Theradiag, a company specializing in in vitro diagnostics and theranostics, announced that four tests from its Lisa Tracker range have been launched in the US market, under the licensing agreement with Miraca Life Sciences that was announced in November 2015.

Miraca Life Sciences will start to market and promote four tests under the name “InformTx” that utilize technology and raw materials from Theradiag’s Lisa Tracker range. These four biotherapy monitoring tests (Infliximab/Remicade, Adalimumab/Humira, Certolizumab/Cimzia and Vedolizumab/Entyvio) deal mainly with inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. The launch of InformTx by Miraca Life Sciences marks the first time that monitoring has been available in the US market for Certolizumab and Vedolizumab. No other US medical laboratory offers the full set of these monitoring tests, giving Miraca Life Sciences a substantial competitive advantage.

The tests have undergone rigorous validations in Miraca Life Sciences’ CLIA-certified and CAP-accredited laboratory, located in Phoenix, Arizona.

It is estimated more than 330,000 IBD patients in the United States are treated with biologics, two times more than in Europe.

Theradiag will sell the required materials and will receive royalties on Miraca Life Sciences’ sales in the USA.

“Miraca Life Sciences’ launch of our first four tests in the USA is a major milestone in our geographical expansion strategy and represents a source of large potential sales in the years to come. Its expertise and knowledge of the US market make it the ideal partner to develop our Lisa Tracker range in the United States. The partnership enables us to make our biotherapy monitoring tests available to US clinicians, helping them to optimise biotherapy treatments,” said Michel Finance, CEO of 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 75 employees.