JURUPA VALLEY, Calif.–(BUSINESS WIRE)–GenBody America, LLC, the U.S. affiliate of GenBody, Inc., a Korean corporation, today announced that it has opened and ramped up production at its Jurupa Valley, California factory. The facility has the capability to produce 1.5 million visually readable anterior nasal swab COVID-19 antigen test kits per week.
Additionally, Samsung Electronics is introducing a production line relocation and inventory management system for GenBody’s new factory in Korea, which will double that plant’s throughput to 6 million test kits per week by the end of April 2022. Coupled with GenBody America’s Jurupa Valley’s factory throughput, the company will have the capability to produce 7.5 million tests per week, which will be available to customers throughout the United States. Samsung will incorporate their processes at the GenBody America factory by the end of Q2 2022.
“We’re excited to open our facility in Riverside County as COVID testing continues to be a critical need across the United States. A lot of hard work and effort has gone into creating this factory and we’re proud to be able to manufacture these test kits in the U.S. and continue the fight against COVID through this endemic state, as people resume their daily lives,” said David Yoo, CEO of GenBody America. “Additionally, GenBody America will be adding approximately 100 jobs in the Southern California region with this new manufacturing facility.”
GenBody’s COVID-19 antigen test kits are sold and distributed to Point-of-Care providers, CLIA-certified labs, and facilities with CLIA waivers across the U.S., and are also authorized for serial testing of asymptomatic individuals.
“With more than 60 diagnostic test manufacturers, it’s an honor for GenBody to be chosen by Samsung. They don’t choose just anyone. Samsung is helping to increase capacity with system automation as we look to increase production of our high quality rapid tests here in the United States,” continued Yoo. “To have 7.5 million test kits at our fingertips will help alleviate rapid test shortages in the United States, and prepare for the next COVID-19 surges and variants.”
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, 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 now manufacturing 300,000 tests per day. The U.S. factory has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM
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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