Trinity Biotech PLC 6-K, filed May 23, 2022
Trinity Biotech PLC (TRIB)
6-K
2022-05-23
For: 2022-05-23
View Original
Added on
April 12, 2026
About this 6-K
Trinity Biotech PLC filed this 6-K on May 23, 2022.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
F O R M 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2022
TRINITY BIOTECH PLC
(Name of Registrant)
IDA Business Park
Bray, Co. Wicklow, Ireland
(Address of Principal Executive Office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form
20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7):
Indicate by check mark whether by furnishing the information contained in this Form, the registrant
is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with
Rule 12g3-2(b): 82-
EXPLANATORY NOTE
On May 20, 2022, the Company announced that it 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.
EXHIBIT INDEX
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Exhibit
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Description
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized.
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TRINITY BIOTECH PLC
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Trinity Biotech plc
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(Registrant)
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By:
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/s/ John Gillard
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John Gillard
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Chief Financial Officer
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Date: May 23, 2022
Exhibit 99.1
May 23, 2022
Contact: Trinity Biotech plc
Terence Dunne
(353)-1-2769800
E-mail: terence.dunne@trinitybiotech.com
Trinity Biotech Announces CE Mark of its 10-Minute Covid-19 Antigen Test
DUBLIN, Ireland, May 20, 2022 (GLOBE NEWSWIRE) -- 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.