FDA approved Roche’s Ebola test under Emergency Use Authorization in response to the recent outbreak of the disease in West Africa. The test has not been cleared for general use but has been authorized for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories.

The LightMix® Ebola Zaire rRT-PCR Test is for use on patients with signs and symptoms of the infection in conjunction with epidemiological risk factors, such as individuals traveling from the region. The test is designed to detect the virus in whole blood samples using Roche's LightCycler® 480 or cobas z 480 instruments.

Manufactured by TIB Molbiol and distributed by Roche, the test is a one-tube duplex assay for the simultaneous, qualitative detection of Ebola and an endogenous human house-keeping gene used as an internal control.

“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.

According to the company, the end-to-end process from sample preparation of whole blood to results can be achieved for 96 results in just over three 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.

Back in October, Diggelman told analysts at Frost & Sullivan that Roche was assessing whether to request FDA emergency approval for its Ebola test.

The global cost of preventing and containing Ebola will soar to $5.9 billion by 2016, Frost & Sullivan projects. A key reason why, the consultancy contends, U.S. regulatory red tape may be delaying commercialization of new rapid diagnostics.

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