Biotechnology

How At-Home Rapid Tests Could Help Prevent the Next Pandemic

Loosening restrictions on at-home rapid tests will mitigate future outbreaks
July 24th 2023

Introduction

The COVID-19 pandemic highlighted the value of at-home rapid tests during public health emergencies. Following decades of neglect for rapid test development, the pandemic suddenly spurred federal and private R&D investment, regulatory streamlining, and mass deployment. However, this momentum — which has led to novel technologies, improved regulatory mechanisms, and a growing at-home diagnostics market — is at risk of being lost following COVID-19. We risk being unprepared for the next major public health crisis. Federal policymakers should take the following steps to improve near-term preparedness:

  1. Streamline regulatory requirements for rapid tests: Congress should direct the Food and Drug Administration (FDA) to set requirements for rapid tests that prioritize their public health benefits, such as their ability to interrupt transmission, reduce healthcare burdens, and eliminate transmission risks from public testing. These benefits justify reduced requirements for tests that use modified sample types or swab types and other regulatory improvements that lower the barriers to the market. 
  2. Expand the Independent Test Assessment Program (ITAP): Congress should direct the National Institutes of Health (NIH) to expand ITAP, its pioneering program to quickly and reliably determine test accuracy during the COVID-19 pandemic. To ensure a smooth test assessment pipeline for the next pandemic, ITAP should integrate expertise from the Biomedical Advanced Research and Development Authority (BARDA) and the FDA, and should conduct regular “sprints” to validate tests targeting a particular pathogen of concern, such as mpox or seasonal influenza.
  3. Introduce a platform technology pathway for diagnostics: Congress should direct the FDA to establish a streamlined regulatory process for adding new pathogens to existing testing platforms. This will enable the development of “dual-benefit” at-home testing systems that can target both endemic and emerging threats.
  4. Stockpile reconfigurable tests and components: Congress should direct the Administration for Strategic Preparedness and Response (ASPR) to prioritize stockpiling of tests that can be reconfigured to target a novel pathogen of concern in the Strategic National Stockpile (SNS). ASPR should also expand vendor-managed inventory for test components that are most likely to create supply chain bottlenecks in emergencies.

U.S. national security depends on our ability to leverage COVID-era advancements in rapid testing to respond to future public health threats. These recommendations will help the federal government capitalize on existing rapid testing technologies and improve near-term preparedness for public health crises.

Background

Up-to-date information drives an effective response in any emerging outbreak. Rapid tests are an inexpensive tool for quickly identifying outbreaks, interrupting infection transmission, calibrating public health measures, and connecting infected individuals with medical care while minimizing the risks of transmission.

This white paper focuses on tests for at least one specific infection that are easy to administer, deliver rapid results, and are available for over-the-counter (OTC) purchase. These tools are referred to as at-home tests, home-use tests, point-of-need tests, and point-of-person tests. This category is distinct from multiple other testing modalities, as shown in Figure 1.

OTC at-home rapid tests are distinct from:

  • prescription-use at-home tests, which can be self-administered at home only after receiving a prescription from a healthcare provider;
  • point-of-care tests that are administered by a medical professional wherever the patient receives care (e.g., doctor’s office, pharmacy, school nurse’s office);
  • laboratory-developed tests (LDTs), which are uniquely regulated tests that are run within a single laboratory; and 
  • at-home collection devices, which allow a patient to self-collect a sample at home to send to a laboratory for testing, sometimes without a prescription.

The 2022 National Biodefense Strategy and Implementation Plan identifies rapid diagnostics as a top priority for controlling future outbreaks. It sets a goal to deploy rapid, low-cost, point-of-need tests within 90 days of the first detection of an outbreak (goal 3.2.3). This vision builds on the experience of the COVID-19 response: during the pandemic, rapid tests were used to interrupt transmission in real time, a role that was rarely filled by earlier forms of hospital- or laboratory-based testing. They also allowed for screening of asymptomatic and mildly symptomatic individuals, another gap left by most hospital- and lab-based testing, and enabled rapid initiation of antiviral treatment through test-to-treat programs.

The urgency of this mission is clear when looking back at the early experience of COVID-19. Rapid testing proved immensely cost-effective, and these tools will be even more critical going forward. The number of familiar and novel pandemic threats from nature and human activity is growing, and the next pandemic threat may prove more deadly than COVID-19. It is critical that the U.S. leverages its learnings from the COVID-19 pandemic to prepare. 

The COVID-19 pandemic accelerated the development of rapid tests in three ways: 

  • It prompted regulators to define clear regulatory pathways; 
  • It spurred the U.S. government and private companies to invest in test development; and 
  • It prompted the majority of American households to use rapid tests. 

Thanks to these developments, multiple rapid testing technologies have reached commercialization (Table 1). Additional testing technologies such as diagnostics incorporating CRISPR technologies, biosensors, and breath-based testing for volatile organic compounds are in development and may be ready for home use within five years.

The COVID-19 pandemic demonstrated that a successful emergency response depends on standing capabilities to combat endemic diseases. It proved time-consuming and unreliable for the CDC to scale up diagnostic production from scratch during the crisis. By the end of March of 2020, the FDA was receiving a normal year’s worth of applications for infectious disease diagnostics every month. The high workload continued through the entire year due to the lack of pre-existing diagnostic tools to meet the needs of the pandemic. Although private test developers eventually produced large volumes of rapid tests, they needed years to establish the supply chains and infrastructure for this capability. Currently available tests have numerous limitations that make them unsuited for future public health emergencies. Only a concerted effort by policymakers and test developers to bring existing testing capabilities out of the lab and into the home (Table 2).

Prior federal actions to enable rapid test deployment

To meet the National Biodefense Strategy goal 3.2.3, the federal government must update its approach to rapid tests. Multiple federal agencies have jurisdiction over regulating, funding, stockpiling, and deploying rapid diagnostics, which complicates federal ownership, accountability, and reform. (See below for a selection of key actors; a more detailed mapping of relevant agencies is provided in the Appendix.)

  • HHS Testing and Diagnostics Working Group (TDWG): a spin-off from Operation Warp Speed that led HHS efforts to understand the barriers to COVID-19 test deployment and directed $46 billion of investments to solve them. Composed of staff from CDC
  • National Institutes of Health (NIH): typically only invests in basic research; during the COVID-19 pandemic
  • Biomedical Advanced Research and Development Authority (BARDA): invests in the development of diagnostic tests against known and unknown threats
  • Food and Drug Administration (FDA): decides which tests to approve/clear/authorize
  • Administration for Strategic Preparedness and Response (ASPR): leads stockpiling and supply chain strengthening efforts

Tests can only be sold over-the-counter (OTC) with approval from the FDA. Prior to COVID-19, the agency prohibited OTC at-home use of any pathogen-specific tests.1 But during the pandemic, the agency proactively released guidance that described how manufacturers could apply for an OTC authorization, which led to a boom in pandemic-era rapid tests. The agency subsequently adopted numerous flexible policies to rapidly process applications from diagnostics manufacturers and reduce its elevated workload during the pandemic.

The federal government also funds R&D to develop rapid tests for emergency preparedness. Prior to the pandemic, the NIH and BARDA made investments in this area, but there was no single program or agency at the Department of Health and Human Services (HHS) to conduct rapid test R&D. This changed during the COVID-19 pandemic when the NIH created RADx, a temporary program that served as a miniature Operation Warp Speed for COVID-19 test development. RADx pioneered a novel model for diagnostics R&D by delivering rapid funding, regulatory advising, test validation assistance, and other wraparound services to grantees. The RADx program is now winding down and it remains to be seen whether HHS agencies such as BARDA can emulate this model to support test development for pathogens beyond COVID-19.

Once they are developed, ASPR has the authority to stockpile medical countermeasures — including diagnostic tests — for use during public health emergencies. The agency faces numerous competing demands for stockpile resources and was caught flat-footed by supply chain shortages for PPE, swabs, and other testing supplies during the COVID-19 pandemic. ASPR now stockpiles some of these key components, but it is possible that tests and test supplies will be deprioritized in the face of scarce resources.

Multiple agencies have also examined opportunities to harness data from rapid tests for public health measures, but this policy area remains undeveloped. At NIH, the RADx Mobile At-Home Reporting through Standards (MARS) program worked to establish common frameworks for data sharing, and established an ad-hoc website where members of the public can upload their rapid test results. CDC also has a role to play as part of its larger efforts to collect public health data to improve its emergency response capabilities. One promising opportunity is the agency’s new Center for Forecasting and Outbreak Analytics (CFA), which forecasts epidemics using data collected through the data-sharing frameworks pioneered by MARS.

Unmet needs for the next biological incident

Despite these efforts, the rapid diagnostics industry that emerged in the past few years faces potential collapse due to waning demand for COVID-19 tests and the lack of a clear regulatory pathway for approving non-COVID-19 OTC tests. New tools are needed to maintain momentum in this area for the next public health emergency. This may include new methods for investing in test development, improved regulatory pathways, independent test validation, and stockpiling. These changes will ensure that rapid tests are available for our response to future public health threats.

The future of the rapid diagnostics industry is uncertain. In one scenario, manufacturers of COVID-19 rapid tests diversify their business and pivot to producing tests against endemic diseases like seasonal influenza, sexually transmitted infections, and/or wellness applications. This would ensure a warm base of testing platforms, regulatory clarity, and active supply chains that can quickly adapt tests to new diseases while also combating endemic diseases.

But the industry may be unable to pivot, due to a lack of viable regulatory pathways for approving at-home tests, a lack of commercial demand, or a lack of federal investment in the industry. In the absence of standing industry capacity, the federal government should stockpile testing components to ensure readiness for future health emergencies. The decisions of regulators and public health officials will play a critical role in determining which scenario unfolds. 

Regardless of the ultimate outcome for the rapid diagnostic market, the federal government can take targeted steps to enable more efficient deployment of diagnostic tools in emergencies. The recommendations below aim to expand the use of at-home tests between pandemics and facilitate the rapid reconfiguration and deployment of these testing platforms in future public health crises. By proactively addressing these challenges, the federal government can ensure the nation is better prepared for the next health crisis and maintain a resilient rapid diagnostics capability.

Recommendations for Congress:

The federal government can use existing rapid testing technologies to prepare for future pandemics now, even as it facilitates the development of still more transformative technologies. Long-term technological and regulatory innovation in this field will depend on sustained R&D from key agencies such as BARDA and the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), as well as newcomers such as the nascent Advanced Research Projects Agency for Health (ARPA-H). These investments would complement the following regulatory and policy changes:

1. Direct the FDA to streamline approval for OTC tests

At-home rapid tests provide numerous benefits over traditional laboratory tests for fighting infectious disease threats, but they are subject to a more opaque and stringent regulatory process. Historically, public health officials have been skeptical of these tests because they assumed that patients would fail to use them correctly. As a result, the FDA requires numerous costly studies prior to OTC approval to assuage these concerns. Although scrutiny of a test’s accuracy is clearly valuable, the FDA should clarify and streamline the OTC approval process given the unique benefits of at-home rapid diagnostics demonstrated during the COVID-19 pandemic, which include:

  • Speed. Rapid tests reduce disease transmission by offering near-immediate results. This enables earlier identification and treatment of cases, as well as identification, notification, and subsequent testing of people who were exposed to an infected individual.
  • Accessibility. Low-cost OTC rapid tests enable frequent and widespread testing in all population groups, especially those with limited healthcare access (e.g., rural and low-income households).
  • Reduced healthcare burdens. Rapid tests help preserve healthcare system capacity in emergencies by averting unnecessary visits to healthcare facilities.
  • Safety. At-home testing eliminates the transmission risks inherent in visiting a testing site for patients, healthcare workers, and bystanders.
  • Potential linkages to public health. When manufacturers share rapid test results with public health authorities, it enables timely and proportionate outbreak response. This data also allows for post-market surveillance of test performance.

This change in FDA posture would build on the administration’s prior flexible assessment of the only approved OTC rapid test before COVID-19. In 2012, the FDA assessed the safety and effectiveness of an at-home OTC HIV test and granted significant weight to its public health impacts in the assessment. Despite the test’s relatively low accuracy compared to available laboratory testing, the FDA conducted a formal risk analysis and concluded the benefits from expanding testing access outweighed this concern. This analysis resulted in the agency’s first and only approval/authorization of a rapid test for OTC use prior to the COVID-19 pandemic. In 2016, a panel of expert advisors to the agency revisited the question of at-home testing and concluded that the benefits of expanded OTC testing likely outweighed the risks for multiple priority pathogens. 

The route to OTC approval remains unclear and prohibitively expensive for many rapid diagnostics developers. They must conduct rigorous studies to win approval and face strict limitations on the types of evidence sponsors can present. Re-evaluation of these standards should be a key priority given the demonstrated value of at-home tests during the COVID-19 pandemic and their potential to help fight numerous other infectious diseases.

2. Direct the NIH to expand ITAP for future health emergencies

The RADx initiative’s Test Verification Core quickly generated high-quality data on test performance that allowed for faster test development and approval. This success led the NIH and FDA to establish the RADx Independent Test Assessment Program (ITAP) in October of 2021. This program accelerated regulatory approval for OTC tests by providing technical assistance to manufacturers and independent evaluation of test performance in NIH labs. 

ITAP quickly earned the respect of both industry and federal partners. The program fills a large gap in emergency preparedness, and it should be maintained and strengthened going forward. In the early months of a pandemic, samples from positive patients are scarce and clinical trials are unfeasible, which limits test development. ITAP or a similar program would help facilitate and prioritize access to clinical samples for validating OTC test candidates that have the greatest potential for deployment. To ensure this capability doesn’t atrophy in the absence of an immediate emergency, ITAP should conduct regular “sprints” to rapidly validate new tests targeting a newly chosen pathogen of interest, such as a circulating respiratory virus or an emerging disease threat of potential concern.

ITAP (or a successor program) should integrate BARDA as well as the NIH and FDA to leverage the full breadth of federal expertise in diagnostics development for assessing and supporting promising candidates. In addition to validating individual tests, this collaboration might also validate components and processes common to a wide array of tests, (e.g., sample collection procedures and materials). This type of partnership is not unprecedented. In 2020, the FDA, the Gates Foundation, and multiple research partners established an ad hoc collaboration to conduct studies validating self-collection procedures and swabs that generate appropriate samples for COVID-19 testing. Because the resulting data were freely usable by all sponsors, this single collaboration decreased the number of costly studies each individual sponsor would need to conduct to produce an at-home test. This directly enabled the proliferation of rapid tests that followed. ITAP should emulate this success and provide standing research infrastructure to launch fresh validation studies during future emergencies.

3. Direct the FDA to establish a platform tech path for diagnostics to simplify approval for at-home testing platforms

The first at-home molecular diagnostics reached the market during COVID-19 and additional innovations (e.g., CRISPR-based tests) are on the horizon. To leverage these technologies during an emergency, sponsors must be able to quickly update their platforms to target a novel pathogen and repurpose existing supply chains, test readers, and private sector expertise.

This ability is hindered by the FDA’s current approval processes, which center on individual products rather than multi-product platforms. When companies submit applications to the FDA for a product targeting a novel threat, the FDA requires that they only consider information related to the novel pathogen while assessing the product’s safety and efficacy. This information is typically impossible to gather until an early response has failed, and the pathogen has become widespread enough to enable full-scale clinical trials.

Congress and the FDA are updating this approach. In Section 2503 of the PREVENT Pandemics Act, enacted as part of the Consolidated Appropriations Act in 2023, Congress directed the FDA to establish a new approach for its evaluation of treatments and vaccines. Notably, it did not include diagnostics, which are legally considered a type of medical device. The act instructed the HHS Secretary to establish a new pathway for sponsors to reference data from earlier submissions for similar products when submitting an application for a treatment or vaccine that shares a technical design — otherwise known as a “platform technology” — to enable earlier and more reliable FDA evaluations. 

Congress should direct the FDA to establish a similar platform technology pathway for in vitro diagnostics, and to provide clear guidance to manufacturers on how to use this pathway. This would enable the rapid deployment of novel tests using pre-approved platform technologies that are already well characterized due to their use in other approved tests. The enacted language in the PREVENT Pandemics Act should serve as a template outlining high-level recommendations for a similar approach to diagnostics. FDA officials at the Center for Devices and Radiological Health, the Office of In Vitro Diagnostics, and the Office of the Commissioner are already considering ways to leverage platform technologies to aid regulatory decisions. These offices should participate in developing the new regulatory pathway, given their experience pioneering accelerated approval mechanisms for rapid diagnostics against COVID-19. This will also help ensure the new pathway has an actionable design with minimal ambiguity for sponsors or reviewers.

4. Direct ASPR to stockpile reconfigurable tests and components

Supply chain bottlenecks routinely throttled the availability of COVID-19 tests, particularly during the early pandemic response. However, it is impossible to stockpile disease-specific at-home tests for the next pandemic without knowing its cause. Thus, it is necessary to instead ensure a warm base of manufacturing systems that can quickly pivot production to requisite tests once a novel pathogen emerges. 

To achieve this goal, ASPR should prioritize stockpiling rapid test technologies and components needed to rapidly reconfigure existing supply chains, materials, and testing platforms to target a novel pathogen. In some cases, this emphasis on reconfigurability will require stockpiling basic components for home-use tests like swabs, which were a significant bottleneck for the COVID-19 response. In other cases, it may be possible to stockpile entire test kits that can be reconfigured in a matter of days to test for a new target pathogen. This is a capability that has already been demonstrated for next-generation CRISPR diagnostics.

To achieve reconfigurability while minimizing costs, ASPR should continue its transition toward a “living stockpile” model, in which stockpiled materials are regularly deployed and replenished on a first-in, first-out basis during non-emergency periods. For example, stockpiled swabs might be deployed each year for use by seasonal influenza test manufacturers, minimizing costs from product expiration while providing practice for deployment in an emergency scenario. This pass-through inventory might be physically housed in the Strategic National Stockpile, but may also be maintained as vendor-managed inventory, an arrangement by which ASPR contracts with private-sector suppliers to maintain an expanded, ongoing pass-through inventory of key components. ASPR’s recently established Office of Industrial Base Management and Supply Chain might serve as a leader for this work and coordinate with partners across HHS and industry. 

Conclusion

The COVID-19 pandemic underscored the critical importance of at-home rapid tests for managing public health emergencies. Significant progress was made in terms of research, development, regulation, and deployment of at-home rapid tests during the pandemic. By capitalizing on the recommendations outlined in this white paper, the United States can leverage current and future capabilities in rapid testing to fortify our national security, enhance our response to future public health threats, and protect the health of all Americans.


Appendix: Agencies active on rapid diagnostics

References
  1. The sole exception, a test for HIV, was approved in 2012.