Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, announced that the US Food and Drug Administration (FDA) has provided an Emergency Use Authorization (EUA) for the LightMix Ebola Zaire rRT-PCR Test 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. 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.

"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, Roche Diagnostics Division. "As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies. The FDA's granting of this EUA supports our commitment to healthcare professionals working to combat this deadly disease."

The LightMix Ebola Zaire rRT-PCR Test has also been CE marked by the test's manufacturer, TIB MOLBIOL GmbH, and is available for use on the LightCycler 480 or cobas z 480 instruments in markets accepting the CE mark. In addition, TIB MOLBIOL GmbH has submitted an Expression of Interest (EOI) for Emergency Assessment by the World Health Organization Prequalification of the In vitro Diagnostics Programme.

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 end-to-end process from sample preparation of whole blood to results can be achieved for 96 results in just over 3 hours. The test can also be used for smaller numbers of samples with a manual extraction processes, as well as labs using Roche's MagNA Pure 96 instrument for high throughput automated nucleic acid extraction. The test was developed to be run on the LightCycler 480 or the cobas z 480 qPCR instruments, allowing the response to be most effective through utilization of abroad installed instrument base.

This test has not been FDA cleared or approved; This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non-US laboratories; This 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; and This 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.