Swiss pharmaceutical giant Roche has announced that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the LightMix® Ebola Zaire rRT-PCR Test. This test is for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as individuals traveling from West Africa. By quickly detecting the virus, the test allows healthcare providers to start patient treatment as early as possible.
The test is used for the detection of Ebola Zaire Virus in whole blood samples using the large installed base of Roche’s LightCycler® 480 or cobas z 480 instruments. Roche’s cobas z 480 Analyzer, designed for real-time PCR with digital data capture, provides accurate qualitative results.
Manufactured by TIB MOLBIOL GmbH and exclusively distributed by Roche, the LightMix® Ebola Zaire rRT-PCR Test is a one-tube duplex assay for the simultaneous, qualitative detection of Ebola Zaire Virus (detected in the West Africa outbreak in 2014) and an endogenous human house-keeping gene used as an internal control. The test can be used for high throughput automated nucleic acid extraction using Roche’s MagNA Pure 96 instrument as well as for a smaller volume of samples with a manual extraction process.
According to the CNBC press release, the implications of FDA authorization for the LightMix® Ebola Zaire rRT-PCR Test are as follows:
- The test has not been FDA cleared or approved
- The test has been authorized by the FDA under an EUA for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories
- The test has been authorized only for the detection of RNA from Ebola Zaire virus (detected in the West Africa outbreak of 2014) and not for any other viruses or pathogens
- The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
In March 2013, the FDA received several new authorities and responsibilities under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), one of which was Emergency Use Authorization (EUA) authority. EAU allows the FDA to “allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives”. The law also allows FDA to authorize these products without first ensuring that they meet existing good manufacturing practice (CGMP) regulations.
Since then, FDA has been authorizing the use of diagnostic tests for Ebola under its EUA authority, including two Ebola diagnostic tests developed by the Centers for Disease Control and Prevention (CDC). The LightMix® Ebola Zaire rRT-PCR Test is the latest in this line of tests for use under Emergency Use Authorization.