Trinity Biotech Announces FDA Submission of High Sensitivity Troponin I Product
December 17 2015 - 8:00AM
Trinity Biotech plc. (Nasdaq:TRIB) is pleased to announce today
that it has submitted to the U.S. Food and Drug Administration
(FDA), for 510(k) clearance, its Meritas Point of Care Analyzer and
Meritas cardiac troponin-I (cTnI) point-of-care assay for use in
the diagnosis of myocardial infarction (MI). The cTnI assay will
enable health care professionals to quickly determine patient
cardiac status in Emergency Department settings, to accelerate
patient care and to reduce overall costs of delivering health care.
The Meritas cTnI assay is run on the Meritas
Point of Care Analyzer. The single-use, pre-calibrated cTnI assay
is simple to use, and delivers cTnI results in about 15 minutes in
both whole blood and plasma samples. The assay combines sensitive
antibody reagents and the use of advanced injection moulding
technologies to create high-fidelity micropillar structures to
control sample fluidics. Clinical data was collected at 14
geographically dispersed locations across the United States and MIs
were determined by a panel of independent adjudicators.
The following table outlines the clinical
performance results of the product at the time of admission to the
hospital emergency room.
|
|
|
Sensitivity |
Specificity |
Whole Blood |
|
66 |
% |
|
94 |
% |
Plasma |
|
78 |
% |
|
95 |
% |
|
|
|
Litigation Reform Act of 1995. Investors are
cautioned that such forward-looking statements involve risks and
uncertainties including, but not limited to, the results of
research and development efforts, the effect of regulation by the
United States Food and Drug Administration and other agencies, the
impact of competitive products, product development
commercialisation and technological difficulties, and other risks
detailed in the Company's periodic reports filed with the
Securities and Exchange Commission.
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
Trinity Biotech plc
Kevin Tansley
(353)-1-2769800
E-mail: kevin.tansley@trinitybiotech.com
Lytham Partners LLC
Joe Diaz, Joe Dorame & Robert Blum
602-889-9700
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