Over the last half century, in vitro diagnostics has consistently been an area of considerable innovation, and the product of this endeavour has played an increasingly important role in the early recognition, diagnosis and management of disease. Today, we stand on the threshold of another explosion in the development of diagnostic technology.
With our increasing knowledge of the molecular interactions that underpin the normal functioning of the human body – as well as the aberrations that occur with disease – we are beginning to discover the fundamental markers of disease and predisposition to disease. This has led to the development of more targeted therapies together with complementary diagnostic tests.
We are going to see tests that will identify a person's predisposition to disease, detect the presence of that disease at a molecular level, identify the best therapy and then monitor compliance with that therapy. The monitoring of the effectiveness of a therapy and patient compliance is fundamental to a successful outcome in chronic diseases such as diabetes.
In Europe, there are currently two main trends in the delivery of lab medicine services: the centralisation of lab services and the increasing use of automation in core laboratories on the one hand and the proliferation of point-of-care testing on the other.
Technology is available to facilitate both these trends. Enhanced sample processing power-linked to tracking systems and pre-analytical sample preparation stations make the automated core lab a reality, while the development of miniaturisation and micro-fabrication processes means that point-of-care testing for virtually any analyte is now available. Despite this innovation, the two trends are somewhat contradictory, in that one promotes centralisation and the other decentralisation.
To understand this apparent contradiction, it is necessary to appreciate that services are now being reorganised to put patients first. In future, more care will be delivered in the primary care environment, and secondary care will be organised to make patient visits more effective. Core lab services and point-of-care testing address fundamentally different requirements. The core lab can provide efficiently delivered and cost-effective bulk testing together with specialist services where time is not a critical factor. When speed of response is important, or where the face-to-face dialogue between doctor and patient is needed, point-of-care testing will be preferred.
Innovations in IT coupled with well-organised logistics will be necessary if the revolution in diagnostics is to take place. However, the healthcare sector seems to lag behind in this area. This is undoubtedly having an adverse impact on the application of modern diagnostics and on patient outcomes. Errors occur in test requesting, sample identification and delivery as well as in the transmission of results. The great challenge is to use information technology to link test results to
knowledge, and thereby support both the doctor and the patient in making the best use of test results.
There are great benefits to be gained from the impending revolution in diagnostics technology. The patient will benefit from better education and support, faster delivery of care and access to better tests. The healthcare provider will benefit from improved customer satisfaction, more efficient services and more efficient use of resources. However, these benefits will only be achieved if there is a better understanding of the benefits that diagnostic tests bring and a change in the way resources are allocated.
Diagnostic services exist to serve the patient and his/her carers, yet they are always regarded as a cost centre rather than a facilitator. As a consequence, there are situations where under-investment in diagnostic services has resulted in a lost opportunity to benefit the patient and make better use of resources. A broader view of resource allocation is required, one that focuses more on outcomes and less on costs.
Despite the exciting new possibilities for in vitro diagnostics, it remains the Cinderella of healthcare: unrecognised, unappreciated and under-funded. Since handsome princes only exist in fairytales, our first task must be to raise awareness of the value of in vitro diagnostics, the value of the information that the tests provide and the positive benefit that it can have on decision-making. The diagnostics industry is working with three groups of stakeholders to raise this awareness: lab medicine professionals, patient groups and health economists.
The in vitro diagnostics industry has always had close contacts with the professional associations of lab medicine, and it is now looking to partner with them to promote awareness of in vitro diagnostics. With the encouragement of the European Diagnostics Manufacturers Association (EDMA), a new forum, European Laboratory Medicine (ELM), has been set up to unite the many professional organisations in lab medicine. This forum will increase awareness of the value of lab medicine in general and in vitro diagnostics in particular.
In response to the changes that are occurring in healthcare delivery and the increasing emphasis on the patient and the needs of the individual, the industry is also establishing closer relationships with patient groups. At the European level, the EDMA works with the European Platform of Patient Organisations, Science and Industry (EPPOSI), and with representatives of patient organisations at the EU level, it is developing a paper on the importance of early diagnosis. This will endorse the EDMA’s conviction that early diagnosis ensures that treatment is relevant and cost-effective. The EDMA also supports patient organisations’ activities at the European Parliament to raise awareness of the value of in vitro testing.
Despite the modest cost of in vitro testing and the contribution it can make in terms of early diagnosis and better control of treatment, lab medicine is still a target for cost cutters. The in vitro testing industry is therefore working with health economists to challenge the notion that the lab is a cost centre. It wants to establish the idea that health is an investment and raise awareness of the real need for in vitro testing.
There are two basic sources of health problems: chance factors and individual choices (for example, diet and lifestyle). Better individual choices will lead to better health and lower healthcare costs. Thus, the development in the general public of a proactive attitude towards health is of great importance. People are becoming better informed about the value of in vitro tests and are starting to approach their doctors about them. So it is important for lab professionals to keep family doctors properly informed about in vitro tests and their uses and for patient organisations to keep their members and the public informed about the value of the tests.
With the cooperation and partnership of diagnostics manufacturers, diagnostics service providers and healthcare planners, we can take full advantage of the expected breakthroughs in diagnostic technology.