CROISSY-BEAUBOURG, France--(BUSINESS WIRE)--Regulatory News:
THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, today announces that it has obtained the CE marking for its i-Track10 automated analyzer for biotherapy monitoring.
One of the key points of the agreement signed last April with IDS, which manufactures diagnostic test kits and instruments for the clinical market, was the access to their cutting-edge analyzer named i-Track10.
Manufactured by IDS for Theradiag, this latest generation analyser is the first to be fully compatible with the full range of biotherapy monitoring products. It allows continuous loading, random access analysis and integration into laboratory automation systems.
The CE marking application for i-Track10 is now complete and its market launch has been registered with the French National Drug and Health Product Safety Agency (ANSM).
Internal assessments have confirmed the reliability, flexibility and analyzing speed of the device and independent evaluations have been scheduled to start over the coming weeks.
Feedback from initial presentations to customers and distributors have confirmed the interest and relevance of this unique innovative automated solution.
Theradiag CEO Bertrand de Castelnau commented: “We are delighted to announce the CE marking of this new analyzer as this is a key milestone for Theradiag. Our R&D teams are entirely satisfied with its operation and the quality of the results obtained from our internal assessments. All our technical staff are committed to the success of the project and our entire distribution network is ready for the launch of this innovative product in the first half of 2020.”
Next financial press release:
FY 2019 revenue, February 4, 2020, after market close
Upcoming events Theradiag will attend in 2019:
- 18-21 November: MEDICA, Düsseldorf, Germany
- 6-7 December: GETAID, Paris, France
- 8-10 December: CFR (French Rheumatology Conference), Paris, France
- 12-14 December: AIBD, Orlando US
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