CROISSY-BEAUBOURG, France--(BUSINESS WIRE)--Regulatory News:
THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, today announces that it has CE marked the first four i-Tracker® test kits in its TRACKER® range.
In November 2019, after signing an agreement with IDS on the development and distribution of its TRACKER® range on the new technology platform, Theradiag CE marked its i-Track10® automated analyzer. At the ECCO Congress in February 2020, the Company presented the excellent initial results obtained using recently developed i-Tracker® kits on the new analyzer.
Theradiag continues to innovate and is now ready to offer the first four i-Tracker® test kits: i-Tracker® Infliximab, i-Tracker® Anti-Infliximab, i-Tracker® Adalimumab and i-Tracker® Anti-Adalimumab, all compatible with its i-Track10® latest-generation automated analyzer offering random access continuous loading.
These initial kits represent the latest generation of the TRACKER® test ranges, bestselling products on the biotherapy monitoring market. They have been completely redesigned to improve user-friendliness and reliability when used on the i-Track10® analyzer. Thanks to the random access platform, these tests yield precise results within a very short timeframe, enabling clinicians to adjust treatment immediately. They offer quantification over a broad measurement range, simpler use and enhanced platform productivity, thereby facilitating the work of laboratory technicians.
CE marking has now been done for the first four i-Tracker® kits and their market launch has been registered with the French National Drug and Health Product Safety Agency (ANSM). These Infliximab and Adalimumab kits are approved for both originator molecules and biosimilars. They have also been standardized in accordance with the international standards issued by the World Health Organization (WHO).
Theradiag plans to continue further developments and roll out the process of its i-Tracker® tests CE marking to the full range of LISA Tracker. This will enable the Company to market its i-Track10® solution to major hospital centers and private laboratories in France and abroad, where Theradiag operates.
Theradiag CEO Bertrand de Castelnau commented: “We are delighted to announce this new milestone of CE marking, which now allows us to market our new range of innovative test kits. Using them with our i-Track10® platform helps clinicians improve individual therapeutic drug monitoring and helps laboratories obtain top-class results for the benefit of patients.”
- FY 2019 results, March 18, 2020, after market close
- Annual General Meeting, May 14, 2020
Upcoming event Theradiag will attend:
- March 26-29, 2020: 2020 JFHOD Hepato-gastroenterology and Digestive Oncology Congress, Paris.
Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases and cancer. Theradiag is thus participating in the development of customized treatment, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. Theradiag notably markets the Lisa Tracker® range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies. The Company is based in Marne-la-Vallée, near Paris, and has over 60 employees.
For more information about Theradiag, please visit our website: www.theradiag.com