U.S. FDA Issues Emergency Authorization for Two New Ebola Tests

Yasmeen Abutaleb

October 28, 2014

Oct 25 (Reuters) - Federal health regulators granted emergency authorization on Saturday for two new tests made by BioFire Defense that detect Ebola in humans, highlighting new steps by the government to prevent a severe outbreak in the United States.

The U.S. Food and Drug Administration has been working closely with Salt Lake City-based BioFire, a subsidiary of medical diagnostics maker BioMerieux, to obtain the necessary performance data to allow for the authorizations, the federal agency said in a news release.

BioFire's tests can detect Ebola in a blood or urine sample in one hour, compared with the 24 to 48 hours current tests take to deliver results, said Matt Scullion, vice president of sales and marketing for BioFire Defense.

The test can also be performed in a hospital with BioFire lab equipment, whereas current tests need to be sent to specialized labs.

"We have managed to come up with a system that has automated all of the traditional steps that you'd go through to set up a test like this," Scullion said. "All the hospitals already using our systems can begin testing patients."

More than 300 U.S. hospitals have BioFire lab equipment, Scullion said, including Emory Hospital and Bellevue Hospital, where Dr. Craig Spencer, who recently returned from treating Ebola patients in West Africa, is currently being treated for the disease.

"We understand the importance of quickly diagnosing Ebola cases in the U.S. and abroad. FDA is committed to working with companies in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola for emergency use during this epidemic," the agency said.

Under an emergency use authorization, the FDA may allow unapproved medical products to be used to fight life-threatening diseases on an emergency basis when there are no approved or available alternatives.

"Obviously, having more tests authorized for use during this outbreak is a benefit," said Sharon Yao, an FDA spokeswoman. "Hospitals can now test human specimens for Ebola in their facilities and obtain a determination in under two hours."

So far only a handful of people have been diagnosed with Ebola in the United States, most of them medical workers who contracted the disease after treating other patients.

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