DARPA Biosurveillance Project Pivots to Probe COVID-19

A U.S. Defense Department research program that has not yet even officially begun may contribute advanced testing devices for COVID-19 and other future pandemics.

The program is being run by the Defense Advanced Research Projects Agency (DARPA) and is called the Detect It with Gene Editing Technologies. The acronym, DIGET, is pronounced “dig it.”

The military requires timely and comprehensive threat detection to support overall readiness, counter the spread of disease and promote stabilization missions, but state- of-the-art diagnostic and biosurveillance systems are not able to keep pace with disease outbreaks and sometimes fail to support decision making at the time and place of need, according to the DIGET website. The program aims to leverage advances in gene editing technologies to develop diagnostic and biosurveillance technologies that enable detection of any threat, anytime, anywhere.

The website explains that the goal is to develop and deploy two devices: a disposable point-of-need diagnostic for up to 10 pathogens and host biomarkers, and a massively multiplexed detection (MMD) device for 1,000 or more targets. Both devices must be simple to operate, low-cost and rapidly reconfigurable. The MMD device will enable early threat detection, assess disease severity and improve situational awareness.

The program will likely kick off officially around the end of summer, but as initial research, DARPA has funded a feasibility study with the Broad (rhymes with road) Institute of MIT and Harvard. Renee Wegrzyn, a program manager within DARPA’s Biological Technologies Office, describes the DIGET program as “our foray into diagnostics and biosurveillance using gene editing technologies” and adds that such technologies can “get very precise genetic information” and “do it very quickly.”

She reports that once the pandemic started to spread and initial gene sequencing data for the virus became available, the researchers changed direction. “During the course of this study, the COVID-19 pandemic took place, so we were able to quickly pivot. In about three weeks we were able to take some of the first sequencing information that was available on the virus and use that information to develop tests that were very sensitive and specific for the virus that causes COVID-19,” she says. “Those proofs of concept have now been published by our Broad Institute team, and they’re moving forward, trying to get the clinical proof of concept to support that initial laboratory study.”

That three-week turnaround, Wegrzyn indicates, is unusual. “That’s a really unprecedented timeline and in a scenario where we weren’t even trying to plan for it, so I really hope that with the anticipated successes of the DIGET program, we can even shorten the timelines further for the next outbreak.”

While the initial research may prove beneficial as early as this fall when the COVID-19 virus could make a comeback, the ultimate goal is for federal Food and Drug Administration approval at the end of the four-year program.

Wegrzyn envisions test devices known as “assays” that offer fast results and can be used at home or in austere battlefield conditions, such as the Arctic, deserts or jungles. Pregnancy tests are a common type of assay. The Broad Institute already has developed an assay device in which a colored band appears if a particular agent, such as COVID-19, is present. “We think these tests could be run more rapidly, getting a definitive result in a shorter amount of time. We’re targeting less than 30 minutes. We also have configurations of the test we published that are basically a strip-based test,” she says.

Also, the new tests could be reconfigured quickly as situations change. “If there’s a sequence change in the virus, or if there’s a new viral threat that emerges, we would hope to have more mature technology that time so that we could quickly turn around new tests,” Wegrzyn says.

Additionally, the MMD devices might ultimately be able to test 1,000 different patient samples to look for one agent, such as COVID-19, or they might be used to test for 1,000 different agents from a single patient sample. “We could look, for example, at every single human pathogen known that we can have a probe for. We’ve never had that ability for bio surveillance,” she notes.

And that capability could allow scientists to learn about and respond to pathogens much more quickly. For example, the technology could allow for widespread testing in a particular region with no known outbreak just to see if certain pathogens are circulating within the population. “We can get a really early detection so that we can then have an early implementation of either a quarantine or a deployment of medical countermeasures, whatever that might be,” Wegrzyn suggests.

Such a capability could save lives during future pandemics. “We’re always behind the game it seems on biosurveillance for influenza. We saw this for H1N1, and again very strongly we’re seeing this with the COVID-19 pandemic, so that capability, I think, will really help us change the game,” she adds.