Biomerica Signs Two Definitive Agreements with Mount Sinai Medical School in New York to Scale-up a Laboratory Version Serolo...
April 02 2020 - 7:38AM
Biomerica Inc. (NASDAQ: BMRA) today announced it has signed two
separate definitive license agreements with Mount Sinai’s Icahn
School of Medicine in New York to license technologies pertaining
to a laboratory version serological test for SARS-CoV-2
(“COVID-19”) virus infection which have been developed at Mount
Sinai. This test uses the ELISA microplate format that can run on
existing open system equipment found in most hospitals and clinical
laboratories in the United States.
Biomerica has extensive serological test
development, scale-up and manufacturing capabilities and expertise.
Based on the data received from Mt. Sinai, the Company intends to
scale-up commercial manufacturing of the Mt. Sinai licensed
technology. Biomerica has the equipment and capacity to manufacture
over 1,000,000 tests in the ELISA microplate format per month at
its manufacturing facility in Irvine, California. While there are
unknowns about the transfer and scale-up process, if successful the
Company believes it could have commercial sales within weeks.
Biomerica will file for expedited clearance with the FDA under the
new EUA process for this new test format.
This ELISA microplate format is a serology test
that detects antibodies (proteins produced by the immune system in
response to infections) in the blood of patients who have been
infected with the COVID-19 virus causing the current pandemic.
These antibodies show up in detectable quantities in approximately
8 days following infection, and remain detectable for as long as 3
months or more. Persons who have tested positive for the antibodies
and are no longer infectious, can possibly be cleared to return to
work as they have a lower likelihood of reinfection and/or
spreading the virus.
Serology tests are a potentially powerful tool
for identifying anyone who has been infected, whether they had
symptoms or not. Antibodies to coronaviruses typically remain in
humans for up to 90 days or more. Serological testing is important
in identifying the total number of people who have been infected
with COVID-19 and will allow for further studies that establish
whether the immune response protects from future re-infection.
Further, this type of testing could be particularly important for
the immune surveillance of health care workers, first responders,
government workers, and others whose infection risks could be
heightened by working with COVID-19 infected individuals.
Zackary Irani, Chairman and Chief Executive
Officer, stated, “If person has already been infected with
SARS-CoV-2, they develop antibodies through an immune response that
should give them immunity. The entire Biomerica team is working
tirelessly to make our low-cost tests available to the hundreds of
requests we have received. At the same time, we still remaining
committed to our strategy of growing our colorectal disease
detection product EZ Detect™, and finalizing clinical trials and
gaining FDA approval for our HP Detect™ H. Pylori test and our
InFoods® IBS diagnostic-guided 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 SARS-CoV-2 (COVID-19) tests, the rapidity
of testing results, pricing of the Company’s test kits, demand
for orders, availability of the Company’s COVID-19 test kits,
patent protection on test technology, the Company’s ability
to develop and manufacture new products not yet developed or
validated, and the efficacy of such undeveloped tests. 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 tests;
regulatory approvals necessary prior to commercialization of the
Company’s COVID-19 tests; availability of the Company’s COVID-19
tests; capacity, resource and other constraints on our suppliers;
dependence on our third party supply chain and 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 test technologies, the Company’s
ability to develop and manufacture certain tests it has not yet
finalized and has never previously manufactured. 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 INFORMATIONCompany
Spokesperson949-645-2111www.biomerica.com
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