BBI Contributing Editor
CHICAGO, Illinois — This year's American Association for Clinical Chemistry (AACC; Washington) conference in the McCormick Place convention center along Chicago's Lake Michigan shoreline was a forum for, among other developments in the clinical diagnostics sector, the continued expansion of the point-of-care (POC) testing market. Among a variety of AACC exhibitors with new tests emphasizing the growth of POC testing, Biosite (San Diego, California) unveiled a new BNP (brain natriuretic peptide) test that not only represents an advance in markers for major cardiovascular diseases, but also is configured to take advantage of the migration of testing outside of the central laboratory to a variety of alternate sites both within and outside of the hospital or reference laboratory. Biosite's BNP test could find widespread application in the primary care or specialist office setting for screening of patients for heart failure, to help determine if more comprehensive and expensive imaging and physiological tests are indicated. A number of other new point-of-care (POC) tests were described at the AACC conference that demonstrate a continued expansion of the POC testing products market, and that provide the data management tools needed to properly manage testing outside of the central lab.
According to James Nichols, PhD, of Baystate Medical Center (Springfield, Massachusetts), the market for POC testing products totaled $4.9 billion worldwide in 1998, accounted for 25% of total in vitro diagnostic test volume and was growing at approximately 12% per year worldwide. In the U.S., the market is estimated at about $3.2 billion for 2000, including the hospital bedside, physician's office and self-testing segments, with growth forecast at about 9% per year through 2006.
New products for POC testing exhibited at the AACC meeting included a POC coagulation testing system under development by the LifeScan (Milpitas, California) unit of Johnson & Johnson (New Brunswick, New Jersey); a new co-oximeter and enhanced data management features for the GEM product family from Instrumentation Laboratory (IL; Lexington, Massachusetts); the AccuChek Inform POC glucose testing system from Roche Diagnostics (Indianapolis, Indiana); the Micromat II glycated hemoglobin test system from Bio-Rad Laboratories (Hercules, California) and the Aio dry chemistry test system from Innotrac Diagnostics Oy (Turku, Finland).
The new coagulation testing system under development by LifeScan represents the first entry into the hemostasis market by a company that until now has focused exclusively on whole blood glucose testing. LifeScan was, until recently, the leading supplier of blood glucose testing products for diabetics, but lost its top position in that market because it failed to implement new technologies that allowed tests to be performed more rapidly and with smaller blood samples. The company has now taken steps to recapture market share in the glucose segment, in part via the acquisition of Inverness Medical Technology (Waltham, Massachusetts). New devices such as the SureStepFlexx glucose system also are helping to improve LifeScan's ability to provide customers with enhanced connectivity for glucose monitoring at the hospital bedside. In addition, entry into the POC coagulation testing segment demonstrates an expanded market focus. The new system, which will offer only prothrombin time measurement at least initially, was developed internally, and uses optical (infrared) detection of clot formation. Turnaround time will be approximately 90 seconds, with a sample volume requirement of only 20 ul of whole blood. The product will use lyophilized reagents, and will report results in International Normalized Ratio units only. Upon launch in 1Q02, the company plans to have obtained CLIA-waived status and clearance for self-testing applications.
As shown in Table 1, POC coagulation testing products represent the largest segment of the overall hospital POC hemostasis testing products market, although not the most rapidly growing one. The market consists of products for testing of coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), and activated clotting time (ACT), as well as a relatively new segment comprised of products for assessment of platelet function. The market totaled an estimated $61.8 million in the U.S. in 2000, including $48 million in sales of coagulation testing products and almost $14 million in sales of platelet function testing products.
Companies pursuing the rapidly growing POC platelet function testing market include Radiometer Medical (Copenhagen, Denmark), which acquired Accumetrics (San Diego, California) and its Ultegra product line in June for about $10.6 million; Dade Behring (Deerfield, Illinois), with its PFA-100 system; and Helena Laboratories, with the Plateletworks system. The total market is expected to grow at a 13.4% compound annual rate through 2005, with growth in the platelet function testing segment considerably outpacing growth in the coagulation segment. However, another segment of the market is emerging for coagulation testing products used outside of the hospital setting, including products for physician's office testing, testing by home health care providers, and self-testing. That segment may represent a more attractive opportunity for products such as the new LifeScan system.
Instrumentation Laboratory continues to invest to upgrade its GEM product family for point-of-care testing. The latest version of the GEM system is the GEM Premier 3000, offering POC measurement of blood gases, electrolytes, glucose, lactate and hematocrit in a multi-test cartridge configuration. The GEM 3000 represents the only multi-test cartridge POC system that offers both glucose and lactate along with blood gases and electrolytes. Test cartridges are available in 13 different configurations. Another new feature is the addition of web interface capabilities in the GEM (GEMweb), allowing, for example, QC data to be accessed from the system from a remote PC using a standard web browser. The system can also be configured remotely via the web. IL is working with Telcor (Lincoln, Nebraska) to add the Quick-Multi-Linc (QML) option that will allow the GEM Premier to be managed remotely in an integrated network of multi-vendor POC testing systems. The new co-oximetry system from Instrumentation Laboratory, GEM OPL, is manufactured by AVOX Systems (San Antonio, Texas) and expands IL's offerings in critical care testing. IL already offers a coagulation testing module, GEM PCL, as an option for the GEM system.
AccuChek Inform represents the first POC glucose testing product introduced by Roche Diagnostics based on the Palm Pilot platform. The system is targeted at applications in hospital bedside testing, and allows use of barcode scans for essentially all data entry operations. Test results are stored in the device and are uploaded to the laboratory when the meter is placed in its charging cradle.
Another new POC testing system based on the Palm computer architecture was exhibited at the AACC meeting by Quantum Design (San Diego, California). The Quantum Magnetic Assay Reader III uses paramagnetic particle detection to achieve high sensitivity (better than one ng/ml) in under three seconds for a variety of reporter-based assays. The Palm architecture allows remote connection to a PC for data capture and management. The company is seeking partners to develop assays for the reader and believes the meter will cost between $1,000 and $2,000. The advantages of magnetic detection technology include high stability, rapid turnaround time, ability to measure the total amount of analyte in one volumetric measurement (thereby enhancing sensitivity) and low cost. Initial applications under investigation include replacement of colloidal gold labels or latex particles with magnetic labels in various immunoassay procedures.
The Bio-Rad Micromat II is a new hand-held affinity chromatography system that provides total glycated hemoglobin measurements at the point of care. The system will compete in the market for POC assessment of glycated hemoglobin markers now dominated by Bayer Diagnostics (Tarrytown, New York) with the DCA 2000. At present, the Micromat II is classified as a "moderately complex" device under CLIA.
A new cardiac marker system was unveiled at the AACC exhibition by Innotrac Diagnostics Oy. The system menu includes troponin I (both complexed and free), CK-MB, and myoglobin, with high-sensitivity CRP, PSA and TSH assays under development. The system will initially be targeted at applications in the emergency department and cardiac care, similar to the Stratus CS system from Dade Behring. All reagents are contained in individual test cups and 12 cups are supplied in a pen cartridge that is loaded onto the Innotrac analyzer. Sample types include whole blood, plasma and serum, and sampling can be performed directly from a primary specimen tube, with a volume of from five to 20 microliters depending on the test. Up to 88 samples can be loaded on the system, along with reagents to perform up to 360 tests. Turnaround time is 18 minutes and the company plans to sell to distributors at a price of under $2 per test, perhaps setting the stage for price erosion in the cardiac marker segment.
Development of improved information management technologies for POC testing is a high priority for suppliers, as they respond to the needs of users for improved quality of POC test results as well as better charge capture for testing services provided at the point of care. POC testing in hospitals is now subject to a considerable degree of oversight by organizations such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Oakbrook Terrace, Illinois), and participation in proficiency testing programs such as those offered by the College of American Pathologists (CAP; Chicago, Ilinois) or COLA (Columbia, Maryland) is necessary for all POC testing programs except those performing only CLIA-waived testing. However, even those programs performing only waived tests, such as whole blood glucose measurements, are required to perform daily quality control testing and to maintain records of such testing. JCAHO also requires an initial evaluation of accuracy, precision and reportable ranges before a POC testing program is implemented. Finally, agencies such as CAP require that all results be recorded in the patient's medical record, and also mandate regular re-validation of analyzers and monthly review of records. Those requirements, along with the need to ensure accuracy and reporting of results for proper patient management, have made POC data management systems a mandatory feature for any new product family. About 70 hours per week is required to manage a typical hospital POC testing program without an automated data management system, so a considerable investment can be justified to procure a system that minimizes labor requirements.
Examples of systems available from suppliers include the DataLink 3.0 Data Management System from LifeScan, with more than 300 installations; GEMweb and IMPACT from Instrumentation Laboratory; the Precision Net POC glucose data management system from Abbott Diagnostics (Abbott Park, Illinois); the RapidLink Critical Care Information Management System from Bayer Diagnostics; and the AccuData system from Roche Diagnostics. In addition, there are now at least two suppliers offering vendor-neutral POC data management systems, including Telcor's QML system and the RALS-Plus from Medical Automation Systems (Charlottesville, Virginia).
(For additional coverage of this year's AACC meeting, see the September 2001 issues of BBI's sister publications, Cardiovascular Device Update and Diagnostics & Imaging Update.
Table 1 | ||||||
Year | Total Sales | Growth | Coagulation Testing Products | Growth | Platelet Function Testing Products | Growth |
2000 | $61.8 million | N/A | $48.1 million | N/A | $13.7 million | N/A |
2001 | $71.2 million | 15.1% | $51.7 million | 7.6% | $19.5 million | 41.6% |
2002 | $81.6 million | 14.7% | $56.0 million | 8.2% | $25.7 million | 31.8% |
2003 | $92.3 million | 13.1% | $60.1 million | 7.4% | $32.2 million | 25.6% |
2004 | $103.8 million | 12.4% | $64.9 million | 7.8% | $39.0 million | 21.1% |
2005 | $116.0 million | 11.7% | $70.2 million | 8.2% | $45.8 million | 17.6% |
CAGR, 13.4%
2000-2005 | N/A | 7.9% | N/A | 27.2% | N/A | |
Source: The BBI Newsletter
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