Market Demand

Makers of clinical chemistry and integrated analyzers look to meet shifting customer needs

By Gary Tufel

For manufacturers of clinical chemistry and integrated analyzers, responding to customer needs and changes in the healthcare marketplace requires constant vigilance and a willingness to reshape business plans and product lines in a timely fashion.

Unquestionably, the healthcare sector is undergoing significant changes. Hospital closures and the corresponding consolidation of existing laboratories, for instance, are creating a need for higher volumes of testing in labs where, previously, low or medium volumes were all that were needed. And although product updates are already common in this competitive environment, these and other factors add even greater impetus for manufacturers to update the features of existing analyzers or create new ones. The results include some truly remarkable advances in analyzer performance and features, including significant increases in throughput that ultimately benefit both patients and labs.

In addition to throughput, analyzers’ physical size and menu of available tests are also important. Randox Laboratories, Kearneysville, W Va, for instance, offers big functionality in a small footprint with its RX Monza, a compact semiautomated clinical chemistry analyzer with the functionality of a much larger, fully automated instrument. The analyzer’s versatile and easy-to-use software, flexibility to perform both clinical chemistry and coagulation testing, and extensive RX series test menu, enables labs to provide complete patient profiling as well as routine and specialized testing.

In vitro diagnostic (IVD) manufacturers respond to changes in the healthcare sector by creating analyzers with new capabilities and feature sets, including greater use of automation, increases from low- or medium-volume to high-volume devices, and upgraded technology to offer a wider array of tests and provide faster and more accurate results. This article looks at a handful of specific product examples showing how IVD companies are responding to a shifting healthcare environment.

ON THE MENU

In a market with highly varied demands, flexibility can also pave the way to success. A case in point is the ChemWell Fusion model 4800 by Awareness Technology Inc, Palm City, Fla, a user-programmable, PC-controlled, fully automated, open system analyzer capable of performing enzyme-linked immunosorbent assay (ELISAs) and chemiluminescent immunoassays on the same instrument.

“The ChemWell Fusion analyzer offers ELISAs and chemiluminescent immunoassays in one compact open system,” says Jamie Ristaino, director of sales at Awareness Technology. “The analyzer can perform both types of assays on the same microwell plate utilizing eight-well strips, or function as a dedicated ELISA or chemiluminescent immunoassay analyzer using standard 96-well microplates. ChemWell Fusion gives clinicians freedom of choice when it comes to the assays and methods they wish to utilize within their laboratories.”

Launched in 2014, the Stat Profile Prime, by Nova Biomedical, Waltham, Mass, is a blood gas analyzer that combines advanced microelectronics with individual cartridges that incorporate biosensors, calibrators, and liquid quality control. The platform offers simple operation, and uses Nova’s zero maintenance and clot block technologies to maximize uptime and keep clinicians closer to their patients.

“We have been very pleased with the launch and market impact of the Stat Profile product line,” says Brad Bullen, core product manager at Nova Biomedical. “The Prime analyzer that we’ve added to this lineup uses our zero maintenance cartridge technology to produce quality results.”

For many IVD companies, responding to market demand means adding more tests to an analyzer’s existing menu. “We continue with menu expansion for the Thermo Scientific Indiko and Indiko Plus analyzers, including new drugs-of-abuse assays, new offerings in the oral fluids field, applications for therapeutic drug monitoring, and a full menu of immunosuppressant drug monitoring immunoassays,” says Kevin J. Barta, niche products marketing manager in the clinical diagnostics division of Thermo Fisher Scientific, Waltham, Mass.

Selecting which tests to prioritize for development, regulatory clearance, and addition to an analyzer’s already overflowing offerings can make for a tough call. Not every test has a ready-made market or offers growth that can justify the substantial resources needed to include it on the menu. But the need to be responsive to calls from the marketplace can make a decision easier.

“Growth in the niche market for drug monitoring is mature and steady,” says Barta. “But we continue to focus on customer needs and requests for new immunoassays.”

MEETING THE MARKET

With hospitals across the country undergoing significant consolidation and rebalancing in response to emerging healthcare reform policies, existing clinical labs are also under pressure to consolidate and take on the workload of labs that are being phased out. Meanwhile, the growing number of accountable care organizations (ACOs) is also seeking to right-size their commitment to clinical laboratories, ensuring that member populations in all of an ACO’s healthcare settings have access to testing.

Sometimes, companies seeking to meet the needs of their target market also have to deal with changing performance standards or regulatory requirements. Being able to respond quickly to such shifting demands can put a manufacturer’s new products in a favorable position relative to the competition.

“The blood gas, electrolyte, and metabolite point-of-care market is going through a time of transition,” says Bullen. “Beginning on January 1, 2016, such instrumentation will be held to more rigorous quality control standards than in the past. We anticipate that products such as our Stat Profile Prime will replace many existing handheld or single-cartridge systems. In the space where many separate products would previously have been used, a single Prime instrument would operate, without changing the clinician’s workflow.”

Analyzers already on the market offer widely varied throughput, responding to the differing test volumes handled by laboratories in different settings. The Architect series of integrated analyzers by Abbott Diagnostics, Abbott Park, Ill, encompasses three instruments with high, medium, and low throughput. At the high end, the Architect ci16200 can perform 2,000 tests per hour, including 1,800 clinical chemistry tests and 200 immunoassays. The system is designed to meet the needs of large hospital and reference labs that handle a high volume of tests, but need the streamlined performance of clinical chemistry and immunoassay tests on a single platform. Other integrated analyzers in the Architect line offer throughput and features better suited for labs with a lower volume of testing.

Analyzers by other manufacturers are equally tailored to their target markets. The Ace Axcel clinical chemistry analyzer by Alfa Wassermann Diagnostic Technologies LLC, West Caldwell, NJ, offers medium-volume throughput of 285 tests per hour, with performance aimed primarily at reference labs, physicians’ offices or outpatient settings, and community screening events. Nova Biomedical’s Stat Profile pHOx Ultra Plus is a blood gas analyzer that performs 38 tests per hour in such settings as reference and independent labs, and in inpatient critical care and point-of-care locations.

“Lab consolidation and reimbursement challenges are important concerns for customers, and effective use of higher volume solutions is one important answer,” says Barta. “Within those consolidated spaces, though, it is important to retain options for maximizing the workflow. Having the right tool for the job—especially when that tool is designed to accommodate virtually any laboratory space—can be critical to maintaining or increasing productivity on a limited budget.”

To select the right balance of instruments and tests, clinical laboratories need to have a clear idea of the volume and types of testing they conduct in any particular area. The amount of testing to be performed typically also dictates the size of the analyzers needed for the job. Devoting too much analyzer space to tests that a lab rarely performs is a waste, while trying to perform a large volume of tests on small analyzers is simply a recipe for errors and delays.

“Thermo Scientific’s self-contained, small-footprint, benchtop special chemistry instruments provide laboratories with the option to consolidate their specialty testing onto one instrument, bringing the power of automated testing into virtually any size laboratory space,” says Barta. “For larger laboratories, the unique menu offerings and easy setup and maintenance of these instruments make them an attractive offering for freeing up space, allowing larger instruments to handle the bulk general chemistry workload.”

Making the most of laboratory benchtop space is also a winning strategy for the Envoy 500+ chemistry system, the latest analyzer from ELITechGroup, Lincoln, RI. Designed especially for use in physician office labs, primary care centers, clinics, urgent care centers, and small hospitals, the Envoy 500+ features its own line of barcoded reagents for testing electrolytes, enzymes, general chemistry, and lipids. In addition, third-party manufacturers offer reagents for nearly 20 special chemistry tests that can be performed on the Envoy 500+.

“The Envoy 500+ is the fastest benchtop chemistry analyzer on the market,” says Dianna Poissant, vice president of sales and marketing at Vital Diagnostics, Lincoln, RI, an ELITechGroup Co. “It provides high throughput and walkaway capabilities to ensure quick turnaround of results for laboratories that are operating close to the patient.”

In addition, says Poissant, ELITech operates a centers of excellence program that leverages the fast turnaround time of the Envoy 500+ analyzer to provide results in real time, during the caregiver and patient interaction. “This process enhances the patient experience, communication, and clinical outcomes by providing quality, accurate, and timely test results,” she adds.

Getting a good match for a product’s target market usually means making adjustments to the product’s configuration and menu with the market in mind. “For the ChemWell Fusion,” says Ristaino, “we are looking to expand our product offerings and grow our market in physician office laboratories and the medium- to low-volume laboratory industry.”

“Open systems such as the ChemWell Fusion fill a niche within the clinical laboratory industry, especially in the medium- to low-volume segment,” says Ristaino. “Such systems can offer lower costs and the flexibility to choose test methods, without the large investment in equipment and commitment to large test offerings found in proprietary, closed systems.”

GETTING AUTOMATIC

In recent years, most manufacturers of clinical chemistry and integrated analyzers have come to embrace some level of automation in their products. But with continual advances taking place in robotics, software, reagent formulations, and other areas, it can be challenging to keep a system on the cutting edge of the field.

Introduced in 2006, the Advia 1800 clinical chemistry system by Siemens Healthcare Diagnostics, Tarrytown, NY, is a high-throughput dedicated chemistry engine for core laboratories, designed for environments where efficient automated processes are in place. “Many Advia chemistry systems are in laboratories with track-based automation, and system features such as onboard aliquoting and direct-from-track sampling are designed to further enhance the workflow advantages generally offered by an automation track,” says John Gillespie, director of media and public relations at Siemens Healthcare Diagnostics. “Other Advia systems are in laboratories that do not have track-based automation, but instead have chosen workflow solutions such as the Siemens VersaCell X3 solution, which can connect up to three chemistry and immunoassay systems with one-touch sample management.”

Siemens has undertaken continuous improvements to the Advia 1800 system in order to meet the evolving needs of the clinical laboratory community. Key areas of advancement include:

• Extended connectivity to Aptio automation and to the VersaCell family of advanced robotics.
• Regular software upgrades to improve system performance in such areas as assay definition loading; rerun and flagging behavior; reporting behavior; audit and utilization management tools; and calibration, control, and reagent management. Additional software updates have improved information flow between the instrument and laboratory automation, the CentraLink data management system, and laboratory information systems.
• Assay menu additions, from 81 assays in 2007 to 120 assays today, including Syva EMIT drug-testing assays. Many test formulations have also been improved to achieve better sensitivity and precision, and better performance with samples that have endogenous interferents such as lipemia and hemolysis.
• Reliability has been steadily increased through continuous improvement of such components as probes, pumps, mixers, sensors, cuvette and reagent covers, and ion-selective electrodes (ISE).

Other fully automated products include Abbott Diagnostics’ Architect series of clinical chemistry and integrated analyzers and Arkray’s Aution products, which offer full automation in a single footprint.

NEW KIDS ON THE BLOCK

Among the newest clinical chemistry analyzers to hit the market is the Advia chemistry XPT system by Siemens, which was launched in February 2015. The system is a high-throughput dedicated clinical chemistry instrument engineered to meet expanding workloads. To simplify cross-training, its intuitive user interface is shared with the company’s Advia Centaur XPT immunoassay system.

The Advia chemistry XPT system features a starting menu of 115 assays, using reagents in common with the Advia chemistry family, and incorporates Siemens’ VeriSmart technology, a combination of hardware and software verification checks at all stages of sample processing. Other key features of Siemens’ latest offering include:

• 60 reagent positions and concentrated reagents provide high onboard test capacity and long walk-away times.
• Consistent, predictable turnaround times, with up to 2,400 tests per hour.
• Designed for automation, utilizing direct-from-track sampling and onboard aliquoting to immediately release samples to the next workstation, driving productivity and improving laboratory workflow.
• Direct connectivity to Siemens’ Aptio automation, Advia automation solutions, CentraLink data management system, and Siemens remote service.

Efficiency is an important element of an analyzer’s performance—and sometimes a key to gaining adoption by laboratories. The SK500 chemistry system by Sekisui Diagnostics, Lexington, Mass, is especially suited for low- to moderate-volume laboratories seeking significant throughput combined with minimal use of space and water. “The SK500 can perform 580 tests per hour when including the optional ion-selective electrode (ISE) module,” says Tim Lynch, Sekisui senior global product manager for clinical chemistry, “and it utilizes just 13 L of water per hour.”

Launching at this year’s annual meeting of the American Association for Clinical Chemistry, the SK500 has yet to make its formal debut in the marketplace. The announced menu of tests under development for the SK500 encompasses more than 40 assays, including tests for anemia, diabetes, electrolytes, enzymes, lipids, routine chemistry, and special analytes.

CONCLUSION

The varied demands of today’s clinical laboratory marketplace have created a mixed-bag response from IVD manufacturers, making available analyzers with a wide range of capabilities and features. Not every lab aspires to provide throughput of more than 9000 tests per hour; some can and will continue to require fewer than 50 tests per hour. Some manufacturers already offer high-throughput devices that can handle testing volume for large labs and those that are expanding, others are developing devices that can offer higher volumes, and still others are perfectly content to continue offering benchtop analyzers that can be used by small clinics and doctors’ offices, where moderate volume is the key.

Added volume means added size and cost, so size is part of the equation too. In effect, manufacturers and labs are all measuring one another up, and looking for the best fit. But there’s no doubt that with the wide variety of analyzers and features on the market, there’s something for every lab.

Gary Tufel is a contributing writer for CLP. For more information contact CLP chief editor Steve Halasey via [email protected].