The face of diagnostic tests is changing fast and that is absolutely thrilling for a clinical academic working in diagnostics like myself. Over the past decade, we have seen lots of new innovations coming through that change how we use diagnostic tests.
First of all, miniaturisation of in-vitro diagnostics has allowed the development of point-of-care tests. A lot has been said about how these tests speed things up because we no longer have to send the sample to the central laboratory and wait for the results to come back. However, rather than focusing on the fact that these tests provide results faster, we should focus on the fact that they create new possibilities. For example, acute care in the community can be made more precise by introducing such new diagnostic technology that provides information on the spot. As a result, it allows patients, especially the elderly, to receive care close to home rather than having to be admitted to hospital. Various new care models have emerged that have incorporated these diagnostic tests in their patient flow; it will be interesting to see what the effects of these models are, what the exact contribution of the diagnostic test technology is, and how they can be translated to other settings and countries.
This highlights the general shift in where and by whom tests are performed. We have seen the development of handheld ultrasound devices to diagnose pneumonia which can be done in primary care, and tests that link with smartphone apps to allow patients to monitor their gestational diabetes. Again, this leads to more changes than simply a different place and operator. These tests disrupt current pathways and require changes to protocols, training, interpretation guidance etc. Shifts in setting may require different test thresholds that define an abnormal test result, clinicians may need to gain confidence with the new technology before they feel comfortable to base their management decisions on the result, treatment protocols may have to be adapted to the new diagnostic information. All this will require evaluation work, evidence that quantifies changes to the care process, benefits and harms for patients, and cost consequences.
In situations where new diagnostic test technology potentially will disrupt how we currently manage particular health problems, interaction between industry, clinicians and healthcare providers early in the development process is key. Mapping where the test might be useful with early modelling, making budget changes explicit and exploring feasibility and acceptability in clinicians might prevent disappointment later on. The NIHR Diagnostic Evidence Cooperatives in Oxford, Leeds, Newcastle and London offer opportunities for the diagnostics industry to work with clinicians and build an appropriate evidence base for new tests. This has resulted in some very good examples of how this leads to better care for patients and a more efficient access to market for industry.
At the UK Diagnostics Forum, we bring together all stakeholders including industry, academia, healthcare providers, regulators and funding bodies. Past editions have sparked new collaborations, calls for funding and have contributed to new initiatives such as the Precision Medicine Catapult. Now in its 5th edition, we are very happy to welcome a wide range of speakers who will each present their perspective on how diagnostics can disrupt the way we work. The Forum is taking place in Oxford, from 26-27th May: we hope to see you there!