Diagnostics

XPRIZE winner Nanobiosym gets FDA emergency use authorization for Zika diagnostic test

The authorization for the Gene-RADAR Zika Virus Test is designed to cut the amount of time it takes for a diagnosis of the Zika Virus by analyzing blood samples with nanotechnology.

Nanosym Gene-RADAR scanner

Nanobiosym Gene-RADAR scanner

Nanobiosym, a former Nokia XPRIZE winner, has been granted emergency use authorization for its point of care diagnostic test to detect the Zika virus from the U.S. Food and Drug Administration.  The authorization for the Gene-RADAR Zika Virus Test is Nanobiosym’s first FDA-cleared test, although this is one of several that’s been authorized to screen for the Zika virus, which is carried by mosquitos.

The Gene-RADAR Zika Virus Test is designed to cut the amount of time it takes for a diagnosis by analyzing blood samples with a nanochip.

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Nanobiosym CEO Dr. Anita Goel said it marked a major step towards validating the company’s platform in an interview with MobiHealthNews,

“It’s a step toward our bigger vision of mobilizing, decentralizing and personalizing the entire next generation of healthcare infrastructure,” said Goel.

The authorization is not the same as a clearance and only lasts as long as the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus as well as the Zika virus infection, a company press release said.

Nanobiosym’s Zika Virus test will only be used to detect the presence of the virus in human serum, not for any other body fluids or any other viruses or pathogens, the release said.

What makes the Zika Virus particularly worrisome is that when infection occurs during pregnancy, it can produce devastating neurological problems in developing infants, such as severe microcephaly, decreased brain tissue, and brain damage. More than 43,000 people in the U.S. and its territories have been infected by the Zika virus, including at least 4,750 pregnant women, according to data from the Centers for Disease Control.