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CORRECTED-Roche may seek fast-track approval for Ebola virus test
2014年10月17日 / 凌晨4点54分 / 3 年内

CORRECTED-Roche may seek fast-track approval for Ebola virus test

(Corrects Oct 16 story to make clear in lead and headline that Roche is evaluating whether to submit the test for emergency use approval, but has not yet done so.)

ZURICH, Oct 17 (Reuters) - Roche Holding AG is evaluating whether to submit its Ebola virus test for emergency use approval in the United States, in response to the world’s worst outbreak of the disease, the drugmaker’s head of diagnostics said on Thursday.

Roland Diggelman said Roche has an Ebola test that can run on its polymerase chain reaction (PCR) systems, but said it was currently only labelled for use in research purposes.

“We are in discussions for emergency use application by the FDA (Food and Drug Administration),” Diggelman told an analyst call after the company’s third-quarter results.

A spokesman for Roche said the company has already filed for so-called CE mark approval in the European Union. The CE mark is awarded to products that comply with European regulations.

He said it takes approximately two hours for the company’s Ebola test to detect the virus. It is possible to run around 480 samples per day on a single Roche LightCycler 480 machine. Only laboratories that fulfil specific safety requirements would be able to handle Ebola samples.

A total of 4,493 people have died from the world’s worst Ebola outbreak on record and the situation in Guinea, Liberia and Sierra Leone is deteriorating, the World Health Organization (WHO) said on Wednesday.

Public anxiety about the disease has grown in the United States after a second Texas healthcare worker became infected with the disease after treating Liberian national Thomas Duncan.

The WHO recommends testing for viral ribonucleic acid (RNA) or viral antigen in suspected or probable cases of Ebola. (Reporting by Caroline Copley; Editing by David Holmes)

我们的标准:汤森路透“信任原则”
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