FDA Issues Emergency Use Authorization For Ebola Diagnostic Device

By Nick Otto

FDA officials recently issued an emergency use authorization (EUA) for Utah-based BioFire Defence’s FilmArray Biothreat-E test for the detection of the Ebola Zaire virus. The test runs and can only be used with the device maker’s FilmArray systems.

“There is no adequate, approved, and available alternative to the emergency use of the FilmArray Biothreat-E test for diagnosing Ebola Zaire virus infection,” the FDA said in its EUA letter to Dr. Phillips of BioFire Defense, LLC.

The agency added in the letter that the EUA does not constitute an FDA approval and will only exist until the Department of Health and Human Services declares that “circumstances exist to justify the EUA is terminated.”

As part of the EUA, the FDA said it will waive a number of requirements for the device, including:

• Current good manufacturing practice requirements, including the quality system requirements with respect to the design, manufacture, packaging, labeling, storage, and distribution of the FilmArray Biothreat-E test
• Labeling requirements for cleared, approved, or investigational devices, including labeling requirements, except for the intended use statement, adequate directions for use, and any appropriate limitations on the use of the device including information

The device maker will, however, be required to include a fact sheet for healthcare providers on interpreting the device results, and another fact sheet for patients on understanding the device’s results.

The FDA calls the FilmArray Biothreat-E test “an automated reverse transcriptase polymerase chain reaction system for the in vitro qualitative detection of Ebola Zaire virus.”

The device can be used with “whole blood specimens” or “with urine specimens when tested in conjunction with a patient-matched whole blood specimen.” Once a specimen is collected, the FDA said it takes roughly five minutes to begin the test, with results being produced about an hour afterwards.

According to Reuters, roughly 300 hospitals in the U.S. are equipped with the BioFire lab device, including Emory Hospital and Bellevue Hospital. Reuters added that current tests can take anywhere from 24 to 48 hours to deliver test results.

As of October 24, more than 10,000 cases of Ebola have been confirmed, resulting in close to 5,000 confirmed deaths, according to the Centers for Disease Control and Prevention.