Regulatory News :

Theradiag (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostics and in vitro diagnostics, has signed, through its subsidiary Prestizia, two partnership agreements for the development of theranostics assays in HIV/AIDS with the research teams of the French National Center for Scientific Research (CNRS) / Institute of Molecular Genetics of Montpellier (IGMM) and the University of Montpellier (UM2).

"By strengthening its collaboration with CNRS on microRNAs, and extending it to lncRNAs, Theradiag is now at the forefront of research and development of new diagnostics and monitoring tools for HIV/AIDS," comments Odile Prigneau, Managing Director of Prestizia.

The purpose of the first agreement is to implement two of the four theranostics projects part of CaReNA, a collaborative project between Theradiag, Splicos and CNRS signed in 2013 and funded by OSEO1. These two theranostics projects are:

  • a companion diagnostic test to the anti-HIV treatment under development by Splicos (SPL-464),
  • a predictive and monitoring test of HIV/AIDS.

As part of the agreement, CNRS will bring scientific and material support to Theradiag in identifiying microRNA signatures, including technical validations, and biological and statistical analysis of the signatures.

The second agreement is an extension to the existing agreement between Prestizia and the CNRS for the identification of HIV/AIDS tropism through microRNAs to a new research program on long non-coding RNAs (lncRNAs, another type of non-coding RNAs).

Like microRNAs, lncRNA signatures could be used in the development of new diagnostics, prognosis and monitoring tools for AIDS, particularly to determine the HIV viral load and tropism (CXCR4 or CCR5). The purpose of this partnership will be to determine the scientific, clinical and industrial value of these new biomarkers, which are still largely unexplored in applied research. Commercialization of the first HIV tropism test developed by Theradiag is planned for 2015.

"We are applying our theranostics strategy to other large therapeutic areas, such as cancer with our development program on rectal cancer launched in 2013, and to the monitoring of biotherapies in chronic inflammatory diseases with our complete, CE-marked, theranostics range LISA TRACKER. The potential markets for our theranostics kits are huge as they account for more than 80 million dollars in anti-CCR5 treatments in HIV/AIDS, and represent a 300-million-dollar market in autoimmune diseases2," concludes Michel Finance, CEO of Theradiag.

In June 2013, Theradiag opened a new research facility dedicated to applied research for the development of microRNA-based assays within the Cap Alpha incubator in Montpellier and recruited 4 scientists.

About the CaReNA Project
CaReNA is a collaborative project between Splicos, an alternative RNA splicing specialist, Theradiag and the CNRS for the development of RNA-targeting therapeutic and diagnostic solutions in the treatment of HIV/AIDS and obesity. Total funding by OSEO, the National Agency of Innovation, could reach ?18 M. As part of the project, Theradiag will develop 4 new diagnostics and/or monitoring kits.

About Theradiag
Backed by 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, cancer and AIDS. Theradiag is thus participating in the development of "customized treatment", which favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is also developing new diagnostics biomarkers thanks to its microRNA platform, in order to diagnose and monitor HIV/AIDS and rectal cancer. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 55 employees.

For more information about Theradiag, please visit our website: www.theradiag.com

1 OSEO - The French National Agency for Innovation 2 Company assessement based on the number of patients under treatment (or elligible) in the two types of pathologies.

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