Trinity Biotech Announces European Approval of Guideline Compliant, Point-of-Care, High Sensitivity Troponin I Product
January 29 2014 - 8:27AM
Trinity Biotech plc. (Nasdaq:TRIB) today announced it has obtained
the CE mark (i.e. European approval) for its Meritas, high
sensitivity Troponin I (hsTnI) product. With its unrivalled
precision, it is now the only point-of-care product capable of
meeting all of the guidelines stipulated by the world's leading
cardiac organisations for detection of heart attacks.
Troponin market
Troponin is the leading marker used in the detection of heart
attacks or myocardial infarctions (MI). The worldwide market
for Cardiac Troponin testing is estimated to be $1.2bn, growing at
a rate of 12% per annum. Of this market, approximately $350m
represents point-of-care testing carried out in the Emergency Room
(ER) with the remainder being laboratory based
testing. Historically, laboratory based testing has
demonstrated significantly greater accuracy, albeit in a much
slower timeframe. Typically, laboratory testing takes
approximately 90 minutes versus the 15 minutes which can be
achieved in the point-of-care environment. Speed is a crucial
factor in the diagnosis and treatment of heart attack patients.
In 2007, a task force consisting of the ESC (European Society of
Cardiology), ACCF (American College of Cardiology Foundation), AHA
(American Heart Association) and WHF (World Heart Foundation) was
convened to define MI and its diagnosis. Based on the
recommendations of this task force, Troponin has been identified as
the preferred biomarker to identify suspected heart attacks. A
heart attack is diagnosed when Troponin levels in the blood exceed
the 99th percentile reference limit of a normal healthy population
whilst accompanied by one other clinical symptom. The task
force further stipulated that high sensitivity Troponin assays
should also demonstrate excellent precision at very low
concentrations of Troponin, namely 10% or less variation at the
99th percentile value of the normal population. The current
point-of-care market for Troponin is dominated by three
participants, none of whose products come to near to meeting this
guideline.
Since 2012, following its acquisition of Fiomi Diagnostics,
Trinity has been developing a high sensitivity Troponin test
capable of delivering laboratory based quality in the Emergency
Room environment. The objective was to develop a test capable
of meeting the 2007 guideline with a testing time of no more than
15 minutes. With the launch of the Meritas Troponin test
these objectives have now been achieved. Trinity is thus in
the unique position of being the first company to commercialise a
fully guideline compliant product for use in the $350m Emergency
Room market.
Meritas Troponin I Product
This Troponin test, which is the first test to be launched on
Trinity's Meritas platform, has the following key
characteristics:
- It demonstrates a limit of detection of 19pg/ml of whole blood
and achieves a variation of 10% at 36pg/ml which corresponds to the
99th percentile of the reference population;
- Testing will be carried out in the Emergency Room with results
available patient-side within 15 minutes;
- Tests will be run on the Meritas analyser, which is a cost
efficient analyser approximately the size of a desk
telephone. It has been specifically designed with ease of use
in mind, using a single drop of whole blood in a one-step
process.
In summary, this landmark test delivers unparalleled sensitivity
and precision at the point-of-care, which allows doctors to
evaluate whether or not patients are having a heart attack within a
short time of admission.
Next Steps
With this CE mark, Trinity intends to immediately launch the
product for sale in Europe and other selected markets through its
specialist Cardiology Distributor network, which has been recruited
over the past number of months.
However, CE marking of Meritas Troponin is only the first step
in the commercialisation of Trinity's range of point-of-care
cardiology products. Trinity will immediately commence US
clinical trials and is confident that a product displaying such
high clinical and current guideline compliant performance will meet
and indeed exceed the very tight performance specifications
necessary for FDA approval. Meanwhile, Trinity is in the
process of developing products for the detection of BNP and
D-dimer. The BNP product is already at an advanced stage with
CE marking expected by mid-2014, to be followed by an FDA
submission, thus leaving Trinity in a very strong position to take
a very significant portion of the worldwide point-of-care cardiac
diagnostic testing market in the years ahead.
Due to its unique technology the Meritas platform is eminently
suitable for use in detecting conditions in a range of other
diagnostic fields – particularly those requiring higher
sensitivity. Following completion of its cardiac range of
tests, Trinity will proceed to develop a range of other tests on
this platform.
Comments
Dr. Frank Peacock, Professor of Emergency Medicine at Baylor
College of Medicine, Houston, Texas stated "The Meritas Troponin
test outperforms most historical central laboratory tests, is on
par with some of the latest high sensitivity laboratory assays only
available in Europe and does it all at the point-of-care in just 15
minutes. Its availability resolves a longstanding critical need and
serves as an inflection/pivotal point in improving patient
care."
Commenting on today's news, Ronan O'Caoimh CEO said "We are
delighted to launch for the first time an Emergency Room Troponin
test with superlative precision, which is in a category apart from
its competitors. Until now, physicians haven't had a reliable
tool to quickly and confidently test patients with chest pain at
the point-of-care. As a result, patients needlessly waited
hours to receive the treatment they needed and were often
misdiagnosed, leading to poor outcomes. The Meritas Troponin
test, now for the first time, provides physicians with an
incredibly precise tool in the point-of-care setting to quickly and
accurately test these patients in just 15 minutes from a drop of
whole blood."
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.
CONTACT: 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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