Lab Automation Markets

Lab Automation Markets

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The Worldwide Market for Lab Automation has been prepared by Kalorama Information. We serve business and industrial clients worldwide with a complete line of information services and research publications. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-oriented executive by providing a thorough presentation of essential data and concise analysis.

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Author: Joseph A. Constance

Publication Date: July 2008

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CHAPTER ONE: EXECUTIVE SUMMARY...1

Perspective ... 1

Pressures to Automate in the Clinical Lab... 2

Variety of Processes ... 4

Automating the Drug Discovery Lab... 4

Variety of Processes ... 5

Emerging Trends ... 5

Advantages and Trade-Offs ... 6

World Market Summary... 7

Methodology ... 8

CHAPTER TWO: INTRODUCTION...11

Why Automate ... 12

The Clinical Laboratory... 12

The Drug Discovery Laboratory... 13

An Evolving Market ... 15 Key Issues... 16 Work flow... 17 Labor Issues... 20 Operating Costs... 22 Compatibility... 23

Targets for Automation ... 26

Health care Trends Impacting Automation... 32

Automation Equipment Trends ... 33

Total Lab Automation ... 39

Modular Automation ... 42

FDA Regulation... 45

Reimbursement ... 46

CHAPTER THREE: RECENT MARKET DEVELOPMENTS ...49

Labcyte and Allegro Combine Operations ... 49

Agilent Acquires Velocity 11... 50

New Closed-Loop Smart Gripper... 51

Tecan-VWR Alliance ... 51

New Sample Processing Platform ... 52

Automate Sample Preparation ... 53

Test Liquid Handling Instrumentation... 54

High Throughput Flexibility... 55

Robotics Research Lab Established ... 55

Hamilton purchases TekCel ... 55

Workcell Enhancements... 56

Low Temperature Sample Storage... 57

Automated Microplate Processing ... 57

Automation Partnership... 58

CHAPTER FOUR: MARKETS ...59

Overview ... 59

Clinical Lab Automation Markets... 60

Sample Transport Systems... 69

Storage-Retrieval Systems... 71

Work Stations... 73

Specimen Handling Systems ... 74

LIMS ... 77

Drug Discovery Lab Automation Markets ... 80

Plate Readers ... 83

Automated Liquid Handling Systems ... 86

Robotics... 89

Dissolution Testing... 93

LIMS ... 96

Storage-Retrieval Systems... 99

CHAPTER FIVE: CORPORATE PROFILES...103

Abbott Diagnostics ... 103

Agilent Technologies Inc. ... 105

Ai Scientific... 107

Aurora Biotechnologies ... 108

Beckman Coulter Inc. ... 109

BioTrove Inc. ... 112

Caliper Life Sciences... 113

Dynacon Inc. ... 116

Eppendorf AG ... 118

LabVantage Solutions Inc. ... 123

Molecular Devices ... 124

Motoman Inc. ... 126

Olympus Corp. ... 128

PerkinElmer Life and Analytical Sciences Inc. ... 129

F. Hoffmann-La Roche Ltd... 131

RTS Group ... 133

Siemens Medical Solutions USA Inc... 135

Sotax ... 137

SSi Robotics ... 139

PaR Systems Inc. ... 139

The Automation Partnership ... 140

Tecan Group Ltd... 142

ThermoFischer Scientific Inc. ... 144

L I S T O F E X H I B I T S

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: World Market for Clinical Laboratory Automation

Systems 2008-2012 ... 8 Table 1-2: World Market for Drug Discovery Laboratory

Automation Systems 2008-2012 ... 8

CHAPTER TWO: INTRODUCTION

Table 2-1: Median Hourly Wages in the Clinical Laboratory ... 21

CHAPTER FOUR: MARKETS

Figure 4-1: NAACLS-Accredited Educational Programs in Clinical

Laboratory Sciences ... 62 Table 4-2: World Market for Clinical Laboratory Automation

Systems 2008-2012 ... 67 Table 4-3: North American Market for Clinical Laboratory

Automation Systems 2008-2012 ... 67 Table 4-4: European Market for Clinical Laboratory Automation

Systems 2008-2012 ... 68 Table 4-5: Asian Market for Clinical Laboratory Automation

Systems 2008-2012 ... 68 Table 4-6; Rest of World Market for Clinical Laboratory

Automation Systems 2008-2012 ... 69 Table 4-7: Clinical Laboratory Automation Systems US Installed Base –

Major Systems 2006-2012... 69 Table 4-8: World Market for Clinical Laboratory Automation Sample

Table 4-10: World Market for Clinical Lab Work

Stations 2008-2012 ... 74 Table 4-11: World Market for Clinical Lab Specimen

Handling Systems 2008-2012... 77 Table 4-12: World Market for Clinical LIMS 2008-2012... 79 Table 4-13: World Market for Drug Discovery Laboratory

Automation Systems 2008-2012 ... 82 Table 4-14: North American Market for Drug Discovery Laboratory

Automation Systems 2008-2012 ... 82 Table 4-15: European Market for Drug Discovery Laboratory

Automation Systems 2008-2012 ... 82 Table 4-16: Asian Market for Drug Discovery Laboratory

Automation Systems 2008-2012 ... 83 Table 4-17: Rest of World Market for Drug Discovery Laboratory

Automation Systems 2008-2012 ... 83 Table 4-18: World Market for Drug Discovery Lab Plate Readers 2008-2012 ... 86 Table 4-19: World Market for Drug Discovery Automated Liquid

Handling Systems 2008-2012... 89 Table 4-20: World Market for Drug Discovery Robotic Systems 2008-2012 ... 93 Table 4-21: World Market for Drug Discovery Dissolution

Testing Systems 2008-2012 ... 94 Table 4-22: World Market for Drug Discovery LIMS 2008-2012 ... 99 Table 4-23: World Market for Drug Discovery Storage-Retrieval

Systems 2008-2012 ... 101 Table 4-24: Laboratory Automation Market Leaders Percentage

Executive Summary

New technologies based on manufacturing automation have been transforming hospital clinical laboratories and corporate drug development laboratories. Laboratory automation systems and technologies generally involve any device, software or process that improves the efficiency of a laboratory. Ever since the Japanese introduced lab robotics and automation systems in the early 1980s, many laboratories in North America, Europe and elsewhere have installed fully functional automation systems.

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Systems that automate the laboratory are indispensable for laboratories facing difficult market competition. Lab automation technology includes integrated hardware and software designed to process and analyze specimens. In the case of drug discovery, lab automation systems speed the identification of drug targets. Automation hardware can be installed in the form of a complete automation system – total laboratory automation (TLA) — or as discreet hardware devices that perform specific tasks – modular automation.

The purpose of laboratory automation systems is to improve the quality and efficiency of laboratory operations. These systems may provide a solution to the quality demands and staff shortages faced by today's clinical laboratories. On the drug discovery front, lab automation has facilitated drug development by reducing the potential for error

and by facilitating high throughput screening (HTS). Several vendors offer automation systems.

The benefits of automation in the clinical laboratory are well documented. They involve replacing manual, potentially dangerous, error-prone steps with automated processes requiring minimal operator intervention. This approach can increase productivity, decrease turnaround time, improve staff safety, minimize errors, improve the handling of specimens, and allow labs to reallocate personnel to more important and productive tasks. Furthermore, by providing rapid turnaround time for critical tests, the intralaboratory tracking of specimens, and preventing errors in specimen aliquoting, the benefits of automation can reach outside the laboratory to provide a positive impact on patient safety.

For drug discovery, bringing a new drug to market has been both a very time-intensive, laborious and expensive undertaking. Thousands of compounds are typically identified in the drug discovery process, but only a few make it to clinical trials with human subjects. Once a drug reaches clinical testing, another three to six years on average are needed to complete the commercialization process. All in all, developing and introducing a new drug to the market costs about $900 million and takes about 15 years. Given such lengthy development cycles and high research costs, big pharma is always interested in more cost-effective and timely approaches to drug discovery.

Lab automation can be used throughout the pre-clinical drug discovery process, involving microtiter plates, automated analyzers, HTS, robotics and liquid handling systems, among other systems. Automation is not always harnessed to lower labor costs, but also to improve experimental accuracy and work flow efficiency. In drug development, scientists test many samples to measure a drug’s characteristics so the quality of results is crucial. Automation also allows highly qualified researchers to properly analyze results or develop new areas for research rather than undertaking the laborious and repetitive manual steps of an experimental set-up.

Pressures to Automate in the Clinical Lab

Many clinical laboratories are facing a number of issues that are challenging their ability to remain competitive. These challenges have been caused by the reduction of government reimbursement rates for laboratory tests, cost-restraint measures established by the managed care industry, and the continuing trend toward containment of national health care costs. As pressures increase for clinical labs to become more productive and

cost efficient, their management must examine more closely their labs’ internal processes to find ways to increase productivity with smaller budgets. In order to survive in the future, it will be necessary for labs to run more tests; test in fewer sites; operate with less equipment; maintain lower operating costs; hire less skilled labor; and harness additional automation.

Automation will increasingly become crucial for clinical laboratories that want to achieve higher productivity and cost efficiency. Automation helps streamline the work flow and results in a more reproducible process with less hands-on interaction, which can significantly reduce costs and errors, and decrease the need for skilled labor. Automation can help alleviate pending labor shortages caused by retirement. Current professionals are reaching retirement age in disproportionate numbers. Forty percent of medical laboratory employees are between the ages of 46 and 66 according to the American Society for Clinical Pathology, and nearly half of the current workforce will be ready for retirement by 2010. The US Department of Labor's Bureau of Labor Statistics estimates that 13,800 medical laboratory professionals are needed each year through 2012 to fill vacant positions.

One of the main motivators for harnessing automation in clinical laboratories involves minimizing those non-value-added steps, including such processes as sorting tubes, decapping, centrifugation, loading analyzers, and prepping and sorting materials for storage. Non-value-added steps usually can be addressed by automated systems. This frees up a medical technician’s time. Because labor accounts for more than 60% of the cost of producing test results, automation and better information management systems effectively can reduce the manual, hands-on procedures in a lab and optimize the efficiency of labor in the laboratory. Automating a lab increases the available time for value-added steps — the tasks that technologists perform that help make a difference in the quality of the test results and a diagnosis — such activities as reviewing critical results and deciding whether to rerun or perform reflex testing based on a specific result.

When the trend toward clinical laboratory automation first began, in the early to mid 1990s, much of the talk about automation focused on automating all lab functions – total laboratory automation (TLA). Targeted to the largest, highest-volume laboratories, TLA requires a major financial commitment – several millions of dollars — and the space for installing equipment. But TLA is not an affordable nor practical solution for the majority of small to mid-sized hospital and other diagnostic laboratories. The trend for most clinical labs, and for many automation system manufacturers, is toward modular automation, which includes consolidated and integrated analyzers, independent work

cells or self-contained work stations, and automation for transport, handling, and pre- and postanalytical processes.

Variety of Processes

Sample processing is the most labor intensive aspect of a laboratory and is a logical point at which to implement automation. Much automation occurs at a lab’s preanalytical front end. Here, the idea is to increase productivity and achieve faster testing turnaround times. Such automating tasks as sorting samples, loading and unloading centrifuges, decapping tubes, and sorting samples to specific analyzers can quickly improve turnaround times, decrease human error and reduce labor costs.

Consolidating to fewer work stations that have broader menus is an initial step to a more efficient laboratory. This often works best by moving routine analyzers closer in a central sample processing area. The processes that can be automated in a clinical laboratory most often include specimen management, analyzers, modular work cells, and pre- and postanalytical work stations. Of course, controlling automated systems involves the use of software, and for this reason, laboratory information management systems (LIMS) are coming into greater play.

Automating the Drug Discovery Lab

Automation has transformed the drug discovery process by making it feasible to identify many targets through combinatorial technologies that have facilitated compound collection. Automating compound management has minimized late stage drug rejections. The automation market brings an array of tools for the pharma community. Automation eliminates bottlenecks in many processes downstream, facilitating target identification and screening.

The completion of the human genome project heralded the start of HTS that made feasible the screening of close to 100,000 assays per day. Automation has truly given labs a good edge to screening capabilities over traditional processes. TLA has been implemented by some big research laboratories and the top pharmaceutical companies. However, automation has led to the development of few safe and efficacious drugs. While more data can be generated more rapidly, that capability cannot replace the process of asking the proper scientific questions. Automation and the data explosion must be accompanied by increasingly optimized processes for knowledge integration, information flow and decision-making.

Variety of Processes

Drug company laboratory automation systems range from simple semiautomated liquid handling devices to fully integrated automated systems that consist of several pieces of robotics, pipetting stations, incubators, plate washers and detectors. Many laboratory managers initially buy semiautomated work stations that can pipette and deliver small volumes of reagent or wash samples in microwell plates or other vessels for virtually continuously on a daily basis. By freeing lab technicians and scientists from such boring and mundane tasks, these work stations allow workers to spend more time on more value-added activities, such as designing experiments.

Semiautomated work stations can also facilitate the study of drug absorption, distribution, metabolism, and elimination mechanisms that help assess a compound’s ability to penetrate such biological barriers as the intestine, the skin, and the blood-brain barrier.

Robotics also has also found its place in the drug discovery laboratory, often finding application in HTS and assay development. To reduce screening costs and conserve precious compounds and reagents, assay miniaturization has become a critical issue in the laboratory. New liquid handling technology is available to allow the precise measurement and dispensing of liquid quantities in the 10 nanoliter range. Several companies, among them Packard BioScience and PerkinElmer, offer instruments and systems for HTS that incorporate homogeneous assay formats. Applied Biosystems has a wide range of instruments that automate many of the routine laboratory procedures, including chromatography, mass spectrometry, and DNA and peptide synthesis.

Emerging Trends

Certain trends appear to be significantly influencing the future of laboratory automation. These include smaller, more-flexible analyzers and automation based on next-generation technology including microfluidics; powerful software for lab management; and web-based real-time services. These trends will enable successful labs to offer speed and flexibility. Labs will no longer need to make huge investments in large systems to achieve the required productivity. Powerful, smaller systems will do that. Labs will no longer need to wait for the next monthly summary of quality control results to find out how their performance compares with their competitors. Moreover, the technologies that are emerging in microtechnology and information systems will allow in vitro diagnostic (IVD) manufacturers to partner with labs to provide needed productivity.

Laboratory automation and robotics are transforming, and will continue to transform, the typical lab workday. Scientists are now able to set up, run, and analyze the results of experiments in a fraction of the time they needed in the past, with little hands-on interventihands-on. As a result, medical technicians who used to spend their days performing tasks of tedious repetition now have the time to think creatively about the implications of their experimentation and to design effective follow-up projects or develop alternative approaches to their work, or to examine more effectively diagnostic results.

At the corporate level, and particularly for firms involved in drug discovery and clinical diagnostics, automation and robotics are helping companies squeeze the maximum results possible, improving productivity. Automation in the drug discovery lab will continue to be driven by the need for consistency and to reduce errors. Lowering error rates can impact the conclusions made downstream. In addition, organizations increasingly want their research scientists to concentrate on their areas of expertise.

With automation, the world of laboratory medical technicians will change from one that requires them to be on their feet much of the day, running from one system to another, monitoring the progress of the analyzers, and intervening when maintenance or service is required, to one in which they remain seated and monitor the activities of the analyzers. More importantly, the dwindling resources of skilled laboratory technologists will be better used for more-valued activities, such as reviewing test results and analyzing different processes.

Manufacturers will continue to give several of their lab automation products the maximum flexibility in application. And look for the trend to continue toward modular automation rather than TLA. The modular approach offers labs the opportunity to automate only those processes they may need to optimize in order to increase efficiency and productivity. TLA requires a heavy investment in complete lab automation to be applied, potentially automating areas of a laboratory that do not require much of an increase in efficiency.

Advantages and Trade-Offs

Automating a laboratory and all of its processes is not simply a matter of automating a few machines and setting samples up for testing. Lab management and employees must understand what automation entails and how it fits in with their specific situation. There could be some drawbacks to incorporating automation into a laboratory setting. It is possible that lab management could rely entirely on automation to the neglect of written

procedures and following protocol when a system interruption occurs, because of computer, not mechanical problems. What might bring a system down is the failure of computer systems that support and run the entire lab operation, such as a network connection between the lab and the main system.

And automation should not be used simply as a tool to introduce worker layoffs to a laboratory. It might be used to save head counts from growing in the future. But it must be harnessed for making improvements in work flow efficiency and productivity, as well reductions in operating and some labor costs. The advantages of automation lie in generating tests that have multiple advantages over traditional assays, including generating accurate, information-rich data.

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A shrinking number of medical technicians, an increasing need for diagnostic procedures for aging baby boomers, new testing requirements, and the drive to reduce costs are combining to push hospital and clinical laboratories to incorporate more automation. And while drug development labs are already well automated, the drive to further automate them will continue. Automation will continue to be a critical component of pharmaceutical drug discovery, biotechnology and clinical specimen processing. Laboratories are increasingly investing to automate pre- and post- analytical processes because of the long-term cost advantages they offer. With increasing demand for more intensive data gathering and comparison, such as for genomics and other advanced studies, technology continues to rely on automated systems.

Generally, there is more room for automation growth in the clinical laboratory market than in the drug discovery laboratory segment of the market. Pharmaceutical and biotechnology company labs are already heavily automated. There is some room for automation, especially if it optimizes product discovery. But the greatest growth in automation technology in the near future will occur in clinical laboratories, most of which have depended on manual processes and systems in the past. The market for automation systems in the clinical laboratory will grow in the 6% to 9% range annually in the next few years. Automation technology for drug discovery and research laboratories will grow, but in a lesser 3% to 4% annual range. The markets are seen in Tables 1-1 and 1-2.

Table 1-1

World Market for Clinical Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2010 2012

$5.0 $5.78 $6.87

Source: Kalorama Information

Table 1-2

World Market for Drug Discovery Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2010 2012

$3.24 $3.50 $3.78

Source: Kalorama Information

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This report analyzes the current and potential world markets for medical laboratory automation systems and equipment – both for the clinical diagnostics lab and the drug discovery and research laboratory. This report generally offers forecasts future growth to 2012. Market segments covered include: sample transport systems, specimen and liquid handling systems, storage and retrieval systems, work stations, plate readers, robotics, dissolution testing and laboratory information management systems.

This report also reviews the nature and direction of research and trends, and gives insight into some issues facing the industry. The report profiles several companies involved in developing and marketing these systems: Abbott; Agilent, Beckman Coulter, Motoman, PerkinElmer and Siemens, among others.

Market forecasts are based on an examination of current market conditions and on investigations into the development of new products by key companies. The market data provide multiple year forecasts for different product segments covered in the report. The information presented in this report is the result of data gathered from company product literature and other corporate brochures and documents, as well as information found in

the scientific and trade press. In addition, interviews were conducted with company executives and researchers.

Introduction

Lab automation technology essentially involves any hardware or software designed to perform complete specimen processing and analysis, and in the case of drug discovery, systems that speed the identification of drug targets. Automation hardware can be installed in the form of TLA — a complete automation system or as modular automation — devices that perform specific tasks.

Clinical laboratory testing plays a crucial role in the detection, diagnosis and treatment of disease. Clinical laboratory technologists and technicians, also known as medical technologists and technicians, perform most of these tests. Clinical laboratory personnel examine and analyze body fluids, tissues and cells. They look for bacteria, parasites, or other micro-organisms; analyze the chemical content of fluids; match blood for transfusions, and test for drug levels in the blood to show how a patient is responding to treatment. They also prepare specimens for examination, count cells and look for abnormal cells. They use automated equipment and instruments that perform a number of tests simultaneously, as well as microscopes, cell counters and sophisticated laboratory equipment to perform tests. Then they analyze the results and relay them to physicians. The complexity of the tests performed, the level of judgment needed, and the amount of responsibility workers assume depend largely on the amount of education and experience they have.

For the drug development community, automation has impacted the traditional drug discovery process, making it possible to identify many targets through different combinatorial technologies that facilitate the collection and analysis of thousands of

compounds. Compound management automation has minimized late stage rejections of drug candidates. The automation business offers a variety of tools to the biotechnology and pharmaceutical industries. Such tools can help remove many bottlenecks on the route to downstream target identification and screening, and new product introductions.

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The Clinical Laboratory

Automation has evolved into a critical factor dictating the progress and evolution of medical laboratories. Automation is a proactive process, involving a laboratory’s management to an extensive degree beyond the initial decision to purchase equipment. Managers must understand the complexities of automation, and how it fits their own situation. Most lab managers understand that automation is vital for confronting the challenges that lie ahead and recognize the importance of leveraging the opportunities it creates. Automation can help alleviate labor shortages but should not be used simply positions. Still, the shortage of medical technologists is becoming more significant every year as fewer students enter the field. Annually, only about 4,000 people in the US are graduating in the field. Schools are graduating 30% fewer students than about a decade ago and 56% fewer students than about two decades ago.

Current professionals are reaching retirement age in disproportionate numbers. About 40% of medical laboratory employees are between the ages of 46 and 66, according to the American Society for Clinical Pathology, and nearly half of the current workforce will be ready for retirement by 2010. The US Department of Labor's Bureau of Labor Statistics has estimated that 13,800 medical laboratory professionals will be needed each year through 2012 to fill vacant positions.

Automation can help respond to the increased demands that will accompany an aging population. The aging baby boomer population is generating increased demand for medical testing. By 2040, 26% of the US population will be at least 60 years old, up from 16.3% in 2000, according to the Center for Strategic and International Studies, Washington, DC.

Automation optimizes the functioning, effectiveness, and accuracy of a laboratory. Laboratory automation allows for more testing to be performed in a shorter period time. It optimizes work flow processes to provide rapid, accurate and

cost-effective test results. Work station consolidation, which reduces the amount of manual testing that is necessary, often is a result of automation.

Automation can produce a more dynamic and robust laboratory. Automation frees medical technologists to spend more time on the difficult cases that require careful analysis and assessment. Automation can also help a laboratory move from being viewed as an expense into being viewed as a revenue-generating resource. With an increased capacity for testing, a laboratory can expand its client base by serving outside health care facilities in addition to accommodating in-house needs.

An automation system reduces the amount of manual testing required and produces a corresponding improvement in the accuracy of test results. If stringent rules and algorithms are incorporated, there will be less need for further manipulation of samples. Less sample manipulation means fewer opportunities for error. Labs can use the transition time to automation to reevaluate their work flow rules and processes. They can review their autoverification rules or implement new tests that were previously unavailable, whether such tests offer improved precision or provide entirely new testing capabilities. As the amount of throughput increases, more data are generated. The laboratory has to analyze more samples in less time, so decision rules, protocols, and priorities surrounding the data, as well as filtering of the data, need to be taken into consideration.

The Drug Discovery Laboratory

The evolution of genomics, proteomics and systems biology has changed the nature of life science, enabling investigators to study many molecules simultaneously. That ability has led to the creation of large numbers of new potential drug targets and related volumes of information and data. In turn, these events have caused researchers to harness automated procedures that free them from routine tasks and lower the cost of research and development. Lab automation offers benefits beyond allowing scientists to carry out more tasks faster. Automation makes possible a much higher reproducibility of data and better documentation of that information. It enables the production of more data points more easily. Improving the quality of the data makes it possible to perform analyses that were more difficult to perform previously.

The market for lab automation has emerged only in the last decade or so. The evolution of lab automation parallels the development of modern drug discovery. But what really spurred on lab automation’s development was the arrival of a standardized

format microplate. The microtiter plate — the microplate — was originally developed in the 1950s. The plate usually has 6, 24, 96, 384 or even 1536 sample wells arranged in a 2:3 rectangular matrix. Some microplates have been manufactured with 3456 or even 9600 wells. Each well of a microplate typically holds between a few to a few hundred microliters of liquid.

The 96-well microplate format was applied to scientific assays in the 1970s, and has become a ubiquitous tool since. Today, the 384-well format became the norm in high throughput screening (HTS) by increasing the capacity of the original as well as offering less usage of sample, solvents, and reagents. The trend continues with the 1536-well plate. While keeping that number within the same external dimension, the resulting density stretches the ability of most of today’s available liquid handlers and other robotics.

To increase throughput and limit human intervention, equipment suppliers have developed several laboratory automation tools. These range from simple semi-automated liquid handling systems to fully integrated automated systems that consist of robot arms, pipetting stations, incubators, plate washers and other components. To reduce the costs of screening and to conserve compounds and reagents, scientific groups increasingly rely on miniaturized assays. High density formats can reduce assay volumes to low- or even submicroliter ranges. Researchers can purchase microwell plates from several vendors.

Many of the procedures involved in drug discovery are routine and repetitive. For this reason, they are targets for automation. Semiautomated or automated work stations can deliver small volumes of reagent or wash the samples in microwell plates or other vessels constantly for 24 hours. Instruments are on the market that can free researchers from the need to perform or even oversee mundane tasks, permitting them to work on more value-added tasks, such as experimental designs. Handling small volumes of reagents can be difficult because the physics of moving and measuring small volumes differ significantly from what is involved with transporting larger, more conventional volumes. But vendors are moving toward improving that situation.

By incorporating unit automation and some basic techniques, such as the use of microplates and column- and row-wise reagent addition, significant reductions in development times for research have been attained.

An Evolving Market

The lab market requires continuous improvements in automation, as was made clear by Andy Thomson, senior vice president, Centralized Diagnostics, Roche Diagnostics Corp. in IVD Technology, January/February 2007. This is prompting manufacturers to provide open automation products. Mid-volume labs require flexible, powerful analyzers that can function as stand-alone instruments or be linked to other analyzers. Such an approach can minimize sample touches, achieve predictable turnaround times and decrease errors. This trend in expanded connectivity is leading labs back toward total lab automation.

IVD manufacturers are responding by releasing new instruments and technologies that meet such needs. At the same time, many mid-volume labs are beginning to accept automation. As the complexity and cost of automation increase, labs are looking for flexibility in their automation solutions, possibly open solutions that will connect to numerous competing instrument platforms, and offer more testing options and choices. One vendor cannot provide all of the automated testing solutions that labs require. The vendors that can offer cost-effective open automation solutions will gain a disproportionate share of the lab instrument business. Meanwhile, the IVD companies that continue to market closed systems will find it more difficult to meet their customers’ connectivity demands.

In the past, high-volume automation solutions could not be justified in mid-volume labs because the benefits could not outweigh the costs. Large analyzer footprint was another barrier that could not be overcome. IVD manufacturers have been slow to respond to the needs of mid-volume labs due to high development costs. They have either made their equipment less expensively or built it smarter by reengineering their existing equipment. However, by rethinking their existing instrumentation, IVD manufacturers can offer cost-efficient automation products to mid-volume labs.

Essentially, to remain competitive, IVD manufacturers must continue to develop integrated platforms that accommodate multiple reagents and detection technologies, handle multiple-sized tubes, and support intelligent connectivity to automation systems, according to Thomson. To the extent that such features can be synchronized, the resulting platforms will become more compact, more efficient, and less costly. As the required investment for developing new automation technologies increases, laboratories will look for vendors that have the economies of scale to make such significant investments, and the commercial operations and project management resources to deliver and implement complete automation solutions, according to Thomson.

Key Issues

To be successful in the market place, manufacturers of automation equipment must be aware that automating a clinical laboratory involves a number of decisions. Helping labs to address their concerns can facilitate equipment sales. Among the concerns are which areas to automate, what volumes are necessary to justify automation and how to sell automation to management. If automating the lab does not address an organization's major concerns, it will be difficult to sell the initiative to upper level management. A lab must realistically assess its needs. It might be more affordable for a laboratory to automate only high-volume, labor-intensive areas of operation.

When a lot of capital is involved, management wants to see immediate results. Quick results are possible, but only if the most critical area is addressed first. This might be a preanalytical area where inefficiencies were most readily apparent, due to poor work flow design. Equipment suppliers should work with labs to enable them to consider current equipment and to plan for the future. What might be best is an open, non-proprietary laboratory automation system that is modular and scalable. Into such a system can be incorporated existing equipment. Even small labs with staffing problems can benefit from automation if an open, modular system is utilized.

A significant amount of training may be required to break old habits. Until technicians feel comfortable with new processes and procedures, they may slip back into doing things the way they used to. When work flow changes, work styles must also change.

Meanwhile, molecular diagnostics, including proteomics, and computer-assisted image diagnostics, are two big areas that will change the future. As science identifies the genes and their products that impact directly on carcinogenesis and inflammatory conditions, researchers will want to identify these molecules in tissue and essentially create patient-tailored diagnoses. They will examine tissue-gene profiles, which will stratify people in terms of therapeutics. When there is a new therapeutic modality, people will want to know if a gene comes into play.

Regarding the management of lab data and information, laboratory information management systems (LIMS) manufacturers are moving to bring more products to market. Laboratories are generating increasing amounts of data as analytical techniques become more sophisticated. Thus, there is greater pressure on these labs to automate and integrate systems to make use of the additional data. LIMS are key to the enablement of automation, the sharing of information, collaboration and integration across several data

sources. Forward thinking LIMS vendors must form partnerships with software vendors, to ensure that information sharing through LIMS will be possible and easily accessible. Many companies stress that connectivity, internet-based communication, standardization, and automation will continue to be key topics over the next few years.

Lab management continues to look for new solutions. Fueled by growing community testing programs, lab consolidation and a diminishing labor pool, labs are asking for greater productivity from their systems. They can no longer afford to run the bulk of their workload manually or on instruments that merely mechanize the reading steps of the analysis. IVD manufacturers have responded by developing larger systems with larger footprints, but with higher costs. This approach was not too effective, and manufacturers are approaching the limits of improvements on current technologies.

Achieving higher throughput by enlarging capacities, replicating instrument resources, increasing the size of the analyzers, and consolidating tests is facing the physical constraints of lab space availability and lab budgets. The next generation of analyzers must address the size issue by adopting emerging microtechnologies. New technologies, such as microfluidics, will make it possible to create consumables that are much smaller per test unit and which will accomplish functionality that is currently achieved by hardware, such as pumps and tubing. IVD manufacturers are developing new detection and separation schemes that offer improved sensitivity. Manufacturers will also have to improve microfabrication techniques to support such goals.

Working with small total reaction volumes, 100 nl to 50 µl, new analyzers will operate with smaller samples, potentially reducing the amount of blood drawn from patients. And the mechanism involved in sample preparation, sorting and retrieval will evolve to be more cost-effective and offer greater flexibility than current solutions. The smaller lab automation systems will be flexible, offering labs the choice of targeted solutions that provide the greatest advantages while minimizing the costs of additional instrumentation. Labs must also have the option of selecting the automation solutions that best meet their unique needs.

Work flow

Automation helps streamline the work flow and results in a more reproducible process with less hands-on interaction, which can significantly reduce costs and decrease the need for skilled labor. In the future, regardless of their size, more laboratories will be using more automation. Automation optimizes the functioning, effectiveness and accuracy of a

laboratory. It enables technicians to undertake more testing in a shorter period of time. It optimizes work flow processes. This generates rapid, accurate and cost-effective test results. Many laboratories use the transition to automation as an opportunity to reevaluate their work flow rules and processes. While the transition to automation causes operational and management changes in the laboratory, there are ways in which the conversion requires surprisingly little change. If the changeover is successful, laboratory customers will not see any disruption in services, since the outgoing system can typically be run in parallel with the automated system during the final transition stages.

The switch to automation can be surprisingly quick, and preparation usually takes no more time than it does to bring standalone units online. Many laboratory staff can continue to perform the same functions as before, such as providing samples that are ready for testing and receiving results, although the new speed with which results are returned may be surprising.

In order for laboratory management to determine the need and potential benefits of automating laboratory processes, it must undertake a thorough, detailed analysis of the current, preautomation, laboratory processes. Such work flow analyses demonstrate the strengths and weaknesses of the existing process so that an informed decision can be made as to whether automation will lead to a real improvement. As a supplement to internal reviews conducted by laboratory personnel, competing vendors may bring specialists into the laboratory to study and report their findings. In addition to identifying and enabling the correction of some process flaws, these findings reinforce the potential benefits of automation and lay the important basis for developing weighted criteria on which to base the evaluation of competing products.

As an example, a work flow configuration that can make more efficient use of space and is better suited to automation may involve a series of concentric circles representing specimen processing, automated analysis, semiautomated analysis and manual procedures. One feasible configuration would place closest to the specimen processing area the assays for which rapid turnaround time is necessary.

Semiautomated analysis can reside in a second concentric circle outward from specimen processing. Most assays performed in this area require a reasonable turnaround time but are performed on semiautomated instrumentation. The last concentric circle would contain manual assays or assays that can potentially be automated, such as high-performance liquid chromatography systems, other chromatographic procedures and radioimmunoassay procedures. The implementation of such an organizational strategy

may be further individualized into specimen flow by type of specimen, for example, whole blood, plasma, or serum.

Optimal automated specimen flow through the clinical laboratory is based upon proper product line organization. All blood specimens are sent through the specimen receiving area to a line where assays are performed on a whole blood matrix. The tests ordered, such as blood gas analysis, whole blood glucose, total calcium, and ionized calcium, may then be performed. After the whole blood matrix product line is complete, specimens are sent to the specimen processing area, where centrifugation and separation of serum or plasma occur. After centrifugation, the specimens may be sent down a serum or plasma product line, where the appropriate tests are performed based upon previously placed orders.

Once assayed, specimens may be sent to a specimen archive for further testing. Whole blood analysis may also be performed on a cell-counting instrument. Implementing the proper product line configuration for moving specimens eliminates the need to sort all specimens in the specimen receiving area and may obviate aliquoting specimens until they have arrived at the location at which the assay will be performed. Following such a work flow approach will support the successful implementation of an automation platform into the laboratory operation.

Generally, once the policies for a lab have been determined, lab management should examine the work flow model that describes how the lab should function. Different labs will have different structures depending on their mission and how they decide to carry it out. Diagnostic labs are going to have a different structure than research labs.

Following up on a point made previously, equipment suppliers should collaborate with potential lab customers in helping them model their lab’s processes. Modeling laboratory processes results in a graphical description of how the lab works, what the major structural elements are (databases, work flow management systems, document management, etc.), and how they are used. The modeling exercise also provides a means of determining if a potential area is ready for automation. If it is not, the areas where issues exist can be analyzed to determine how much effort and cost it will take to overcome those issues and whether it is worth it. This type of work flow analysis will enable a lab’s management to determine the ability of each process to be part of an integrated work flow system. Rather than using automation products to fix bottlenecks, lab managers should look ahead and determine how they want their labs to operate.

Setting policies and practices that are used to develop all automation projects and a developing a work flow model that shows how each automation element fits into the larger picture will result in a more stable and streamlined operation. And equipment vendors can consult with labs in doing this, and possibly garner equipment sales in the process.

As a lab’s productivity improves, it can add advanced data management capabilities for additional automation. Then, as a budget allows, other systems can be added, including everything from table-based, robotic work stations all the way to linear automation systems that use a conveyor track to move individual sample tubes through the lab. Several large automation vendors offer incremental modular automation solutions.

Automated systems and integrated work flow solutions will improve laboratory processes. For instance, many anatomic pathology laboratories utilize some automated or semi-automated equipment to perform routine tasks. Many laboratories continue to utilize labor intensive work flow procedures that are organized as discrete processes. Both tissue staining procedures and patient record keeping are performed manually. As a result, the quality of tissue staining may vary. Records may contain inaccuracies and differences of interpretation are can occur.

However, the real breakthrough in laboratory automation will occur when several different pieces of automated equipment are seamlessly integrated to provide a continuous work flow environment. Integrating work flow through automation and information technology significantly improves the practice of anatomic pathology, for example, improving the quality and consistency of stained slides, reduce labor costs and eliminate errors in patient records.

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Clinical laboratory technologists and technicians held about 319,000 jobs in the US in 2006. More than half of jobs were in hospitals. Most of the remaining jobs were in offices of physicians and in medical and diagnostic laboratories. A small proportion was in educational services and in all other ambulatory health care services.

But there are labor shortages, and automation can help alleviate them. The attrition of laboratory professionals can be ascribed to a number of causes, among them the coming retirement of those from the baby boom generation; dissatisfaction with

salaries and the position; inadequate training programs; and a lack of awareness among young people about the laboratory professions.

In most institutions, an aging laboratory workforce is a great concern. The baby boom generation is nearing retirement age, which will doubly impact the shortage by expanding the demand for health care while at the same time increasing the shortage of laboratory professionals. Wages are another cause of attrition for laboratory personnel. These have not kept pace with other allied health professions. Because the present workforce is driven more by money than in years past, salary is often the determining factor when selecting a career. The median hourly wages of staff clinical laboratory technologists and technicians in 2005 in various specialties and laboratory types can be seen in Table 2-1.

Table 2-1

Median Hourly Wages in the Clinical Laboratory

Hospital Private clinic Physician office laboratory

Cytotechnoligist $26.39 $31.64 $25.69

Histotechnologis 21.50 21.63 23.29

Medical technologist 21.77 20.00 20.00

Histotechnician 18.50 20.86 18.27

Medical laboratory technician 17.41 16.94 16.63

Phlebotomist 11.70 12.15 11.25

Source: American Society for Clinical Pathology

Job satisfaction is tied to workload, recognition and salary. In many institutions, staffing shortages require the remaining workforce to perform the same volume of tests as a fully-staffed lab. Technicians are asked to work overtime and double shifts, and they are expected to maintain the same turnaround times. This can lead to exhaustion, burnout and increased potential for error. Temporary workers can sometimes help bridge the vacancy gap, but they are difficult to locate and come at a significant cost to the facility.

Clinical laboratory work also remains a hidden profession. Workers are not commonly viewed by the public, thus recognition of their role and responsibility in patient specimen collection and processing is limited. The lack of public knowledge about professional lab opportunities — another problem involved in many shortage situations — is evident when people are questioned about what careers are available in

the medical field. Very few are aware of the variety of careers available in the medical field other than doctors, nurses and paramedics.

Another cause of the lab labor shortage is the increased demand for laboratorians in alternate and complex lab testing facilities. Laboratory personnel are being hired in physicians' office laboratories, clinics, veterinarians' offices, industrial laboratories and research laboratories. For employers, these represent more competition for the limited, available pool of candidates. The volume of laboratory tests continues to increase with both population growth and the development of new types of tests.

Technological advances will continue to have opposing effects on employment. On the one hand, new, increasingly powerful diagnostic tests will encourage additional testing and spur employment. On the other, research and development efforts targeted at simplifying routine testing procedures may enhance the ability of nonlaboratory personnel—physicians and patients in particular—to perform tests now conducted in laboratories.

Although hospitals are expected to continue to be the major employer of clinical laboratory workers, employment is expected to grow faster in medical and diagnostic laboratories, offices of physicians and other ambulatory health care services.

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When automating, several important questions must be asked, including what changes will affect delivery of laboratory results, how can automation improve services, and how can automation decrease operating costs. A laboratory often considers

automation when it is under pressure to reduce operating costs and improve its efficiency. Automationhas the potential to enhance the economic survival of a lab,reduce its operating costs, improve the quality of services, and provide a safer work environment. The need for automationshould be assessed in the context of whether the institution is planning to expand or to just cut costs. Every ramification must be considered. For example, contractual arrangements with unions must be taken into account. This will become particularlyimportant when the system is fully implemented because contractsmay determine who may be laid off. Additionally, needsfor upgrading or changing information systemsand analytical instruments must be assessed.

A successful automation project depends on stakeholder acceptance — the staff and administration, as well as physicians. The employees are most concerned about job

security, but it is important to let them know that automation is a tool that will help improve their job performance. For the administration, the focus needs to be on the financial bottom line, with emphasis on the opportunityfor both revenue enhancement and expense reduction. Physicians are primarily concerned with turnaround times oftest results as well as enhancing the information provided by the tests.

The financial planning involved in estimating the cost of a lab’s automation investment requires projections of revenueand expenses. Equipment vendors may help labs by helping them perform a break-even analysis that shows that automation will reduce costs or enhance revenue. Variousapproaches may be used. A traditional return on investment (ROI) analysis relates net income to investment capital. The formula for calculating a ROI may be refined to take into account sales as well. This approach recognizes thatit might not be beneficial to tie up assets, thereby lowering profitability. The same formula can be used for an expense analysis by keepingsales constant. The net profit margin increases with a reduction in expenses, and with automation, the key expense reduction is for labor. Productivity can be calculated by dividingthe number of tests performed by the total number of paid full-time employees. The calculation of labor savings should take into account how the number of employees will be reduced. With layoffs, there often will be severance or retraining expenses to equip the laid-off employees for other jobs.

There has been a trend away from justifying automationsolely on an ROI analysis because not all of the benefits canbe quantified in financial terms. Automation provides added value by improving efficiency and reducing processing errors, by improving turnaround times, offering automated repeat and reflex testing, enhancing safety and optimizing specimen tracking – all of which directly or indirectly benefit the cost of operations.

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One vendor’s piece of equipment should be able to connect to and communicate with another vendor’s equipment. Labs are looking for more standardization and improved compatibility among different vendor’s systems. Ideally, a laboratory automation system should combine the best components from a variety of equipment vendors. In fact, this is almost a necessity as most vendors are small and specialize in certain versions of automation and analysis equipment, and with the rapid progress in equipment

capabilities, changing components is a frequent occurrence. However, this could be complicated by a lack of standards in component operation and communication.

The laboratory automation community has recognized the need for standards and as a result, there is a trend towards open standards in programming languages and communications protocols to improve the interoperability of devices and software within a system. Standards cover aspects of automation ranging from bar code labels, specimen containers, and carriers to the electromechanical and computer interfaces between devices, automation systems and information systems.

Automation platforms should integrate instrumentation and work stations. An associated challenge is ensuring that systems are compatible. One response to the need for standardized communication is the development of the Health Level 7 (HL7) Standards Development Organization, an international community of health care experts and information scientists that have collaborated to develop standards for the exchange, management, and integration of electronic health care information.

A related issue is the need for compatibility among laboratory robots. Compatibility also comes into play when an automated system would need to work in conjunction with multiwell plates of 384, 96, 24 and 6 wells. Integrated imaging would need to be applied to each well to determine cell growth and clonality, making possible customizable treatments. Full integration with external data systems for the automated selection of positives and the recording of cell line history would be a requirement too.

On the drug discovery front, standards have been developed for specific instruments, such as high-performance liquid chromatographs, mass spectrometers, nuclear magnetic resonance spectrometers, infrared spectrophotometers, and ultraviolet spectrophotometers. But many standards have been successful only in very narrow areas. Economic drivers for broad standards are not strong in small volume, highly fragmented markets.

Some systems differ with regard to which size and type of tubes can be processed. Some systems have tube carriers or racks that can handle any size of tube, but the centrifuge, decapper, aliquoter, or recapper may not be so versatile. In some systems, larger tubes must be decapped or centrifuged manually. Some vendors may be able to accommodate different sizes, but laboratories may have to standardize to a single tube size. Laboratories, especially those with many outpatient or off-site locations, should not underestimate the challenge of standardizing tube size and type. In addition, some

systems handle previously spun, uncapped tubes differently from capped, unspun samples, such that the former need separate, manual handling.

The capacity and functionality of each centrifuge in a lab may differ, depending on the system. Some tracks can accommodate all types of tubes, but some centrifuges cannot. A mechanism that balances different-sized tubes is important because prebalancing the tubes or placing the tubes individually in the centrifuge may delay processing. The number of centrifuges that can be connected to the track must be considered, especially in higher-volume laboratories or in laboratories with a high frequency of stat test requests. In addition, multiple centrifuges may be necessary for laboratories contemplating automation of coagulation testing.

The design of an automation system and analyzers dictates how an analyzer will connect to a track. Two different types of connections are common. Point-in-space sampling involves the direct sampling of the primary tube or an aliquot from the track, and robotic arm sampling involves removing the specimen from the track temporarily. Each option has slight variations, including the amount of sample manipulation required and the length of travel to the analyzer. Point-in-space, direct-from-track sampling decreases turnaround time by reducing the distance a sample must travel and eliminating or reducing a line up of samples at each analyzer. But shunting samples to long dedicated queues or using a robotic arm for each analyzer can lead to delays and impair ability to perform stat assays without manual intervention. Although most laboratories experience little downtime for the tracks themselves, it is important to understand the mechanism by which specimens can be loaded onto the analyzers when the track is inoperative.

The processing of pediatric microtainers, urine and fluid specimens is generally different from routine blood samples, and laboratories with a high percentage of these samples may find themselves processing a lot of samples manually even after automating. No automation system can process these nonstandard specimens.

Manufacturers of several systems claim to accept analyzers from other vendors. The option to integrate different vendors on the track may warrant some thought, although it would be important to specify how troubleshooting and intercomponent communication would occur if multiple vendors were used. Commitment of individual vendors to long-term support of third-party analyzers connected to their automation system, including both hardware and software upgrades, also needs to be clarified.

Interaction between different software programs occurs at many levels in an automation system, and successful systems require smooth, seamless, and fault-free

integration of these programs. Multidirectional, coordinated communication must link the management information system, preanalytical processing components, the specimen transportation system, analyzers, and the postanalytical archiving system. Ideally, an operator should be able to use one screen to monitor and manage the entire system. Middleware is software that connects various components or applications. It is software that can help a lab’s large information system communicate and assign special processing tasks to equipment. Most vendors offer middleware that enables automatic release of results, which can be customized as needed by the laboratory, but the ease of programming these rules may differ, depending on the middleware solution. If other vendor systems can be connected, the different software systems must be integrated seamlessly.

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Although it may still seem radically innovative in the context of many clinical laboratories, automated production in the manufacturing sector had been the norm for many years. In laboratory science, however, a technician-intensive work process has remained commonplace. Some labs are aggressively catching up. Dwindling reimbursements, evolving technology and the persistent shortage of qualified technologists have stimulated decisions to automate an increasing number of pre-analytic functions.

Lab automation entails a broad array of processes that occur in the lab — from the receipt of the sample to the reporting of the validated results. These processes range from labeling and transporting tubes to reagent reloading and sample storage. Any or all of these processes can be automated, whether the lab's goal is to have system-based, modular work cells or TLA.

One target of automation in clinical diagnostics is to minimize non-value-added steps, such as processes like sorting tubes, decapping, centrifugation, loading analyzers, and sorting for storage. Such non-value-added steps can all be handled by automation components. This, in turn, frees up the technician’s time. Because labor accounts for about two-thirds of the cost of producing test results, automation and better information management can reduce the manual, hands-on steps in a lab while improving a staff’s productivity.

Another automation target: laboratories handle and process several types of test tubes. The test tubes vary in shape, length and diameter. Their caps vary in size, shape

and functionality. Most importantly, however, the tubes contain different additives. Vacuum test tubes commonly used for blood collection have color-coded caps indicating substances that may have been added to pre-treat blood or preserve it for processing. The additives in each tube are designed to optimize the results for specific tests and should not be intermixed. So, the color of each cap must be accurately identified to achieve a successful outcome.

It is important to perform cap inspection, and automation can help with this task. Studies have shown that a significant majority of all laboratory errors are caused during the pre-analytical phase. Test tube handling prior to the analytical process can directly affect the outcome of a test. While clinical labs already use bar codes to automate the identification of test tubes and reagents, much of the preliminary sorting of multiple sized tubes is still performed by hand. Cap inspection advances the tube identification process by avoiding sorting errors.

On one front, megapixel imaging technology can provide important tube and cap information before laboratory testing is performed. By applying data about each test tube and cap, lab automation can automate the handling and sorting of differently sized tubes by identifying colors and providing diameter measurements. Increasing instrument intelligence can also help automate complex sorting applications. In order to automate 80% of a large, international reference lab’s test volume, the automation system may need to sort more than 1,000 different tests each day. The data provided by cap inspection makes this challenge much easier.

Lab automation can prevent pipette crashes by determining if a decapping operation is successful or, if closed container sampling is implemented, whether a given cap type can be pierced. Automation can streamline the fluid aspiration process.Test tube and cap data make it easier and faster to perform the calculations needed to determine the distance the probe or pipette must travel after the liquid is detected. Automation also can reduce carry-over by giving lab instruments the data needed to calculate the precise distance to extend the probes. By minimizing excess exposure of the probe to serum, labs can reduce the amount of liquid waste generated by washing the probes after each aspiration.

To perform cap inspection, an imaging system measures each test tube and cap and matches the dimensions to test tube profiles stored in a database. Once the imager finds an exact match, it transmits the tube and cap data, along with the decoded symbol data, to an instrument. A well-engineered imager can inform the instrument with the