CROISSY-BEAUBOURG, France, December 02, 2021--(BUSINESS WIRE)--Regulatory News:
THERADIAG (ISIN: FR0004197747, Ticker: ALTER) (Paris:ALTER), a company specializing in in vitro diagnostics and Theranostics, today announces the launch of four additional kits in its i-Tracker® tests range and the validation of a new parameter in the United States, all dedicated to biotherapy monitoring.
In addition to its eight kits that have already received CE marking1, Theradiag is expanding its range with 4 more kits of i-Tracker® tests: i-Tracker® Golimumab, i-Tracker® Anti-Golimumab, i-Tracker® Rituximab and i-Tracker® Anti-Rituximab, all of which being adapted to its latest generation random-access analyzer i-Track10® and the IDS-iSYS automated system manufactured by the company IDS.
As of the date of this press release, the Golimumab and anti-Golimumab kits are already CE marked, while the Rituximab and anti-Rituximab kits will be in the coming weeks. The Golimumab kits are devoted to monitoring biotherapies used within the framework of chronic inflammatory diseases treatment in gastroenterology, rheumatology and dermatology; the Rituximab kits are notably dedicated to biotherapies used in rheumatology and oncology.
While expanding its range, Theradiag is also strengthening its offer in the United States. A new parameter has been validated in the laboratory of Veracyte2, a Theradiag’s partner in the United States: the Infliximab biosimilar Avsola®. This biosimilar has been approved by the FDA (Federal Drug Administration) to treat chronic inflammatory diseases such as rheumatoid arthritis, Crohn disease and ulcerative colitis. After Inflectra® and Renflexis®, Avsola® is the third biosimilar validated on Theradiag's OptimAbs Infliximab test.
Bertrand de Castelnau, CEO of Theradiag, commented: "We are very proud to announce these two decisive bits of news that materialize the strategy we have adopted in recent semesters: the extension of our R&D and the intensification of the internationalization of our offer. This commercial strategy allows us to contribute to the development of individualized therapeutic monitoring of even more biotherapies and for even more patients around the world".
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 2020, the Company posted revenue of €10.4 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: https://www.theradiag.com/
1 An initial four kits were granted CE marking in March 2020and an additional four in January 2021
2 Formerly HalioDx, renamed Veracyte since the acquisition of the group by the eponymous American company
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Bertrand de Castelnau
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