GENBODY AMERICA STANDS BEHIND THE ACCURACY OF ITS COVID-19 RAPID ANTIGEN TESTING SOLUTIONS

JURUPA VALLEY, Calif., Feb. 11, 2022 /PRNewswire/ -- GenBody America reaffirms its well-established commitment to providing accurate and reliable COVID-19 rapid antigen testing. To date, GenBody America has provided millions of COVID-19 rapid antigen tests throughout the United States, and all clinical trials of GenBody's POC tests have consistently yielded accurate results.

On Sunday, February 6, 2022, GenBody was contacted by the Utah Department of Health (UDOH) with a concern that the GenBody test was not performing as expected.

After investigating those concerns, David Yoo, CEO and founder of GenBody America, said, "the figures cited by the State of Utah conflict with our experience in the remainder of the country and in our clinical trials."

GenBody America's highest priority is to provide people with a highly reliable method for accurate COVID rapid antigen testing which – when handled and administered in accordance with the Instructions for Use (IFU) affirmed by the clinical trials - provide public health officials and those they serve with the information they need to make wise decisions about their health and to navigate their lives during these challenging times.

"As soon as we became aware of discrepancies in Utah's testing results – which we haven't seen elsewhere – we immediately reached out to help identify and solve any issues there may be," said Yoo. "So far, our due diligence has shown no reason to believe that there is any issue with the test itself."

GenBody America has offered and looks forward to working with the State of Utah to better understand the process the State created and implemented related to the administration of our test. Understanding the State's procedures will allow us to ascertain any factors that may have led to the figures cited by the State of Utah. 

The IFU for any rapid antigen test is designed to insure the sensitivity and specificity of that particular test, and the IFU for the GenBody COVID-19 Ag test - affirmed by the clinical trials - is the only method to consistently ascertain precise results.

Yoo emphasized, "GenBody America and its customers have every reason for great confidence in the GenBody POC test and its ability to provide necessary and accurate results, and the concerns expressed by Utah are not the result of any product defect or shortcoming when used properly in accordance with the IFU."

About GenBody America
GenBody America is the U.S. 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&D, while supplying point of care providers throughout the world with reliable rapid antigen tests. GenBody is constructing a U.S. factory that is expected to have production capacity of approximately 300,000 tests per day.

For more information, visit: www.genbodyamerica.com. For more information on purchasing tests, please email [email protected].

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 U.S.C. § 360bbb-3(b)(1).

SOURCE GenBody America

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