This story has been updated.
The military is using an Ebola screening machine that could have diagnosed the Ebola cases in Texas far faster, but government guidelines prevent hospitals from using it to actually screen for Ebola.
It’s a toaster-sized box called FilmArray, produced by a company called BioFire, a subsidiary of bioMérieux and it’s capable of detecting Ebola with a high degree of confidence — in under an hour.
Incredibly, it was present at Texas Health Presbyterian Hospital in Dallas when Ebola patient Thomas Eric Duncan walked through the door, complaining of fever and he had just come from Liberia. Duncan was sent home, but even still, FDA guidelines prohibited the hospital from using the machine to screen for Ebola.
The FilmArray retails for about $39,000 per unit and can screen for the genetic markers of a wide number of respiratory, gastro-intestinal and other illness, including Ebola, but only with the right “kit” in place. Current FDA guidelines would not have allowed Dallas Presbyterian Hospital to get that kit. That’s despite the fact that it can provide results with higher than 90 percent certainty and it’s one of the machines that the military is currently using to screen for Ebola in Africa.
The FilmArray performs polymerase chain reaction tests to determine the presence of Ebola on the basis of genetic markers. ”It will take the Ebola cells, break them open, expose the [ribonucleic acid] in the Ebola and match those with a target we’ve identified,” company representatives told Defense One. The machine can work off of blood or even saliva samples.
BioFire Diagnostics, a Utah-based firm that produces disease detection technology, confirmed that the Dallas Presbyterian Hospital did in fact have one of the machines (possibly for as long as two years) sitting on the shelf when Duncan came in.
But unless hospitals agree to use the machine specifically for research purposes, rather than actually diagnosing patients with Ebola, they can’t look for Ebola in samples, which they did not. These are so called research use only machines.
The FDA rules in what are called “research use only” machines are far more lax than for machines that must provide clinical diagnosis. According to representatives from BioFire, even after the FDA approved the use of the machine for Ebola screening and allowed workers at the hospital to acquire the proper kit for Ebola testing, a 10-20 day “validation” procedure would kick in before they could change the machine’s use from diagnostics to research — and the results would have to go to the Centers for Disease Control for confirmation.
The FilmArray is also what the medical team at Emory used it (RUO) to diagnose the first two Ebola U.S. patients, Kent Brantly and Nancy Writebol. In a recent paper, published in the journal Lab Medicine. They write “Polymerase chain reaction (PCR)–based microbiological analyzer (BioFire FilmArray [BioFire Diagnostics, Inc, Salt Lake City, UT]) designed to detect a panel of viral, bacterial, fungal, or parasitic pathogens, many of which might be found in patients returning from a resource-poor region and might complicate care. Among other pathogen-specific markers, this instrument detects Ebola viral RNA, a capability that we believe could have value for monitoring progression of and recovery from Ebola infection in this setting.”
Dr. Luciana Borio, assistant commissioner for counterterrorism policy and acting deputy chief scientist at the FDA, recently told National Journal that the agency was looking to speed up evaluation of new drugs to treat Ebola.
The FDA didn’t immediately respond to a request for comment.
The screening machine is more than good enough for the military, though, which played a big role in the machine’s development for Ebola detection.
In March, the Defense Department, through the Joint Program Office for Chemical and Biological Defense (JPEO) awarded BioFire a $240 million contract to adapt the FilmArray for use to screen for illnesses like Ebola.
The company participated alongside two other companies for the Next Generation Diagnostics System prize. The winning system had to be able to spot a wide number of chemical or biological agents, diagnose them on a minute level, and return a positive or negative.
“This is a fantastic opportunity to deliver the most cutting edge diagnostic system to our warfighter,” Kirk Ririe, CEO of BioFire Defense said in a March press release. “The motivated team at JPEO has pushed an aggressive schedule and a cost effective approach that will be met by exploiting our FilmArray’s commercial diagnostic capabilities, to provide for our nation’s bio-defense and improve DOD health care.”
Company officials confirmed that FilmArray and another BioFire products called JBAIDS are in fact in use by the U.S. military in West Africa right now.
Speaking before a congressional panel Thursday, CDC Director Dr. Tom Frieden acknowledged that airport screening for Ebola was extremely limited. He also said that he was open to any strategy to reduce risks to the general population from Ebola. Other witnesses at the hearing said the U.S. is rapidly speeding up the development and deployment of new diagnostic systems.
What might those look like? Probably a great deal like the machine that the military is using to screen for Ebola in Africa right now.
Update: BioFire has confirmed to Defense One that they have approached the FDA seeking emergency use authorization to allow more hospitals to use the FilmArray to screen for Ebola.
The FDA responded to Defense One’s request for comment with the following statement:
“The FDA understands the importance of quickly diagnosing Ebola cases in the U.S. and abroad. We are committed to working with BioFire and other companies in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola for emergency use during this epidemic. The FDA works extremely rapidly to make a determination on an Emergency Use Authorization once the information is submitted to the agency for review. The FDA may not authorize the use of a diagnostic test before reviewing data about its performance in detecting Ebola virus in human specimens and determining that the standard for authorization is met. Doing so would also be irresponsible and potentially unsafe.
It is important to note that the FDA has been reaching out to commercial companies to encourage them to work with us on the development of rapid diagnostic tests. Additionally, the FDA has already authorized the use of three in vitro diagnostic tests to help detect Ebola virus. Additionally information can be found here.”
On October 10th, the FDA has granted emergency use authorization to three screening system called Ebola Zaire Target1, which was also developed with help from the Defense Department; the CDC Ebola Virus NP Real-time RT-PCR Assay; and the CDC Ebola Virus VP40 Real-time RT-PCR Assay.