The FDA has given Nanobiosym Diagnostics Emergency Use Authorization (EUA) for its Gene-RADAR Zika virus test. The portable medical device means it can be used in hospitals and offers fast, accurate results.
Dr Anita Goel, chairman and CEO of Nanobiosym, a digital health company, commented: "This FDA EUA represents a major milestone towards realising our deeper vision: to decentralise, personalise, and mobilise the next generation of healthcare, much like cell phones transformed the telecommunications industry.
"The FDA's prompt feedback has accelerated our journey from winning the first XPRIZE for healthcare to bringing this new technology to patients and providers battling Zika on the front lines."
According to the Centers for Disease Control (CDC), more than 43,000 people in the US and its territories have already been infected by the Zika virus, including at least 4,750 pregnant women. One of the greatest threats of Zika infection occurs during pregnancy, potentially resulting in significant neurological problems in the developing baby, such as severe microcephaly, decreased brain tissue and brain damage.