Trinity Biotech Announces Application for Early Sjogrens Syndrome Test Panel PLA Code
February 07 2024 - 8:30AM
Trinity Biotech Plc. (Nasdaq: TRIB) (the “Company”) today announced
that its New York based reference laboratory, Immco Diagnostics,
has applied for a Proprietary Laboratory Analyses (PLA) code for
its Early Sjögrens Syndrome Test Panel, to allow for an optimised
market access strategy to deliver broader patient access and
improved profitability.
It is estimated that up to approximately 3
million people in the US have Sjögrens Syndrome, making it one of
the most prevalent autoimmune syndromes. Individuals with Sjögrens
Syndrome suffer most notably from dry eyes and dry mouths, as well
as difficulty swallowing, increased dental cavities, joint pain and
swelling, among other ailments. There is an acute shortage of
evidence-based standardized screening tools for Sjögren’s Syndrome,
contributing to a prolonged diagnostic journey and an overall trend
of underdiagnosis. The provision of effective diagnostic tools can
significantly improve clinical outcomes and reduce the cost burden
of care in Sjögrens Syndrome disease management for payors and
health systems.
The Early Sjögrens Syndrome Test Panel is a
valuable immunological tool for clinicians to both identify
patients earlier, when therapeutic intervention is most effective,
and to also identify patient cohorts most at risk of progression to
Sjögren’s Syndrome.
A PLA code is a distinct, specific code assigned
to a particular test and approved by the American Medical
Association’s (AMA) Current Procedural Terminology (CPT) Editorial
Panel. PLA codes must be requested by the clinical laboratory or
manufacturer that offers the test. The PLA code allows the clinical
lab or manufacturer to preferentially differentiate the test in
terms of payor pricing and avoid the utilization of multiple
generic lower value CPT codes, ultimately incentivising Immco
Diagnostic’s commercial partners to provide broader patient access
to this key diagnostic tool.
Subject to approval, we expect the PLA code for
the Early Sjögrens Syndrome Test Panel to become effective in Q3
2024, which should allow Immco Diagnostics to implement a further
optimised market access strategy, aimed at delivering better
patient access, while affording improved profitability for both
Immco Diagnostics and our commercialization partners.
Immco Diagnostic’s laboratory provides
specialised autoimmune diagnostic solutions to health networks
including the largest lab chains in the US.
About Trinity Biotech
PlcTrinity 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.
Forward Looking StatementsThis
release includes statements that constitute “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 (the “Reform Act”), including but not limited to
statements related to Trinity Biotech’s cash position, financial
resources and potential for future growth, market acceptance and
penetration of new or planned product offerings, and future
recurring revenues and results of operations. Trinity Biotech
claims the protection of the safe-harbor for forward-looking
statements contained in the Reform Act. These forward-looking
statements are often characterised by the terms “may,” “believes,”
“projects,” “expects,” “anticipates,” or words of similar import,
and do not reflect historical facts. Specific forward-looking
statements contained in this presentation may be affected by risks
and uncertainties, including, but not limited to, our ability to
capitalize on our purchase of the assets of Waveform, our continued
listing on the Nasdaq Stock Market, our ability to achieve
profitable operations in the future, the impact of the spread
of COVID-19 and its variants, potential excess inventory levels and
inventory imbalances at the company’s distributors, losses or
system failures with respect to Trinity Biotech’s facilities or
manufacturing operations, the effect of exchange rate fluctuations
on international operations, fluctuations in quarterly operating
results, dependence on suppliers, the market acceptance of Trinity
Biotech’s products and services, the continuing development of its
products, required government approvals, risks associated with
manufacturing and distributing its products on a commercial scale
free of defects, risks related to the introduction of new
instruments manufactured by third parties, risks associated with
competing in the human diagnostic market, risks related to the
protection of Trinity Biotech’s intellectual property or claims of
infringement of intellectual property asserted by third parties and
risks related to condition of the United States economy and other
risks detailed under “Risk Factors” in Trinity Biotech’s annual
report on Form 20-F for the fiscal year ended December 31, 2022 and
Trinity Biotech’s other periodic reports filed from time to time
with the United States Securities and Exchange Commission.
Forward-looking statements speak only as of the date the statements
were made. Trinity Biotech does not undertake and specifically
disclaims any obligation to update any forward-looking
statements.
Contact: |
Trinity
Biotech plc |
Eric
Ribner |
|
Des Fitzgerald |
LifeSci Advisors, LLC |
|
+353-1-2769800 |
+1-646 -751-4363 |
|
|
E-mail:
investorrelations@trinitybiotech.com |
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