Expand Beyond Routine - Thermo Fisher...

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clinical diagnostics Expand Beyond Routine Expect More Innovation

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clinical diagnostics

ExpandBeyondRoutineExpect More Innovation

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Diagnostic ApplicationsWe focus on high-value diagnostics that help to support the best patient outcomes. With our innovative tools and a portfolio that supports improved workflows, we can partner with you to make the world healthier.

Expect a Partnership

70% of US clinical decisions are based on diagnostic tests

accounting for 3% of healthcare spending

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation2

Source: AdvamedDx - “Infographic The Value of Diagnostics”

Drugs of Abuse

Drug Monitoring

ID/ASTOncology

Prenatal

Sepsis

Transplant

Allergy AutoImmunity

Drugs of Abuse

Drug Monitoring

ID/ASTOncology

Prenatal

Sepsis

Transplant

Allergy AutoImmunity

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Innovative New Products

Prelude LX-4 MD HPLC

The Thermo Scientific™ Prelude LX-4 MD™ HPLC is listed with the FDA as a Class I medical device for general clinical use. The device features four parallel channels, which can deliver up to four different separations to a single mass spectrometer with identical or different methods to enhance sample throughput. Not available in all countries.

• Run more samples with method flexibility

• Increase your confidence in results

• Quantitate with robust and reproducible flow

• Maximize your return on lab investments

For In Vitro Diagnostic Use.

Phadia 2500E

The Phadia™ 2500E Laboratory System is designed for high volume laboratories, delivering approximately 10,000 to 25,000 tests per week, and is built upon the proven performance of Phadia Laboratory Systems in thousands of laboratories worldwide. Phadia Laboratory Systems detect and quantify relevant antibodies in blood samples to identify possible allergy or autoimmune diseases.

High Productivity and Automations

• Throughput: 2400 results in one assay

• Continuous Random Access

• Onboard Dilutions

• Onboard reagent storage

• Accurate, standardized and reproducible test results

For In Vitro Diagnostic Use.

Laboratory medicine is at a crossroads. New diagnostic approaches, emerging business models and deepening connections with clinicians are just some of the massive changes the modern lab faces. By delivering new instruments, consumables, and services with comprehensive workflow solutions, we allow for more cost-effective and efficient disease diagnosis and monitoring.

Powerful Advances

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation 3

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Select Laboratory Offerings

Indiko Plus Total System Solution

Experience an uncompromised level of performance and ease of use with the Thermo Scientific Indiko™ Plus Clinical and Specialty Chemistry analyzer. This fully automated random access benchtop system combined with the extensive menu of barcoded reagents and consumables provides an excellent solution for patient monitoring. This complete system solution offers improved productivity for any size laboratory, providing confidence to daily workflow.

For In Vitro Diagnostic Use.

Drugs of Abuse

We enable today’s clinical laboratory to move beyond the routine with our high performance speciality diagnostics offerings.

Rely on our drugs of abuse testing (DAT) products as a complete solution for your testing program, including sample collection devices, expansive test menu, compact bench-top clinical analyzers, and data management options. Drug screening laboratories around the world test with confidence using our gold standard Thermo Scientific™ CEDIA™ and Thermo Scientific™ DRI™ technologies, widely accepted as the leading methods for testing urine samples. With our DAT solutions, you can obtain accurate and reliable results rapidly for your busy lab.

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation4

Beyond the Routine

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Allergy and Autoimmune

EliA™ Autoimmune Assays

Thermo Fisher Scientific provides automated autoimmune testing solutions on a variety of Phadia Laboratory Systems accommodating the needs of laboratories of all sizes.

The Phadia™ 2500E Laboratory System is designed for high-volume laboratories, delivering approximately 10,000 to 25,000 tests per week, and is built upon the proven performance of Phadia Laboratory Systems in thousands of laboratories worldwide.

For In Vitro Diagnostic Use.

ImmunoCAP Specific IgE Blood Tests

ImmunoCAP™ Specific IgE blood testing provides reliable results that help healthcare professionals better diagnose and manage patients with allergic conditions. These tests are available on the full line of Phadia Laboratory Systems designed to deliver accurate and reproducible test results, increase operational efficiency and shorten turnaround times — from small local clinics to large commercial laboratories.

For In Vitro Diagnostic Use.

Our goal is to deliver quality diagnostic test results that enable healthcare providers to better diagnose and manage allergy and autoimmune diseases. We achieve this by developing, manufacturing and distributing high quality diagnostic technologies.

Select Laboratory Offerings

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation 5

Distinguished Technologies

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The B•R•A•H•M•S PCT sensitive KRYPTOR Assay

Thermo Scientific™ B·R·A·H·M·S PCT sensitive™ KRYPTOR™ is an immunofluorescent assay used to determine the concentration of PCT (procalcitonin) in human serum and plasma. B·R·A·H·M·S PCT sensitive KRYPTOR is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.

PCT is ubiquitously and uniformly expressed in multiple tissues throughout the body in response to sepsis. Muller B, et al., found elevated circulating levels of PCT are important markers in response to microbial infections and a powerful tool in the early detection of sepsis.3 Following stimulus by a bacterial endotoxin or trauma, PCT plasma concentrations:

• Rise 3 – 6 hours after bacterial invasion

• Exhibit peak values between 12 – 48 hours

• Have an observed half-life of 24 hours

This rapid and sustained response to bacterially induced systemic inflammation is an important hallmark of PCT as a marker of sepsis risk. The immunoassay B·R·A·H·M·S PCT can be measured on Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS platform. The outstanding precision is the hallmark of KRYPTOR assay performance based on the TRACE™ method.

Sepsis is a common and frequently fatal medical condition that is the result of the body’s inflammatory response to an infection.1 Angus, D. et al., reported in Critical Care Medicine that 751,000 severe sepsis cases occurred in the US in 1995 and mortality was 28.6%, or 215,000 deaths nationally.2 In 2009, septicemia or sepsis was the single most expensive condition treated in U.S. hospitals. Costs for stays with a principal diagnosis of septicemia totaled nearly $15.4 billion.

Sepsis

Unique Measuring Principle

TRACE™ (Time Resolved Amplified Cryptate Emission) is a fascinatingly elegant method which measures the signal that is emitted from an immunocomplex with time delay based on nonradiative energy transfer from a donor to an acceptor. It is based on the basic research for which the French chemist Jean-Marie Lehn received a Nobel Prize®.

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation6

Select Laboratory Offerings

1. Angus DC, et al., Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care, Crit Care Med 2001;29(7):1303-1310.

2. Elixhauser A, et al., Septicemia in U.S. Hospitals, 2009. HCUP Statistical Brief #122; October, 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb122.pdf

3. Muller B, et al., Ubiquitous expression of the calcitonin-i gene in multiple tissues in response to sepsis. J Clin Endocrinol Metab 2001 Jan;86(1):396-404.

For In Vitro Diagnostic Use.

Early Identification

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Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation 7

Antibody Screening

Thermo Scientific™ LABScreen™ multiplexed antibody assays allow for the rapid and precise determination of antibody profiles against HLA and MICA. Their proven consistency, high sensitivity and reproducibility have set the standard in pre- and post-transplant monitoring.

LABScreen Multi for TRALI

Human leukocyte antigens (HLA) and human neutrophil antigens (HNA) have been implicated in clinical cases of Transfusion Related Acute Lung Injury (TRALI). LABScreen Multi is the only FDA-cleared IVD test capable of detecting HLA Class I and Class II and HNA 1, 2, 3, 4 and 5 antibodies. This high throughput, multiplexed assay is ideal for transfusion centers implementing TRALI risk reduction measures.

For In Vitro Diagnostic Use.

Select Laboratory Offerings

Transplant Diagnostics

As a worldwide leader in HLA diagnostics, our DNA typing and antibody screening tests are used by laboratories worldwide to determine the compatibility of donors and recipients and to monitor patients. We also help researchers expand the boundaries of transplant science through a wide range of research products, including assays and analytical hardware and software.

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Workflows for the Entire LaboratoryThermo Fisher Scientific unites deep scientific expertise, a collaborative culture and rich resources to deliver the lab equipment and consumables you need to achieve your diagnostic goals — quickly, reliably and safely. Our smart lab solutions make it faster and easier for you to focus on what matters most — delivering answers and innovations that save and improve lives.

Collection Preparation Processing Analysis Disposal

Equipment and Consumables to support Clinical Workflows

TransportSwabs

Containers

Refrigerators

Refrigerators

Freezers

Shakers

IncubatorsMixers

Biosafety Cabinets

Micro PlateShakers

Micro PlateWashers

Micro PlateReaders

Autoclave Bags and Holders

PCR Consumables

PCR Consumables

PCR Systems

Water Purification

Systems

Water Purification

Systems

CentrifugesPetri Dishes

Pipettes and Tips Pipettes and Tips

Inoculating Loops

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation8

Delivering Answers

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Microbiology Laboratory

VersaTREK System

The Thermo Scientific™ VersaTREK™ system combines instrumentation, media and software to offer the best in versatility, recovery, growth measurement, VorTrexing™ agitation, reliability and ease of use, all with one-touch access to patient information and reporting. Sensititre ID/AST System

Identify antimicrobial resistance and achieve true minimum inhibitory concentration (MIC) results with the Thermo Scientific™ Sensititre™ ID/AST System, which offers flexible, customizable testing options, from manual to full automation, to accommodate laboratories of all sizes. The Sensititre system’s unique true MIC results, along with custom plate options, provide greater sensitivity and better antimicrobial resistance tracking, which are critical in the fight against resistance. The system provides critical information on the appropriate antimicrobial and dosage to effectively target a particular organism, an important capability in the rise of personalized healthcare and companion diagnostics. Combined with the VersaTREK instrument, the system provides better detection, which means faster results with fewer system limitations.

For In Vitro Diagnostic Use.

Our microbiology portfolio enables laboratories to streamline their clinical microbiology operations with solutions at every step of the workflow, including collection and transport systems, specimen processing, ID/AST and more. Our products help customers worldwide diagnose infectious diseases; determine appropriate antimicrobial therapy; and implement effective infection control programs.

Comprehensive clinical microbiology workflow solutions

We offer clinical solutions that span the entire workflow giving you the power to diagnose infections quickly and accurately for better patient care.

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation 9

Collection & Transport Set your laboratory up for success and choose from a comprehensive offering of collection and transport systems designed to ensure the delivery of healthy and viable organisms.

Identification Get accurate, simple, rapid and convenient solutions for all your organism identification needs, all in one place.

Specimen Processing Maximize your preanalytical processing with an extensive prepared media portfolio, stains and reagents for manual or automation.

AST Optimize workflows and fight antimicrobial resistance with customizable and robust antimicrobial susceptibility testing systems fit for laboratories of all sizes.

Detection & Screening Facilitate early diagnosis of sepsis, control the spread of HAIs and improve patient care with powerful, versatile and cost-effective detection and screening.

Quality Control Put your trust in proven quality control methods and products, for reproducible results and consistent microbiology testing.

Laboratory Supplies Streamline procurement and complement your test program with a complete range of supplies, from loops and needles to environmental systems, to support the entire clinical workflow.

Workflows for the Entire Laboratory

Streamline Operations

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Anatomical Pathology Laboratory

Thermo Fisher Scientific provides a full line of anatomical pathology equipment and consumable solutions that allow laboratorians the ability to produce high-quality results faster and more efficiently. We achieve this by manufacturing products that provide safe, lean workflow solutions that help pathologists make confident diagnoses.

PrintMate AS Cassette Printer

Meet the needs of lean workflow and reduce errors in the laboratory with the fast, reliable Thermo Scientific™ PrintMate™ Cassette Printer, ideal for use in on-demand or high-volume batch printing applications.

TISSUE PROCESSING

Thermo Scientific

Excelsior AS Tissue Processor

Improving processing quality while accelerating results

TISSUE EMBEDDING

Thermo Scientific HistoStar Embedding Center

Ergonomic, high-capacity workstation with LED illumination

MICROTOMY

Thermo Scientific

HM 355S Microtome

Providing safety, comfort and precision cutting

LA

BELING & TRACKING

Thermo Scientific SlideMate AS On-Demand Slide Printer

Reducing patient identification errors while enhancing Lean workflow

COVERSLIPPING

Thermo Scientific ClearVue Coverslipper

Intelligent, automated coverslipping for a perfectly lean workflow

AR

CHIVING & STORAGE

Thermo Scientific Blockstore and Slide Filing Cabinets

High-quality steel cabinets for every storage requirement

HIST

OLOGY CONSUMABLES

Thermo Scientific Histology Consumables

Full range of technically advanced histology consumables

IMMUNOHISTOCHEMISTRY

Thermo Scientific

Autostainer 360 and PT Module

Open and affordable IHC solution for high-quality IHC performance

GROSSING

Thermo Scientific GrossLab Senior Pathology Workstation

Superior quality, value packed pathology workstations

LA

BELING & TRACKING

Thermo Scientific PrintMate AS On-Demand Cassette Printer

Meeting the needs of Lean workflow and error reduction within your laboratory

CRYOTOMY

Thermo Scientific

CryoStar NX70 Cryostat with Cold Disinfection

Fast, safe and complete protection for users throughout the day

STAINING

Thermo Scientific Gemini AS Slide Stainer

Perform multiple staining protocols simultaneously

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation10

SlideMate AS Slide Printer

Reduce patient identification errors while enhancing lean workflow with the Thermo Scientific™ SlideMate™ Slide Printer. Eliminate the need for handwriting or labels by printing text, numbers, linear bar codes and 2-D bar codes directly onto slides.

Workflows for the Entire Laboratory

For In Vitro Diagnostic Use.

Confident Diagnoses

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Supporting Your Lab’s Assay Development NeedsTogether, we are moving medicine forward by bringing you advanced diagnostic tools that enable you to develop and offer innovative diagnostic tests. With years of experience and expertise in high-quality research platforms, we have you covered.

Prelude MD HPLC

Help meet the demand for fast, accurate in vitro diagnostic tests with the Thermo Scientific™ Prelude MD™ HPLC. The Prelude MD HPLC, a Class I medical device, provides automated sample cleanup and two channels of HPLC separation for greater productivity and certainty from laboratory-developed clinical diagnostic tests. Combine the Prelude MD HPLC with the Thermo Scientific™ Endura MD™ mass spectrometer and ClinQuan MD™ software, and get the quantitative accuracy of LC-MS easily and confidently.

For In Vitro Diagnostic Use.

Clinical Diagnostics

Endura MD Mass Spectrometer

Develop in vitro diagnostic tests that leverage the sensitivity, quantitative accuracy, and confidence of mass spectrometry with the Thermo Scientific Endura MD mass spectrometer. The Endura MD instrument, a Class I medical device, combines excellent sensitivity, quantitative performance and robustness with built-in usability to help deliver more value and worry-free results from laboratory developed clinical diagnostic tests. Combine the Endura MD MS with the Prelude MD HPLC and ClinQuan MD software, and get the quantitative accuracy of LC-MS easily and confidently.

For In Vitro Diagnostic Use.

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation 11

Meet the most difficult analytical challenges with Thermo Scientific™ MS solutions, integrating high-performance mass spectrometry with innovative sample preparation technology, superior separation technology and application-specific software.

Moving Medicine Forward

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Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation12

We are committed to providing reliable and easy-to-use solutions, services, and support to meet the needs of molecular and clinical diagnostics laboratories.

Molecular Diagnostics

Supporting Your Lab’s Assay Development Needs

7500 Fast Dx Real-Time PCR Instrument

The Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument with SDS Software is a real-time nucleic acid amplification and five-color fluorescence detection system available for in vitro diagnostic use. The 7500 Fast Dx Real-Time PCR Instrument is designed to deliver the performance required for high-quality results in a 96-well format.

For In Vitro Diagnostic Use.

QuantStudio Dx Real-Time PCR Instrument

The Applied Biosystems™ QuantStudio™ Dx instrument offers your clinical laboratory with performance you can trust, security you demand, and flexibility you need in your workflow to meet the needs of your lab today and tomorrow.

For In Vitro Diagnostic Use.

Easy-to-use Solutions

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Ion PGM Dx Instrument System

The Ion PGM™ Dx System delivers the speed and simplicity of the Ion Torrent™ platform, combined with key workflow advantages designed specifically for regulated laboratory environments and in vitro diagnostic applications.

For In Vitro Diagnostic Use.

3500 Dx Genetic Analyzer CS2

3500 Dx Genetic Analyzer CS2 provides laboratories with reliable, versatile, and innovative tools for molecular diagnostic testing. Based on Sanger sequencing, one of the most widely used, widely trusted sequencing methodologies available, the 3500 Dx Genetic Analyzer CS2 can be operated in either IVD mode (for diagnostic HLA typing using SeCore™ HLA typing kits) or RUO mode (to develop other applications).

For In Vitro Diagnostic Use.

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation 13

The Veriti Dx Thermal Cycler

The Applied Biosystems™ Veriti™ Dx PCR Thermal Cycler provides the reliability of Applied Biosystems 9600 and GeneAmp™systems in an IVD instrument. It features a powerful color touch screen to simplify instrument setup and provides precise control for PCR optimization, the ability to run six different thermal cycling profiles at once, and both Fast and standard PCR modes.

For In Vitro Diagnostic Use.

Supporting Your Lab’s Assay Development Needs

Versatile and Innovative

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Point of Care

Thermo Fisher Scientific is the exclusive global collaboration partner and distributor of Samsung for commercialization and co-development of innovative solutions in the POC testing market. Together we provide excellent expertise in clinical diagnostics to fulfill customer needs and improve patient management.

To answer the healthcare industry’s demand for better point-of-care (POC) diagnostics, Thermo Fisher designs, develops and markets POC solutions in key applications, such as the detection of sepsis, drugs of abuse and therapeutic drug monitoring as well as the detection of cardiac problems and women’s health conditions.

• Assists physicians in rapidly diagnosing bacterial infection

• Delivers results within 20 minutes

• Helps reduce antibiotic consumption, side effects and costs

• Expands addressable PCT market to emergency department and clinics

• Low sample volume requirement (20µL) suits test conditions for neonates, children, elderly

B·R·A·H·M·S PCT™ Direct

Samsung™ Point of Care

LABGEO PT10Chemistry POC analyzer and assays for Lipids, HbA1c, wellness, hepatic, renal and electrolyte panels

For In Vitro Diagnostic Use.

LABGEO IB10Samsung’s immunoassay POC analyzer and assays for cardiac testing, d-dimer, TSH and βhCG

For In Vitro Diagnostic Use.

LABGEO HC10Samsung’s hematology POC analyzer and assays for 3 part diff

For In Vitro Diagnostic Use.

The products listed on this page are not available in the US market and have not been cleared/approved by the FDA

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation14

Demand Better

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Clinical OutcomesOur clinical lab expertise enables us to better understand your needs, source high value diagnostic products and provide tailored solutions. We place a high emphasis on quality-of-care improvement and patient satisfaction enhancement.

Operation EfficiencyWe can improve your operational efficiency by providing the right product at the right place at the right time. Additionally, we offer a wide range of product and supply chain solutions including patient flow improvement and streamlining internal processes.

Financial PerformanceWe provide sustained cost savings, new programs and monitoring tools to help improve your financial performance. We can help you achieve profitable growth.

Through our Fisher HealthCare brand, we deliver the critical solutions and the go-to expertise that enable you to optimize in-house workflows and ensure the very best patient outcomes. We want to help you deliver fast diagnoses to save lives.

Fisher HealthCare Solutions

Clinical Diagnostics: Expand Beyond Routine - Expect More Innovation 15

Optimize Workflows

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Thermo Fisher Scientific products are distributed worldwide. Not all intended uses and applications mentioned in this brochure are registered in every country.

Nobel Prize® is a registered trademark of the Nobel Foundation; KRYPTOR and TRACE are trademarks of CIS bio international, licensed for use by B·R·A·H·M·S, a part of Thermo Fisher Scientific; CEDIA is a trademark of Roche Diagnostics; Samsung and Samsung LABGEO are trademarks of Samsung C&T Corporation. All other trademarks are property of Thermo Fisher Scientific and its subsidiaries. Images of laboratory instruments and settings are the property of Thermo Fisher Scientific. All other images are used under license from Shutterstock.com.

Visit www.thermofisher.com to view our vast product portfolio and learn more about what we can offer© 2015 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

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Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.