Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

Regulatory NewsRegulatory News | 25 March 2021 |  By 

The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases.

“The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that 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,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDER) and Timothy Stenzel, MD, PhD, director of FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), wrote in a Health Affairs blog post.

FDA has already taken some actions aimed at smoothing the way for COVID-19 testing that can be conducted completely outside of the laboratory setting. In July 2020, the agency issued a new template that developers of at-home and over-the-counter COVID-19 diagnostic tests could use for submitting emergency use authorization (EUA) requests. Most recently, in March 2021, the FDA issued a new template and accompanying fact sheet detailing a streamlined path to EUA for COVID-19 tests to screen asymptomatic individuals. (RELATED: FDA issues at-home and OTC COVID-19 testing template, Regulatory Focus 29 July 2020; Updated: FDA smooths the path for COVID screening tests, Regulatory Focus 17 March 2021)

Shuren and Stenzel outlined five policy changes that could help rapidly expand access to reliable testing options at home, at the point of care, and in remote settings in the future.

First, they encouraged federal investment in novel technologies that could result in the development of innovative testing options such as breath analyzers or light-based devices, for instance. One existing mechanism for spurring development is the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative, which could be expanded beyond COVID-19 development. Other possible mechanisms include prize competitions and grants.

“Consider that the first [point-of-care] COVID-19 tests authorized by the FDA came from developers applying existing technology that had already been developed prior to COVID-19,” they wrote. “Although it may be difficult to predict diagnostic needs, 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.”

The second recommended policy change is for the government to conduct and independent evaluation of the ability of non-laboratory providers and consumers to use and interpret point-of-care and at-home tests. Test developers frequently have difficulty obtaining patient specimens to validate their tests, Dr. Shuren and Dr. Stenzel wrote. Centralizing testing materials and evaluation within the government could potentially expedite validation and authorization, while simultaneously increasing public confidence in the performance of the test, they argued.

Third, they called for government investment to happen now, while the COVID-19 crisis is still ongoing. This type of investment would allow the government to “financially support modifications to detect the target pathogen, ramp up large-scale production, and provide guaranteed reimbursement for use of applicable and already FDA-approved [point-of-care] and at-home tests.”

The fourth prong of their plan calls for using wide-scale availability of FDA-approved point-of-care and at-home tests, coupled with telehealth technology, to create a large source of data that could assist in tracking the next public health threat. “The more accurately this information is collected, the easier it will be for federal, state, and local public health officials to track disease status, react to disease spread, and collaborate with the clinical community to determine how best to respond,” they wrote.

The fifth element of their plan is to create a reimbursement mechanism to support prescription at-home tests, over-the-counter tests, pooled testing, and screening tests. “While outside the purview of the FDA, federal and state agencies can facilitate wider access by ensuring insurance coverage and reimbursement policies support the widespread use of FDA-authorized tests,” they wrote.
Health Affairs


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