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24th July 2006

Growth in Point-of-Care diagnostics to increase, says new report.

A report, released today, has concluded that the Point-of-Care diagnostic market is poised for exceptional growth over the coming years, thanks to the increased availability of accurate, rapid tests; patient demand for instant results; integration with drug delivery technology; and an industry-wide shift to supplement lab-based testing with testing in the home, doctor's surgeries and over the pharmacy counter. However, despite these clear market opportunities technological obstacles, such as standardisation and data management, need to be overcome in the short to medium term.

The report, compiled by Cambridge Consultants, follows a workshop held in May 2006 where thought-leaders from across the diagnostics industry discussed the future of Point-of-Care testing (POCT) and the role of technology. The 24-hour workshop attracted delegates from a variety of backgrounds, who ranged from front-line clinicians to diagnostic companies developing tests and devices.

"The delegates concluded that in the near future a larger percentage of diagnostic testing will be done in front of the patient and not in the centralised labs. Although, this doesn't mean that the high-throughput lab testing is dead," said Dr Simon Burnell, diagnostics campaign manager at Cambridge Consultants. "Instead, growth in POCT is expected to supplement these centralised tests. In the future, routine tests will be carried out by the doctor or the pharmacist in what we refer to as a 'hub and spoke' industry model. This will create an exciting phase for the market as this new approach to diagnostics will require new technology and approaches to product design to be explored,"

After discussing the opportunities for POCT, the delegates turned their attention to the technology and whether it was adequate. The delegation agreed that the current wet chemistry used in diagnostic testing is adequate and that the barriers to faster adoption lie in post-test data management and quality control. However, the delegation also agreed that new and emerging technologies, such as micro and nano technology and novel labels, offer the promise of revolutionising POCT and diagnostic testing in the future. The group felt that in the meantime the industry needed to work together on an evolutionary approach to enabling doctors and patients to collate the results from the tests in a meaningful and useful fashion. It was felt that standardisation would speed the adoption of future POCT technology, as well providing the patient with a common user interface - ensuring that the tests are carried out reliably.

"Diagnostics companies could learn a lot from the mobile phone industry. As a group they came together to focus on standardising aspects of their technology as they realised that this would benefit the consumer, as well as the companies who were then free to innovate and add value," comments Dr Burnell. "The diagnostics industry needs to follow suit and work out a way of providing data from Point-of-Care devices in a simple and common format. This approach will enable doctors and pharmacists to carry out tests and feed this information back into the healthcare system. It also enables patients to record their own 'at-home' test results in some form of online management system, in much the same way as we manage our bank accounts online today."

So where are the opportunities? The report concluded that while the industry is about to enter a phase of significant change, the market for POCT differs from region to region. In the US defensive medicine dominates and concerns over liability means that a final confirmatory central test is required. However, there remains a significant opportunity for 'non-professional' POCT in the home.

In Europe, adoption is driven by clinical benefits and centralised purchasing, although the rate of acceptance is different within each country. In countries with decentralised health services, like Sweden and Germany, POCT uptake is moving fast with high awareness amongst physicians and patients. One delegate even suggested that in the near future 80% of the tests carried out in Sweden will be POCT. At the other end of the spectrum are the centralised healthcare services, such as the UK's NHS, which is focussed on realising cost benefits and is typically driven by government policy. In addition, the NHS' difficulty in deploying a centralised IT infrastructure on time and within budget suggests that countries with centralised health services will struggle with POCT adoption. Under this framework, the emphasis is on diagnostics companies, who must provide clear evidence to illustrate the long term clinical and financial benefits.

The report is available free of charge and can be downloaded here.

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