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BioFire Defense of Salt Lake City says the U.S. Food and Drug Administration on Saturday gave an emergency OK for hospitals to use a BioFire tool to test patients for the new Ebola strain.
The FilmArray BioThreat-E is the first commercial Ebola test to be authorized for emergency use on patients with symptoms of Ebola, the biomedical company said in a news release.
BioFire had requested the emergency authorization from the FDA on Oct. 18.
Kirk Ririe, chief executive of BioFire Defense, said Monday that he attempted to deliver two FilmArray machines and Ebola test kits to Bellevue Hospital Center in New York City this weekend. However, state law there requires the Bellevue laboratory to first get approval for the new tests, he said.
Bellevue is treating Craig Spencer, the fourth person diagnosed with Ebola in the United States. There are 116 FilmArray machines in New York and New Jersey hospitals.
Some 300 U.S. hospitals already use FilmArray, a toaster-size diagnostic device, to quickly determine which bloodstream, respiratory or gastrointestinal bug is making a patient sick.
The hospitals will simply add the BioThreat-E panel, or kit, to test for the Ebola Zaire virus, the one that has sickened more than 10,000 this year and killed more than 4,900, mostly in three West African countries. BioFire Defense says it has 800 such panels ready to ship.
In about an hour, the polymerase chain reaction, or PCR, diagnostic tool can analyze human blood, saliva or other bodily fluid at the molecular level, find genetic markers for various diseases and post the result on a laptop computer. It was patented in 2012.
Besides the commercial test, the FDA also gave emergency authorization for a second Ebola test to be used by laboratories designated by the Department of Defense, the company news release said.
"We believe that a fast, easy-to-use and accurate Ebola test will help in the fight against this horrible virus," said Kirk Ririe, chief executive officer of BioFire Defense. He said years of collaboration with the Department of Defense, FDA and other federal agencies made it possible.
Randy Rasmussen, chief executive of a sister company, BioFire Diagnostics, said that since FilmArray already is routinely used in 300 hospitals, "The rapid authorization of emergency use of the FilmArray Ebola test by FDA instantly creates an extensive Ebola testing network in the United States."
The U.S. military is using FilmArray to test for Ebola in Africa. The company has a $240 million, eight-year contract with the Defense Department to expand FilmArray into a broader biological-warfare detection system.
Last week, BioFire Diagnostics announced plans to build a $55 million plant next to This Is the Place Heritage Park in Salt Lake City. It also said it expects to double its workforce of 700 over the next few years.
The two BioFire companies began as Idaho Technology Inc., a spin-off from the University of Utah. The French medical diagnostics company bioMérieux bought BioFire earlier this year and split it into the two subsidiaries.
Twitter: @KristenMoulton