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COVAXX Announces Emergency Use Authorization (EUA) of UBI SARS-CoV-2 ELISA Antibody Test for COVID-19

  • COVAXX, a subsidiary of United Biomedical, Inc. (UBI), is fighting COVID-19 with both serological antibody tests and a multitope vaccine in development from its proprietary synthetic peptide-based platform.
  • Serological testing will be increasingly important with the deployment of vaccines to monitor antibody levels and map the spread of the virus which has affected more than 96 million people.

COVAXX, a subsidiary of United Biomedical, Inc. (UBI), has announced receipt of FDA Emergency Use Authorization (EUA) for its COVID-19 antibody test, UBI SARS-CoV-2 ELISA. The test is highly valued in its ability to efficiently identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, as well as monitor antibody levels from deployment of vaccines.

“Our mission at COVAXX is to democratize health and safeguard lives worldwide by tackling the global COVID-19 pandemic using cost-effective, scalable and proven science-based solutions,” said Mei Mei Hu, co-founder and CEO of COVAXX and a member of the executive committee of UBI.

“Nasal swabs and PCR tests have been the baseline for protection during the past eight months, answering the questions: ‘Do I have the virus?’ ‘Am I infectious to my friends and co-workers?’” added Lou Reese, COVAXX co-founder and executive chairman. “As we start vaccinating the world, the focus and questions will shift. Now people want to know: ‘Do I still have antibodies?’ ‘Is my vaccination still working or do I need a boost?’”

The COVID-19 pandemic has mandated a critical need for rapid and accurate testing throughout the U.S. and internationally. The RT-PCR diagnostic tests currently employed are useful at detecting active infections, but are limited in application to accurately inform public health officials of the true scope of the outbreak and potential of reaching herd immunity. In contrast, antibody tests are more suited to approximate the level of immunity in a population, and can be deployed economically and at large scale.

The UBI SARS-CoV-2 ELISA Antibody Test being marketed and commercialized by COVAXX, is a qualitative enzyme-linked immunosorbent assay (ELISA) high-precision antibody blood diagnostic test using patients’ blood, is shown to have 100% specificity and sensitivity after 15 days post-symptom onset in patients who have developed antibodies against SARS-CoV-2. The tests are manufactured in Long Island, N.Y., and can differentiate between COVID-19 and other coronaviruses (e.g., HKU1 and NL63).

Partnership with the University of Nebraska Medical Center (UNMC)

UNMC Chancellor Jeffrey P. Gold, M.D. said: “This is important news. We at the University of Nebraska Medical Center and the Global Center for Health Security are proud of our work to continue building crucial bridges on the road toward breakthroughs that improve public health. This is especially critical at this current moment. We believe these tests will work hand-in-hand with vaccines and proven public health measures, serving as a spotlight to help move our nation out of this COVID-19 pandemic.”

UNMC is the highly respected home to the Global Center for Health Security, as well as the National Training, Simulation and Quarantine Center (TSQC), and is one of the nation’s largest biocontainment units. In May 2020, COVAXX established a strategic partnership with UNMC to provide large-scale, high-quality diagnostic testing and processing for organizations, using the ELISA antibody test.


COVAXX is a subsidiary of United Biomedical Inc (UBI), founded in 1985, with headquarters in New York. The company is a scientific trailblazer creating technological firsts, including the manufacture and commercialization of more than 100 million antibody blood tests, and 5 billion vaccine doses against infectious diseases in animal health. With proprietary access to UBI’s core technology platforms, COVAXX can develop and commercialize high precision antibody tests and a promising COVID-19 vaccine that together would form a unique Differentiating Infected from Vaccinated Individuals (DIVI) system.

COVAXX (not to be confused with single “x” COVAX) is developing UB-612, the first multitope vaccine designed to activate both B and T-cell arms of the immune system to fight against SARS-CoV-2. Preclinical studies have shown that the UB-612 vaccine candidate is safe and generates high titers of neutralizing antibodies. The company is currently completing Phase 1 clinical trials of the vaccine in Taiwan, and has an agreement with the University of Nebraska Medical Center (UNMC) to conduct trials in the United States.

Recently, COVAXX announced a global logistics partnership with Maersk, the world’s largest shipping and integrated logistics provider, that creates a framework for all transportation and supply chain services that will be needed to deliver COVAXX’s UB-612 vaccine around the world.