Rapidly screening for Ebola at U.S. hospitals has just gotten easier thanks, in part, to military-funded research. Salt Lake City-based BioFire announced over the weekend that they had received emergency use authorization from the Food and Drug Administration for hospital workers to use the Bio-Threat E array (a special kit) on the company’s polymerase chain reaction (PCR) machine, the FilmArray, to screen for Ebola.
It’s basically the same machine that the U.S. military is using to fight the disease in Africa, although the tests are slightly different. On Saturday, the FDA had authorized the Ebola screening kit, the Bio-Threat E, for clinical use under the Emergency Use Authorization. The Dallas hospital that treated Thomas Eric Duncan, the Liberian man who became the first individual to die of Ebola in the United States, but was not authorized to use it to test patients showing symptoms of Ebola.
Health workers in more than 300 hospitals around the country, including 30 lab hospitals in the New York tri-state area, use the machine to screen for a wide variety of illnesses such as listeria, influenza and various other respiratory and intestinal sicknesses. With the right diagnostic kit in place, the FilmArray can also be used to screen for Ebola, delivering results in about an hour with higher than 90 percent certainty. Technically speaking, it may be able to do so days before an Ebola carrier develops a fever and becomes contagious, though the FDA has not authorized its use in patients that are not showing symptoms. One of the hospitals scheduled to receive the machine for that purpose is New York’s Bellevue.
Doctors and medical staff at Emory University in Atlanta were able to use it to diagnose U.S. doctor Kent Brantly and aid worker Nancy Writebol because the machine there had a research designation.
“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,” an FDA spokesperson told Defense One.
One of BioFire’s FilmArray machines
BioFire, a subsidiary of BioMerieux, began the process of requesting emergency use authorization on Sept. 22 and finally got in the last necessary results and paperwork on Oct. 22, according to an FDA spokesperson.
Emergency use authorization differs from full FDA approval. The authorization is good for a year (with the potential for renewal) or until circumstances no longer justify it. It dates back to the 2004 Project BioShield Amendment in Section 564 of the Federal Food, Drug and Cosmetic Act and has been used numerous times since its inception.
The screening machine works by matching the ribonucleic acid in a blood, saliva or other fluid sample against an Ebola target to determine the genetic presence of Ebola. It’s one of the main screening solutions that the U.S. military is using in Africa. In March, BioFire received a $240 million contract from the Defense Department to adapt the FilmArray for use to screen for the virus (as well as other illnesses.)
The FDA’s authorization may seem like a small bureaucratic victory, but it could alter the way officials around the country deal with the Ebola scare.
The availability of more and better Ebola screeners in more hospitals will allow authorities to much more rapidly evaluate potential Ebola cases and possibly do so before symptoms like fever present themselves — in other words, possibly before the carrier is contagious or poses a threat. That means that random screening with an effective PCR machine could potentially decrease any public health threat from an individual — without being quarantined.