FDA Issues Policy to Expedite Coronavirus Diagnostics

As part of the U.S. Food and Drug Administration (FDA)’s aggressive commitment to address the coronavirus outbreak, the FDA issued a new policy on February 29, 2020, for certain laboratories seeking to develop diagnostic tests for the SARS-CoV-2 coronavirus, which causes the disease known as COVID-19.

The potential public health threat posed by COVID-19 is high, both globally and to the USA, says the FDA.

The new FDA policy is for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed a review of their Emergency Use Authorization (EUA) requests.

Previously, the FDA had authorized an EUA for COVID-19 for the Centers for Disease Control and Prevention (CDC) and some public health labs across the USA.

“We believe this policy strikes the right balance during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations.”

“This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. 

This can best be achieved with the wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care.

On February 4, 2020, the Secretary of HHS determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of the COVID-19 outbreak. 

The guidance issued today describes a policy enabling laboratories to immediately use tests they developed and validated in order to achieve more rapid testing capacity in the U.S.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” said Nancy Messonnier, M.D., director of the CDC’s Center for the National Center for Immunization and Respiratory Diseases (NCIRD).

The immediately in effect guidance issued today describes the circumstances where the FDA does not intend to object to the use of these tests for clinical testing while the laboratories are pursuing an EUA with the FDA. 

“We applaud the FDA’s approach to speed the path toward emergency use authorization for COVID-19 diagnostics. This step may reduce development costs, speed the process for availability at more testing sites, incentivize private development and, ultimately, help save lives,” said Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response.

The FDA guidance provides recommendations for test developers, including information regarding test validation, FDA notification, and interim confirmatory clinical testing.

Following the completion of their test validation, laboratories should communicate with the FDA, via email, in order to notify the agency that the test has been validated. Laboratories should submit a completed EUA request within 15 business days of notification.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Coronavirus diagnostic testing news published by Coronavirus Today.