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USFDA allows labs to test for coronavirus prior to review

Joe C Mathew     March 1, 2020

As Coronavirus Disease 2019 (COVID 19) spreads to over 50 countries including the United States, the US Food and Drugs Administration (USFDA) announced a new policy to facilitate quick development and use of rapid COVID19 diagnostic tests by specialised laboratories in that country on February 29.  

The policy will allow laboratories that develop validated COVID-19 diagnostics tests to use it even before the USFDA completes the review of their Emergency Use Authoritization (EUA) request. The EUA itself is a permit to use, based on scientific data, certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a declared public health emergency.

In a press release, USFDA Commissioner Stephen M Hahn said the 'policy strikes the right balance during this public health emergency' as it reflects the agency's commitment to addressing critical public health needs and rapid response and adaptation to a dynamic and evolving situation.

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

The press release stated that rapid detection of COVID-19 cases in the US requires wide availability of diagnostic testing to control the emergence of a rapidly spreading, severe illness. "The FDA has authorised one EUA for COVID-19 that is in use by the US Centers for Disease Control and Prevention (CDC) and some public health labs across the country. 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 US", it stated.

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"We applaud the FDA's approach to speed the path toward emergency use authorisation for COVID-19 diagnostics. This step may reduce development costs, speed the process for availability at more testing sites, incentivise private development and, ultimately,  help save lives," said Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA). The agency is identifying "industry partners to develop rapid diagnostics that can be used in commercial and hospital labs or even doctors' offices so that medical professionals and their patients have the information they need to take action", he said.

First detected in Wuhan City, Hubei Province, China, the respiratory disease caused by a novel coronavirus, has now spread to 50 locations internationally. The virus named "SARS-CoV2", has the capability to rapidly spread, leading to a significant impact on health care systems and causing societal disruption. "The potential public health threat posed by COVID-19 is high, both globally and to the US", the release said.

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USFDA has stated the effective response to the COVID-19 outbreak, will include rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts. "This can best be achieved with a wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care", it said.

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