image In 1999 the $460 million hematology market had a better than expected year with a 5 percent growth rate, according to a Merrill Lynch (ML) market analysis.

The same report named Beckman Coulter, Inc. of Fullerton, Calif., Abbott Laboratories of Abbott Park, Ill., Bayer Diagnostics of Tarrytown, N.Y., and Roche Diagnostics of Indianapolis the Big Four hematology vendors, sharing 77 percent of the U.S. market, for hematology systems.

The way the report breaks it down, Beckman Coulter is the market leader with a 32 percent share, Abbott is a close second with 28 percent, Bayer takes 12 percent and Roche accounts for 5 percent. The remaining 23 percent is a mix of other vendors.

Not everyone agrees with the Merrill Lynch numbers. For example, Beckman Coulter’s Alan Burton, marketing manager for cellular analysis, claimed a market share of 40 percent for the California company, while Roche’s Joe Fall, director of hematology, maintained that company had grown its 8 percent share in 1999 to 10 percent in 2000.

While market share is subject to interpretation, the importance of hematology in healthcare is not. Hematology measures the size and shape of blood cells, and positive results are manually reviewed. System manufacturers have largely automated sub-fraction of white blood cell counts or differential counts, but 30 to 40 percent of all differential counts are still done manually. Sicker hospital patients may be increasing this percentage.

For some time, the trend in hematology has been to automate testing, particularly routine tasks. The four major vendors all offer automated systems designed to lower costs and errors and create greater efficiency and safety.

New hematology solutions are moving beyond routine tasks to scalable, modular systems with enhanced data management and interpretation.

Automated slide makers and slide stainers are popular items for integration, but the migration of flow cytometry to hematology platforms did not fulfill its promise. Its complexity and slow turnaround time made it a difficult fit for high-volume operations with less skilled operators. Manufacturers are still adding flow, but none are claiming, as they once did, that it will shut down flow labs.

“Some flow testing, say, CD64 for stem cell analysis, is only done by flow labs that are open from 9 to 5, but patients need analysis 24 x 7,” Burton said. “So there is a need for after-hours flow testing. But it requires a higher skill set, so there is a trend to simplify and automate it.”

Another important trend is the emergence of tests for reticulocytes, CHr, CD61, CD64, and T4 and T8, and on the horizon, even a CSF test. It seems that this will finally be the year that 5-part CBC differentials will replace the 3-diff standard test, providing clinicians more extensive disease state information.

Beckman Coulter recently signed an agreement to market the AcT 5diff CP (cap piercing) analyzer, manufactured by ABX Diagnostics of France and Irvine, Calif. The AcT CP features ABX’s five-part differential analysis and cap-piercing, but it runs on software designed by Beckman Coulter. Intended for the physician office lab, the Windows NT-based AcT 5diff CP can handle up to 60 samples per hour. “ABX and Beckman Coulter are in the second year of a seven-year worldwide OEM agreement to produce about 3,000 units per year,” said Jim Mulry, marketing manager for ABX. Last year, Beckman marketed the AcT 5-diff without cap piercing.

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Burton said the AcT 5diff CP will elevate quality of care without putting small labs into bankruptcy. He also noted that the current reimbursement for 3-diff testing is higher than for 5-diff, a discrepancy that should disappear soon.

Improved reimbursement for 5-diff testing would be good news for ABX, which has staked its future on it. In addition to manufacturing analyzers for other diagnostics’ companies, ABX makes a line of instruments which is sold by its own sales force. Mulry noted that ABX’s Pentra 120 Retic hematology analyzer is designed for the large volume testing segment. It includes quantitative leukocyte enumeration, walk-away automation, random access reticulocyte enumeration and optional slide preparation and staining unit.”

Beckman Coulter recently received FDA clearance for its immature reticulocytes fraction test for use on the Gen•S, for which it developed and launched its fully automated, trackless hematology system in July 2000. The Gen•S Cell puts the Gen•S hematology flow cytometer, the Gen•S SM Integrated SlideMaker and the automated Gen•S ST SlideStainer into a single, integrated system. A new version of the Gen•S system with random access and improved detection technology, is scheduled to be released soon.

Meanwhile, ABX’s Pentra 60 C+ hematology analyzer, which was FDA cleared the last week of December 2000, incorporates the same differential and counting technology as the Pentra 120 but also offers data management and closed-tube sampling.

Abbott’s Cell Dyn 4000 series has an expanded menu that includes CD61 and T4– T8 testing, its Cell Dyn Workcell system makes it possible to link more than one 4000 to a slidemaker stainer.

Migrating different testing technologies to a single hematology platform for workflow and efficiency is what labs are demanding, Burton said.

In 1999, Roche signed an agreement to market hematology systems made by Sysmex Corp., a Japanese company, that says it is the world leader in hematology automation.

In 1989 Sysmex released the first mechanical slide maker, the SP-1 and the first hematology workcell, the HS System. In 1997, it launched an integrated slide maker/stainer, the SP-100.

“Automated sample transport systems typically have a payback period of three years or less,” according to Roche’s Fall. “They streamline and simplify the work flow and add a new level of consistency. But all hematology analyzers are still class II medical devices whose job it is to separate normal samples from abnormal ones by flagging abnormal results for review. Today most hematologists are looking for an analyzer that will reduce the number of samples that require review.”

Toward that end, Sysmex recently released the XE-2100, a hematology analyzer that combines flow cytometry with random access discrete testing, a 5-part fluorescence-enhanced diff, a quantitative NRBC count with automatic WBC correction and a fluorescent optical platelet count. The addition of fluorescence measurements has the potential to replace “suspect flags” with reportable numbers. The FDA recently set guidelines under which manufacturers can submit their hematology analyzers for clearance to report these numbers.

Building on its reputation for reliable differentials, Bayer is introducing two new boxes to complement its Advia 120 and the Advia 60, which is manufactured for them by ABX. The new Advia 70, which will include a 5-part differential, and the Advia S60, a stand-alone semi-automated slidemaker stainer, are both aimed at the small- to medium-size lab. Why introduce a stand-alone slidemaker stainer rather than follow the pack with an integrated unit? “The driver of slide making is review rates,” said Bob Barca, Bayer’s director of marketing for hematology. “The technology that the Advia system uses reduces review rates.”

In keeping with the company’s plan to bring more disease management tools to the clinician, Bayer also is adding a CHr marker (for immature reticulocytes) to its 120 series. Another such tool, this one for the emergency department, is a CSF test for the Advia 120 that could significantly reduce the turnaround time on spinal tap results, which are often performed manually. “Because the Advia 120 provides large amounts of data on several sample parameters, we’re looking at using neural networks and sophisticated algorithms to provide clinicians better information and direction for improved disease management,” Barca said.

As research reveals more and more information about the way blood factors affect our health, the companies that make hematology products will continue to look for new and innovative ways to incorporate that research into their products and work toward simplifying this complex area of the diagnostic laboratory.