When the COVID-19 pandemic paralyzed the world, the U.S. military was forced to conduct hundreds of emergency medical evacuations out of combat zones, pause critical training evolutions, and redirect vast amounts of medical and logistics resources toward fighting the mysterious and deadly disease.
Today, with COVID-related panic in the rearview, researchers are focused on Pathogen X – a hypothetical next pandemic-causing disease that might be mitigated or contained with better preparation.
Rapidly diagnosing and categorizing Pathogen X is one of the use cases officials at the Pentagon’s Chemical and Biological Defense Program reportedly see for GeneCapture, a developmental technology that creators and funders say can diagnose infections and pathogen families within an hour for about $20 per test — compared with 72 hours and around $160 for more conventional broad-edged testing.
To date, the military has invested nearly $12 million to support the development of GeneCapture as a deployable diagnostic tool, with the bulk of that funding coming from the Chemical Biological Defense Program, or CBDP, and the Defense Health Agency.
The development team, out of the HudsonAlpha Institute in Huntsville, Alabama, is also raising funds to begin clinical trials with the U.S. Food and Drug Administration, whose certification is a pre-requisite for any military fielding or deployment.
Retired Army Col. Dave Zimmerman, a 29-year medical officer who commanded the 65th Medical Brigade in Korea and served as a director at the Office of the Surgeon General, told Military Times he could have used the GeneCapture device in his younger years as a medevac pilot.
“Having a capability on board for your flight medics, where we get a Nine Line [medevac request], we fly to a location, the medic gets out and starts assessing — the more tools the medic has, the better he’s going to be able to treat the patient,” said Zimmerman, who now acts as an independent advisor and consultant for GeneCapture.
“And there’s been many instances in Afghanistan where we would fly and someone would be injured and have some kind of illness and we wouldn’t be able to know until we got back to the hospital. … I’ve been deployed six times, so I’ve seen a lot of things in many different countries. And this is what I would want for my soldiers now.”
Zimmerman added that the size of the diagnosis device, which is portable and handheld, and its ability to test blood or fluid samples without needing refrigeration or temperature control are also conducive to battlefield uses worldwide.
If GeneCapture sounds a little bit like Theranos, a blood-testing startup that made headlines and attracted supporters — including former defense secretary Jim Mattis — before imploding amid revelations of fraud and bad science, the team has heard it all before. When that scandal became public, according to GeneCapture CEO Peggy Sammon, the surrounding suspicion and cynicism had “a bad ripple effect” on all technology development in the space.
“We’re so different from Theranos. They were trying to determine, fraudulently, what’s the chemistry in a small sample of blood,” she told Military Times. “We’re saying, ‘What living organism is colonizing your body? What’s living in the sample?’ We’re totally different setups … and a comment I’ve made to a lot of people is [that] you can’t win eight [military technology development] contracts without showing actual data.”
Officials with the CBDP said they couldn’t comment on the technology or their plans for it, but did confirm the office’s involvement with GeneCapture.
The technology that enables this novel medical capability is what the development team calls “direct RNA capture,” which uses an array of probes within the diagnosis device to determine the unique genetic signature for each pathogen by the presence of its RNA, an identifying molecule for living organisms.
“If that RNA is in the sample, it attaches and lights up, and that’s how we know what it is,” Sammon said, noting that conventional PCR disease testing requires a testing solution and depends on a reaction that takes time to develop to determine the presence of a specific pathogen.
According to GeneCapture materials, internal testing is ongoing for the diagnosis of urinary tract infections — an application the FDA has shown particular interest in — as well as bacterial and fungal wound infections; animal and plant toxins; and biothreats such as dengue fever, coronavirus, influenza, typhus, lassa fever and Pathogen X, among others.
The technology’s inventor, Dr. Krishnan Chittur, was motivated to find a better diagnosis method after his infant daughter was diagnosed with an infection and placed on antibiotics for three days while doctors waited for lab results to determine what exactly was making her sick.
Sammon, who met Chittur in 2009 and has helped the team raise some $7 million in private funding in addition to government grants, said working with the military on its needs has helped to ruggedize the platform — they worked to develop a cartridge-reading device about the size of a toaster that does not require laptops, delicate pipettes or test tubes.
“We’ve tried to look at this as, How can this be more rugged?” she said. “If you get so focused on it, you come up with something that works. And I think others have not looked at it this way.”
Zimmerman said he’s currently working with GeneCapture to help coordinate a private test in Kansas City, where, though the military wouldn’t be formally involved, soldiers would be able to “put their hands on” the prototype and provide feedback.
He said he’s particularly enthusiastic about the promise of GeneCapture for the yet-to-be-determined conflict of the future, which may involve new weapons and mystery threats and variables.
“When you go into … a war in the future, there’s a lot of unknown, right? Because the enemy always gets a vote. And you never know how you’re going to be attacked or what you’re going to be exposed to,” Zimmerman said. “Having the best and simplest equipment for your medical professionals to help diagnose what’s wrong with the patients is critical. … I’m all about giving the soldier the advantage when it comes to saving others’ lives.”
