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FDA Grants Extension of Shelf-life & Expiration Date for GenBody COVID-19 Ag Test

GenBody America Doubles Down on Protection & Prevention from COVID-19 in the Midst of Variant Surges and an Upcoming Flu Season by Obtaining Approval from FDA to Extend Shelf-Life of Tests from 12 Months to 21 Months

JURUPA VALLEY, Calif.--(BUSINESS WIRE)--#Covid19--GenBody America, LLC, the U.S. affiliate of GenBody, Inc., a South Korean manufacturer of rapid diagnostic tests and reagents for point-of-care applications for COVID-19, today announced that the FDA has granted an extension of the shelf-life for its COVID-19 Ag test from 12 months to 21 months when stored at 2° - 30° C (approx. 35° - 86° F). This extension was granted after FDA review of long-term studies demonstrating that the GenBody tests maintain their performance long after the initially defined 12-month window.

“As the public fatigues from COVID-19, and as preventative measures and guards are lowered when it comes to travel and in-person gatherings, we believe it’s still extremely important for people to invest in reliable and regular rapid testing to safeguard themselves, their employees, and their family members,” said David Yoo, CEO & founder of Genbody America. “This FDA extension reassures our customers that they will have access to viable rapid tests now and through any upcoming surge that is likely to occur as new variants emerge and flu season sets in.”

More than two years into the pandemic, it has become increasingly clear that the COVID-19 virus is here to stay and will continue to impact global health, economies, and protocols well into the future, especially if not properly mitigated and managed. For that reason, ongoing access to testing is still a crucial element of prevention, and GenBody America wanted to ensure the public has access to as many tests as possible ahead of the colder months, flu seasons, and holiday travel schedules that created widespread test shortages in past years.

With this extension from the FDA, customers and end users of GenBody America’s antigen tests can be confident that any test purchased from GenBody which remains in inventory will continue to be reliable and stable for use with an extended shelf-life window of 21 months, as an uptick in positive cases is projected in the coming months.

“Ensuring the consistent performance of the GenBody test device over time is critical,” said Dr. Andrew Kim, Chief Medical Officer of GenBody America. “The studies submitted to FDA are performed over a range of storage conditions and temperatures and have demonstrated no decrease in performance over 21 months, which can provide assurance to the user of test quality and stability.”

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. Customers are encouraged to capitalize on this opportunity to stock up on FDA-approved COVID-19 Ag tests while supply remains available ahead of anticipated winter surges.

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 America’s U.S. factory is expected to have production capacity of approximately 300,000 tests per day. The U.S. factory has been funded in part by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, NIH. 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. For more information on the company, please 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).

Contacts

Nicole Rodrigues

NRPR Group – For GenBody

[email protected]

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