Imagine knowing you’ll be too sick to go to work, before the faintest hint of a runny nose or a sore throat. Now imagine thatpreemptive diagnosis being transmitted to a national, web-based influenza map — simply by picking up the phone.
That’s the impressive potential of an ongoing Pentagon-funded research project, spearheaded by geneticists at Duke University. Since 2006, they’ve been hunting for a genetic signature that can accurately assess, well before symptoms appear, whether someone’s been infected with a virus. Eight months into a $19.5 million grant from Darpa, the Pentagon’s out-there research agency, the expert behind the program is anticipating a tool with implications far beyond military circles.
Dr. Geoffrey Ginsburg, director of Duke’s Institute for Genome Science & Policy, is collaborating with a team of colleagues to create a gadget that can detect viral infection hours before the sniffles. Between 2006 and 2009, his team made rapid strides in identifying 30 genetic markers, found through blood samples, that are activated by a virus.
They’ve since moved to human trials, testing 80 people in four studies. Healthy participants were exposed to three different viral strains. Their blood, saliva and urine were then tested for “viral specific signatures,” that would characterize illness.
“Traditionally, we’ve diagnosed these conditions by testing for the actual pathogen, but that’s a slow process and it’s not effective until you’re already symptomatic,” Ginsburg told Danger Room. “To look at the actual host response instead is a really novel approach.”
It’s an approach that Darpa sees as a tactic to boost war-zone performance. By checking soldiers for genetic markers of illness before they’re deployed, the military hopes to optimize the outcome of a given mission. The idea would also prevent an outbreak of illness in close military quarters, by quarantining troops before they have a chance to infect others.
But what Ginsburg and company didn’t anticipate was just how widespread the benefits of the Darpa initiative would be. Not only have they found a specific genetic signature that indicates viral infection, but the team has concluded that viruses and bacterial infections trigger different genes. Which means physicians could one day know whether to prescribe antibiotics, which can treat bacteria but not viruses. The drugs are so overused and wrongly prescribed, experts at a recent congressional hearingwarned that Americans face “a post antibiotic era.”
“This would eliminate the ‘default’ of giving antibiotics, which is a significant public health concern,” Ginsburg said. “So what we’d have, essentially, is a tool to drastically improve clinical judgment in a day-to-day setting, which wasn’t a Darpa goal, but a corollary benefit because we had a chance to find these specific signatures.”
And Ginsburg has a more elaborate vision for the devices, which he hopes to see shrink down from “suitcase size” to that of “a diabetic glucometer,” which would use a finger pinprick to test for illness.
“Imagine a sensor attached to your telephone, that instantly diagnoses viral agents and transmits that to a central community database,” he said. “Google used searches to beat the CDC at tracking H1N1 — this would be surveillance that could take that to the next level.”
Ginsburg anticipates a suitcase-sized device in the war-zone within “a couple years,” and says the devices are already showing excellent accuracy 24 hours before an infected patient becomes symptomatic. In an effort to validate the results in a real-world setting, his team has turned to Duke’s campus, using crowded dorms — already human petri dishes of infection — as improvised research labs.
Now, Ginsburg’s biggest concern is that the devices will be ready before the Food and Drug Administration, who’ve yet to establish regulatory benchmarks for genetic tests, knows what to do with them.
“The major uncertainty, in my mind, is the regulatory atmosphere,” he said. “These are such a new diagnostic tool, the FDA is still trying to figure out not only how to supervise them, but whether they even need to.”
Which is a barrier for the doctor’s office, but not necessarily the war-zone.
“There’s a lot of motivation within the Pentagon to get this going,” he said. “So they might have a way around the rulebook.”