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FDA Issues EUA for Roche Ebola MDx Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration has issued an Emergency Use Authorization for Roche's LightMix Ebola Zaire rRT-PCR Test, a molecular diagnostic test for use by CLIA high-complexity laboratories or similarly qualified non-US labs.

The test is a real-time RT-PCR assay for the qualitative detection of Ebola virus RNA in human EDTA whole blood specimens from individuals with signs and symptoms of infection in conjunction with epidemiological risk factors.

"The LightMix Ebola Zaire test is an easy-to-use molecular diagnostic test providing a solution for healthcare professionals to quickly detect the virus and start patient treatment as early as possible," said Roland Diggelman, COO of Roche Diagnostics.

The assay can be used with the Roche Light Cycler 480 or Cobas z 480 instruments.

The FDA noted that it had waived current good manufacturing practice and labeling requirements for the test as long as the EUA is in effect.

FDA Commissioner Margaret Hamburg said in a letter to Roche that the current threat of Ebola, along with evidence that the test can effectively diagnose infection, justified the authorization of emergency use of in vitro diagnostics for detecting the virus.

Roche first announced it would seek an EUA for an Ebola test in October. Roche has an exclusive license to distribute the test, which is manufactured by Tib Molbiol.

Several other firms and federal labs have sought emergency use authorization from the FDA for their Ebola molecular diagnostic tests. The US Department of Defense's EZ1 test received the first EUA for Ebola testing on Aug. 6, and BioFire Defense received EUAs for two FilmArray Ebola tests in October. In November, Altona Diagnostics received an EUA for its RealStar Ebolavirus PCR detection kit.