnis (continued)

Advanced Staining Solutions

Dako Omnis Solution for IHC and ISH

Hardware Specifications

Features

Processes

Fully automated and simultaneous IHC and/or ISH

Deparaffinization, staining and counterstaining with parallel processing

Operation

Continuous or batch workflow

5-slot racks to optimize capacity utilization and patient-case

management Reagents and slides can be loaded anytime, also during runs Easy-to-use software interface and ready-to-use reagents

Built-in controls to reduce possible human errors

Staining conditions

Temperature controlled onboard reagent storage

Dynamic Gap staining technology

Temperature and humidity controlled processing environment FLEX RTU reagents and protocols for optimal staining results

Connectivity and control

LAN seats for setup and monitoring from anywhere

Full integration with Laboratory Information Systems

1D and 2D barcodes

Data logging, reporting and access rights for traceability and accreditation Learn more about Dako Omnis by visiting www.dako.com/omnis

Turn-around timeIHC: 2 hours 30 minutes

ISH: 3 hours 40 minutes

Throughput165 slides can be loaded in a typical workday (including preparation for an overnight run) Slide capacity 60 slides for IHC or ISH (up to 15 ISH slides)

Reagent capacity60 reagent vials

Bulk fluid capacity8 x 3.5 L bottle and 4 x 7 L bottle

Waste capacity4 x 7 L bottle (non-hazardous)

1 x 7 L bottle (low-hazardous, below limit values)

Dimensions57.1" W x 31.2" D x 60.4" H (145 cm W x 79.3 cm D x 176.3 cm H)

Weight1,323 lbs (600 kg) fully loaded

Voltage120/220-240 VAC

Power consumption1200 W

23

Dako Omnis Solution for IHC and ISH

Advanced Staining Solutions

IHC Ancillaries and Accessories (Dako Omnis)

Clearify

TM

DAB+ Substrate Chromogen System (Dako Omnis)

C

Hematoxylin (Dako Omnis)

C

IHC Microscope Slides, FLEX

C

Mixing Strip, for Dako Omnis

Reagent Vial, Small/Large, for Dako Omnis

Slide Rack, for Dako Omnis

Slide Rack Color Clips, for Dako Omnis

Sulfuric Acid, 0.3 M, for Dako Omnis

Wash Buffer (20x) (Dako Omnis)

C 24

Advanced Staining Solutions

Dako Omnis Solution for IHC and ISH

ISH Ancillaries and Accessories (Dako Omnis)

Fluorescence Mounting Medium (Dako Omnis)

CGM304Ready-to-use20 tests, 0.8 mL

Fluorescence Mounting Medium (Dako Omnis) is intended for mounting of formalin-fixed, paraffin-embedded (FFPE) tissue sections after FISH staining performed onboard the Dako Omnis instrument. The mounting medium also contains 500 µg/L DAPI for improved nuclei staining.

ISH Cleaning Solution (Dako Omnis)

CGC207 Ready-to-use NEW100 tests, 10 mL

ISH Cleaning Solution (Dako Omnis) is an accessory to the Dako Omnis instrument. It is used for cleaning the pipette tip between dispenses of in situ hybridization probes. Washing with ISH Cleaning Solution dissolves ISH probe, allowing remaining probe to be effectively washed away with water. The product is provided in a ready-to-use vial for the Dako Omnis instrument.

ISH Ethanol Solution, 96% (Dako Omnis)

CGM300Ready-to-use 20 tests, 14 mL

ISH Ethanol Solution, 96% (Dako Omnis) is intended for use in automated in situ hybridization assays together with the Dako Omnis instrument on formalin-fixed, paraffin-embedded (FFPE) tissue sections. The solution is used in the wash step after target retrieval. The product is provided in a ready-to-use vial for the Dakoquotesdbs_dbs25.pdfusesText_31