Therapy Areas: Devices
GenBody America Receives Amendment to FDA Emergency Use Authorization for Updated Point-of-Care Test Kits with Individual Reagents
2 September 2022 - - The US Food and Drug Administration has made an amendment to the emergency use authorization for the GenBody COVID-19 Ag kit, which has been updated to include prefilled individual reagent tubes for each test device, according to US-based GenBody America, LLC, the US affiliate of South Korean rapid diagnostic tests and reagents maker GenBody, Inc.

This significantly streamlines the testing procedure, enhancing the versatility of the test kit in multiple testing environments and offering a new level of accessibility for the GenBody test device.

Recently, GenBody America was granted an extension of shelf-life for their COVID-19 Ag Test by the FDA from 12 months to 21 months after FDA reviewed ongoing studies demonstrating consistent performance of the test device beyond the initial expiration date.

GenBody tests have been validated in multiple independently run clinical trials, most recently at Emory University. Ongoing studies are presently underway both to ensure their longer-term integrity as well as their performance against currently circulating variants.

GenBody America is the US manufacturer for 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 is one of a handful of visually readable tests that is EUA authorized by the FDA.

GenBody has over 20 years' experience in the diagnostic industry and vast networks with several key institutes, universities, and hospitals.

GenBody's core strength remains in R and D, while supplying point-of-care providers throughout the world with reliable rapid antigen tests.

GenBody America's US factory is expected to have a production capacity of approximately 300,000 tests per day.

The US 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 been authorized by the FDA under an EUA for use by authorized laboratories, pending full FDA clearance.

The product has been authorized only for the detection of proteins from SARS-CoV-2, and not for any other viruses or pathogens.

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 USC. § 360bbb-3(b) (1).
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