SALT LAKE CITY — A Utah company has received emergency use authorization by the U.S. Food and Drug Administration for two new tests that detect the Ebola virus in about one hour.
BioFire Defense is using FilmArray BioThreat-E, the first commercial Ebola test to be authorized for emergency use on patients showing signs and symptoms of the disease. The test can find genetic markers through blood, saliva or other bodily fluids. It can also be used by laboratories designated by the U.S. Department of Defense. Over 300 hospitals are already using the diagnostic device to detect other conditions in the respiratory and gastrointestinal tract.
“We believe that a fast, easy to use and accurate Ebola test will help in the fight against this horrible virus,” said Kirk Ririe, CEO of BioFire Defense. “We are pleased that years of collaboration with the Department of Defense, FDA and other federal agencies have helped make this possible.”
The company said the BioFire FilmArray system is a highly accurate, fast, and easy to use clinical molecular biology diagnostic device. The system is capable of identifying hundreds of the most prevalent viruses, fungi, bacteria, and parasites associated with common patient infectious diseases in one hour, allowing health professionals to make treatment decisions faster. Other Ebola testing methods. including those used by the U.S. Centers for Disease Control, take 24-48 hours.
“The FilmArray system is in routine use in over 300 hospitals,” said Randy Rasmussen, CEO of BioFire Diagnostics. “The rapid authorization of emergency use of the FilmArray Ebola test by FDA instantly creates an extensive Ebola testing network in the United States.”
Last March, BioFire Defense was awarded a $240 million, eight-year contract with the DoD to expand FilmArray’s diagnostic menu by developing biological threat testing capabilities for use across four branches of the military.
The 2014 Ebola epidemic is the largest in history, affecting multiple countries in West Africa, according to the CDC. Two imported cases, including one death, and two locally acquired cases in healthcare workers have been reported in the United States.
A person infected with the virus, which is spread through bodily fluids, can begin showing symptoms between two and 21 days after exposure. Those symptoms include fever, severe headache, muscle pain, weakness, diarrhea, vomiting, stomach pain and unexplained bleeding or bruising.
Many Utah hospitals and clinics are now asking patients at the time they check in for their appointment if they have traveled to West Africa within the past three weeks.