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Regulatory Focus™ > News Articles > 2020 > 3 > FDA Speeds New Coronavirus Diagnostic Tests

FDA Speeds New Coronavirus Diagnostic Tests

Posted 02 March 2020 | By Zachary Brennan 

FDA Speeds New Coronavirus Diagnostic Tests

With a new guidance released on Saturday, the US Food and Drug Administration (FDA) accelerated the ability for certain laboratories to use coronavirus tests they are developing in order to increase testing capacity across the US.

The guidance, which took effect immediately, follows criticisms that the US was not doing enough to increase its ability to test more people, and as coronavirus cases begin to increase rapidly nationwide.

FDA says in the guidance that for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments, for a period of 15 days after validating their tests and while they are preparing their EUA requests, FDA does not intend to object to the use of these tests for specimen testing.

“In the absence of known positive samples for testing, FDA recommends that laboratories confirm performance of their assay with a series of contrived clinical specimens by testing a minimum of 30 contrived reactive specimens and 30 non-reactive specimens,” the guidance adds, explaining further what labs can do.

The guidance comes as FDA inspectors raised concerns with a Centers for Disease Control and Prevention lab in Atlanta that, according to Axios, was not properly manufacturing coronavirus diagnostic tests that were distributed to state labs.

Former FDA Commissioner Scott Gottlieb on "Face the Nation" on Sunday praised FDA’s move to course correct on the coronavirus testing, adding: “We're going to have the capacity by the end of this week to diagnose probably 10,000 people a day or screen 10,000 people a day with the public health labs.”

But Matt McCarthy of Weill Cornell Hospital in New York told CNBC on Monday morning that he still does not have a test at his fingertips, even as FDA on Saturday issued an EUA to authorize the emergency use of a coronavirus test from the New York State Department of Public Health.

Meanwhile, President Donald Trump is expected to meet with biopharma industry leaders from Gilead, GlaxoSmithKline, Sanofi, J&J, Pfizer and others on Monday to discuss their work related to the coronavirus.

FDA Commisser Stephen Hahn was also added to the coronavirus task force on Sunday.

In an FDA webinar on Monday afternoon, Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, focused his comments on the following slides, which reiterate what the guidance explains.

He also said that the design under the original CDC EUA is solid and as to the assays, "We believe we resolved the manufacturing issues." He also said FDA and CDC are working with Integrated DNA Technologies (IDT) to sell the CDC's coronavirus kits. Additional IDT lots undergoing qualification by CDC.

Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency


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