By Diagnostics World Staff
April 13, 2017 | Nanobiosym announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Gene-RADAR Zika Virus Test.
The Gene-RADAR Zika Virus Test is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical and/or epidemiological criteria by laboratories in the U. S. that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
This test has not been FDA-cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
“Typically you should see the EUA as a pathway for the technology to get to people who need it in the face of an emergency sooner,” Anita Goel, Chairman and CEO of Nanobiosym, told Diagnostics World. Goel says that once companies are granted the EAU it becomes easier for them to transition to another classification once they apply more data.
According to the Centers for Disease Control (CDC), more than 43,000 people in the U.S. 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.
“This FDA EUA represents a major milestone towards realizing our deeper vision: to decentralize, personalize, and mobilize the next generation of healthcare, much like cell phones transformed the telecommunications industry,” Goel wrote in a statement.