UNITED BIOMEDICAL GROUP’S C19 COMPANY PARTNERS WITH SAN MIGUEL COUNTY, COLORADO TO BE FIRST IN NATION TO TEST AN ENTIRE COUNTY FOR COVID-19 WITH NEW ANTIBODY DIAGNOSTIC TEST

Telluride, CO (March 19, 2020) –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 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, yesterday, 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 Louis 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, social distancing and isolation can do together to stop the spread of infection, and to create a model that could save lives worldwide.” In Italy, a similar test was conducted in Vo, Italy and the rate of infection was lowered by 90%.


Need for more 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 with high false negatives, practical challenges to testing large scale populations, and limited 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, difficult to roll out, and unable to accurately inform public health officials of the true scope of outbreak.


Within the last week, the CDC called for serological antibody tests to be developed and the 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 which can be deployed at large scale to provide a better detection to contain community spread, and more accurately determining the 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. The company has submitted to the FDA for Emergency Use Authorization, and is allowed under FDA guidance to begin distributing the antibody test with specific disclaimers about its status and limitations until an EUA is authorized.


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 World Economic Forum. Mr. Reese was E&Y Entrepreneur of the Year NY Finalist and a member of YPO. They have been featured in Bloomberg, Wired, Time, Forbes, Fortune, and are regular speakers at thought-leadership and health care conferences.


Q&A

Who is the UBI Group?


UBI Group was founded in 1985 and currently has over 5 operating entities and 950 employees globally. We have facilities in China, Taiwan, Ireland and the US. For the past three decades, we have developed, manufactured and sold HIV, HCV, HTLV and FMDV blood diagnostic kits worldwide through various distribution partners including Organon Teknika and BioMerieux. We have also developed, manufactured and sold over 4.5 billion vaccines and ~500 million doses annually through partners. Dr. Chang Yi Wang, our Chief Scientific Officer, is inventor and author of over 100 patents and peer-reviewed publications. She has, together with the UBI team, pioneered the employment of antigenic peptides in the development of 4 blood screening test kits for detection of antibodies to HIV, HCV, HTLV I/II and FMDV for identification and differentiation of viral infections and 2 licensed synthetic peptide based vaccines (FMDV and LHRH) which are globally distributed. She has been awarded Inventor of the Year Award (NYPLA), Pioneer in Technology Award (BMSF), and recipient of funding from Gates Foundation, MOEA and multiple NIH grants over $20M, including for SARS antibody screening diagnostic work. She is currently collaborating with Dr. Anthony Fauci/NIAID and colleagues on HIV functional cure program, and discussed extensively with Dr. Redfield in this area, both leaders in the coronavirus response today.



What is a COVID-19 antibody test and what do the results tell me?


After a person is infected with SARS-CoV-2, the virus that causes the coronavirus disease, 2019 (COVID-19), that person’s immune system will produce antibodies against the virus to fight the infection. A COVID-19 antibody test is able to detect these antibodies from a small sample of blood to diagnose whether a person currently has (or previously had) COVID-19.
The FDA announced on March 16, 2020 that antibody tests can be used immediately to help control the COVID-19 pandemic.



How does the UBI® SARS-CoV-2 ELISA work?


Our test, called the UBI® SARS-CoV-2 ELISA, is a qualitative enzyme-linked immunosorbent assay (ELISA) that detects antibodies to SARS-CoV-2 in human sera or plasma.
The SARS-CoV-2 virus has four structural proteins known as the S (spike), E (envelope), M (membrane), and N (nucleocapsid) proteins. After infection with the virus, a person’s immune system will produce antibodies that specifically bind to portions of the M, S, N, and E proteins to help the cells of the immune system to fight and rid the body of the virus. The antibodies circulate throughout the body so that they can bind to, and help get rid of, the virus. It takes about 8 to 10 days after being infected with the virus for the body to produce enough antibodies to be detected in a blood sample using an antibody test, including the UBI® SARS-CoV-2 ELISA. The antibodies remain in the body for a long time, even after the infection is over, to ensure that the virus has been completely eradicated.
Our test uses small protein fragments, call peptides, that were carefully selected from the M, S, and N proteins of SARS-CoV-2. The peptides we use were synthesized in a lab using a machine, which means that they were not isolated from the active virus or produced using bacteria or other methods. Thus, the peptides we use are very clean and free of impurities that may be present if the peptides were produced using a different method. The synthetic peptides in our test are able to capture and bind to antibodies produced by the body in response to infection from the SARS-CoV-2 virus.
The UBI® SARS-CoV-2 ELISA will determine if antibodies against the virus are present in a small blood sample. If SARS-CoV-2 antibodies are detected in the blood sample using our test, then the result will be considered “positive”. If SARS-CoV-2 antibodies are not detected, then the result will be considered “negative”.



How specific and sensitive is the UBI® SARS-CoV-2 ELISA?


As of March 19, 2020, we have performed validation tests that have demonstrated the UBI® SARS-CoV-2 ELISA to be highly sensitive, specific, and accurate.
We have already tested over 900 blood samples that were collected before the present COVID-19 outbreak and none of these samples tested positive using our test, which means that our test has not produced even one false positive result to-date. These samples included blood samples from patients who have previously tested positive for other human coronaviruses (e.g., NL63 or HKU-1) as well as other infectious diseases (e.g., HIV, HCV, and HBV).
In addition, as of March 19, 2020, 100% of the blood samples collected at day 10 or later after infection from SARS-CoV-2 from patients who tested positive to COVID-19 by other methods were also found to be positive using the UBI® SARS-CoV-2 ELISA.
We are continuing to validate the UBI® SARS-CoV-2 ELISA to ensure that it is highly sensitive, specific, and accurate and will update the answer to this question if any information changes. However, based on our initial validation tests as of March 19, 2020, the key features of our test include:
  • Accurate — 100% specificity and sensitivity
  • Precise — can differentiate between SARS-CoV-2 vs. other coronaviruses circulating in US
  • Fast — results in 2-3 hours
  • Scalable — can be deployed to screen hundreds or thousands of subjects easily



Why is the UBI® SARS-CoV-2 ELISA better than other antibody tests?


Accuracy, sensitivity, and specificity.
Several companies have announced the production of rapid antibody tests that can provide results in about 15 minutes to determine if you a patient has COVID-19. Unfortunately, the common problem with these rapid tests is that they can be highly inaccurate and provide false positive or false negative results. Some companies that have applied for an Emergency Use Authorization (EUA) with the FDA have acknowledged that their rapid tests are only about 90% accurate, based on initial testing using samples from patients who have previously tested positive to COVID-19 by other methods. The accuracy, sensitivity, and specificity of other antibody tests can vary greatly depending on how they were developed due to a number of factors.
In contrast, the UBI® SARS-CoV-2 ELISA was developed by the UBI Group who has over 30 years of experience in developing, manufacturing, and distributing antibody screening diagnostic kits worldwide, including kits for HIV, HCV, HTLV and FMDV. Validation tests have demonstrated that the UBI® SARS-CoV-2 ELISA is highly sensitive, specific, and accurate. In fact, we have tested over 900 blood samples that were collected before the present COVID-19 outbreak and none of these samples tested positive using our test, which means that our test has not produced even one false positive result to-date. These samples included blood samples from patients who have previously tested positive for other human coronaviruses (e.g., NL63 or HKU-1) as well as other infectious diseases (e.g., HIV, HCV, and HBV). In addition, as of March 19, 2020, 100% of the blood samples collected at day 10 or later of infection from patients who tested positive to COVID-19 by other methods were also found to be positive using the UBI® SARS-CoV-2 ELISA.
Therefore, the UBI® SARS-CoV-2 ELISA is highly sensitive, specific, and accurate in determining if a patient has been infected with SARS-CoV-2 compared to antibody tests developed by others.



What about the current RT-PCR tests being used? How is this different?


The need for large-scale testing has become apparent in the past weeks. While the RT-PCR nasal swab tests currently being used are helpful to test active infections, there are important limitations and restrictions. These include variability in accuracy with high false negatives (up to 50%), difficulty to scale up to test large populations of people, and the ability to only detect active infection but inability to determine if someone has been previously infected but recovered. As a result, the RT-PCR tests have been restricted in application, challenging to roll out, and unable to inform public health officials the true scope of outbreak.
On March 11, 2020, the CDC called for use of antibody tests and the WHO urged all outbreak areas to immediately begin testing with such tests to better track and contain community spread of the virus.



How can communities use large scale screening using these tests?


We have had many governments and corporations inquire about large-scale testing. Antibody tests can be used as a quick screen to identify who has been infected within a community. This can provide leaders, public health officials, and the public with more accurate information about the prevalence of infection in a given population, which can help everyone take steps to contain community spread.
Antibody tests, such as the UBI® SARS-CoV-2 ELISA, can be used to complement RT-PCR tests for a more accurate diagnosis of current infection in symptomatic patients. It can also identify those who have been infected, but have already recovered and developed a level of immunity to the virus. People who have not yet been exposed are still susceptible to the virus and should exercise caution and social distancing to avoid infection. In addition, people may get infected but not know that they are infected because they either have mild symptoms or no symptoms at all. These people, with mild or no symptoms, are still able to spread the virus to others who may be more at risk in developing severe infections. Therefore, large-scale testing is important to understand this information, which can help communities stay safe while staying open.



Disclaimer


According to the FDA’s “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” issued on March 16, 2020, we are required to inform you of the following information:
  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • This test is not for the screening of donated blood