JURUPA VALLEY, Calif.--(BUSINESS WIRE)--GenBody is proud to announce that the company’s visually readable COVID-19 antigen test kit has been issued an amendment to its original Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for use with anterior nasal swabs.
GenBody sells and distributes direct nasopharyngeal and anterior nasal swab antigen tests intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. The test is authorized for use at the point of care, i.e., in-patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. As the Biden-Harris Administration calls for more affordable and readily available rapid tests, GenBody has joined the lineup of relatively few manufacturers who are producing antigen test kits.
“The need for rapid test kits is especially strong now that we are seeing a rise in COVID-19 outbreaks and as the U.S. continues to open up,” said David Yoo, CEO of GenBody America. “We are excited to offer the GenBody COVID-19 Ag test to the U.S. and we are looking forward to bringing additional product releases to market.”
GenBody was awarded a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx℠) initiative award of $10 million in support of U.S. production of GenBody's innovative point of care tests that will increase the testing capacity in the U.S.
About GenBody America
GenBody America is the U.S. affiliate of GenBody, Inc., a leading South Korean manufacturer of rapid diagnostic tests and reagents for point of care applications for COVID-19 and other diseases. Based in Southern California, GenBody America sells and distributes GenBody’s visually readable direct nasopharyngeal and anterior nasal swab COVID-19 antigen test kits to point of care providers, CLIA-certified labs, and facilities with CLIA waivers across the United States. GenBody’s COVID-19 antigen test uses the best of GenBody’s Korean testing technology and is one of a handful of visually readable tests available, EUA authorized by the FDA. With over 20 years combined experience in the diagnostic industry and through vast bionetworks between several key institutes, universities, and hospitals, GenBody’s core strength remains in R&D, while supplying point of care providers around the world with rapid antigen tests they can rely on. GenBody’s U.S. factory is under construction and when complete, is expected to deliver a capacity of 300,000 tests per day. The U.S. factory has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx℠) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, under Contract No. 75N92021C00007.
The GenBody COVID-19 Ag test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.