Can COVID-19 help accelerate and transform the diagnostics agenda?

In 2018, The Lancet published a Series on pathology and laboratory medicine (PALM) in low-income and middle-income countries that summarised the dismal neglect of the laboratory and test-based diagnostic capabilities and availability in many countries.1, 2, 3 The Series served as the starting point for discussions on the importance of PALM to achieve high-quality universal health coverage and suggested ways to overcome barriers. It became clear that much more work in this area is needed to draw attention to this long-standing gap in the global health agenda. The lead Series authors and a global group of experts, including radiologists, announced the Lancet Commission on diagnostics in 2019. They argued that such a Commission is urgently needed at a time of increasing antimicrobial resistance, a growing burden of non-communicable diseases, such as diabetes and cancer, and a changing demography with ageing populations in many countries. Without access to accurate, high-quality, and affordable diagnostic tests, many people will be overtreated, undertreated, not receive treatment, or be exposed to unnecessary or even harmful treatment. Epidemiological and registry data will also be inaccurate. Furthermore, substantial improvements in cancer outcomes with targeted patient-specific therapies are only possible where diagnostic biomarker testing and radiology are available.

Now the COVID-19 pandemic has exposed the importance of diagnostic tests. Rapid lateral flow, PCR, and antigen tests for SARS-CoV-2 are discussed daily by politicians, journalists, and the public and available for home self-use or in public places, at least in many high-income countries. Genetic testing to identify SARS-CoV-2 variants early helps in monitoring the spread of the virus and informs vaccine strategies. This rapid need for diagnostic capacity and testing has also further increased inequity, shown the manufacturing and capability deficiencies in countries where it is needed most, and raised the ugly spectre of nationalism as a reaction to a global emergency.

The global COVID-19 response was evaluated in three reports presented to the World Health Assembly in May, 2021. In its evaluation, the Independent Panel for Pandemic Preparedness and Response made recommendations that are relevant to equitable access to diagnostics, with a focus on adequate financing, health systems strengthening, technology transfer, and a global platform in the form of a transformed Access to COVID-19 Tools Accelerator (ACT-A; panel ). Although diagnostics are part of the current ACT-A, a substantial majority of donor funding is currently spent on vaccines. A second evaluation by the Review Committee on the Functioning of the International Health Regulations only has one recommendation that relates directly to diagnostics: “WHO should develop options to strengthen, and where appropriate, build global genomic sequencing infrastructure with a view to maximizing this critical technology as a component of future pandemic preparedness and response”. The Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme noted the call for an international treaty for pandemic preparedness and response to “ensure universal access to diagnostics, treatments and vaccines for future pandemics based on the principles of solidarity, equity, accountability and transparency”. In all evaluations and pandemic preparedness discussions, diagnostics are almost always mentioned alongside vaccines and therapeutics.

G7 countries to commit to providing 60% of the US$19 billion required for ACT-A in 2021 for vaccines, diagnostics, therapeutics, and strengthening health systems, with the remainder being mobilised from others in the G20 and other higher-income countries.

Transform the current ACT-A into a truly global end-to-end platform for vaccines, diagnostics, therapeutics, and essential supplies, shifting from a model where innovation is left to the market to a model aimed at delivering global public goods.

Establish strong financing and regional capacities for manufacturing, regulation, and procurement of tools for equitable and effective access to vaccines, therapeutics, diagnostics, and essential supplies, and for clinical trials:

based on plans jointly developed by WHO, regional institutions, and the private sector;

with commitments and processes for technology transfer, including to and among larger manufacturing hubs in each region;

and supported financially by international financial institutions and regional development banks and other public and private financing organisations.

This text in this panel is from the Independent Panel for Pandemic Preparedness and Response's report COVID-19: Make it the Last Pandemic.

The publication of the Lancet Commission on diagnostics after almost 3 years of work by Commissioners from different disciplines and 16 countries could not come at a better time. Originally envisaged as an extension of the Series to emphasise the much needed progress of diagnostics globally, and especially widening the remit to include diagnostic radiology, the Commission could now form a crucial springboard for accelerating global attention to diagnostics for pandemic preparedness. Diagnostics must be a central pillar in the discussions about a new framework convention on pandemic preparedness at the forthcoming special session of the World Health Assembly from Nov 29 to Dec 1, 2021. A global diagnostics strategy for pandemics should be part of the reform of the International Health Regulations. The ten recommendations of this Commission, although aimed at a broader diagnostics strategy, can help in the development of a strong diagnostics element in future pandemic preparedness efforts.

With the publication of this Commission, we and the Commissioners hope that there is a real opportunity for transformational change. More attention to diagnostics as a fundamental element of health systems will not only help end the COVID-19 pandemic and strengthen preparedness to combat future pandemics, but will also be crucially important for general disease prevention, high-quality health care, and improved health outcomes globally.