Eighth Test in Theradiag’s Monitoring Range Launched in the USA

Regulatory News:

THERADIAG (ISIN: FR0004197747, ticker: ALTER, eligible for PEA-PME equity savings plans in France) (Paris:ALTER), a company specializing in in vitro diagnostics and theranostics, today announces that its partner Miraca Life Sciences will, from early November, start marketing an eighth monitoring test from the LISA TRACKER® range in the USA, under the name InformTx^TM. InformTx^TM is the monitoring range that Miraca markets in the USA under the technology licensing agreement covering Theradiag’s LISA TRACKER® range.

Therapeutic drug monitoring (TDM) for Renflexis® (infliximab-abda), currently undergoing validation, will supplement the InformTx^TM range. Since Miraca Life Sciences launched the range, TDM now available in the US market has expanded to cover eight biologic drugs treating inflammatory bowel disease (IBD).

In the USA, Miraca Life Sciences is the only company offering TDM for Inflectra® (infliximab-dybb), Cimzia® (certolizumab pegol), Stelara® (ustekinumab) and Simponi® (golimumab). Miraca Life Sciences also continues to offer TDM for Remicade® (infliximab), Humira® (adalimumab) and Entyvio® (vedolizumab).

The InformTx^TM report is unique in that it provides clinicians with quantitative test results, historical test result data, and guidance from the most up-to-date peer-reviewed scientific literature. Testing measures the level of the specified drug as well as patient-derived antibodies to the specified drug. Miraca Life Sciences uses laboratory-validated ELISA technology for InformTx^TM TDM, and testing results are reported within five days.

"Since more drugs are becoming available to treat patients with IBD, Miraca Life Sciences will continue to seek therapeutic drug monitoring options for our clinician colleagues,” said Richard Lash, MD, Chief Medical Officer and Executive Vice President of Operations for Miraca Life Sciences. "Understanding patients’ drug and anti-drug antibody status is critical to guiding optimal care.”

"We are pleased to see our product range, the broadest offering in the USA, being extended. Developing that range is crucial in enabling us to increase our penetration and sales in the US market,” added Michel Finance, Chief Executive Officer of Theradiag.

About Theradiag

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, cancer and AIDS. Theradiag notably markets the Lisa Tracker® range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is developing new biomarkers based on microRNAs for the diagnosis and monitoring of rectal cancer, auto-immune and inflammatory diseases and HIV/AIDS. 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. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 70 employees.
For more information about Theradiag, please visit our website: www.theradiag.com

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