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FDA Grants Emergency Use Authorization to Ebola Test

Roche assay can provide results in just over 3 hours

The FDA has approved an emergency use authorization for a test that can detect the Ebola Zaire virus in blood samples in just over 3 hours.

The LightMix Ebola Zaire rRT-PCR Test (Roche) can be used on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as recent travel from West Africa. The test uses the large installed base of Roche’s LightCycler 480 or cobas z 480 instruments.

The FDA authorization makes available “an easy-to-use molecular diagnostic test, providing a solution for health care professionals to quickly detect the virus and start patient treatment as early as possible,” said Roland Diggelman, Chief Operating Officer of Roche Diagnostics Division.

The LightMix Ebola Zaire rRT-PCR Test has also received a CE mark (meaning it complies with the safety requirements of the European Union). The test is manufactured by TIB MOLBIOL GmbH and 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 housekeeping 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 a broad installed instrument base.

This test has not been FDA-cleared or approved. The FDA’s emergency use authorization allows it to be performed by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories.

There have been 19,497 reported cases of Ebola virus disease, according to the World Health Organization (WHO), with 7,588 reported deaths. Reported case incidence is fluctuating in Guinea and decreasing in Liberia.  There are signs that the increase in incidence has slowed in Sierra Leone, although the country’s west is now experiencing the most intense transmission in the affected countries.

The U.S. incidence of Ebola, in contrast, stands at 4 cases and a single fatality, according to WHO.

Sources: Roche; December 29, 2014; and WHO; December 24, 2014.

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