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THERADIAG Announces CE Marking for Four New i-Tracker® Test Kits for Biotherapy Monitoring

Monday, January 11, 2021

THERADIAG, 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

Contacts
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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