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Rapid triple tests needed to contain mpox, H5N1 bird flu
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Rapid triple tests needed to contain 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. The WHO has reported more than 46,000 suspected cases and 1,000 deaths this year alone. Only 37% of suspected cases of mpox 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 the H5N1 avian influenza virus circulating in American dairy cows, with 46 human cases reported so far. In both cases, public health authorities are concerned 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 detect dangerous mutations early, and we can’t identify hot spots quickly enough to contain the outbreak.

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

Faced with the looming threats of mpox and H5N1, we should strive to develop, approve, and deploy rapid at-home tests as quickly as possible. For mpox, rapid home tests are already under development but require more funding to be validated and deployed quickly. For avian flu, the Food and Drug Administration states that most tests authorized 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 testing or deploying rapid tests just months after the start of an outbreak. In light of the ever-present threat of a new jumping species of virus, we must adapt testing as a tool for rapid outbreak control. The example of South Korea quick response The Covid-19 pandemic shows that widespread testing and contact tracing can help flatten the epidemic curve without a nationwide lockdown.

Imagine a world in which we could deploy 10,000 rapid at-home tests within 10 days of detecting an outbreak. In this world, we could respond quickly to any new or emerging pathogens, 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 must 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 in diverse settings, and provide results in less than a minute.

The good news is that rapid triple testing is within reach, given the attention and investment. Month-long development and approval delays for diagnostics are not inevitable, but are the result of chronic underinvestment, uncertain private sector demand, and regulatory red tape. For example, mpox’s R&D for diagnostics has received only a small fraction of funding is dedicated to therapeutics and vaccines.

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

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

Second, the U.S. government should foster sustainable demand for rapid tests, ensuring that investments in these tests are profitable for the private sector. Long-term reimbursement guarantees from the Centers for Medicare and Medicaid Services could encourage the private sector to continue investing in innovative testing technologies, particularly for common illnesses like the flu or sexually transmitted infections. Additionally, pre-event government contracts for rapid testing could help reduce require uncertainty for the private sector, preserving the expertise and infrastructure needed to rapidly scale up testing during the next emerging outbreak.

Finally, the U.S. government should streamline regulatory approval of rapid tests, as demonstrated by the draft Independent Testing Evaluation Program. During Covid-19, the United States got rapid tests much later than countries like the United Kingdom or the United Kingdom. Slovakia. One of the main reasons for this was the Food and Drug Administration’s strict accuracy standard for emergency use authorization. But for public health screening, early, fast and frequent testing is at least as important as accuracy. After all, in the face of an emerging epidemic, a good test in hand today is far more valuable than a lab test next month.

To address this issue, the FDA should evaluate rapid tests based on a public health benefitsnot just clinical precision measurements. For example, the FDA could issue an internal guidance document that reframes its approach to evaluating infectious disease diagnostics, prioritizing factors such as timely results and accessibility, alongside measures traditional precision tools. Alternatively, Congress could direct the FDA to establish a dedicated authorization pathway specifically for public health tools.

Achieving triple rapid testing capacity is an ambitious goal. However, there are plans for equally ambitious – and successful – global health initiatives. During the Ebola outbreak in West Africa from 2014 to 2016, the United States led an international effort that helped contain the outbreak. provide the largest sum paid by a single donor government. Additionally, the President’s Emergency Plan for AIDS Relief, launched by President George W. Bush, is credited with saving more than 20 million lives. The United States should demonstrate the same leadership and commitment and apply it to the goal of achieving triple rapid testing capacity.

We have learned the hard way that what starts 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 United States can pave the way for widespread and equitable access to the diagnostics urgently needed to combat 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 rapid triple testing with rapid reconfiguration, deployment and results today. Instead of scrambling to develop tests after a crisis has already occurred, we will be in a much better position to stop the next outbreak – 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 executive director of Blueprint Biosecurity.