When biochemist Kary Mullis invented the polymerase chain reaction (PCR) test almost 40 years ago, little did he imagine his invention would be a life-saver during the most catastrophic pandemic of the contemporary era.

When Covid-19 first started spreading in early 2020, PCR tests became the most commonly recognised tests for the coronavirus. PCR pushed the boundaries of medical diagnostics, playing a critical role in screening, diagnosing and containing the spread of the disease.

The pandemic also brought diagnostics into the limelight more generally. Covid-19 demonstrated the importance of access to strong, diverse diagnostics infrastructure in order to address substantial challenges to healthcare and society, according to a recent report by the EU-ASEAN Business Council entitled “Transforming Diagnostic Access: A Roadmap for ASEAN”.

The report lays out recommendations for entities in the public and private sectors to consider adopting better diagnostics in order to improve and bolster healthcare systems across ASEAN.

The driving force behind the report was the way in which Covid-19 put diagnostics front and centre, with antigen rapid tests (ARTs) making their way into homes everywhere, Chris Humphrey, Executive Chairman at the EU-ASEAN Business Council told GovInsider in an interview.

“Governments have learned valuable lessons through Covid-19, and they are now certainly much better prepared in terms of understanding what they can and can’t do to try and stop a future pandemic, no matter what that pandemic might be,” he said.

They have learned to ramp up testing capacity, for instance. Humphrey said that although no tests were available during the early stages of Covid-19, tests were eventually very quickly rolled out throughout the world.

Addressing gaps

Although Covid prompted a rapid expansion of testing and surveillance capabilities, he said more needed to be done at a policy level to ensure people had sustainable access to diagnostics.

Dr Looi Lai Meng, a Pathologist at the University of Malaya Medical Centre, said having policymakers engage in discussions on developing essential diagnostics priorities was critical. She said policymakers needed to have honest conversations about what kinds of diagnostics were required at different levels and what action plans should be put in place.

Dr Looi was speaking at the launch webinar event for the EU-ASEAN Business Council’s diagnostics report, and currently sits on the Lancet Commission on Diagnostics.

Since 2018, the World Health Organization has issued an annual essential diagnostics list, a collection of suggested in-vitro diagnostics that should be provided at the point of care and in laboratories in all countries in order to boost prompt, life-saving diagnoses.

Referring to the list, fellow event speaker Lance Little, Managing Director of Roche Diagnostics Asia-Pacific, said: “I would like to see countries, and us, pushing the narrative around what are the critical tests needed at what point of time.”

Improving capacity and adopting technology for widespread benefits is another call to action for policymakers, Dr Looi said, adding that governments needed to invest in people with the capacity and capability to adopt and innovate with new technologies.

She also said the quality of diagnostics was important, and that policymakers should not forget that. “In this huge rush to develop diagnostics, produce and deliver it to people, don’t let it fall flat on its face,” she said. “Make sure there is quality attached to it and do not short-change quality assurance programmes and checks.”

But high-quality diagnostic technologies are often not accessible, affordable or designed for use in many low- and middle-income countries.

Policymakers might have other, more pressing issues in the health sphere, such as access to basic healthcare rather than high-tech diagnostics, said Martin Carkett, Policy Lead at the Tony Blair Institute for Global Change. That meant tools such as genomics were probably not going to be on their agenda for a while because there were more immediate, basic provisions that they wanted to focus on.

Carkett said diagnostics should form a part of building infrastructure, capabilities and the health ecosystem as a whole, adding that systems were in place to help developing countries. He said it was through channels such as aid budgets that developing countries could build their own capabilities and capacities to tackle diagnostics themselves.

Carkett said developed nations could provide aid in the form of financial support and technical knowledge on diagnostics, but that such things took time and weren’t a quick fix because they were part of building entire health ecosystems.

Other impediments

Carkett said hefty costs and profitability appeared to be major factors affecting the rollout of robust diagnostics methods, and that it was necessary to put in place the right incentives and commercial models to incentivize the pharmaceutical and life science industries to keep developing them.

Traditionally, diagnostics has been underfunded around the world, accounting for around just 2 per cent of healthcare spending, Humphrey said, nevertheless pointing out the critical role they played in healthcare.

“If you have better diagnostics and catch diseases earlier, you can have better targeted and often less invasive treatment for the patients, which means it’s lower costs for them and less of a strain on the health system,” he said.

Humphrey said that sometimes people died from diseases that were entirely curable unless they were not detected early enough or at all.

Carkett said diagnostics could be costly, and that most governments would face fiscal constraints, but that authorities needed  increasingly to consider their long-term economic benefits when weighing costs.

He also said patient behaviour affected the implementation of diagnostics, with few people not wanting to get tests, and preferring to get very sick before visiting doctors, which meant higher costs for healthcare systems.

He said it was necessary to help change people’s behaviour to make them more inclined to use tools such as wearables to keep a closer eye on their health and take more personal responsibility. He said the Covid pandemic, for example, had made people significantly more comfortable with doing diagnostics such as ART tests at home.

Carkett said much of the policy focus should be on incentivising the design of “at-home diagnostics”. Doing diagnostics easily and cheaply at home would help prevent the spread of Covid-19 and other respiratory or infectious diseases, and ease the burden on healthcare systems.

“We should take advantage of that and, as much as possible, try and push more diagnostics,” he said.

Resilient healthcare

Healthcare systems are trying to move more upstream, maintaining health as much as possible rather than waiting for people to fall sick and engage the system, Carkett said. That meant that healthcare professionals were trying to “catch diseases earlier and earlier”, and diagnostics were an important part of that.

He cited the example of genomics as an important means of figuring out if a person had a predisposition to certain diseases before then ever encountered a disease. That would allow them to make certain lifestyle and behavioural changes earlier, which could reduce that predisposition.

He said wearable devices were another diagnostic tool that could assist in the detection of irregular symptoms, such as heart palpitations. Wearable technologies, which have experienced a boom in recent years, could look at a person’s lifestyle and tell whether they were more likely to get certain diseases because of their lifestyle choices.

Carkett said such technologies could help people become more active and monitor their diets through apps, for instance, which he said was  a major part of avoiding diseases such as obesity, diabetes and cardiovascular disease.

He added that although such technologies were not part of diagnostics in a traditional sense, they were an important part of what diagnostics was ultimately trying to do in terms of preventing disease onset.

Road ahead

Humphrey said technology for diagnostics as a whole was advancing all the time, with better, more accurate tests coming out, making it possible to better predict the spread of diseases in the population.

He said advances in technology would also lower the price point for diagnostics, noting that when the first computers were sold, they were expensive, but that they are now affordable.

Carkett said artificial intelligence was set to play a crucial role in diagnostics, but that it is still very early days. He said AI could help glean insights from vast datasets that humans might not be able to find, or which might take them a long time to find. Such insights could advance understanding of the causes of certain diseases and the types of molecular signatures they might leave, whether they be in the blood, urine or other tissue samples.

He said governments could play a role in these efforts by fostering and incentivising the development of AI as an industry, but that ultimately, the onus was on pharmaceutical companies and life science companies to develop new diagnostics leveraging AI.

Humphrey said that having AI tools in a pandemic situation would greatly aid governments in reacting quicker and targeting diseases, since AI could help predict how a pandemic would spread and where it would spread.