This summer, the World Health Organization (WHO) declared the rapid spread of mpox in Africa a public health emergency of international concern. The 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 have been confirmed with lab-based testing.
Meanwhile, the U.S. Centers for Disease Control and Prevention continues to express concern about the H5N1 bird flu virus circulating in American dairy cows, with 46 human cases reported so far. In both outbreaks, public health authorities worry we’re missing many unreported cases because of insufficient testing.
No FDA-approved rapid tests exist that specifically test for H5N1, and the first near-point-of-care test for mpox was approved by the WHO only in late October. Without widespread testing, we don’t know the true number of infections, don’t catch dangerous mutations early on, and can’t identify hotspots fast enough to contain the outbreak.
Covid-19 brought us rapid and widely accessible tests that can be used in low-resource environments. So why aren’t we applying 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 at-home rapid tests as quickly as possible. For mpox, at-home rapid tests are already under development but require more funding to be validated and rolled out quickly. For bird flu, the Food and Drug Administration states that most authorized tests for influenza A may be capable of detecting H5N1 — a subtype of influenza A. However, no existing rapid tests can differentiate between seasonal flu A and H5N1.
Our long-term vision should be more ambitious than relying on unspecific tests or deploying rapid tests only months into an outbreak. In light of the ever-present threat of a new virus jumping species, we need to adapt tests as tools for rapid outbreak control. The example of South Korea’s rapid response to the Covid-19 pandemic shows that widespread testing and contact tracing can help flatten the epidemic curve without nationwide lockdowns.
Imagine a world where we could deploy 10,000 at-home rapid tests within 10 days of detecting an outbreak. In this world, we could rapidly respond to any novel or emerging pathogen, allowing us to identify cases at the outset of an outbreak and focus our medical countermeasures, potentially preventing widespread transmission.
To make this ambitious vision a reality, the international health community should develop, approve, and stockpile tests that meet three key criteria: rapid reconfiguration, rapid deployment, and rapid results. These “triple rapid” tests could be rapidly reconfigured for new pathogens, deployed across 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. Months-long development and approval timelines for diagnostics are not inevitable, but result from chronic underinvestments, uncertain demand for private industry, and regulatory red tape. For instance, mpox R&D for diagnostics has received only a small fraction of the funding going into therapeutics and vaccines.
To achieve triple rapid test capacity, the U.S. 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 National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) program substantially increased rapid testing capacity. RADx has worked closely across government and industry to fund, de-risk, and validate rapid tests. It has also guided test developers through the regulatory process and helped integrate diagnostics into public health infrastructure, with a special emphasis 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 the NIH to ensure ongoing support for innovative diagnostics development and approval.
Second, the U.S. government should foster sustainable demand for rapid tests, ensuring that investments in rapid tests will pay off for private industry. Long-term reimbursement guarantees from the Centers for Medicare and Medicaid Services could incentivize private industry to keep investing in innovative testing technologies, including for common illnesses like influenza or sexually transmitted infections. In addition, pre-event government contracts for rapid tests could help reduce demand uncertainty for the private sector, preserving the expertise and infrastructure needed to quickly ramp up testing during the next emerging outbreak.
Finally, the U.S. government should streamline regulatory approval for rapid tests, as demonstrated with the Independent Test Assessment Program. During Covid-19, the U.S. got rapid tests much later compared with countries like the U.K. or Slovakia. One key reason for this was the Food and Drug Administration’s stringent accuracy standard for Emergency Use Authorization. But for public health screening, early, quick, and frequent 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 laboratory test next month.
To address this, the FDA should evaluate rapid tests based on broader public health benefits, not just clinical accuracy metrics. For example, the FDA could issue an internal guidance document that reframes its approach to evaluating infectious disease diagnostics, prioritizing factors such as rapid result delivery and accessibility next to traditional accuracy metrics. Alternatively, Congress could direct the FDA to establish a dedicated authorization pathway specifically for public health tools.
Achieving triple rapid test capacity is an ambitious goal. However, the blueprints for similarly ambitious — and successful — global health initiatives exist. During the 2014-2016 Ebola outbreak in West Africa, the U.S. led an international effort that helped contain the outbreak, providing the largest sum by a single donor government. Additionally, the President’s Emergency Plan for AIDS Relief, launched by President George W. Bush, is credited with saving over 20 million lives. The U.S. should channel the same leadership and commitment and apply it to the goal of achieving triple rapid test capacity.
We have learned the hard way that what begins as a localized cluster of infections can quickly escalate into a global crisis. By championing the development, approval, and manufacturing of rapid tests for mpox and H5N1 now, the U.S. can pave the way for widespread and equitable access to diagnostics that are urgently needed to fight the outbreaks.
Beyond mpox and H5N1 bird flu, we should aim to shift the diagnostics paradigm from reactive to proactive outbreak control. To do so, we need to invest in triple rapid tests 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, D.C., where she focuses on biosecurity and pandemic preparedness. Jacob Swett is the executive director of Blueprint Biosecurity.