Biomerica Begins Shipping Samples of 10 Minute Test for COVID-19 Virus Exposure
March 17 2020 - 8:16PM
Biomerica Inc. (NASDAQ: BMRA) today announced it 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 US. 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 FDA under the COVID-19 Emergency Use Authorization (EUA), aimed
at the possible clearance and eventual use of the test in the US.
At this time, the product is not available for sale or use in the
US.
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.
About Serology TestsBiomerica’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 Chief Executive Officer, 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.
1. Emerging Microbes & Infections 2020, VOL. 9 Molecular and
serological investigation of 2019-nCoV infected patients.
About Biomerica (NASDAQ:
BMRA) Biomerica, Inc.
(www.biomerica.com) is a global biomedical technology company that
develops, patents, manufactures and markets advanced diagnostic and
therapeutic products used at the point-of-care (in home and in
physicians' offices) and in hospital/clinical laboratories for
detection and/or treatment of medical conditions and diseases. The
Company's products are designed to enhance the health and
well-being of people, while reducing total healthcare costs.
Biomerica primarily focus is on Gastrointestinal and inflammatory
Diseases where the Company has multiple diagnostic and therapeutic
products in development.
The Private Securities Litigation Reform Act of 1995 provides a
"safe harbor" for forward-looking statements. Certain information
included in this press release (as well as information included in
oral statements or other written statements made or to be made by
Biomerica) contains statements that are forward-looking, such as
statements relating to the efficacy of the Company’s COVID-19 test,
the rapidity of testing results, pricing of the Company’s test
kits, demand for international orders, availability of the
Company’s COVID-19 test kits, and patent protection on the rapid
test technology. Such forward-looking information involves
important risks and uncertainties that could significantly affect
anticipated results in the future, including, without limitation:
results of studies testing the efficacy of the Company’s COVID-19
test; regulatory approvals necessary prior to commercialization of
the Company’s COVID-19 test; availability of the Company’s COVID-19
test kits; capacity, resource and other constraints on our
suppliers; dependence on our third party manufacturers; dependence
on international shipping carriers; governmental import/export
regulations; demand for our COVID-19 test; competition from other
similar products and from competitors that have significantly more
financial and other resources available to them; governmental virus
control regulations that make it difficult or impossible for the
company to maintain current operations; regulations and the
Company’s ability to obtain patent protection on any aspects of its
rapid test technology. Accordingly, such results may differ
materially from those expressed in any forward-looking statements
made by or on behalf of Biomerica. Additionally, potential risks
and uncertainties include, among others, fluctuations in the
Company's operating results due to its business model and expansion
plans, downturns in international and or national economies, the
Company's ability to raise additional capital, the competitive
environment in which the Company will be competing, and the
Company's dependence on strategic relationships. The Company is
under no obligation to update any forward-looking statements after
the date of this release.
CONTACT INFORMATION
Company Spokesperson 949-645-2111 www.biomerica.com
Biomerica (NASDAQ:BMRA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Biomerica (NASDAQ:BMRA)
Historical Stock Chart
From Apr 2023 to Apr 2024