Biomerica Begins Shipping Samples of 10-Minute Test for COVID-19 Exposure

Biomerica Inc. has commenced shipping initial samples of its COVID-19 IgG/IgM Rapid Test (a finger prick blood test with results in 10 minutes, that can be performed by trained professionals anywhere, e.g. airports, schools, work, pharmacies and doctors’ offices) to countries outside the United States. Evaluation test kits have been requested by Ministries of Health in multiple countries through the Company’s distribution partners who are working with their government agencies to assess the tests and forecast demand.

This disposable point-of-care serology test is different than the current polymerase chain reaction (PCR) tests in that initial studies indicate that serology tests can identify if someone has been exposed to the COVID-19 virus, and can further detect if a person was recently infected with the disease even if they have never shown or are no longer showing symptoms. This can help health agencies focus on prior contacts of persons previously infected. Existing PCR tests generally only show positive if a person is currently infected and the virus is still present. Furthermore, PCR tests require patient samples to be sent to a lab, thus increasing the cost of the test and reducing the speed to obtain a result. Biomerica’s test could also be used in conjunction with the PCR test by rapidly pre-screening larger groups of individuals, who if tested positive could be further tested using a PCR test for verification.
 
Biomerica is positioned to begin filling large international orders of this disposable one-use tests within weeks, assuming international product shipping channels remain open and active.
 
In addition, Biomerica has begun the application process with the U.S. Food and Drug Administration (FDA) under the COVID-19 Emergency Use Authorization (EUA), aimed at the possible clearance and eventual use of the test in the United States. At this time, the product is not available for sale or use in the United States.
 
Biomerica is also announcing that it has filed a provisional patent application with broad claims around technology that can be used to identify several Corona viruses including SARS-CoV-2, SARS, MERS and potential future mutations or strains of these viruses. 
 
Biomerica expects to sell these disposable, single-use devices for less than $10 per test.
 
Biomerica’s rapid-test technology is a serology test. Serology tests look for the presence of antibodies, which are specific proteins made in response to infections. The antibodies detected by serology tests indicate that a person has had an immune response to the novel Corona Virus (SARS CoV-2), whether symptoms developed from infection or the infection was asymptomatic. Antibody test results are important in detecting infections with few or no symptoms.¹
 
Zackary Irani, chairman and CEO, stated, “We are saddened by the continued global spread of the SARS-CoV-2 virus and the devastating effects on the lives of people affected by COVID-19. While the Biomerica test is new and being evaluated by various institutions, we are hopeful our low-cost test can be one of the tools used to contain this virus while vaccines and other permanent solutions are developed. Our launch of this COVID-19 test is by no means a shift in the company’s stated strategy of growing both our colorectal disease detection product, finalizing clinical trials and gaining FDA approval for our HP Detect H. Pylori test and our InFoods IBS therapy product. We were simply unable to ignore our ability to help address the continued international threat of COVID-19 by utilizing our deep industry connections, experience in the diagnostics space, and ability to rapidly deploy company resources.”

Reference 
¹ Emerging Microbes & Infections 2020, VOL. 9 Molecular and serological investigation of 2019-nCoV infected patients.