Trinity Biotech PLC 6-K, filed Jan 5, 2021
Trinity Biotech PLC (TRIB)
6-K
2021-01-05
For: 2021-01-05
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Added on
April 12, 2026
About this 6-K
Trinity Biotech PLC filed this 6-K on January 5, 2021.
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 January, 2021
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- ___________
This Report on Form 6-K is incorporated by reference into the Registrant's Form F-3 Registration Statement
File No. 333-239701 and Form S-8 Registration Statements File Nos. 333-195232 and 333-182279.
EXPLANATORY NOTE
The following exhibit is attached:
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99.1
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Press Release: Trinity Biotech Announces CE Mark of its Covid-19 IgG ELISA Antibody Test
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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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(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: 5 January 2021
EXHIBIT INDEX
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EXHIBIT NO.
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DESCRIPTION
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Exhibit 99.1
Press Release dated January 5th, 2021
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Contact:
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Trinity Biotech plc
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Terence Dunne
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(353)-1-2769800
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E-mail: terence.dunne@trinitybiotech.com
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Trinity Biotech Announces CE Mark of its Covid-19 IgG ELISA Antibody Test
DUBLIN, Ireland (January 5th, 2021). Trinity Biotech plc (Nasdaq: TRIB) has
achieved CE Mark approval and registration for its Covid-19 IgG ELISA antibody test, the Captia™ SARS-CoV-2 IgG ELISA.
Trinity Biotech has launched the test in countries throughout the European Union as well as other countries that recognise the CE Mark designation. This is in addition to our launch of the product in
the US following submission under the FDAs Emergency Use Authorisation pathway.
Test Overview
The test uses a recombinant form of coronavirus spike protein to detect IgG antibodies which are the focus for SARS-CoV-2 vaccine development. The detection of IgG antibodies indicates either past
exposure to the virus or the desired immune response following vaccination.
Trinity Biotech expects that the antibody test will have a number of uses, including:
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Assessing if an individual has previously had a SARS-CoV-2 infection and may now be assumed immune.
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Monitoring individuals in the weeks and months following vaccination, to assess the degree to which their immune system builds an antibody response to the virus.
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Assisting governments manage the prevalence of Covid-19 immunity in the population.
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Screening people prior to vaccination to avoid vaccinating individuals who already have a circulating antibody response, particularly in an environment where vaccine supply is constrained.
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The instrumentation platforms that perform this type of ELISA test are available in virtually all clinical testing laboratories. Trinity Biotech have significant capacity for ELISA manufacture
within their current operations and intend to leverage their existing distribution network to optimise the commercialisation of the test kit.
Performance Evaluation
A study of healthcare workers using the Trinity Biotech ELISA took place between June and October 2020. In addition to extensive internal testing, eighty-eight participants provided appropriate
samples for calculation of the Sensitivity and Specificity at ≥14 days post Day 0 (date of oro/nasopharyngeal swab). Participants were tested with a PCR test and the Trinity Biotech ELISA.
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Sensitivity
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95.9%
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Specificity
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100.0%
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A high Specificity value indicates the potential risk of a false positive result as low - this is a critical parameter when determining immune status and minimising the risk of an individual being
incorrectly determined as having immunity.
Other Details
For sales enquiries, please contact customerservicesgroup@trinitybiotech.com
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.