Developing a quick, mobile test to detect the presence of the deadly Ebola virus in a patient has become a priority for medical technologists.
Deaths from the recent Ebola outbreak in west Africa have soared above 1,000. The World Health Organization (WHO) declared the outbreak an international public health emergency last week and outlined ways to minimize the spread of the virus through airports and other travel pathways.
One small company, PositiveID of Delray Beach, Fla., has developed a prototype device for testing for Ebola and other viruses and bio-threats, relying largely upon millions in federal dollars to fund its research. The device looks like a mini-clamshell laptop. When closed, it is somewhat smaller in width and length than the iPad mini, but much thicker -- about 2-inches thick. It weighs about 2 pounds.
Called the Firefly DX, it can be used to test a person's blood or other body fluid sample for the presence of Ebola and other diseases at an airport screening area or a remote field location within 10 to 15 minutes.
By comparison, existing lab tests might take two to four hours, once a patient's sample has actually reached a lab, something that can take days in some remote regions.
"The best way to prevent the spread of the Ebola virus throughout the world is to detect is as early and quickly as possible, at the source, and we believe our Firefly system will give us that ability," PositiveID CEO William Caragol said in a statement.
The prototype could take two more years of refinement before being put into actual use, according to PositiveID. But the time to actual third-party testing of a finished device could be cut to just over a year, assuming new federal funding now being sought is approved, PostiveID President Lyle Probst said in an interview.
The entire Firefly system, developed in a Pleasanton, Calif. lab, could ultimately cost $3,000 to $5,000 and includes one main laptop device, a battery charger and a carrying case. In addition, each test per patient could cost $25. If purchased in large numbers, the system's price could drop to $1,000 and each test per patient could drop to as low as $5, Probst said.
The Firefly system relies on what is called real-time "polymerase chain reaction chemistry" to produce the molecular diagnostic results. To run a test, a sample of a patient's blood or other body fluid is placed into a small hole in the center of a one-use cartridge that fits inside the mini-laptop unit, which is then closed. The testing process is started by simply pressing a large button on the exterior.
KTVU in San Francisco posted an online video report showing how the device works.
PostiveID has developed a prototype device, the Firefly DX, to conduct quick tests for infectious diseases, including Ebola. The mini-laptop device can be opened to insert testing cartridges inside that include a small hole in the center for taking blood samples. (Photo: PositiveID)
"We call it a laboratory in the palm of your hand," Probst said. "It will do the whole testing process that you do in a lab to detect some type of organism in 10 to 15 minutes, compared to several hours in a lab."
Training to run the tests should be a simple process for airport personnel or field workers, Probst said. "We've taken the guesswork out of it and the person running the test doesn't need to be a programmer or even a medical person." A small blood sample can be taken with a finger prick, while a swab can be used to swab the nose or the mouth of a patient.
On the technology side, PositiveID has designed the system to allow different test programs to be encoded on an RFID chip inside the one-use cartridges. The reagents and other fluids needed to conduct the test are also inside the cartridge, and those test results are transmitted to the laptop device optically.
Once transmitted to the larger Firefly device, the data is further interpreted and can be sent to a smartphone or other device via Bluetooth or Wi-Fi, with the data eventually stored in a cloud-based system easily accessible by multiple parties. The data can also be read on an LED display.
Firefly runs on a proprietary, open-source operating system built with C, C++ and HTML tools, Probst said. A separate battery charger can re-charge the device's Lithium-Ion battery.
Much of the research on Firefly actually began a decade ago and cost $35 million in funds from the U.S. Department of Homeland Security, Probst said. A team led by Probst first built an 800-pound, closet-sized machine called the M-Band, which is used to test air quality and to detect and identify airborne viruses, toxins and bacteria within two hours. PostiveID has partnered with Boeing to license M-Band to customers; it is currently being tested by the U.S. Department of Defense in South Korea, Probst said.
Using the know-how gained from the M-Band project, Probst said PositiveID raised $2 million from a classified government program that he wouldn't name plus $1.5 million raised internally to begin downsizing M-Band into the Firefly prototype. That process began three years ago, with the current version of the prototype substantially readied more than a year ago.
"We've talked with several government agencies and there's a very large need for a device such as this, so I fully anticipate government funding in place this year," Probst said. Eventually, the final device will be even smaller than the prototype, he predicted, since keeping it small and highly mobile is a key driver for the project. A ruggedized device for Defense Department use is also contemplated.
Firefly can also be used to detect radiation poisoning from a blood sample to determine the exact level of radiation exposure, which can useful for patients undergoing cancer treatment as well as astronauts in outer space, Probst said.
"The largest application will be for diseases, including flu and Ebola or a pathogen that comes into the country intentionally or unintentionally," Probst said. It could even be used to test cows for Mad Cow disease, he said.
Probst was trained originally as a biologist, but also holds an MBA and manages the business side of PositiveID, which employs just 10 full-time staff. Manufacturing and other processes are outsourced.
Work on Firefly is obviously timely, given the current Ebola outbreak and likely outbreaks in the future.
The WHO has urged all nations, including the U.S., to be prepared to detect, investigate and manage Ebola cases, including providing access to a qualified diagnostic lab for Ebola detection at international airports and major land crossing points.
Probst said he thinks other companies might be developing mobile Ebola testing devices, but placed PositiveID on the "cutting edge" of development.
A Denver company, Corgenix Medical, is also working on a rapid diagnostic test kit for Ebola, but the work is in early stages and could last another three years, according to a statement released Monday. It isn't clear whether the Corgenix test kit would be used as a mobile device like the Firefly, or in some other form like a home test kit. Corgenix didn't respond to a request to comment.
Corgenix is working with the Viral Hemorrhagic Fever Consortium headed by Tulane University to use a $2.9 million National Institutes of Health grant to accelerate efforts to develop rapid result diagnostic kits to be ready by the time of the next Ebola outbreak.
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