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

NEW YORK–(Business WIRE)–COVAXX, a subsidiary of United Biomedical, Inc. (UBI), has announced receipt of Food and drug administration Unexpected emergency Use Authorization (EUA) for its COVID-19 antibody examination, UBI SARS-CoV-2 ELISA. The check is extremely valued in its capability to efficiently identify individuals with an adaptive immune response to SARS-CoV-2, indicating current or prior infection, as effectively as observe antibody ranges from deployment of vaccines.

“Our mission at COVAXX is to democratize health and safeguard life throughout the world by tackling the worldwide COVID-19 pandemic working with price tag-efficient, scalable and proven science-primarily based answers,” mentioned Mei Mei Hu, co-founder and CEO of COVAXX and a member of the executive committee of UBI.

“Nasal swabs and PCR assessments have been the baseline for safety for the duration of the past eight months, answering the inquiries: ‘Do I have the virus?’ ‘Am I infectious to my buddies and co-workers?’” additional Lou Reese, COVAXX co-founder and govt chairman. “As we commence vaccinating the entire world, the focus and thoughts will shift. Now folks want to know: ‘Do I nevertheless have antibodies?’ ‘Is my vaccination still working or do I require a enhance?’”

The COVID-19 pandemic has mandated a important will need for rapid and precise screening through the U.S. and internationally. The RT-PCR diagnostic exams at the moment employed are useful at detecting energetic infections, but are restricted in software to accurately notify general public well being officers of the true scope of the outbreak and possible of reaching herd immunity. In distinction, antibody tests are far more suited to approximate the level of immunity in a inhabitants, and can be deployed economically and at significant scale.

The UBI SARS-CoV-2 ELISA Antibody Test remaining promoted and commercialized by COVAXX, is a qualitative enzyme-joined immunosorbent assay (ELISA) high-precision antibody blood diagnostic take a look at applying patients’ blood, is revealed to have 100% specificity and sensitivity immediately after 15 times submit-symptom onset in individuals who have formulated antibodies towards SARS-CoV-2. The assessments are created in Extended Island, N.Y., and can differentiate amongst COVID-19 and other coronaviruses (e.g., HKU1 and NL63).

Partnership with the College of Nebraska Healthcare Center (UNMC)

UNMC Chancellor Jeffrey P. Gold, M.D. mentioned: “This is significant news. We at the University of Nebraska Medical Center and the World-wide Center for Health and fitness Protection are proud of our do the job to go on building very important bridges on the road towards breakthroughs that make improvements to general public wellbeing. This is primarily critical at this current minute. We consider these tests will perform hand-in-hand with vaccines and demonstrated general public well being steps, serving as a highlight to support move our nation out of this COVID-19 pandemic.”

UNMC is the hugely respected residence to the Worldwide Heart for Well being Security, as effectively as the Countrywide Teaching, Simulation and Quarantine Heart (TSQC), and is a person of the nation’s greatest biocontainment models. In Could 2020, COVAXX recognized a strategic partnership with UNMC to deliver huge-scale, high-excellent diagnostic screening and processing for corporations, applying the ELISA antibody exam.


COVAXX is a subsidiary of United Biomedical Inc (UBI), started in 1985, with headquarters in New York. The enterprise is a scientific trailblazer making technological firsts, such as the manufacture and commercialization of far more than 100 million antibody blood exams, and 5 billion vaccine doses towards infectious diseases in animal health. With proprietary access to UBI’s core technologies platforms, COVAXX can acquire and commercialize high precision antibody checks and a promising COVID-19 vaccine that together would variety a special Differentiating Contaminated from Vaccinated Persons (DIVI) method.

COVAXX (not to be confused with one “x” COVAX) is developing UB-612, the 1st multitope vaccine designed to activate the two B and T-cell arms of the immune method to struggle from SARS-CoV-2. Preclinical experiments have revealed that the UB-612 vaccine prospect is secure and generates higher titers of neutralizing antibodies. The organization is at this time finishing Stage 1 scientific trials of the vaccine in Taiwan, and has an agreement with the University of Nebraska Professional medical Middle (UNMC) to conduct trials in the United States.

Just lately, COVAXX introduced a world logistics partnership with Maersk, the world’s greatest shipping and built-in logistics company, that makes a framework for all transportation and supply chain companies that will be essential to produce COVAXX’s UB-612 vaccine all over the earth.

For much more data on the COVAXX/UBI antibody test and artificial, peptide-primarily based vaccine in opposition to COVID-19, check out www.covaxx.com and observe us on social media. Twitter: @covaxxvaccine Facebook: #covaxxvaccine LinkedIn: covaxxvaccine and Instagram: @covaxxvaccine.