USA – Bending the arc of testing for COVID – and beyond

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)…