Biomerica Receives CE mark for New High-Volume Version of 10 Minute Test for COVID-19 Exposure and Expands International Dist...
May 07 2020 - 6:36AM
Biomerica Inc. (NASDAQ: BMRA) today announced it has received a CE
mark and launched a new high-volume production version 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) being sold in countries outside the US. This new
high-volume version of the disposable serology test allows the
company to ramp up production utilizing a proprietary card system
that eliminates most plastic. The high-volume production version of
this test is intended for larger customers doing high-volume
screenings. This version also has the benefit of being
environmentally friendly.
The Company also is announcing it has shipped
and continues to supply the previously announced cassette version
of its disposable finger prick test to its distribution partners
who are supplying multiple customers that include NATO, and
government agencies in Germany, Switzerland and the Netherlands
among others. The high-volume version of the test uses the same
technology as the cassette version which has been well accepted in
Europe and other countries in terms of performance.
Patents and high-volume laboratory
version testBiomerica has also expanded its provisional
patent applications to include new technology that is being
validated to simplify blood sample collection for its high
throughput ELISA test. The company expects to launch its
ELISA high-volume laboratory version serology test with high
accuracy and low cross-reactivity in accordance with the newly
released EUA guidance.
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.
Zackary Irani, Chairman and Chief Executive
Officer, stated, “The devastating effects on the lives of people
affected by COVID-19 continues to be problematic. Our
existing point of care test has been well accepted in international
markets and we are now expanding sales distribution to other
countries. Our launch of these COVID-19 serology tests 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.”
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 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
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