NEW YORK (Reuters) – Federal health regulators granted emergency authorisation yesterday 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 US 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 US 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.
