Roche wins FDA approval for emergency use of rapid Ebola test

Ebolavirus under an electron microscope--Courtesy of CDC

Amid growing efforts from diagnostic companies to counter the deadly Ebola outbreak, Roche ($RHHBY) snagged FDA approval for emergency use of its rapid Ebola test.

The Swiss company got a regulatory greenlight for its LightMix Ebola Zaire rRt-PCR test, a diagnostic tool that can process as many as 96 results in just over three hours, Roche said in a statement. The test is approved for patients with signs and symptoms of Ebola Zaire virus infection, and runs on the company's LightCycler 480 or cobas z 480 instruments.

Roche's LightMix diagnostic product is CE marked, but has not yet been cleared or approved for general use by the FDA.

Roland Diggelmann, COO of Roche Diagnostics Global--courtesy of Roche

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

Roche is far from the only med tech company developing quick Ebola diagnostics. Big names like Cepheid, Corgenix ($CONX) and France's bioMérieux are forging ahead with their own products, notching regulatory wins and roping in funding to roll out their Ebola tests. In June, Colorado-based Corgenix scored nearly $3 million in funding from the U.S. National Institutes of Health to continue work on its Ebola diagnostic tool, which works similar to a home pregnancy test and can deliver results within minutes on a testing strip.

In October, bioMérieux's BioFire Diagnostics subsidiary won emergency authorization from the FDA for two of its Ebola tests. The company's diagnostic tool forgoes the need for specialized lab processing and can detect the disease in a blood or urine sample in one hour, beating out traditional tests which can take up to two days to deliver results. Cepheid is also making headway with its product, raking in $3.3 million in November to develop its "Xpert Ebola" test that can diagnose Ebola in an hour or less using saliva or a drop of blood.

- read Roche's statement
- here's the Reuters story

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