Developing diagnostics: challenges and opportunities during COVID-19

Daniel Berman, head of global health at Nesta Challenges, writes about the challenges the UK faces when it comes to sourcing and manufacturing life-saving medical devices like rapid diagnostics and shares key lessons from how COVID-19 test developers can learn from those working on AMR.

“Britain has an innovative, but relatively small diagnostics industry. We now need to grow it, substantially and quickly." This is one of the big asks of the recent Department of Health and Social Care’s report into scaling up the UK’s testing programmes in response to the outbreak of COVID-19. The report calls for the development of “resilient, diagnostic capability in the UK capable of meeting the testing demands over the coming months and years."

The development, manufacture and the final commercialisation of diagnostics is, undoubtedly, a complex process and there are many issues to get to grips with, from defining needs, product testing and validation and regulation. At the same time, bigger issues - like how the government funds R&D and how to overcome the so-called valleys of death in which companies struggle to raise private capital - can make it even more difficult to launch new and timely innovations. These issues jumped into the spotlight during the first few months of the COVID-19 pandemic.

As Boris Johnson recently pointed out in his ‘Build, Build, Build’ speech about the post-COVID-19 recovery, the UK’s talents in research and development too often do not translate into commercially successful businesses, saying, “[w]e must end the chasm between invention and application that means a brilliant British discovery disappears to California and becomes a billion dollar American company." This is an opportunity for the diagnostics sector.

Working with the Longitude Prize, an £8 million prize to develop diagnostic tests in the fight against antimicrobial resistance (AMR), I get to interact with diagnostic test developers every day; tracking the issues and trends that shape the industry. As we move into the post-COVID-19 recovery period, there are some emerging insights that we can draw from the way companies responded to the pandemic, that tell us a lot about innovation and bringing diagnostic tests into a health system.

For example, when the call to action from governments went out, many of the companies working on rapid diagnostics for AMR redirected their skills to the COVID-19 response. Fifteen of the 54 companies competing for the Longitude Prize informed us that they started working on COVID-19 tests as well as continuing development of AMR tests. 

They faced a number of significant challenges early on, with factories being closed due to lockdown and the demand for reagents going through the roof, to the post office being unable to make deliveries. At a more structural level, some companies claimed that they were willing to manufacture other companies’ tests but the government, at the time, had no way of supporting that cross business partnering.

There are of course differences in the design of diagnostic tests for viral infections like COVID-19 and bacterial infections but ultimately, they serve the same function - to diagnose and to guide treatment. At face value, there’s no denying that a pandemic has been an extraordinary stress-test for the UK’s diagnostics industry.

Crucially, it has exposed structural weaknesses that hamper medtech product innovators, especially around manufacturing capabilities at short-notice, collaboration across sectors, and questions of supply-chain resilience. There is also the challenge of regulators maintaining flexibility while avoiding tests coming to market that do not produce consistent accurate results.

It is inevitable that a rapid rethink of the structural barriers that proved obstacles to the initial development of COVID-19 tests will have lasting impact, to the benefit, I hope, of the wider diagnostics industry. We must learn the lessons of COVID-19 to ensure increased numbers of needed, validated diagnostics are manufactured and brought to market successfully.

We will continue to advocate for rapid testing (including community testing) to be prioritised, not only when we are faced with immediate health crises but also to address longer term public health challenges: UTI diagnosis, identifying which antibiotic will work the first time around, predicting and providing the right antibiotics to avoid sepsis, and so on.

We are encouraged that government is focused on supporting diagnostic developers and manufacturers for COVID tests, but to support an expanded diagnostic industry there needs to be an extension of this urgency to other testing priorities. The AMR threat has not abated. 700,000 people will die from a resistant bacterial infection in 2020, with the number set to grow each year, which puts this threat into pandemic proportions.