Point of Care Facilities Authorized to Use GenBody’s Nasopharyngeal and Anterior Nasal Swab Test Kits to Test People Without Symptoms
JURUPA VALLEY, California, December 09, 2021--(BUSINESS WIRE)--GenBody America is proud to announce that its COVID-19 antigen test kits are now authorized for use for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Recently, the company received an amendment to its original Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) allowing for the company’s visually readable COVID-19 antigen test kit for use with anterior nasal swabs.
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GenBody COVID-19 antigen test kits are now authorized for use for individuals without symptoms or other epidemiological reasons to suspect COVID-19 (Photo: Business Wire)
The FDA Letter of Authorization states: "The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests."
According to the FDA, "Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission."
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 tests are 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.
"This new ‘claim’ allows CLIA-waived laboratories to use GenBody test kits to test individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests," said David Yoo, CEO of GenBody America. "The median incubation period for coronavirus disease 2019 (COVID-19) is approximately five days, according to study results published in medRxiv. Serial testing allows CLIA-waived laboratories to test individuals without symptoms to catch a wider spectrum of the course of the disease when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests."
In March, the FDA issued a new supplemental template "for test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing. This template applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. As part of this new template for test developers, the agency provided recommendations aimed to streamline the authorization of screening tests with serial testing."
GenBody was awarded a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) 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 that is 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 (RADxSM) 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.
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