United Biomedical, Inc. (UBI) and its subsidiary c19 are taking on the COVID-19 pandemic by partnering with San Miguel County, Colorado, to be the first in the United States to test an entire county with their COVID-19 antibody test for the SARS-CoV-2 virus. The testing is being offered free of charge by UBI and c19 and will be administered by the Public Health Department of San Miguel County, with the goal of detecting and containing community spread, and providing a more accurate assessment of disease prevalence.

“We are thankful for UBI/c19 for taking the leadership to offer these accurate blood tests to our entire county, free of charge, which can be instrumental in saving lives,” said Dr. Sharon Grundy, Public Health Medical Officer for San Miguel County and Medical Director of Primary Care at the Telluride Medical Center. “When we reported this in our county meeting, the entire team cried.”

UBI is a leading international biopharmaceutical group that has successfully developed diagnostics and vaccines for chronic and infectious diseases for more than 30 years. The company has developed an antibody blood screening test for COVID-19 and, at the same time, is progressing a vaccine for COVID-19, which is currently in animal testing. The company is leveraging its prior work with SARS and its extensive collaborations in China, Taiwan and the world, to validate and commercialize this antibody diagnostic test and vaccine through existing manufacturing infrastructure. Through its c19 subsidiary, the company will be one of the first in the nation to offer these antibody tests.

“We have the technology to test with high accuracy and we believe it is our civil responsibility to help serve our communities,” said Mei Mei Hu and Lou Reese, co-founders of UBI’s c19. “We will start with our beloved and isolated town of Telluride and diligently expand through San Miguel, Colorado. Our goal is to show what mass testing and strategic isolation can do together to stop the spread of infection, and to create a model that could save lives worldwide.” A similar test was conducted in Vo, Italy, and the rate of infection was lowered by 90%.

Need for More High-Quality, Reliable Tests

The COVID-19 pandemic has mandated a critical need for rapid and accurate testing throughout the US and internationally. The RT-PCR tests currently being employed are useful at detecting active infections; however, they have important limitations and restrictions. These include variability in accuracy, practical challenges to testing large scale populations, and ability to only detect active infections without being able to determine if someone has been previously infected. As a result, these tests are restricted in application and unable to accurately inform public health officials of the true scope of an outbreak.

The CDC has called for serological antibody tests to be developed and the World Health Organization (WHO) urged all outbreak areas to immediately begin testing with such tests to better track and contain community spread. Antibody tests can help complement RT-PCR tests for a more accurate diagnosis. It can be deployed at large scale to identify asymptomatic patients and those who have already been infected and then recovered, and to provide a more accurate assessment of prevalence of infection and fatality rate.

The UBI/C19 Antibody Test is Accurate and Ready for Distribution

UBI’s c19 has developed a high-precision antibody blood diagnostic test that has been validated in China, Taiwan and California labs and has virtually 100% sensitivity and specificity in patients who have developed antibodies against the virus (seroconverted). The tests are manufactured in Long Island, N.Y. and can differentiate between COVID-19 and other coronaviruses (e.g., HKU1 and NL63). Results can be obtained within a couple hours. While the company has submitted to the FDA for Emergency Use Authorization, under new FDA guidance this week recognizing the urgent need for access to more high-quality testing, UBI/c19 antibody tests will now be available for use by and marketed to U.S. laboratories prior to EUA.

UBI/c19 also has a COVID-19 vaccine in development that is currently in animal testing. The company’s platform technology has been commercialized in millions of animal health vaccines against infectious disease and tested in multiple human trials for other indications.

About UBI and c19

c19 is a subsidiary of UBI. It is led by Mei Mei Hu, Lou Reese, and Dr. Chang Yi Wang. Dr. Chang Yi Wang, founder of UBI, has been a leader in the infectious disease field since the 1990's. She has developed and sold HIV, HCV, HTLV and FMDV blood diagnostic kits worldwide through global distribution partners, developed and sold over 4.5 billion vaccines, and is the inventor and author of over 100 patents and peer-reviewed publications. Ms. Hu was named to Fortune 40 under 40 and Time 100 Next lists, and is named a Young Global Leader of the World Economic Forum. Mr. Reese was EY Entrepreneur of the Year NY Finalist and is a member of YPO. They have been featured in Bloomberg, Wired, Time, Forbes, Fortune, and are regular speakers at thought-leadership and health conferences.

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