Nanobiosym Diagnostics Inc. (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.
“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,” says Dr. Anita Goel, M.D., Ph.D., Chairman and CEO of Nanobiosym and a Harvard-MIT trained physicist and physician. “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 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.
Currently, Zika virus RNA has been detected in serum up to 13 days post-symptom onset in non-pregnant patients, up to 62 days post-symptom onset in pregnant patients and up to 53 days after the last known possible exposure in an asymptomatic pregnant woman. In addition, recent studies have demonstrated Zika virus RNA detection in semen and whole blood 34 days and two months post-infection, respectively. The Gene-RADAR Zika Virus Test should be performed according to CDC’s algorithm for Zika testing.
“Access to this important new testing technology represents an important breakthrough in ‘real-time’ Zika testing, and partnering with Nanobiosym allows us to bring cutting-edge Gene-RADAR testing to our patients here in Florida,” says Dr. D.T. Jayaweera, M.D., Executive Dean for Infectious Disease Research at the Miller School of Medicine at the University of Miami, which has signed a Memorandum of Understanding with Nanobiosym to evaluate the real-world clinical and operational utility of the Gene-RADARplatform. “Mitigating the further spread of Zika virus infection in Florida and effectively managing the spectrum of neurological problems in newborn babies and adults is a top priority for us.”