Theradiag Announces the Launch of a New Range of Assays for Automated Therapeutic Drug Monitoring of Biologics for Use on IDS-iSYS
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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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