WHERE IS THE DIAGNOSTICS REVOLUTION?
Did the pandemic improve diagnostics? Have governments applied the lessons learnt? Has there been a meaningful return on the billions of dollars deployed?
The Chance To Build A Better Healthcare System
The pandemic proved many theoretical assumptions at new scales. The event forced billions of people around the world to learn about modern diagnostics and become competent in self-testing. It unlocked R&D funding and streamlined regulation to fast-track innovation. Through this collective action, global funding and streamlined regulation, it appeared at the time inevitable that the Covid-19 pandemic would revolutionise global healthcare. The future had been accelerated, medicine would transition from treating late-state illness to identifying and curing early-stage infections. The lessons learnt would be quickly applied to both preparing for the next pandemic and addressing other high-burden infectious diseases. Notable events and statistics include:
In 2020, global spending on health hit $9 trillion, or 10.8% of global GDP.
The US Rapid Acceleration of Diagnostics (RADx) program invested over $1.5 billion in accelerated diagnostics development.
The UK government spent an estimated £13.9 billion to make COVID-19 testing freely available from 2020-2021.
The World Health Organisation (WHO) established the Access to COVID-19 Tools Accelerator (ACT-A) to increase global access to tests, vaccines, and therapeutics.
WHERE ARE THE NEW HIGH ACCURACY TESTS?
One clear lesson learnt during the Covid-19 pandemic was the practical benefits of the widespread availability of Lateral Flow Test (LFT) diagnostics to combat infectious disease. Whilst laboratory-based Polymerase Chain Reaction (PCR) remains the gold standard for accuracy, it is difficult to scale its capacity to population-level surveillance or its speed to test-and-trace suitability in times of emergency. LFTs not only provide these capabilities but do so at a fraction of the cost of central laboratory PCR testing.
The pandemic created a once-in-a-generation opportunity for the world's diagnostics industry to enhance its products, systems, and services to take advantage of a new market opportunity.
However, despite the overwhelmingly positive views by patients and healthcare providers around the experience of having at-home testing during the pandemic, since the WHO downgraded the Covid-19 pandemic from a global health emergency, there have been few signs of new LFTs for other infectious diseases.
One notable cause for this absence is that unlike the urgent demand created by the global Covid-19 pandemic where at-home access was more important than gold-standard performance, for other applications, test performance needs to be comparable to PCR, but due to technical limitations, current LFT tests cannot deliver this.
“Whilst laboratory based PCR testing remains the gold standard for accuracy it cannot be easily scaled-up in times of emergency.”
The Advantages and Opportunities of Lateral Flow Tests
The central strength of aN LFT is its accessibility and scalability. Due to its price, speed, and simplicity, it can be produced, deployed, run, and reported by the billions. Additionally, the pandemic demonstrated LFTs have a number of other less obvious advantages:
Scalability - LFTs can be manufactured in huge quantities to allow frequent, widespread testing.
Community testing - LFTs enable decentralised testing directly in the community and homes without requiring samples to be sent to centralised laboratories.
Frequent testing - The simplicity and low cost of LFTs allow recurring testing programs (e.g. daily / weekly testing).
Self-testing - LFTs can be self-conducted, unlike PCR tests. This expands access and versatility.
Societal testing - LFTs are better suited for large-scale screening, surveillance, and infection prevention programs.
Connectivity - LFTs can include instructions for the patient to link a result directly to a telemedicine virtual healthcare service.
Demand
The urgent need for new diagnostics solutions is clear: For example, commercial LFTs don't yet exist for 4 out of 8 WHO priority diseases with epidemic potential. In addition, there is clear evidence that LFTs could also play an important role in decentralised testing for WHO-priority diseases like Tuberculosis, Ebola, HIV, and antimicrobial resistance. Finally, as the pandemic made clear, there is a real opportunity to enhance care pathways, surveillance systems and digital tools by linking LFT test results to health records, healthcare platforms, and monitoring systems.
Central Lab Testing
Although the gold standard in regards to accuracy, the current model of central laboratory-led diagnostics is limited and unable to replicate the many advantages demonstrated by LFTs:
Capacity: PCR relies on fixed lab capacity and infrastructure.
Speed: PCR has a slower turnaround time often negating its accuracy advantage.
Logistics: PCR samples need transport and results need communication.
Frequency: PCR is not suited for frequent serial testing.
Scalability: PCR supply cannot be amassed for future needs.
Price: PCR unit costs are fixed and do not meaningfully reduce with scale.
Challenges
Covid created a unique environment from focus, to funding, to regulation. As Covid-19 is no longer a global emergency this support is rapidly reducing, and with this reduction, the opportunity to apply Covid era innovation to the wider healthcare industry is fading. For example:
Funding: Government emergency grant funding has all but been removed.
Investment: As demand is less clear Private industry investment is more speculative, therefore higher-risk, and as such harder to secure.
Regulation: Regulatory friction is returning increasing costs and burden to innovation.
Infrastructure: Without a clear and singular focus it is difficult to access well-characterized R&D reference materials and samples.
Recommendations
Now that Covid-19 has been downgraded from its emergency status it is tempting to quickly return to the pre-pandemic healthcare status quo. However, this would miss capitalising on the knowledge gained and systems established during the crisis and in better preparing for a future emergency with similar characteristics.
To ensure the opportunity is not missed, public funding and private investment must be sustained, and regulation should continue to streamline diagnostic innovation. Other recommended actions should include:
Sustained post-pandemic funding for LFT R&D.
Invest in LFT manufacturing capacity.
Regulatory convergence and harmonisation.
Develop target product profiles to guide the industry.
Improve access to specimens and standards.
Consider product requirements early in the research.
Evaluation of real-world LFT use.
Increased focus on public-private partnerships.
The Covid-19 pandemic has shown the world what is possible if healthcare were to move from treatment to prevention. It has not however shown governments or industry how to capitalise on that knowledge. That is an entirely new problem that will need an entirely new solution.