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16 November 2017updated 13 Jul 2021 1:09pm

Understanding the value of in vitro diagnostics

In vitro diagnostics can improve the accuracy and cost-efficiency of NHS treatments during challenging times. 

By Doris Ann Williams

The UK’s population is growing and it is growing older. But vastly improved length of life, one of the great successes of the last century, is set to provide some of the great trials of this one. The NHS is undoubtedly one of the UK’s prized assets, but faced with more people and tighter budgets, delivering the world-class care it is known for becomes more of a challenge. Managing budgets effectively is a more desirable path than cutting certain expenditures entirely; and in vitro diagnostics (IVDs) represent an opportunity to break up bureaucracy, streamline decisions and most importantly, improve primary care.

IVDs are non-invasive tests used on biological samples from a person (for example blood, urine or tissues) to consider symptoms and determine the status of that person’s health. IVDs provide useful information on how the body is functioning; they are used for diagnosis, screening, assessing predispositions and therapeutic monitoring of diseases such as diabetes. Innovations in IVDs have been a key element in cutting costs in healthcare systems by making treatment more precise and efficient. At such a pressurised time for the NHS, however, even more needs to be done.

There are three main types of IVDS: clinical laboratory testing, point of care testing and self-testing. It is thought that around 70 per cent of clinical decisions are informed by IVDs. They are a crucial factor in the NHS frontline and a fundamental part of almost every patient pathway. 

If used effectively, IVDs can help to reduce or avoid hospital referrals – because they can get to the correct diagnosis quicker – and to support patients to look after their own health. A more accurate diagnosis can also reduce risk of unnecessary prescriptions of antibiotics. If general practitioners use IVDs in instances, for example, where a patient may be showing symptoms of deep vein thrombosis, then a simple test can rule out this diagnosis for many people. The cost of this test is less than one tenth than that of a hospital referral, signifying a clear business case for the use of the IVD. As resources are freed up for use elsewhere in the NHS, a healthier population directly correlates to a more productive one, supporting wider economic growth. 

Research and Development (R&D) by the IVD industry has led to the creation of many new and innovative IVDs across a wide range of disease areas. But the industry still faces a glass ceiling when it comes to the uptake and diffusion of IVDs within the NHS. This is in part down to budget silos. The current budget for testing and general pathology in the NHS is separated from the rest of the budget for a medical pathway. This can be a disincentive for the introduction of cost-saving and potentially life-saving new tests because while the on-going costs are borne by the innovators, the savings don’t accrue until further down the patient pathway. In general, the understanding of IVDs is lacking. As such, the NHS is too inflexible when it comes to adopting new IVD tests. In fact, uptake of new IVDs within the NHS typically takes about 10 years. Solutions are still thought of as pharmaceuticals and consideration is not given to how IVDs could be adopted to improve outcomes.

In fact, IVDs are well placed to deliver on many of key ambitions in the Five Year Forward View, including disease prevention, patient empowerment, implementing new models of care and driving efficiency savings. Consider, for example, that by 2025 it is expected that 5m people in the UK will have diabetes. IVDs are essential to diagnosing diabetics and then help them to manage their condition and enjoy quality of life. The best way of ensuring that a person is on top of their diabetes is by testing their blood sugar at regular intervals, particularly before meals. Self-monitoring can be a great way to help control blood sugar as it allows flexibility in lifestyle and treatment choices, as well as helping to monitor for symptoms of hypo or hyperglycaemia. 

The current landscape facing the IVD sector is difficult. On the one hand, there is an increasing demand for tests; it is expected that there will be a 10 per cent annual increase in demand for blood and tissue tests over the next 10 years due to an ageing population and rising incidence of chronic disease. On the other, the final report of the Carter Review stated there was an opportunity for the NHS to save around £200m in the provision of pathology services. This is despite the fact that the NHS only spends about £800m annually on IVD products – less than 1 per cent of the total NHS budget. Recent research has found pathology services in the UK are struggling to cope with the increasing demand for samples to be tested, in part due to workforce shortfalls. 

So, how are IVDs different? IVDs are tests used on samples taken from the human body to determine status of health unlike pharmaceuticals, which aim to treat or manage a condition or disease. An IVD has no physical contact with the body unlike medicines, designed to be absorbed and act systematically. For IVDs, innovation comes primarily from clinicians’ insights, rather than laboratories.

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Delivering benefits for patients and the NHS is at the heart of the IVD industry. However, it should be noted that the industry also makes a valuable contribution to the UK economy, employing more than 8,000 people, with annual sales of approximately £850m to the NHS and playing a significant role in UK exports; £1.1bn were exported in 2013.

Ultimately, the IVD industry is clear in its aim to grow benefits for the NHS, the UK economy and, of course, patients. We need to get as much care as possible out of hospitals and into communities. IVDs can help us to do that.

Doris-Ann Williams is the chief executive of BIVDA.