Accelerating diagnostic tests to prevent a future pandemic

Guest piece by Bill Rodriguez, CEO of FIND

Preparing to face down the next Disease X

Imagine a world where, once SARS-CoV-2, the virus that causes COVID-19, had been identified and sequenced, the rapid diagnostic tests, the treatments, and the vaccines we needed to respond were already available, requiring only minor adjustments before they could be rolled out at scale. Imagine that global manufacturing capacity and public health infrastructure were already in place, and the authorizations and programmes to get these vital tools quickly to those who needed them – in every country in the world – were finalized in days, rather than months.

In this scenario, hundreds of thousands of lives would have been saved. Lockdowns would have been prevented or shortened. And the roughly $3 trillion economic impact of the SARS-CoV-2 pandemic would have been dramatically reduced.

This is the 100 Days Mission – a plan for the world to be able to respond to and extinguish the global threat of the next Disease X within 100 days of the World Health Organization (WHO) declaring a major outbreak or pandemic. This may sound like a lofty ambition, but it is achievable if:

• Enhanced surveillance systems are in place for early threat detection
• Point-of-care testing platforms are developed and rolled out worldwide to diagnose disease outbreaks as they happen
• Manufacturing capacity is established globally, in a coordinated and distributive framework for rapid technology transfer to minimize over-reliance on any one source and keep supply pipelines open
• Our testing systems are linked to rapid public health interventions, breaking chains of transmission in real time – and keeping our health systems from being overwhelmed
• Worldwide testing is accompanied by accelerated development of vaccines and therapeutics, which can be similarly rolled out in 100 days
• Global equitable access to tests, vaccines and therapeutics is assured

Pandemic preparedness encompasses a comprehensive test-treat-vaccinate strategy, linking public health interventions and clinical care. Although getting all of this right in 100 days might seem like a tall order, with thorough preparation, investment, and readiness, we believe it is well within our grasp.

What has already been achieved

Close collaboration among global health agencies like the Coalition for Epidemic Preparedness Innovations (CEPI) and FIND, the global alliance for diagnostics, during the COVID-19 pandemic, alongside academia, industry, and national and global public health agencies, provided a roadmap for ultrafast development and distribution of both vaccines and diagnostic tests for future pathogens that threaten to overwhelm us the way SARS-CoV-2 has.

The key diagnostic achievements during COVID-19 are instructive:

• Accurate polymerase chain reaction (PCR) tests for SARS-CoV-2 were available for limited use in laboratories within 8 days of the WHO declaration of COVID-19 as a Public Health Emergency of International Concern (PHEIC)
• Simple PCR tests for COVID-19 were authorized for use and available for scaled-up testing in major health centres within 64 days of the WHO PHEIC declaration
• Rapid antigen tests for COVID-19 were developed, validated, and authorized for use by WHO in any health setting within 236 days
• Private sector innovation and high-volume demand enabled scaled-up manufacturing of rapid tests, which halved the price of rapid diagnostic tests in just over 12 months. This was an important factor in increasing global access to testing, particularly in low- and middle-income countries
• Since the start of the pandemic, more than 7 million SARS-CoV-2 genome sequences have been shared by all 193 UN Member States to global databases like GISAID. For the Omicron variant, 163 countries have shared more than 2 million genome sequences
• Manufacturing capacity for COVID-19 tests has been significantly expanded in Latin America, Africa, and Southeast Asia since mid-2021

Past challenges and preparing for success

Despite many successes in testing during the pandemic, the global COVID-19 testing effort had many shortcomings, and significant challenges remain to be understood and addressed. In particular, the global inequity of access to tests, treatments, and vaccines, especially in remote areas and low- and middle-income countries, has greatly hampered COVID-19 control.

Delays in the availability and uptake of COVID-19 tests and vaccines contributed directly to the emergence and global spread of the Delta and Omicron variants, extending the pandemic into its third year. Earlier use of tests, surveillance tools, and vaccines in every country would have significantly mitigated the emergence and impact of these new variants.

However, despite the challenges, the future looks bright. Before the COVID-19 pandemic, research, development, and demand for diagnostic tests resulted in poor surveillance, limited manufacturing capacity, unstable supply chains, and poor distribution and use of tests on a global basis. Today, this is no longer the case.

By thoroughly examining and supporting every aspect of the development, validation, manufacturing, regulatory authorization, rollout and access to key diagnostic tests – PCR, rapid tests, and genomic sequencing, as well as promoting research and development of novel future technologies – we can prepare and shave vital days off the COVID-19 timelines to achieve the 100 Days Mission for any future threat, with our goal to be fully prepared by 2026.

Testing is the essential first step in pandemic preparedness – identifying the enemy and directing the development of vaccines and treatments. At FIND we are working closely with CEPI and with our global partners on diagnostic pandemic preparedness in five key areas:

1. Diagnostic test kits for the highest priority pathogens, which can be adapted quickly to any emerging pathogen, including novel diagnostic platforms
2. Normalizing regular diagnostic testing
3. Ensuring global access to diagnostic testing through reliable local manufacturing capacity and investments in testing networks in low- and middle-income countries
4. Global surveillance systems to detect and monitor emerging pandemic threats, old and new
5. Global cooperation and coordination on areas such as testing policy, emergency regulatory authorization, and global data sharing

Diagnostics for priority pathogens

FIND is working with CEPI to devise a process for prioritizing key pathogens and virus families for vaccines and diagnostic tests across proven platforms (e.g., PCR testing, lateral flow antigen tests), with input from WHO and other global stakeholders.

Normalizing diagnostics

Governments have a significant role in creating incentives for diagnostic research and development, and in normalizing the use of diagnostics in primary healthcare, at home, at pharmacies and hospitals, and in other non-clinical settings. Through diplomacy, advocacy, and policy development. FIND will work with partners, including WHO and other global stakeholders, to assist governments worldwide in normalizing use of diagnostics in diverse care settings.

Global access

FIND will work with industry and global health agencies to expand the manufacturing base in low- and middle-income countries, including ‘modular’ manufacturing processes that are transferable and scalable, allowing for rapid production of key diagnostic tests in every region of the world.

While future testing needs will differ from those of the COVID-19 pandemic depending on the characteristics of Disease X, the preparation will focus on the capacity needed for a COVID-level surge, where 1 in every 1,000 at risk people could be tested daily. The capacity to supply accurate diagnostics for pandemics through the 100 Days Mission will need to be matched by sufficient demand between pandemics to sustain global production below surge capacity at affordable prices. In this way, pandemic preparedness strengthens health system capacity to also address every day endemic diseases.

Global surveillance

FIND will continue to work with the WHO International Pathogen Surveillance Network and global partners such as the Africa Centres for Disease Control and Prevention to enhance global surveillance, including genomics capacity, building surveillance capacity for key endemic diseases like HIV, malaria, and TB; for vaccine-preventable diseases like yellow fever and mosquito-borne arboviruses like Zika and Chikungunya, and for the growing threat of antimicrobial-resistant bacteria. This will include promoting digital health systems for systematic data collection and rapid dissemination of key information when a pathogen threat occurs.

Global coordination

FIND will continue to work in partnership with CEPI, industry, and WHO to strengthen international coordination on diagnostics research and development.

COVID-19 taught the world some harsh lessons about being unprepared. We now have an opportunity to learn from past mistakes and prevent another global health catastrophe. The key is stronger, more resilient health systems. Ensuring we are ready to respond effectively to a new threat within 100 days is ambitious, but achievable – and essential if we are to prevent a future pandemic.