INFECTIOUS DISEASE TESTING
Disease Management the Focus of DPC's Corporate Commitment

The modern medical advances that sustain and prolong life also require more cautious interpretation of the various infectious disease symptoms that can represent many different clinical possibilities. With increased world travel and growing difficulties in treating infectious agents, it is important to document the presence of infection, determine its specific nature, and implement appropriate infection control and therapy. Infectious diseases are a leading cause of death worldwide and with our growing, aging population, there are more and more patients with fewer resources to handle them. Current economic pressures call for faster and more accurate results to help reverse these trends, while the healthcare industry has had a difficult time managing its budget. Steps have been taken to reduce cost in many areas. Ironically, although new diagnostic methods have been developed to reduce the time for diagnosis of many pathogens, diagnostics has been hit hard with reimbursement cuts that hinder the physician's ability to order needed tests for the patient. As a result, the diagnosis is delayed, the length of hospital stay is increased and inappropriate antibiotics are administered. The chance of spreading undiagnosed infections to other patients, with the related increased cost of nosocomial outbreaks, is greatly increased. We must not only detect disease but also monitor, confirm and control it to have a chance at success in healthcare. Because of these issues, DPC is committed to providing total solutions for infectious disease diagnostics. We are developing a complete line of infectious disease assays with a focus on disease management aboard the IMMULITE^® family of immunoassay systems.

Whereas the rest of the industry has stopped with the high-volume ToRC, hepatitis and HIV assays, DPC is going beyond the "norm" to provide fully automated routine and esoteric assay panels on an automated platform. In addition to offering hepatitis and ToRCH assays, DPC is developing assays for EBV, enteric antigens and ToRC avidity to help improve the diagnosis of mononucleosis, the management of diarrheal diseases and the specificity of ToRC assays. DPC was first to fully automate an H. pylori IgG assay and Lyme screen testing, and the first major company to receive European CE marking for infectious disease assays. In an effort to complete the diagnostic panel, DPC has developed off-line Western blots that detect specific antibodies against major proteins of various infectious agents. With the growing interest in cytokines and other inflammation markers as the result of some exciting findings in relation to infectious diseases, DPC is the first company to offer assays for these analytes together with infectious disease assays all on random access automated instruments—the IMMULITE family of immunoassay analyzers.

DPC's automated infectious disease assays represent a major advance over classic clinical microbiology, which requires several days to weeks to grow and identify microorganisms. Now, a microbiology lab can have the diagnostic answers in a few hours to a day. DPC's random access infectious disease menu is growing rapidly and already is one of the largest on the market. While the chemiluminescent technology of the IMMULITE system provides a high level of accuracy, a unique QC program provides quality monitoring without manual intervention. By replacing microplates with automated assays, the IMMULITE systems provide the key benefits of improved productivity and efficiency.

As one can see, a major focus for DPC is to develop a total package of quality immunodiagnostic assays to detect different infectious diseases. It is our responsibility to maintain the quality of our assays and systems to ensure that patient results are accurate and timely. Molecular advances have opened up to us the possibility of developing highly specific antibodies to design better assays and, therefore, to give the laboratory better predictive values that will lead to better diagnoses. It is the responsibility of healthcare to determine the most cost-effective pathway to help care for the patient. Although there are several considerations in developing a particular test, the most important is clinical need. The test should improve the quality of care delivered to patients by offering rapid turnaround time and availability. Unlike many diagnostic companies, DPC believes that open communication with laboratory management is an essential step in developing the right strategy and the right assays for the coming years. At the same time, laboratory management must make strategic plans, such as moving toward more automation of their infectious disease diagnostic techniques, to manage their budget and increasing workflow. Together, DPC and laboratory management are finding the solutions that will help the physician treat the patient more effectively and that will translate to better outcomes with infectious disease management. By focusing on disease management and the needs of our customers, DPC is helping, in a small way, to help healthcare to realize these aims.

DPC's goal is to become a major player in the infectious disease serology market within the next few years. We have gone out of our way to solve questions and problems in some infectious disease areas that have gone largely ignored by other companies. The development of test panels focused on disease management will enable the lab to be involved in the clinical diagnosis while controlling costs and workflow. As attitudes begin to change in the management of infectious disease, we will be there. Where other companies have left off, DPC is moving forward to provide "the total solution" for the infectious disease laboratory. It will not be feasible for us to solve all infectious disease problems with immunodiagnostic assays. However, DPC will continue to develop new technologies to meet the needs of the infectious disease lab now and into the future. DPC is determined to meet the challenge of developing infectious disease assay packages and systems that provide solutions for the laboratory and clinicians.