The role of the In Vitro Diagnostics Industry
In vitro diagnostic testing has traditionally been positioned in a clinical support role, as an aid to the physician's final diagnosis. While this utilisation is clearly appropriate, it also means that the ability of laboratories and IVD manufacturers to contribute optimally to the healthcare system depends to a very large degree on the physician's knowledge and behaviour. Often, however, clinicians have not kept up with the rapid pace of innovation and development in IVD technology which has led to a large repertoire of highly sensitive and specific tests. This fact has undermined the ability to maximise testing utility and the opportunity to reduce morbidity and downstream healthcare costs. Whilst the majority of healthcare professionals and management concentrate on the daily task of moving the ever expanding waiting list of patients requiring treatment through the limited resources available, there is growing interest in the use of diagnostics to predict or detect at an early stage many conditions which, if treated at their outset, can avoid the need for more costly interventions at a later date, and thus shorten the queue from the other end.
Study shows poor awareness of IVDs
The Clinicians' general lack of awareness of IVDs was recently confirmed in a study conducted in the United Kingdom by Watson Biomedical on behalf of a forum of professional and industry associations lead by the British In Vitro Diagnostics Association (BIVDA). BIVDA exists as a trade association for the industry dedicated to the development, manufacture and supply of IVDs in the UK, and in conjunction with the Department of Trade and Industry is carrying out a project designed to improve the competitiveness of the industry. In addition, BIVDA represents British interests in Europe in the area of legislation and market awareness. This latest study was aimed at hospital and general practitioners, the pathology professions and healthcare management. In response to a question regarding the factors that would increase their overall use of diagnostic testing, about half of the physicians surveyed cited needs for a wider range of tests, increased test accuracy, more definitive tests and more information regarding the availability of tests. This, however, was in the context of very limited awareness of the advances the diagnostic industry has achieved over the past decade.
Short term financial pressures
In addition to the limitations in physicians' knowledge concerning the optimal use of IVD tests, physician behaviour is increasingly being shaped by financial pressures, whether exerted by hospital administrators or by managed care organisations. While in years past, physicians might have felt remiss in their treatment of a patient if they failed to order vast profiles made up of the IVD tests available at the time that might assist them in arriving at a differential diagnosis or in possibly unearthing a hidden condition, current thinking encourages a more discriminating approach to IVD testing, but unhappily in a climate of limited awareness of the tools available.
Another recently published survey reveals the possible consequences of increased efficiency in the use of clinical laboratory services. Over a period of seven years (1985 to 1991), the IVD test-ordering practices of eighty-five general practitioners in the town of Maastricht (Netherlands) were monitored by the laboratories receiving the requests. The laboratories were asked to provide constructive feedback to each physician regarding his or her ordering patterns and the appropriateness of each request. The effect on testing volume was considerable. Over the seven-year period of the study, the number of tests requested (which were tracked for each of four clinical disciplines), declined by up to sixty percent. This period also marked a change in technology in analytical instrumentation, the multichannel profiling machines delivering up to twenty-three simple tests giving way to selective analysers and the growth in availability of immunoassays for thyroid, fertility and other hormones, cancer markers, cardiac markers, infectious diseases, specific proteins, and therapeutic drugs. Financial pressures and the rationalisation of testing procedures coincided with an increasing availability of more and more highly specific diagnostic assays.
The argument for reversing the trend
Because it was easy to measure and therefore easy to cut, the pathology laboratory workload has become a favourite target for budgetary reductions. There is now, however, a growing recognition in the healthcare community that IVD testing now accounts for only a small fraction (about one percent) of total health care expenditures, and that further cuts in this area might result in a net increase in overall health care costs due to missed diagnoses and over or under medication due to inadequate monitoring of therapeutic drugs. Indeed this is a new paradigm that may provide the IVD industry with the opportunity to assume its rightful place as an equal partner with the therapeutic side of health care delivery. The new model recognises that relatively small IVD expenditures can lead to significant net savings for the health care system.
It is a major part of BIVDA's remit to explore the evidence to support this position. Whether it is testing for infections such as Helicobacter pylori, responsible for hundreds of thousands of cases of chronic dyspepsia, or the utilisation of tests for the cardiac specific Troponin assays in the differentiation of the causes of acute chest pain, to cite just two examples, the use of IVDs can deliver significant downstream savings in the health care budget and in the quality of life of the individuals concerned. It has been argued that the use of IVDs to detect the early stages of late-onset (type 2) diabetes as an alternative to allowing the onset of the serious sequelae of the condition to bring the situation to the attention of the practitioner would help reduce the overall costs of the disease, some five percent of the total healthcare budget. This in addition, of course, to the benefits brought to the sufferer in terms of quality of life and personal performance at work and at leisure. It is estimated that, in the UK alone, some one million individuals are diabetic, but undiagnosed, all of which will in time succumb to the expensive and unpleasant complications of uncontrolled glycosylation, and further swell the waiting lists.
One important component of health management
The in vitro test is, of course, only one component of the total clinical investigative procedure. Physicians retain ultimate discretion in assigning a disease state to each patient based upon a mix of clinical and laboratory findings. In many instances, however, the balance of that mix leans strongly towards laboratory findings. Moreover, the IVD test has a number of roles within the overall patient management programme, including screening, diagnosis, therapeutic monitoring, compatibility testing and post-surgical monitoring. The leading diagnostic company in the world invests one million dollars a day in research and development, in parallel hundreds of small biotech companies, many working in conjunction with universities, carry out research projects related specifically to diagnostic tools and new technologies. The challenge is to provide information concerning the fruits of this work to the medical practitioner faced with a deluge of material detailing advances across the whole spectrum of medicine and pharmaceuticals. In addition, the positive financial outcomes of the use of these new tools need to be brought to the attention of doctors, health administrators and politicians alike.
Diagnostics clearly have the potential to evolve into a wholly integrated component of the health care mix. More self-administered diagnostics will follow the pregnancy test onto the shelves of the pharmacist and the supermarket. Rapid technological advancement in such areas as vascular disease markers, tumour markers, DNA probes for infectious diseases, genetic testing and pharmacogenetic screening strongly suggests that IVDs will assume an increasingly important role in detecting and managing an even broader range of diseases. They offer the prize of reducing the waiting lists from the opposite end to that generally processed by the healthcare system, and offer a real opportunity to reduce the overall costs of healthcare in a variety of scenarios. The challenge is one of information exchange, in an area of human endeavour already overloaded with news of advances and innovation. It is a challenge taken up by the British In Vitro Diagnostics Association, attracting significant encouragement from professional and administrative organisations as the evidence to support its position grows.
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