BBI Contributing Writer

DUSSELDORF, Germany – Over the course of the next 25 years, the age structure of the world population will continue to shift, with older age groups making up an increasingly larger share of the total. For example, during the 1998-2025 period, the world's population aged 65 and above will more than double. According to United Nations statistics in 1995, 6.6% of the world population was over 65; this will grow to 10.4% in 2025. By 2025, countries in North America, Europe and Japan will have 20% to 25% of their population over 65. This phenomenon is not restricted to the above countries. India's population for example, which is currently young like most of Asia, is rapidly aging. The present population of 55 million over the age of 60 is expected to jump to 177 million by 2025.

The expected bulge in the geriatric population is creating both problems and opportunities. The demand on world health care systems by the aging population will be far beyond what governments' present health infrastructure can cope with. Cash-strapped governments therefore are looking for the most cost-effective strategies to deal with the health care needs of the elderly.

While the major influx of the elderly will be felt in 2025, the first wave of post-World War II baby boomers will reach 60 years of age in 2005. This is creating in vitro diagnostic products opportunities in two main areas – diabetes and point-of-care testing.

The International Diabetes Federation estimates that in 1999, diabetes affected more than 150 million people worldwide. According to the World Health Organization (Geneva, Switzerland), the number of diabetics worldwide is forecast to grow by 13% a year until 2005 and as high as 20% a year until 2025 and beyond. The 1998 worldwide market for glucose testing is estimated at $3 billion and is growing at an annual rate of 12% to 18%.

The market for glucose monitors or self-testing devices is therefore one of the fastest-growing segments in the world of in vitro diagnostics. There was a significant increase in the number of glucose self-testing devices shown at Medica 99, held here last November. The recent FDA market approval of two noninvasive glucose monitoring systems – MiniMed's (Sylmar, California) continuous glucose monitoring system and the GlucoWatch from Cygnus (Redwood City, California) – has heightened market interest in non-invasive testing for glucose. Readying itself for market launch in 2000-2001 is GlukoMediTech AG (Witten, Germany). GlukoMediTech is developing a long-term implantable glucose sensor for continuous monitoring of the glucose level in diabetic patients, based on two measuring systems: polarimetry and infrared spectroscopy. The optics for both of these systems have been miniaturized. The company is working on the miniaturization of the sensor's electronics and ultrafiltrating system and a prototype should be available this year. The sensor will be implanted into the subcutaneous fat tissue of the stomach area for a period of three to five years and transmits the test data wirelessly to a receiver, or "glucose watch," which is worn on the wrist. The ultimate goal is the development of an implantable insulin pump and its combination with the glucose sensor to form a cell that will automatically supply the necessary amounts of insulin to the individual.

Some new POC offerings

Point-of-care testing plans to answer the need for a more cost-effective approach to health care delivery and patient testing. The on-site delivery of routine tests that are now sent to remote laboratories is expected to become commonplace in the next five years. Already, most of the manufacturers of large laboratory analyzers have introduced smaller, table-top units for coagulation, hematology, biochemistry and immunoassay testing. In 1998, POC testing in ambulatory settings (excluding glucose and pregnancy self-testing) comprised 8% of the $18 million IVD market. By 2002 it is expected that POC testing will increase to occupy 15% to 20% of the market. In anticipation of this market expansion, many companies are beginning to invest in POC test development.

Dry reagent multistrips have made urinalysis testing available just about anywhere, but it does take some experience to read the strips objectively. Small readers are available for sites running 10 to 50 tests per day. These are generally slow and require a significant amount of sample handling. Alternatively, fully automated instruments serve the laboratory setting. The market for urine strip readers has been dominated by the two major strip vendors, Bayer Diagnostics (Munich, Germany) and Roche Diagnostics (Basel, Switzerland). However, two smaller players have launched mid-range, semi-automated systems to serve the growing POC testing market. Menarini Diagnostics (Neuss, Germany) introduced Aution Jet, the latest addition to the Aution Orchestra line of urinalysis systems. Aution Jet is a semi-automatic urine analysis system that has a throughput of 450 tests/hour and measures up to 10 parameters with automatic temperature compensation. 77 Elektronika (Budapest, Hungary) markets the Lab-U-Reader automated urine analyzer and the accompanying LabStrip U10 and U11 urine multistrips. An intelligent CCD image processor allows up to 200 samples to be read in 20 minutes.

For the physician's office, Menarini markets the HA-8140, a fully automated HPLC instrument for the measurement of glycated hemoglobin (HbA1, HbA1c fractions), fetal hemoglobin (HbF) and the detection of the main hemoglobin variants. A cap-piercing system allows for primary tube sampling and, according to Menarini, the four-minute test time makes it ideal for point-of-care testing.

Or Sense Ltd. (Rehovot, Israel) is developing noninvasive test devices for both hemoglobin/hematocrit and glucose testing. The device platform technology is based on a noninvasive optical method of measurement in the NIR range. Or Sense reported that initial clinical trials will be carried out this year. Future products in the Or Sense pipeline include non-invasive monitors for cholesterol, triglycerides, albumin and other critical care analytes.

J&S Medical Associates (Framingham, Massachusetts) is developing lateral flow, rapid-test devices similar to those used for pregnancy tests for rheumatoid factor, ASO titre and mononucleosis. These tests are generally performed by latex agglutination, which requires some expertise in discerning weak positive and negative results.

Multiparametric instrumentation

The gaining acceptance of POC testing will translate into the need for very user-friendly and sophisticated instrumentation able to perform a wide variety of tests, including biochemistries, immunochemistries, hematology and coagulation, on a single box. Awareness Technologies' (Palm City, Florida) ChemWell is a fully automated analyzer capable of running both enzyme immunoassays and general chemistries on standard microwell plates. The system automatically dilutes, pipettes, incubates, reads, washes, and calculates results. The random-access instrument can process about 250 tests per hour. It is a completely open system that can use any company's reagents. Awareness will help customers apply existing reagent kits to work on the system. The instrument list price is $25,000 and it has been sold in 10 countries.

Scil Diagnostics (Martinsried, Germany) plans to launch the Scil Start, a fully automated, point-of-care, benchtop analyzer, by the end of 2000. This is a closed system that will have sealed single-use reagents packaged in cartridges containing five to 100 tests each. The reagent carrousel can accommodate up to 40 different reagent cartridges. Marketing Manager Michael Sprinzl said that Scil wanted to provide a POC analyzer that uses the same liquid reagent technology as that used on main lab systems to ensure test standardization of assays run at different test sites. The system can run all photometric technologies applicable to clinical chemistry, turbidimetry (including coagulation tests), and immunoassays. The initial menu will offer 40 tests, which will be expanded to 70 tests shortly after launch, he said.

Maxmat SA (Montpellier, France) has developed the Maxmat 130, an open analyzer using 96-well microplates. The instrument is set for worldwide distribution by mid-2000 and will list for $25,000 to $50,000. The combination of two optical systems allows photometric and spectrometric determinations in clinical chemistry and immunology, as well as chronometric measurement for coagulation. Maxmat 130 is adapted for random access, batch or stat mode operation, with primary tube sampling and bar coded reagents. The analyzer also allows pre and post-dilution, automatic re-run, quality control and automatic volume management. A bidirectional interface enables the connection with external systems.

Connectivity a POC must

Historically, about 75% of POC testing (excluding OTC glucose and pregnancy testing) involves bedside glucose devices, with pregnancy, hemoglobin and critical analyte testing next in order of market penetration. Some institutions have installed device-specific workstations that transfer the POC data into either the laboratory information system (LIS) or a data management information system. Most arrange to have POC test data entered into the LIS manually over the period of the work day. As both the variety of tests and test sites continues to increase, the manual entry of POC test data will become unrealistic. A major barrier to the widespread use of POC testing is the limited availability of connectivity software and an electronic means to collate patient test results and other data, no matter where they were generated, into a single electronic patient record.

Connectivity products on display at Medica 99 indicated that POC device manufacturers are responding to the need for increased connectivity, not just for their individual instruments but for POC data management systems that can interface with other devices as well.

Agilent Technologies, formerly Hewlett-Packard Laboratories (Palo Alto, California), has formed a global collaboration with Diametrics Medical (St. Paul, Minnesota). Diametrics' IRMA critical analyte analyzer now uses Agilent's IDMS data management software. The IRMA system communicates by either modem or an RS232 line; a built-in ethernet connection is planned for launch this year.

Nova Biomedical (Waltham, Massachusetts) markets a broad line of whole-blood critical care analyzers, including the Nova Stat Profile instruments that can perform up to 14 analytes. The Stat Profile line connects to the LIS with the Nova Patient Data Manager (PDM). The PDM allows for multiple POC and lab-based analyzers to interface to the LIS via a single pipeline and is completely bidirectional. Nova's PDM soon will have interfaces for POC hematology and coagulation devices in addition to those tests provided by Nova.

LifeScan (Milpitas, California), a global leader in glucose monitoring, provides DataLink software that links its SureStepPro system directly to an LIS from multiple sites. The system is bidirectional and allows full process verification. LifeScan plans to launch a multi-analyte and device connectivity system in 2000.

Roche Diagnostics' (Basel, Switzerland) glucose monitoring products use the RALS-G software produced by Medical Automation Systems (Charlottesville, Virginia). RALS-G electronically transfers glucose test data over a hospital's network to a review station in the lab and is totally bidirectional. Due for launch this year are the RALS-Plus and RALS-Net systems. RALS-Plus is designed to include all point-of-care applications, including manual tests such as urines, cardiac markers and occult bloods. RALS-Net is an enterprise data management system that incorporates all the features of RALS-Plus and allows that information to be shared on a network-wide basis, from hospital to hospital.

Alternative therapies draw attention

Companies have taken advantage of the increased interest in alternative therapies and have brought a new level of sophistication to the practice.

Quintsysteme GmbH (St. Polten, Austria) demonstrated QuintStation, a computer-integrated system for electronic homeopathy and acupuncture. The homeopathy module is based on the electromagnetic spectra of various therapeutics, such as medicinal plants and minerals. The QuintStation provides 5000 electromagnetic spectra of these therapies, stored in the computer database. The spectra are transmitted onto the patient using a pulsating magnetic field. The QuintStation also provides fully automatic diagnosis and therapy suggestions based on the measurements derived from the program and using an expert system developed by the company. The system is designed for holistic practices and health centers. The primary indications are allergies, environmental medicine, chronic diseases, and geriatric disorders.

Beijing Weili Technology and Trade Co. (Beijing, China) introduced the WLGY-801 Weili medical instrument, a computerized acupuncture system for diabetes. The system computerizes traditional Chinese acupuncture and determines effective acupoints via electric pulse waveforms. The equipment chooses the traditional acupoints and adds two company-developed acupoints and can accommodate up to nine points. The therapy is intended to improve the micro circulation of pancreatic islet cells and promote islet-cell insulin production.