By Nicholas Borgert

io01.jpg (7171 bytes) While new infectious diseases grab headlines and public expectations for fast solutions to health crises remain high, the clinical microbiology market continues to increase at a snail’s pace. Estimates for the year place the microbiology segment of the IVD industry at about $1.45 billion.

     “This segment is effectively static and barely growing at around 3 percent annually, which may be a liberal estimate at best,” said Kelly Westfall, an industry analyst at Frost & Sullivan.

     Not all aspects are discouraging, however. In 2002, automated microbiology accounted for about $250 million. And molecular diagnostics continues to get major attention — and funding — from all the market’s biggest players.

     Roche remains the PCR monolith, with a 50 percent share in the molecular market and new infectious disease approvals already this year on the Cobas Amplicor system.

For the year 2002, U.S. revenues at bioMérieux North America surpassed company projections, growing at double digits and totaling about $250 million. Percentage of sales devoted to R&D remained the same as last year’s 12 percent.

     The company’s entry into molecular HIV testing has generated significant sales. Marketing Manager Mike Cronin said bioMérieux’s NucliSens HIV-1QT for quantitative HIV viral load testing offers an improved dynamic range for FDA-approved HIV viral load tests. “This one test gives you results along the entire dynamic range, from 50 copies per mil to about 5.4 million copies/mil,” Cronin said.

     Nucleic acid testing continues as a bioMérieux strength. Its NucliSens EasyQ system uses nucleic acid sequence-based amplification (NASBA) and molecular beacons for real-time detection of infectious diseases and viral agents. A related product EasyQ HIV-1 already widely used outside the U.S. provides higher throughput and requires no separate detection step.

      To assist labs with assay development, bioMérieux last year introduced its NucliSens EasyQ Basic Kit. This open-platform assay standardizes home-brew assays. “Molecular is probably the fastest growing segment of the diagnostic marketplace,” Cronin said. “More products will be targeted for the market.” The NucliSens Basic Kit offers a springboard for labss to develop assays for emerging infectious diseases, such as West Nile Virus and even SARS.

     Handling safety is another bioMérieux concern, said Matt Manley, microbiology marketing manager. The company will convert all five of its glass blood culture bottle product lines to plastic bottles beginning in September. “We’ve been working for years on providing customers with safer alternatives for the collection and transportation of blood culture bottles,” Manley said. The company’s BacT/Alert3D automated blood culture system will be the first to include plastic blood culture bottles.

     bioMérieux is also readying rollout of updated software for its Vitek and Vitek 2 systems. In addition to new technology, customers will benefit from a new antibiotics confirmatory ESBL test on the Vitek Gram negative susceptibility card. This will be a rapid confirmatory ESBL test, brand new to the market, according to Larry Donahoe, marketing manager for bioMérieux identification and susceptibility testing products. “That test will also be available in the fourth quarter for Vitek 2, pending FDA clearance,” he said.

BD Diagnostics
During 2002, sales increased about 13 percent at BD Diagnostics, the largest test supplier for the microbiology market segment. That growth rate continued through the first quarter of 2003, said Tom Polen, worldwide director of marketing.

     BD, Polen said, saw continued strong sales of its BacTec blood culture platform and wide acceptance of its new BD ProbeTec ET System assays. The assays feature homogeneous amplification and real-time detection and exploit BD’s proprietary strand displacement amplification technology.

     Lateral flow technology (LFT) continues to be at the center of new BD diagnostic products. The new Directigen EZ RSV rapid test represents the first in a new line of tests using LFT and requires only one device and one extraction reagent. The company is continuing to build on the innovation of the Directigen Flu A+B test, which can distinguish Influenza A viral antigens from those of Influenza B.

     The first test available in the U.S. on the new BD ProbeTec platform is for detection of chlamydia trachomatis and Neisseria gonorrhoeae. Outside the U.S., BD has also launched a molecular assay for Mycobacterium and is developing several new assays to extend the ProbeTec menu.

     BD’s new Phoenix automated identification and susceptibility platform screens and confirms presence of ESBL organisms directly from a primary test card. Prior to this innovation, multiple tests — that prolonged detection time — were required. BD Phoenix is not yet available for susceptibility testing in the U.S.

     To tackle drug resistance issues, BD has developed an open architecture data mining system, BDEpicenter, that seeks out resistance trends among infectious disease test results. The system receives and processes data from multiple platforms. By analyzing a wider number of test results and parameters, Epicenter more quickly and accurately identifies trends within a healthcare system, Polen said. BD’s European customers are already using Epicenter to combat nosocomial infections by monitoring shifts in minimum inhibitory concentration (MIC), shifts in susceptibility rates and the tracking of patient locations using LIS data. “Customers are able to not only identify new nosocomial infection and resistant organism trends, but also identify the location within a facility where infections may be acquired,” Polen said.

     Cleveland-based Trek Diagnostics manufactures and distributes automated systems and diagnostic products. Just four years old, the company acquired the ESP and Sensititre product lines and is focused strictly on serving the microbiology market, said Les Stutzman, director of global marketing. Trek, he said, has the third largest share within the automated blood culture and mycobacteria detection market. Trek ESP is a fully automated FDA-cleared system for routine blood culture, other normally sterile body fluids, mycobacteria detection and M. tuberculosis susceptibility testing on a single instrument platform. According to Stutzman, the system takes a different approach to detecting the presence of bacteria and microorganisms from its competitors. Other systems depend on built-in colormetrics or fluorgenics and detect the presence of carbon dioxide as a byproduct, Stutzman said. “The ESP system measures both consumption of O2 gas and production of CO2, H2, N2 and other gases, measuring the pressure changes in the head space of the culture bottle for detection of a wide range of microbes,” he said. “The result is a more sensitive technology.” Another benefit of ESP, he said, is that the system does not require users to purchase costly specialty media required by other automated platforms. ESP technology is serving as the basis for Trek’s new VersaTrek system.

     Due for introduction this spring, VersaTrek’s “any bottle anywhere” design frees labs from special drawers or incubators for bottle processing. Like its ESP predecessor, VersaTrek offers blood culture, body fluids, mycobacterial detection and susceptibility testing all in one instrument.

     “VersaTrek offers from 96 to 528 locations on one platform,” Stutzman said. “That’s about 38,000 bottles on an annual basis.” And VersaTrek’s Windows software, he said, will be legacy compatible with the current ESP system, enabling customers to make a smoother and less costly transition. 

     With the addition of the soon to be released Sensititre Windows Software (SWIN) platform to the microtitre ID/AST product configuration for standard and customizable plates, Trek will be offering a full line of identification and susceptibility testing available as an excellent backup system as well as a lab’s primary methodology.

Dade Behring MicroScan
MicroScan sales generated about $133 million last year for Dade Behring, while microbiology’s total revenues for the company approached $139 million.

     Prominent among the five new panels MicroScan introduced last year was the MICroSTREP Plus, an overnight MIC panel that provides antibiotic susceptibility testing across a range of 18 antibiotics. Lynn Boyer, U.S. product manager for MicroScan, said the strep-specific panel can be stored at room temperature and is easy to use: additional equipment is not needed to read test results.

     “The Streptococcal MIC testing is an important adjunct to the microbiology routine because of the increase in resistance seen in recent years. MIC results can help the physician select the most appropriate antibiotic for these critical organisms; it tells the clinician the lowest concentration of drugs to be used,” Boyer said.

      Another advance during the year, according to Boyer, was introduction of the    MicroScan ESBL Plus Confirmatory Panel. The panel confirms the presence of suspicious isolates. Strains of E. coli, K. pneumoniae and K. oxytoca may be clinically resistant to therapy with penicillins, cephalosporins and aztreonam despite apparent in vitro susceptibility to some of these agents. Patients infected with ESBL-producing bacteria face an elevated risk of mortality so detection and confirmation is essential to successful patient management.

     “This is especially timely, considering that NCCLS has indicated the need to start confirming suspicious ESBLs,” said Susan Marotta, MicroScan director of U.S. marketing. The new panel confirms the presence of ESBL and also provides susceptibility results for imipenem and meropenem, treatment options of choice.

     Complementing its popular Windows-based LabPro Information system, MicroScan last year introduced a real-time monitoring system called LabPro Alert. “Alert is an automated antibiotic and bacterial review systems that provides a comprehensive review analysis of panel and off-line results identification and susceptibility patterns of organisms running on the panels,” Boyer said. User modification is a prominent features. Alert is totally customizable. Users can create new rules, activate, inactivate or modify any pre-defined rule to support their testing results and review requirements. The system also enables users to input standard operating procedures that can be easily referenced right on the system.

     The emergence of threatening new strains and the problem of drug resistance keeps microbiology dynamic, said Boyer. “These are pretty exciting times,” she said. Marotta agreed. “Microbiology is never mundane; it’s an exciting discipline because it is continuously changing,” she said. “MicroScan’s direct testing methodology enables the user to capture emerging resistance as it occurs without reliance on historical susceptibility patterns.”

Nicholas Borgert is a freelance writer in Charlotte, N.C.