MLO's gallery of experts presents key trends at CLMA 2004

Medical Laboratory Observer, June, 2004

Anne Pontius, MBA, CMPE, MT(ASCP), and a member of MLO's editorial advisory board, is president of Laboratory Compliance Consultants in Raleigh, NC. Pontius organized and chaired this year's CLMA's Executive Track panel supported by Medical Laboratory Observer (MLO), "Expert Opinion: Key Trends in the Clinical Laboratory Industry." The panel discussion at the CLMA/ASCP 2004 conference in Atlanta was based on MLO's executive interview series.

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Representing four well-known companies in the clinical diagnostics industry, these industry leaders addressed the continuing evolution of immunochemistry systems, creating value, integrated data networks, and microscopy automation. Following their joint presentation, panelists hosted a highly informative question-and-answer forum on the challenges that face the industry for the next five years--and how those can be met in order to help laboratory managers navigate and survive in the future. The distinguished guest panelists, in order of appearance, were:

Paul L. Epner is director of global business research, Abbott Laboratories. After majoring in astronomy at college, Epner spent five years as a science teacher. For the last 26 years, his diagnostics career at Abbott Laboratories has included quality/manufacturing, strategic planning/marketing, and customer service/support. Following four years in Asia, Epner is now responsible for worldwide diagnostics market research and market assessment.

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Epner focused on what vendors are doing with automation to assist laboratories feeling the labor pinch. His remarks included a succinct description of the evolution of today's immunoassay/chemistry systems, from "one technology/one box" to what he described as "the ultimate universal technology," where laboratorians can "put in the tube and walk away"--an "accessioning to archival" automation that Epner predicts will not be available for another five to 10 years. He pointed out that the continuing automation of equipment has allowed laboratories to consolidate equipment via the combination of chemistry and immunoassays--thus saving precious space within the lab. The consolidation to one platform has also improved turnaround times, maximized throughput (as well as menus), while minimizing cost structures, simplifying processes, and solving quality problems. Epner sees the assay market moving toward molecular diagnostics because of the "exquisite sensitivity" of that type of testing, particularly with infectious diseases. Epner believes that the rapid deployment and tremendous capabilities of molecular diagnostics will be one of two options for different uses in the future--with some assays that migrate to molecular in the short term, migrating back into highly sensitive and ultrasensitive immunoassays.

C. Douglas White is vice president. N.A. sales and marketing, at Digene Corp. White has 19 years' experience in the clinical diagnostics and biotech industry. He has held executive positions at Abbott Diagnostics, Chiron, Bayer Diagnostics, IGEN International, and is currently responsible for commercial activities in North America and global product management at Digene.

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White's remarks challenged labs to take a proactive approach in creating value for services, and he encouraged labs to look to other opportunities for building revenue. As an example, White spoke about the area of cervical cancer. According to White, significant data demonstrates that by adding an HPV test and HS with cytology testing, a negative predictive value is produced. With this double negative, there is a 99.6% chance the patient will not develop cervical cancer in the succeeding three years. White noted that if, today, every physician stopped doing the annual Pap, replacing it with DNA and Pap together, and waited for another three years [to test], the lab would actually be more profitable, than if it performed an annual Pap. This, he claimed, would significantly reduce the impact on the healthcare system in terms of cost effectiveness. He pointed out that genomics and molecular testing offer an opportunity to expand services and create value for the changing clinical practice and, in turn, produce a new testing paradigm. White urged laboratorians to work together in the market, using improved lab automation to help clinicians with innovative clinical markers. He also stressed that lab equipment--no matter what type--will not be effective if laboratorians and physicians are not working together for change.

NinoTotino is vice president of U.S. marketing for Bayer Healthcare's diagnostic division. He has over 20 years' healthcare sales and marketing experience, and has spent the last six years based in New York at the global headquarters for Bayer's Diagnostics Medical Testing division.

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Totino's remarks were organized around integrated delivery networks (IDNs) or clustering networks, which, he suggested, make instrument-purchasing decisions more complex. As more hospitals join IDNs, not only are testing volumes increasing, the role of laboratory managers in decision making may change. Totino noted hard work is ahead in order to take advantage of automation technologies--used in less than 5% of U.S. hospitals--to improve problems relating to the ongoing labor shortage and to continuing hospital consolidation. Direct access testing is one area, which, he pointed out, will be a trend affecting test volumes in a future that is going to be extremely different. Decisions continue to be made on economics and faster turnaround times, with hospitals now using major leveraging technologies, such as the Internet, to evolve solutions. Manufacturers are providing equipment with smaller footprints and are attempting to consolidate testing requirements on completely open systems. Automation should be employed when it makes good business sense: and in IDNs, the question is, what happens to the core laboratory when other parts of the hospital's IDN wants to automate or integrate but cannot because the existing systems will not allow them to? Requirements for standardization come into play in IDNs, with the need for instruments to have the same technology and the same assay performance. He stressed that, to proceed with confidence, laboratories need also to take advantage of the service and support capabilities offered with automation systems and to work with a partner who can ensure that automation projects actually work faster and give the laboratory staff what it wants.