Trinity Biotech Announces CE Mark of its 10-Minute Covid-19 Antigen Test
May 20 2022 - 9:20AM
Trinity Biotech plc (Nasdaq: TRIB) has achieved a CE Mark for its
10-minute Covid-19 antigen test. This CE mark allows for use by
healthcare professionals and trained users. The Company intends to
launch the test throughout the European Union as well as other
countries that recognise the CE Mark designation.
In addition to its ease-of-use and impressive
speed to result, in extensive clinical trails the test has
demonstrated excellent 99% sensitivity and 99% specificity which
are accuracy levels superior to many of the tests currently on the
market. The test uses an anterior nasal swab sample rather than the
more invasive nasopharangeal swab, providing a more comfortable
patient experience. The test also has several features that benefit
the user including a convenient pre-filled extraction buffer and a
run time of 10 minutes which is faster than many competitor
products. This speed to result and pre-filled buffer allows a
higher throughput of patients for healthcare professionals and
trained users performing the test, while also providing a more
comfortable patient experience without compromising on diagnostic
performance.
In many instances, antigen tests have replaced
PCR as the go-to method for Covid-19 testing and we expect antigen
tests to be an important tool for the management of Covid-19 for
many years to come.
The rapid Covid-19 antigen test has been
developed by Trinity Biotech on the same lateral flow test platform
as the recently World Health Organisation (WHO) approved Trinscreen
HIV™ test and will be manufactured at the Company’s high volume
automated lateral flow manufacturing site in Bray, Ireland.
The Company will continue to examine regulatory
approval pathways in other countries in deciding what further
regulatory approvals to seek for this product.
The Company intends to continue to expand its
rapid test portfolio in infectious disease using the existing
lateral flow test platform and high-volume automated
manufacturing.
Forward Looking Statements
Certain statements made in this release that are
not historical are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. The words
“estimate”, “project”, “intend”, “expect”, “believe” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements involve known and unknown risks
and uncertainties. Many factors could cause the actual results,
performance or achievements of Trinity Biotech to be materially
different from any future results, performance or achievements that
may be expressed or implied by such forward-looking statements,
including, but not limited to, the results of research and
development efforts, risks associated with the outbreak and global
spread of the coronavirus (COVID-19), the effect of regulation by
the U.S. Food and Drug Administration and other agencies, the
impact of competitive products, product development
commercialization and technological difficulties. For additional
information regarding these and other risks and uncertainties
associated with Trinity Biotech’s business, reference is made to
our reports filed from time to time with the U.S. Securities and
Exchange Commission. We undertake no obligation to update or revise
any forward-looking statements for any reason.
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures
and markets diagnostic systems, including both reagents and
instrumentation, for the point-of-care and clinical laboratory
segments of the diagnostic market. The products are used to detect
infectious diseases and to quantify the level of Haemoglobin A1c
and other chemistry parameters in serum, plasma and whole blood.
Trinity Biotech sells direct in the United States, Germany, France
and the U.K. and through a network of international distributors
and strategic partners in over 75 countries worldwide. For further
information please see the Company's
website: www.trinitybiotech.com.
Contact: |
|
Trinity Biotech plcTerence
Dunne(353)-1-2769800E-mail: terence.dunne@trinitybiotech.com |
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