THERADIAG Announces CE Marking for Four New i-Tracker® Test Kits for Biotherapy Monitoring
11 Janvier 2021 - 5:45PM
Business Wire
Regulatory News:
THERADIAG (ISIN: FR0004197747, Ticker: ALTER) (Paris:ALTER) , a
company specializing in in vitro diagnostics and theranostics,
today announces that it has obtained CE marking for four additional
i-Tracker® test kits for biotherapy monitoring.
In 2020, Theradiag had already announced the market launch of
its first four i-Tracker® test kits (i-Tracker® Infliximab,
i-Tracker® Anti-Infliximab, i-Tracker® Adalimumab and i-Tracker®
Anti-Adalimumab) designed for i-Track10® and IDS-iSYS systems.
In 2021, Theradiag will continue its R&D investment and
innovation drive and is now offering four additional i-Tracker®
test kits: i-Tracker® Vedolizumab, i-Tracker® Anti-Vedolizumab,
i-Tracker® Ustekinumab and i-Tracker® Anti-Ustekinumab, all
designed to be compatible with Theradiag’s i-Track10®
latest-generation random access continuous loading automatic
testing solution and with the IDS-iSYS automated analyzer
manufactured by IDS.
These four new i-Tracker® kits have now obtained CE marking and
their market launch has been registered with the French National
Drug and Health Product Safety Agency (ANSM). The Vedolizumab and
Ustekinumab kits have been validated for drugs used to treat
chronic inflammatory conditions in gastroentorology, such as
Crohn’s disease and ulcerative colitis.
These new i-Tracker® test kits let clinicians fine-tune drug
dosage in order to control the blood plasma and serum levels of
biotherapies used to treat many chronic inflammatory conditions in
gastroentorology. They are calibrated in accordance with the
international standards issued by the World Health Organization
(WHO).
The CE marking of these new test kits extends the LISA
Tracker®range, continuing the strategy to develop the i-Track10®
range in the leading hospitals and private labs in France and in
all other countries where Theradiag operates.
Theradiag CEO Bertrand de Castelnau said: “We are
delighted to announce this new CE marking. It means we now have
eight innovative test kits ready for market , all of them
compatible with our i-Track10® platform. The i-Track10® delivers
faster turnaround times for clinicians and patients. By covering
more conditions, this extension to the range is a further step in
the development of individual therapeutic monitoring of even more
biotherapies.”
Financial calendar:
- FY 2020 revenue, February 1, 2021, before market
opening - FY 2020 results, March 22, 2021, before
market opening - Annual General Meeting, May 6, 2021
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/20210111005787/en/
Theradiag Bertrand de Castelnau CEO/Managing
Director Tel.: +33 (0)1 64 62 10 12 contact@theradiag.com
NewCap Financial Communications & Investor Relations
Louis-Victor Delouvrier 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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