Nanobiosym, the Cambridge, Massachusetts-based digital health company whose Gene-RADAR scanner won the Nokia Sensing X Prize a few years ago, has been granted Emergency Use Authorization (EUA) from the FDA for its Zika Virus Test.
EUA is a special clearance pathway the FDA uses for devices that address an immediate public health crisis like Zika. Devices authorized under EUA aren’t cleared or approved and can only be used to address the crisis at hand. While FDA has cleared a number of Zika tests under EUA previously, Gene-RADAR has several advantages over the others. The device is small and can be used onsite at a hospital, rather than doctors having to ship samples to a lab to be tested by a much larger device. The device also has less of a false positive problem than antigen/antibody tests, another kind of assay that’s been cleared.
“Last summer at the height of the mosquito season in Florida, some of the folks at University of Miami, which is affiliated with Jackson Medical Center, were telling me that they were doing over 1,000 Zika tests a month,” Dr. Anita Goel, CEO and founder of Nanobiosym, told MobiHealthNews. “In places like Florida, where there was kind of a panic by some of the people where every pregnant woman wanted to get tested, the issue was, because they had to ship the patient’s samples to a CDC lab and wait for the results to come back, that backlog was anywhere from one to five weeks.”
By contrast, Gene-RADAR should be able to return results in about an hour. From a public health perspective, screening as many people as possible in at risk areas will help contain the spread of the virus. People should know as soon as possible if they’re infected to avoid infecting others.
“The biggest issue about Zika is that it poses a growing threat to public health because a lot of people go undiagnosed,” Goel said. “A lot of people can be asymptomatic. You can be infected and not know you’re infected. And the biggest danger is to an unborn child.”
For Nanobiosym, this is the first time its device has been cleared by the FDA for use. Other Gene-RADAR devices are in the midst of the clearance process. In fact its the first competitor in the recently concluded Tricorder X Prize to get any kind of go-ahead from the FDA.
“It’s a step toward our bigger vision of mobilizing, decentralizing and personalizing the entire next generation of healthcare infrastructure,” Goel said. “But the journey toward validation is a long journey and I want to make sure we are not overstating what this means.”
Goel said that now that the device has authorization for this use case, the company is looking into how to ramp up production and distribute them where the need is greatest.
“We are trying our best to be helpful in the current crisis, so we’re in the process of working out how to expand our production capabilities so we can make more of these available to the people who need it the most,” she said. “But this is a bit of a journey because we’re bringing something new to the world.”
