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December 23, 2021

FDA’s Policy Changes for COVID-19 At-Home Diagnostics—Implications for Addressing Other Infectious Diseases and Future Pandemics

Author Affiliations
  • 1American Enterprise Institute, Washington, DC
JAMA Health Forum. 2021;2(12):e215190. doi:10.1001/jamahealthforum.2021.5190

The response to the COVID-19 pandemic in the US has been transformed through new technologies. The speed of progress in combatting this pathogen has outpaced the advances made against perhaps any similar public health threat over any comparable period. The rapid introduction of 3 highly effective vaccines, the development of monoclonal antibody drugs—and most recently, antivirals that are taken orally—have offered a potent armamentarium to reduce the adverse effects of SARS-CoV-2 infection.

Perhaps one of the most enduring technological innovations will be the advent of accurate diagnostic tests that can be used at home to provide a rapid answer about a person’s clinical status.1 As a result of the regulatory framework fashioned to advance these tests, the technology and commercial pathway to provide them directly to consumers, and the cultural change they have ushered in, our approach to care will have lasting consequences beyond COVID-19 and to how we address other infectious diseases.

In the future, home diagnostic tests will be increasingly coupled with telemedicine visits to introduce rapid assessment into the home for a range of pathogens, such as group A Streptococcus, influenza virus, respiratory syncytial virus, and many more. These virtual visits will be tethered to more definitive diagnostic tests, such as polymerase chain reaction, with delivery of such test kits to a patient’s home and same-day return to the laboratory for conclusive confirmation that a negative test result from an at-home, rapid diagnostic device was not a false-negative result.

This ability to connect at-home diagnostic tests with telemedicine and rapid turnaround of definitive laboratory testing will change infectious disease management. These systems will reduce office visits that can risk the spread of disease to others, make rapid assessment and treatment more possible, and expand access to timely, more affordable medical care. As the leadership of the US Food and Drug Administration (FDA) medical device program stated, “lessons learned from our experiences with COVID-19 could be leveraged to facilitate a large-scale effort for swift, widespread access to accurate and reliable tests for a variety of diseases. They can also inform the response to a future public health emergency.”2

The significance of the innovative policy changes at the FDA in facilitating at-home diagnostics cannot be overstated. It represents a watershed moment in the FDA’s approach to regulation.

In fostering these opportunities to address COVID-19, the FDA addressed many practical challenges, including a streamlined approach to test development and evaluation. For example, the FDA’s adoption of submission templates decreased development uncertainty and burdens on test developers. The issues addressed by the agency went beyond the technical evaluation of the performance characteristics of the devices to encompass how the tests would be used in a novel approach to treatment and in the setting of a public health emergency.3 Key among these challenges was how to collect positive test results for a reportable pathogen like SARS-CoV-2 and how to make sure that patients had access to appropriate follow-up care. In enabling access to at-home COVID-19 tests, the FDA relied on labeling and guidance to consumers, recognizing that the imperative to expand access to testing offset the reality that many positive test results would go unreported and that some patients may not take appropriate actions based on the test findings. The FDA provided a path for developers to build technological solutions into tests or to offer tests that were coupled to services—for example, downloadable apps to visualize and report results—and link them to telehealth services.

Continued advances in technology will expand these opportunities. The FDA has identified accurate molecular tests, breath analyzers, and light-based devices as platforms that can be placed in homes to screen for a range of pathogens, perhaps through interchangeable modules tailored to different tasks. Once these platforms are deployed to homes, they can be used in future public health emergencies as well as for routine clinical applications. Officials at the FDA have noted that “in general, it is easier to add a new, specific target of analysis to an existing platform than it is to create, validate, and manufacture an entirely new test and testing platform.”2

This adaptability is especially relevant to at-home tests because they often undergo additional validation by the FDA to demonstrate accuracy and reliability in the hands of untrained users. The agency recognized that adopting platforms that can be used for testing across a range of pathogens enables these upfront validation steps to be done once with the initial evaluation. The FDA has noted that this work can then be leveraged for future assays that can be run on the same platforms and users can utilize the same tools and follow similar procedures in the same basic testing steps while screening for different pathogens. Deploying standardized technologies can help advance routine clinical care and leave the country on a stronger footing in the event of future pandemics. Existing platforms could be leveraged to quickly make point-of-care and at-home testing more widely available. Developing these technologies, and encouraging their adoption, can inform the response to a public health emergency and thus should be a part of the nation’s future pandemic planning.3

Platforms with many of these characteristics are already in use. Some COVID-19 test developers have created devices for at-home molecular screening that could be used with interchangeable cartridges that, in the future, will enable testing for other viral pathogens on the same device. The familiarization that has taken place through consumer use of these devices creates opportunities for new approaches in how we address infectious disease. But challenges remain, and realizing these goals will require other changes beyond the regulatory review of these products. Chief among them is how we offset the cost of these opportunities for consumers.

Many US consumers were locked out of the opportunity to use at-home tests for COVID-19, especially for routine and serial testing for which the tests were best suited. For many people, the tests were not affordable or hard to obtain, and policy makers struggled to create policies to directly subsidize their distribution to patients. In Germany, England, South Korea, and other countries, at-home tests were provided for free to consumers as a part of national strategies for confronting the pandemic. Ideally, these tests would be provided in a similar way in the US, and after the public health emergency has passed, perhaps by insurers and employers who recognize the value in offering consumers the opportunity for rapid assessment of infectious diseases and avoiding costlier visits to their physicians that can worsen illness or increase spread in households.

The regulatory pathway outlined by the FDA for the Emergency Use Authorization of COVID-19 tests has shaped a foundational change in how these tests are developed and deployed in the US. This change creates the opportunity for a dramatic paradigm shift in the practice of medicine. The wide adoption of these testing platforms, coupled with other advances in care, including the widespread use of telemedicine and the participation of companies providing laboratory services directly to the home, represents a significant advance in delivery of medical care. It represents a cultural shift likely to persist long after COVID-19 becomes an endemic illness—and it should—because it offers profound opportunity to improve the affordability, access, and effectiveness of medical care for a range of common diseases.

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Article Information

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Gottlieb S. JAMA Health Forum.

Corresponding Author: Scott Gottlieb, MD, American Enterprise Institute, 1789 Massachusetts Ave NW, Washington, DC 20036 (scott.gottlieb@aei.org).

Conflict of Interest Disclosures: Dr Gottlieb reported receiving personal fees from National Resilience, Pfizer, Illumina, Tempus, and Aetion for serving as a board member. No other disclosures were reported.

References
1.
Nundy  S, Patel  KK.  Self-service diagnosis of COVID-19—ready for prime time?   JAMA Health Forum. 2020;1(3):e200333. doi:10.1001/jamahealthforum.2020.0333Google Scholar
2.
Shuren  J, Stenzel  T. Bending the arc of COVID-19 test development to increase access and ensure reliability—now and in the future. Published March 22, 2021. Accessed December 21, 2021. https://www.healthaffairs.org/do/10.1377/hblog20210318.9094/full/
3.
US Food and Drug Administration. Policy for coronavirus disease-2019 tests during the public health emergency (revised): guidance for developers and Food and Drug Administration staff. Published November 15, 2021. Accessed December 21, 2021. https://www.fda.gov/media/135659/download
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    1 Comment for this article
    Testing
    Leon Robertson, PhD | Yale University

    If home and drive-through testing were used only by the symptomatic, Dr. Gottlieb's scenario works. But some evidence suggests that on-demand testing contributed to SARS-CoV-2 spread early in the pandemic as people who tested negative traveled, picking up the virus and spreading it in the process, and increases in negative tests preceded surges and reduction in surges followed decreases in testing (1,2).

    References

    1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928719/

    2. https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-12063-2

    CONFLICT OF INTEREST: None Reported
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