Biomerica files for FDA Emergency Use Authorization (EUA) of its Unique Laboratory Antibody Test for COVID-19
June 16 2020 - 8:19AM
Biomerica Inc. (NASDAQ: BMRA) announced today they have submitted
to the FDA an EUA application for an ELISA lab-based serology blood
test for the detection of antibodies that identify if a person has
been infected with the novel coronavirus (COVID-19). Antibody
testing can be an important next step in opening the economy to
tell people if they have been previously infected. This is
the third COVID-19 antibody test introduced by the Company. The
other two, which are finger-prick rapid tests, are actively being
sold outside of the US and have been well received. The
Company also intends to obtain a CE mark to market and sell this
ELISA laboratory test outside the US.
Biomerica performed testing both internally and
at two external labs located in California. The data from this
testing that was submitted to the FDA under the EUA application
showed 100 percent specificity and zero percent cross reactivity
with many common disease states. This test, which uses the
ELISA microplate format, can be run on existing open system
equipment found in most hospitals and clinical laboratories in the
US and outside the US and uses a modified, trimeric spike protein
from the SARS-CoV-2 virus. This spike protein is known
to be the target of neutralizing antibodies, which can help prevent
the virus from entering the cells.1 Persons who are no longer
infectious and have tested positive for the antibodies, can
possibly be cleared to return to work as they may have a lower
likelihood of reinfection and/or spreading the virus.
Antibody tests will also help in better understanding the virus
including how long antibodies stay in the body and if they help in
immunity as well as how many people have been infected in the
population as a whole. 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.
This ELISA laboratory test was developed by
Biomerica and will be manufactured exclusively at Biomerica’s
manufacturing facility located in Irvine, California, using
existing high-throughput, automated equipment. Biomerica has
extensive experience manufacturing similar serology ELISA tests for
other diseases.
"We are working to provide significant, high
specificity and meaningful diagnostic solutions for the novel
Coronavirus," said Zack Irani-Cohen, CEO and Chairmen of Biomerica.
"Our ELISA test will be unique in the market place by simplifying
the blood sample collection process in a proprietary way. We
have been working with the FDA, who has been very responsive, and
we’re looking forward to a quick review for this submission. I’m
very proud of our team members who are working around the clock to
develop, validate and attain regulatory clearance on these covid-19
diagnostic solutions that benefit patients, healthcare workers and
society”.
About Serology TestsSerology
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.2
1. medRxiv preprint doi:
https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun202.
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.
About InFoods® The Biomerica InFoods® IBS
product is designed to allow physicians to identify patient
specific foods (e.g. eggs, broccoli, wheat, potatoes, corn, etc.),
that when removed from the diet, may alleviate or improve an
individual's IBS symptoms including, but not limited to,
constipation, diarrhea, bloating, pain and indigestion. This
patented, diagnostic-guided therapy is designed to allow for a
patient specific, guided dietary regimen to improve Irritable Bowel
Syndrome (IBS) outcomes. The point-of-care product is being
developed to allow physicians to perform the test in-office using a
finger stick blood sample while a clinical lab version of the
product will be the first for which the company will seek
regulatory approval. A billable CPT code that can be used by both
clinical labs and physicians' offices is already available for
InFoods® diagnostic products. Since the InFoods® product is a
diagnostic-guided therapy, and not a drug, it has no drug type side
effects. An estimated 45 million people in America currently suffer
from IBS making it a leading cause for patient doctor visits.
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, FDA clearance, EUA clearance, the rapidity
of testing results, uniqueness of a product, 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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