CINCINNATI, July 29,
2022 /PRNewswire/ -- Meridian Bioscience, Inc.
(NASDAQ: VIVO), a leading global provider of diagnostic testing
solutions and life science raw materials, announced that it
received re-authorization of its Emergency Use Authorization (EUA)
for the Revogene® SARS-COV-2 molecular assay from the
U.S. Food and Drug Administration (FDA). Meridian expects to
begin shipping this product before the end of its fiscal fourth
quarter, ending September 30,
2022.
On November 10, 2021, Meridian
announced the Revogene® SARS-CoV-2 assay was granted
authorization by the FDA. Subsequent to that, it was
determined that the original design of the assay would not detect
the Omicron variant and Meridian delayed marketing the assay to
modify its design to correct for the detection of the variant.
In March, Meridian completed the development work and
submitted an initial set of data to the FDA to validate the
performance of this revised assay. Over the last few months
in consultation with the FDA, Meridian completed additional
clinical studies and the FDA has now re-authorized the EUA.
The Revogene® SARS-CoV-2 assay is a molecular
diagnostic test for the qualitative detection of the SARS-CoV-2
virus from nasopharyngeal, oropharyngeal, anterior nasal, and
mid-turbinate nasal swab specimens and provides impressive clinical
performance with a positive predictive agreement (PPA) of 97.7% and
a negative predicative agreement (NPA) of 97.7%.
The Revogene® SARS-CoV-2 assay can help laboratories
and healthcare systems improve their COVID-19 testing capacity and
enable healthcare providers to quickly deliver the appropriate care
and guide infection control measures for patients. The
flexible Revogene® molecular testing platform can easily
integrate into any laboratory or health system. Additional
FDA-approved tests on the Revogene platform include
Revogene® C. difficile, Revogene®
Strep A, Revogene® GBS LB, and Revogene®
Carba C.
"There continues to be demand for fast, accurate detection of
COVID-19 especially considering the high transmissibility of these
new variants and the upcoming respiratory season," said
Tony Serafini-Lamanna, Executive
Vice President - Diagnostics for Meridian Bioscience. "We
believe our Revogene® SARS-CoV-2 assay and growing
Revogene® platform can help clinicians and health
systems meet these demands now and in the future."
To learn more about the Revogene® SARS-CoV-2
assay, please visit
https://www.meridianbioscience.com/revogene-sars-cov-2/. For
sales inquiries, please contact Meridian Bioscience at
1-888-763-6769 or sales@meridianbioscience.com.
This product has not been FDA cleared or approved but has been
authorized for emergency use by FDA under an EUA for use by
authorized laboratories. This product has been authorized
only for the detection of nucleic acid from SARS-CoV-2, not for any
other viruses or pathogens. The emergency use of this product
is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of COVID-19
under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. § 360bbb-3 (b)(1), unless the declaration is terminated,
or authorization is revoked sooner.
FORWARD-LOOKING STATEMENTS
The Private
Securities Litigation Reform Act of 1995 provides a safe harbor
from civil litigation for forward-looking statements accompanied by
meaningful cautionary statements. Except for historical
information, this press release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934,
which may be identified by words such as "continues", "estimates",
"anticipates", "projects", "plans", "seeks", "may", "will",
"expects", "intends", "believes", "signals", "should", "can",
"guidance" and similar expressions or the negative versions thereof
and which also may be identified by their context. All statements
that address operating performance or events or developments that
Meridian Bioscience, Inc. ("Meridian" or "the Company") expects or
anticipates will occur in the future are forward-looking
statements. Such statements, whether expressed or implied, are
based upon current expectations of the Company and speak only as of
the date made. Specifically, Meridian's forward-looking statements
are, and will be, based on management's then-current views and
assumptions regarding future events and operating performance.
Meridian assumes no obligation to publicly update or revise any
forward-looking statements even if experience or future changes
make it clear that any projected results expressed or implied
therein will not be realized. These statements are subject to
various risks, uncertainties and other factors that could cause
actual results to differ materially, including, without limitation,
factors identified from time to time in the Company's filings with
the Securities and Exchange Commission, including in Part I, Item
1A Risk Factors of the Company's most recent Annual Report on Form
10-K, which contains a list and description of uncertainties, risks
and other matters that may affect the Company. Readers should
carefully review these forward-looking statements and risk factors,
and not place undue reliance on the Company's forward-looking
statements.
About Meridian Bioscience, Inc.
Meridian is a
fully integrated life science company that develops, manufactures,
markets, and distributes a broad range of innovative diagnostic
products. We are dedicated to developing and delivering better
solutions that give answers with speed, accuracy, and simplicity
that are redefining the possibilities of life from discovery to
diagnosis. Through discovery and development, we provide critical
life science raw materials used in immunological and molecular
tests for human, animal, plant, and environmental applications.
Through diagnosis, we provide diagnostic solutions in areas
including gastrointestinal and upper respiratory infections and
blood lead level testing. We build relationships and provide
solutions to hospitals, reference laboratories, research centers,
veterinary testing centers, physician offices, diagnostics
manufacturers, and biotech companies in more than 70 countries
around the world.
Meridian's shares are traded on the NASDAQ Global Select Market,
symbol VIVO. Meridian's website address is
www.meridianbioscience.com.
Contact:
Charlie Wood
Vice President – Investor Relations
Meridian Bioscience, Inc.
Phone: +1 513.271.3700
Email: mbi@meridianbioscience.com
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SOURCE Meridian Bioscience, Inc.
