Nanobiosym Diagnostics Inc. (Nanobiosym) has 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,” said 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 days1 and two months2 post-infection, respectively. The Gene-RADAR® Zika Virus Test should be performed according to CDC’s algorithm for Zika testing (see http://www.cdc.gov/zika/laboratories/lab-guidance.html).
“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,” said 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-RADAR® platform. “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.”
About Nanobiosym
Nanobiosym Diagnostics aims to bring the XPRIZE-winning Gene-RADAR® platform technology to over four billion people on the planet that currently lack access to basic healthcare. In addition to the Gene-RADAR® Zika Virus Test that has been granted an Emergency Use Authorization by the FDA, the Company is developing expanded clinical sample input options to include other body fluids such as whole blood and urine . Currently, the Gene-RADAR® Zika Virus Test has only been authorized for the detection of RNA from Zika virus in human serum, not for any other body fluids or any other viruses or pathogens.
The Nanobiosym Research Institute focuses on creating breakthrough scientific insights and developing transformational technologies that emerge from the convergence of physics, nanotechnology, and biomedicine. Nanobiosym has been awarded several prestigious peer-reviewed awards and grants from U.S. federal agencies, including DARPA, NSF, DOD, DOE, CASIS (in affiliation with NASA), and USAID. Nanobiosym, under Dr. Goel‘s leadership, is harnessing the science of nanobiophysics to develop and clinically validate a pipeline of novel “apps” for the Gene-RADAR® Platform as well as enhance the mobility and other performance metrics of the underlying platform.
For more information, visit www.nanobiosym.com or follow @Nanobiosym on Twitter.
Full Nanobiosym Gene-RADAR® Zika Virus Test EUA at https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm
Further details about the Zika Virus in the U.S. and worldwide at https://www.cdc.gov/zika/index.html
1 Driggers, R.W., et al. Zika virus infection with Prolonged Maternal Viremia and Fetal
Brain Abnormalities. New England Journal of Medicine, June 2, 2016; 374:2142-2151.
DOI: 10.1056/NEJMoa1601824
2 Meaney-Delman et al. Prolonged Detection of Zika Virus RNA in Pregnant Women.
Obstetrics and Gynecology, 128:724–730. DOI: 10.1097/AOG.0000000000001625
