Jurupa Valley, California
Rapid COVID-19 Ag Test
As the SARS-CoV-2 virus began its sweep across the U.S. in early 2020, Yoo was inspired by the nation's lack of diagnostic production capacity to launch a testing startup originally known as Kwell Laboratories. Upon reaching out to acquaintances in South Korea to tap their expertise in pandemic-related diagnostics, Yoo was connected with the executives at GenBody Inc., a leading manufacturer of rapid diagnostic tests and reagents for point-of-care applications for COVD-19 and other diseases.
"GenBody America (formerly known as Kwell Laboratories) is now the U.S. affiliate of GenBody Inc.," Yoo explains. "We partnered with GenBody Inc. to do clinical trials in the United States for their [COVID-19] product and subsequently to submit it to the FDA for emergency use authorization."
The company completed U.S. clinical trials on GenBody's Rapid COVID-19 Ag Test in January of 2021. The clinical trial data was submitted to the FDA in March of that year, and Yoo says the company received emergency use authorization for the tests in July. GenBody America's Rapid COVID-19 Ag Test Kits are now sold through a network of distributors to point-of-care providers, CLIA-certified labs, and facilities with CLIA waivers across the United States.
In early 2021, the company also began building out a 10,000-square-foot manufacturing facility in Jurupa Valley. Funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering and National Institutes of Health, the semi-automated factory was designed to achieve the highest test kit throughput per hour in the nation.
Capable of producing 1.5 million COVID-19 antigen test kits per week, GenBody America's factory was producing 300,000 test kits per day when it opened in March of this year.
"The factory equipment was custom made for us," Yoo says. "The factory is actually a replica of an existing GenBody facility [in South Korea]. GenBody Inc. sent a huge project team out here, and we had our own project team as well. It took us the greater part of a year to get everything going."
Pandemic-related challenges were plentiful as the factory was constructed. "Commodity prices shot up," Yoo recalls. "You couldn't get basic lumber or plywood. We had some delays sourcing materials. At one point, we were basically using air carriers to fly in raw materials to get the factory started. These were the types of materials that would typically go through ocean freight."
Currently employing 57 workers, with the majority in quality assurance and packaging, GenBody America has seen demand for its point-of-care COVID-19 test kits fall as the novel virus has become more endemic. However, Yoo believes the need for testing will continue into the future.
"Testing, masking, and boosting are all ammunition used to fight [disease]," he says. "And SARS-CoV-2 is not going away. It's still killing people. I think, basically, people are going to have to test to live with the virus."
Challenges: "As a diagnostic kit manufacturer, you need a steady market," Yoo says. "The pandemic has been a very unpredictable market. I think our biggest challenge is staying flexible to ramp up and ramp down production as needed."
Opportunities: Yoo says GenBody America recently completed a clinical trial for over-the-counter COVID-19 rapid tests. "We submitted the data to the FDA and are waiting on that," he continues. "If approved, we'll be able to supply our products [directly to consumers]. That's a major opportunity."
Yoo notes that the company is also building out its regulatory team to work on the approval of additional products that are currently produced in South Korea by GenBody Inc. "They have around 78 different products developed for human diseases," he explains. "We plan on running clinical trials and subsequently getting FDA authorization on rapid diagnostic tests for malaria, cancer markers, cardiac markers, influenza A/B, measles, yellow fever, and other respiratory infectious diseases."
Needs: "GenBody American needs smart scientists," Yoo says. "We need great people to come work for us. We're in Southern California, and it's a tight labor pool. I think our only limiting factor is human capital."