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FDA Allows High-Complexity CLIA-Certified Labs to Perform Coronavirus Testing

NEW YORK – The US Food and Drug Administration said on Saturday that it will allow high-complexity CLIA-certified labs to immediately perform tests they've developed and validated for the SARS-CoV2 coronavirus while they are pursuing emergency use authorization.

The agency issued guidance, effective now, describing the circumstances in which it will allow labs to perform such testing. "We believe this policy strikes the right balance during this public health emergency," FDA Commissioner Stephen Hahn said in a statement."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 US"

On Feb. 4, HHS declared a public health emergency, requiring authorization of in vitro diagnostics for emergency use to detect SARS-CoV2, the cause of the COVID-19 outbreak. In response the agency authorized a test developed by the US Centers for Disease Control and Prevention that could be performed at CDC-qualified labs around the country. At that time, the FDA said it was working with other diagnostic developers to accelerate test development and EUA requests, and that several labs had already requested and received the EUA template for the outbreak.

However, the rollout of CDC's test to public health labs was hampered when it encountered problems with a reagent. Last week, the CDC validated a new, modified protocol for the test that local labs with test kits can use, and said it would also ship new kits.

Because of the issues rolling out CDC's test, there were calls from the testing community for the government to make policy adjustments that would allow other labs to step in and perform testing. The FDA earlier declined the Association of Public Health Labs's request grant an exception allowing more labs to develop their own tests. The American Association of Clinical Chemistry also sent a letter to the agency last week in support of APHL's request to allow other labs, particularly those with the expertise and capacity to develop and perform coronavirus tests, to perform them.

The latest policy now allows high-complexity commercial, academic, or government labs to develop and begin using validated COVID-19 tests before the agency has completed review of their EUA requests. According to one estimate there are between 300 and 400 high-complexity CLIA labs in the country that can do this type of testing, many of them within academic medical centers. After validating their tests, the FDA asks labs to notify the agency via email and submit a completed EUA request within 15 days.

In its guidance, the agency noted that false results in a public health emergency can have a significant impact, and provided recommendations for how labs should establish the analytical and clinical validity of their tests and how to conduct interim confirmatory testing.

"Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "We believe this action will support laboratories across the country working on this urgent public health situation."

FDA's guidance issued on Saturday aims to bolster rapid testing capacity to contain the coronavirus outbreak, Hahn said, noting that the guidance does not mean that the FDA is changing its standards for issuing EUAs. "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," he said.

The outbreak of the respiratory SARS-CoV2 virus, detected first in Wuhan City in the Hubei Province in China, has now spread to 50 locations throughout the world, including the US. "SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on healthcare systems and causing societal disruption," FDA said in a statement. "The potential public health threat posed by COVID-19 is high, both globally and to the US. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care."