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FDA approves Corgenix’s Ebola test for emergency use

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Diagnostics company Corgenix Medical Corp said on Thursday U.S. health regulators had approved its rapid Ebola test for emergency use, in response to the world’s worst outbreak of the virus that killed more than 10,000 so far.

The company’s ReEBOV Antigen Rapid Test, which involves putting a drop of blood on a paper strip and waiting for at least 15 minutes for a reaction, was cleared by the World Health Organization last week.

Reporting by Natalie Grover in Bengaluru; Editing by Maju Samuel

The test is less accurate than the standard test, which has a turnaround time of 12-24 hours, but is easy to perform and does not require electricity. It is able to correctly identify about 92 percent of Ebola-infected patients and 85 percent of those not infected with the virus, the WHO said.

The WHO is still assessing four or five other rapid test candidates.

The U.S. Food and Drug Administration cleared Roche Holding AG’s Ebola test, which takes up to three hours to generate results, for emergency use late last year.

Earlier this month, German drugmaker Stada said it would launch a test next month that can diagnose Ebola virus infections within minutes.

The FDA’s emergency use authorization is not intended for general Ebola screening, Corgenix said.

Corgenix’s pink sheet shares were up 3.5 percent at 27 cents in early trading.

Read More at Reuters.com