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Triple rapid tests are needed to control mpox, H5N1 bird flu
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Triple rapid tests are needed to control mpox, H5N1 bird flu

This summer, the World Health Organization (WHO) declared the rapid spread of mpox in Africa, a public health emergency of international concern. WHO has reported over 46,000 suspected cases and 1,000 deaths this year alone. Only 37% of suspected mpox cases in the Democratic Republic of Congo were confirmed with laboratory tests.

Meanwhile, the US Centers for Disease Control and Prevention continues to express concern on H5N1 avian influenza virus circulating in US dairy cows with 46 human cases reported yet. In both outbreaks, public health authorities fear that we are missing many unreported cases due to insufficient testing.

There are no FDA-approved rapid tests that specifically test for H5N1, and the first near-point-of-care test for mpox was approved by the WHO only at the end of October. Without widespread testing, we don’t know the true number of infections, we don’t catch dangerous mutations early, and we can’t identify hotspots quickly enough to contain the outbreak.

Covid-19 has brought us rapid and widely accessible tests that can be used in low-resource settings. So why don’t we apply these rapid tests to mpox, H5N1 bird flu and other outbreaks?

With the threats of mpox and H5N1 looming, we should aim to develop, approve and deploy rapid home tests as quickly as possible. For mpox, rapid home tests are already under development, but require more funding to be validated and released quickly. For bird flu, Food and Drug Administration Member that most licensed tests for influenza A may be able to detect H5N1—a subtype of influenza A. However, no existing rapid test can differentiate between seasonal influenza A and H5N1.

Our long-term vision should be more ambitious than relying on non-specific tests or implementing rapid tests just months after an outbreak. Given the ever-present threat of a new virus species, we need to adapt tests as tools for rapid outbreak control. The example of South Korea quick response of the Covid-19 pandemic shows that widespread testing and contact tracing can help flatten the curve of the epidemic without nationwide lockdowns.

Imagine a world where we could deploy 10,000 rapid home tests within 10 days of detecting an outbreak. In this world, we could respond rapidly to any new or emerging pathogen, allowing us to identify cases early in an outbreak and focus our medical countermeasures, potentially preventing widespread transmission.

To make this ambitious vision a reality, the international health community would need to develop, approve and stock tests that meet three key criteria: rapid reconfiguration, rapid deployment and rapid results. These “triple rapid” tests. they could be rapidly reconfigured for new pathogens, deployed in diverse settings, and provide results in less than a minute.

The good news is that triple rapid tests are within reach given focus and investment. Development and approval timelines of several months for diagnostics are not inevitable, but result from chronic underinvestment, uncertain demand for private industry, and regulatory red tape. For example, mpox R&D for diagnostics has received only a small portion of the funding goes to therapy and vaccines.

To achieve triple rapid testing capacity, the US government should take three key steps.

First, the domestic testing industry needs long-term political support and funding to survive. During the Covid-19 pandemic, the rapid acceleration of diagnosis of the National Institute of Health (RADx) program has substantially increased rapid testing capability. RADx has worked closely in government and industry to fund, de-risk and validate rapid tests. He also guided test developers through the regulatory process and helped integrate diagnostics into the public health infrastructure, with a particular focus on access for underserved communities. Despite the program’s success, RADx is now at risk of being defunded. Congress should establish RADx as a permanently funded entity within NIH to ensure continued support for the development and approval of innovative diagnostics.

Second, the US government should stimulate sustainable demand for rapid tests by ensuring that investment in rapid tests pays off for private industry. Long-term reimbursement guarantees from the Centers for Medicare and Medicaid Services could encourage private industry to continue investing in innovative testing technologies, including for common diseases like the flu or sexually transmitted infections. In addition, pre-event government contracts for rapid testing could help reduce uncertainty demand for the private sector, retaining the expertise and infrastructure needed to rapidly accelerate testing during the next emerging outbreak.

Finally, the US government should streamline regulatory approval for rapid tests, as demonstrated with Independent test evaluation program. During Covid-19, the US received rapid tests much later compared to countries such as the UK or Slovakia. A key reason for this was the Food and Drug Administration’s strict accuracy standard for emergency use authorization. But for public health screening, early, fast and often testing is at least as important as accuracy. After all, in the face of an emerging outbreak, a good test in hand today is far more valuable than a lab test next month.

To address this, the FDA should evaluate rapid tests on a broader basis public health benefitsnot just clinical accuracy measurements. For example, the FDA could issue an internal guidance document reforming its approach to evaluating infectious disease diagnostics, prioritizing factors such as rapid delivery of results and accessibility alongside traditional accuracy metrics. Alternatively, Congress could direct FDA to establish a dedicated authorization pathway specifically for public health devices.

Achieving triple rapid testing capacity is an ambitious goal. However, plans for equally ambitious and successful global health initiatives exist. During the 2014-2016 West African Ebola outbreak, the US led an international effort that helped contain the outbreak, PROVIDING the largest amount by a single donor government. In addition, the President’s Emergency Plan to Fight AIDS, launched by President George W. Bush, is credited with saving over 20 million lives. The US should channel that same leadership and commitment and apply it to the goal of achieving triple rapid test capability.

We learned the hard way that what starts as a localized cluster of infections can quickly escalate into a global crisis. By supporting the development, approval, and manufacture of rapid tests for mpox and H5N1 now, the US can pave the way for broad and equitable access to diagnostics that are urgently needed to fight outbreaks.

Beyond mpox and H5N1 avian influenza, we should aim to shift the diagnostic paradigm from reactive to proactive outbreak control. To do this, we need to invest in triple rapid testing with rapid reconfiguration, deployment and results today. Instead of scrambling to develop tests after a crisis has already unfolded, we’ll be in a much better position to stop the next outbreak in its tracks – whatever it may be.

Janika Schmitt is a fellow at the Institute for Progress, an innovation policy think tank in Washington, DC, where she focuses on biosecurity and pandemic preparedness. Jacob Swett is the CEO of Blueprint Biosecurity.