Regulatory Focus™ > News Articles > FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

Posted 27 October 2014 | By Alexander Gaffney, RAC

FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time.


In March 2013, FDA was given a host of new authorities and responsibilities under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), a piece of legislation intended to bolster the government's ability to respond to health crises, and especially those of a biological nature.

Among the law's many provisions is one that allows FDA to temporarily authorize a medical product ("Emergency Use Authorization") if it determines that an emergency is likely to occur—a "threat justifying emergency authorized use," to quote the legislation. That is a big change from prior legislation, which required a finding that such an emergency already existed in the US, and left little time for proactive efforts.

The law also allows FDA to authorize those products without first ensuring that they meet current good manufacturing practice (CGMP) regulations, which makes it easier to bring products to market without the usual regulatory burdens.

Between the law's passage in March 2013 and August 2014, FDA authorized just a small handful of medical products using emergency provisions, and all for diagnostic tests intended to allow health officials to diagnose emerging diseases like the H7N9 influenza virus and the Middle East Coronavirus (MERS CoV).

First EUA for Ebola

But in August 2014, in the face of a burgeoning outbreak of Ebola Zaire, a hemorrhagic fever, across West Africa, the US government for the first time used its authority under PAHPRA to start preparing for Ebola.

On 5 August 2014, the US Department of Health and Human Services (DHHS) announced that it had determined that "the Ebola virus presents a material threat against the US population sufficient to affect national security," thereby allowing FDA to authorize the use of a diagnostic device for Ebola Zaire, the  Department of Defense's EZ1 Real-Time RT-PCR Assay ("TaqMan").

While FDA granted de facto approval to the device immediately in a letter to the Department of the Army's Division of Regulated Activities and Compliance, it later did so formally through a declaration in the US Federal Register.

Four Other EUAs

Since then, FDA has steadily been authorizing the use of other diagnostic tests for Ebola under its EUA authority as well.

On 25 October 2014, FDA announced it had authorized the use of two diagnostic products manufactured by BioFire Defense LLC, a Utah-based diagnostics company. The two products, the FilmArray Biothreat-E test and the FilmArray NGDS BT-E Assay, are both intended to detect the Ebola Zaire virus.

Critically, FDA said in a statement, "The EUA for the FilmArray Biothreat-E test enables hospitals with laboratories that fit [Clinical Laboratory Improvement Act] characteristics to conduct a PCR test for Ebola in-house, without having to send the sample to an outside lab." The devices can return a diagnosis in about an hour, according to their labeling—substantially faster than other tests now used by professionals.

Two other Ebola diagnostic tests developed by the Centers for Disease Control and Prevention (CDC)—the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay—were also granted EUA status on 10 October 2014.




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