Regulatory Filings • Feb 19, 2020
Regulatory Filings
Open in ViewerOpens in native device viewer

Croissy-Beaubourg, February 19, 2020, 5:45pm CET – THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, has been actively involved in the establishment and validation of a new World Health Organization standard for biotherapy monitoring, with the help of its TRACKER® kits. The new standard relates to the Adalimumab molecule.
For several years now, the National Institute for Biological Standards and Control (NIBSC, based in the United Kingdom), an organization accredited by the WHO, has been officially tasked with setting up and validating standards designed to help characterize, calibrate and validate in vitro assays in order to improve therapeutic drug monitoring (TDM). The program was set up in response to the lack of standardization in dose testing methods recognized by clinicians as an obstacle to the introduction and widespread adoption of biotherapy monitoring in routine clinical practice.
Since its inception, Theradiag has been strongly committed to the standardization of biotherapy monitoring, as this helps clinicians further optimize treatment doses for the benefit of their patients.
After an initial project with NIBSC leading to the introduction of the first international standard for monitoring Infliximab, Theradiag was also chosen to take part in a new study on Adalimumab.
The NIBSC recently announced the results and the validation of this new international standard:
https://www.nibsc.org/about\_us/latest\_news/adalimumab\_standard.aspx
44 participants from 15 countries contributed to the program's assessment.
Theradiag CEO Bertrand de Castelnau said: "We are delighted to have helped establish a new standard for this molecule. On a broader scale, the WHO drive to standardize biodrug dosing confirms the need to use accurate and reliable solutions to calculate active doses in order to optimize treatment and enhance individual patient monitoring. The interest shown in our company for the validation process for these new standards confirms Theradiag's recognition as a leading player in biotherapy monitoring."

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

Theradiag Bertrand de Castelnau CEO/Managing Director Tel.: +33 (0)1 64 62 10 12 [email protected]
NewCap Financial Communications & Investor Relations Sandrine Boussard-Gallien Claire Riffaud Tel.: +33 (0)1 44 71 94 94 [email protected]
NewCap Media Relations Nicolas Mérigeau Tel.: +33 (0)1 44 71 94 98 [email protected]r
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.