Theradiag Announces the Launch of a New Range of Assays for Automated Therapeutic Drug Monitoring of Biologics for Use on IDS...
16 Septembre 2020 - 8:00AM
Business Wire
Regulatory News:
THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker:
ALTER, eligible for the French PEA-PME personal equity plan), a
company specializing in in vitro diagnostics and theranostics, is
pleased to announce the launch of four new i-Tracker® assays
designed to run on the automated IDS-iSYS analyser. These assays
were developed by Theradiag to address the rapidly growing market
of biologics drug monitoring.
The four i-Tracker® assays: i-Tracker® Infliximab, i-Tracker®
Anti-Infliximab, i-Tracker® Adalimumab and i-Tracker®
Anti-Adalimumab were previously launched on the i-Track10®
analyser, an instrument manufactured by IDS for Theradiag.
In the six months since the Theradiag launch, the assays have
undergone validation on the IDS-iSYS analyser and are now available
for use on the installed base of IDS-iSYS analysers in countries
accepting the CE mark.
About Therapeutic Drug Monitoring (TDM) of Biologics
Biologic drugs such as Infliximab and Adalimumab have
revolutionized the management of Chronic Inflammatory Diseases such
as Inflammatory Bowel Disease, Rheumatoid Arthritis, and Psoriasis.
A significant proportion of patients may still experience either
non-response to the therapy or a loss of response over time.
TDM assays provide information for therapeutic decisions to
maximize response and minimize overexposure to the drugs, and their
use is included in many clinical guidelines. It is estimated that
around 2 million patients worldwide are treated with Infliximab and
Adalimumab.
About the i-Tracker® tests
The i-Tracker® tests are the first random access automated
chemiluminescent (CLIA) tests for TDM of Biologics and give precise
results in a very short time for an immediate adjustment of
treatment by clinicians.
The drug measurement kits measure the serum/plasma levels of
biologics which are used in the treatment of many inflammatory
diseases. The Anti-drug kits measure the antibodies that a patient
may raise against the drugs, causing a decrease in treatment
efficacy. The kits are validated both on the princeps molecules and
on biosimilars and are standardized according to the international
standards of the World Health Organization (WHO).
Bertrand de Castelnau, CEO of Theradiag commented:
“Theradiag was the first to introduce the random access approach
and the CLIA technology for its range of TDM of Biologics and we
are glad to now make these products available for the many users of
IDS-iSYS instruments. Access to this large installed base will help
increase adoption of TDM for the well-being of patients.”
Jaap Stuut, CEO of IDS added: "We are pleased to see that
validation of these biologics monitoring markers has been completed
successfully. IDS has distribution rights for these unique assays
in a number of key markets, and making the kits available to our
installed base of customers is a crucial step in the distribution
strategy. These tests also complement our continued focus on
auto-immune diseases, as therapeutic drug monitoring is often
performed by the same immunology teams."
Theradiag’s financial calendar:
- H1 2020 results, Monday, September 21, 2020
About IDS
IDS is a specialist in-vitro diagnostic provider to the clinical
laboratory market. IDS develops, manufactures and markets
innovative immunoassays and automated immuno-analyser technologies
to provide improved diagnostic outcomes for patients.
IDS is headquartered in Boldon, UK, and listed on the
Alternative Investment Market of the London Stock Exchange.
Website: www.idsplc.com
About Theradiag
Theradiag is the market leader in biotherapy monitoring.
Capitalizing on its expertise in the diagnostics market, the
Company has been developing, manufacturing and marketing innovative
in vitro diagnostic (IVD) tests for over 30 years. Theradiag
pioneered “theranostics” testing (combining therapy with
diagnosis), which measures the efficacy of biotherapy in the
treatment of chronic inflammatory diseases. Going beyond mere
diagnosis, theranostics aims to help clinicians set up “customized
treatment” for each patient. This method favors the
individualization of treatment, evaluation of its efficacy and the
prevention of drug resistance. In response to this challenge,
Theradiag develops and markets the CE-marked TRACKER® range, a
comprehensive solution of inestimable medical value.
The Company is based in Marne-la-Vallée, near Paris, has
operations in over 70 countries and employs over 60 people. In
2019, the Company posted revenue of €9.6 million. The Theradiag
share is listed on Euronext Growth Paris (ISIN: FR0004197747) and
is eligible for the French PEA-PME personal equity plan. For more
information about Theradiag, please visit our website:
www.theradiag.com
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version on businesswire.com: https://www.businesswire.com/news/home/20200915006194/en/
Theradiag Bertrand de Castelnau CEO/Managing
Director Tel.: +33 (0)1 64 62 10 12 contact@theradiag.com
NewCap Financial Communications & Investor Relations
Sandrine Boussard-Gallien Quentin Massé Tel.: +33 (0)1 44 71 94 94
theradiag@newcap.eu NewCap Media Relations Nicolas Mérigeau
Tel.: +33 (0)1 44 71 94 98 nmerigeau@newcap.fr
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