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Changing times

Increasing workloads has led to the NHS and commercial companies having a very close working relationship. Here we look at two areas that have seen the greatest change in the last decade, IT and biomarkers

IMMENSE changes seen in pathology during the last decade mean commercial companies now work in partnership with their NHS customers to provide a full range of essential products that support laboratory medicine. They are required to have a presence that outstrips the traditional role of a supplier of analytical instruments and reagents. Increased consideration and understanding of laboratory process is combined with products that incorporate IT, automation, high quality assays and new technology - all of which must be underpinned by ongoing service and support.

These changes have been driven by increasing workloads, both in terms of the volume of testing and the repertoire of analytes that a laboratory service is now expected to provide. This has been compounded by huge financial pressures to make savings and provide a more cost effective service in the future. Many laboratories are required to supply a seamless 24 hour service, seven days a week, and with improving patient awareness of health and disease, requests for once esoteric tests are now commonplace.

The production of increasing quantities of numerical data requires essential overlap in specialist information technology. IT is not only used as a database for results and requests within the laboratory itself, but is a valuable communication tool in its own right. Transfer of bulk electronic data to patient databases and outlying areas, such as GP surgeries and clinics, including request entry at ward and service user level, removes the necessity for paper reporting and saves valuable time, while within the laboratory, intelligent stock control and quality control analysis provides efficiency and minimises human error.

Consequently, suppliers have a commitment to provide IT solutions that will help labs deal with the changing landscape of laboratory medicine. These should support data transfer between existing databases and include innovative new ways to utilise IT, such as multi-site networking, whole system connectivity and the development of remote virtual methods of operation. They should also aim to further improve the undertaking of laboratory administrative tasks, interfacing of analytical platforms with LIMS, and automation of traditionally manual tasks such as dilutions and reflex testing.

Historically, IT has come quite late in the laboratory redesign process and used to fill in the gaps between other elements. However, with increasing utilisation of IT to maximise efficiency in the laboratory process, IT should be considered from the outset.

Patients themselves are able to access medical information far more easily than in the past, thanks largely to the internet, and with patient choice firmly on the NHS agenda current instrumentation must remain flexible and able to accommodate new and innovative assays as the demand dictates. Suppliers must be able to develop assays and technology to keep pace with the demands of the service users, both the professional and the public. The increased awareness of the public means that healthcare professionals themselves must remain alert to changes in both public perception and new technologies, and the commercial supplier engaged in research and development can assist with this.

The number of biomarkers available in the diagnostic arena has grown considerably over the years and as medical advances continue, this number should rise further. With laboratories keen to consolidate instrumentation, the breadth of the assay menu on any analyser is of great importance.

Abbott Diagnostics recognises that research and development into areas of anticipated clinical need is crucial in order to offer analytes that reflect the changes in clinical practice and to serve the advancement of medicine. Examples of new biomarkers that dovetail assay development with currently unmet clinical need are: progastrin-releasing peptide (ProGRP), a tumour marker for diagnosis of small cell lung cancer; human epididymal protein 4 (HE4), a useful biomarker in ovarian cancer detection; and neutrophil gelatinase-associated lipocalin (NGAL), a marker for the early identification of acute kidney injury in the critically ill or post surgical patient.

However, the route from developing a new biomarker to its adoption into routine use takes time. For example, antibodies to cyclic citrullinated peptides (Anti-CCP1) were first described in 1998 and second generation peptides (CCP2) in 2003. These were then employed in commercial ELISA products and a plethora of publications followed on the utility of this marker for the diagnosis of early RA1. But only in 2009, are the NICE clinical guidelines for rheumatoid arthritis (NICE clinical guideline 79) recommending it an early predictor of rheumatoid arthritis.

It is hoped that the availability of new biomarkers will lead to easier diagnosis of particular medical conditions. This advance may also contribute towards increased uptake of personalised medicine. And with new IT solutions, laboratory efficiency can be improved and results communicated more easily and effectively. Both of these areas have seen major change over the last decade and look set to see more in the upcoming years.

References

[1] Van Venrooij et al. Anti-CCP antibody, a marker for the early detection of rheumatoid arthritis. Ann N Y Acad Sci, 2008 Nov; 1143:268-85

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