New TDM assays launched for use on the IDS-iSYS

Immunodiagnostic Systems Holdings plc.

16 September 2020

New range of automated Therapeutic Drug Monitoring assays launched for use on the IDS-iSYS

Immunodiagnostic Systems Holdings plc (IDS), a specialty solution provider to the clinical laboratory diagnostic market, is pleased to announce the launch of four new i-Tracker® assays designed to run on its automated IDS-iSYS analyser. These assays were developed by our partner Theradiag SA (Theradiag) and address the rapidly growing market of biologics drug monitoring.

The four i-Tracker® assays: i-Tracker® Infliximab, i-Tracker® Anti-Infliximab, i-Tracker® Adalimumab and i-Tracker® Anti-Adalimumab were previously launched on the 'i-Track10®' analyser, an instrument manufactured by IDS for Theradiag.

In the six months since the Theradiag launch, the assays have undergone validation on the IDS-iSYS analyser and are now available for use on the installed base of IDS-iSYS analysers in Europe and other territories which accept a CE mark accreditation.

About Therapeutic Drug Monitoring (TDM) of Biologics

Biologic drugs such as Infliximab and Adalimumab have revolutionized the management of Chronic Inflammatory Diseases such as Inflammatory Bowel Disease, Rheumatoid Arthritis, and Psoriasis. Unfortunately, a significant proportion of patients may experience either non-response to the therapy or a loss of response over time.

TDM assays provide information for therapeutic decisions to maximize response and minimize overexposure to the drugs, and their use is included in many clinical guidelines. It is estimated that around 2 million patients worldwide are treated with Infliximab and Adalimumab.

About the i-Tracker® test kits

The i-Tracker® test kits are the first automated chemiluminescent (CLIA) kits for TDM of Biologics and give precise results in a very short time for an immediate adjustment of treatment by clinicians.

The drug measurement kits measure the serum/plasma levels of biologics which are used in the treatment of many inflammatory diseases. The Anti-drug kits measure the antibodies that a patient may raise against the drugs, causing a decrease in treatment efficacy. The kits are validated both on the originator molecules and on biosimilars and are standardized according to the international standards of the World Health Organization (WHO).

Jaap Stuut, CEO of IDS commented:

"We are pleased to see that validation of these biologics monitoring markers has been completed successfully. IDS has distribution rights for these unique assays in a number of key markets, and making the kits available to our installed base of customers is a crucial step in the distribution strategy. These tests also complement our continued focus on auto-immune diseases, as therapeutic drug monitoring is often performed by the same immunology teams."

Bertrand de Castelnau, CEO of Theradiag commented:

"Theradiag was the first to introduce the CLIA technology for its range of TDM of Biologics and we are glad to now make these products available for the many users of IDS-iSYS instruments. Access to this large installed base will help increase adoption of TDM for the well-being of patients."

About IDS

IDS is a specialist in-vitro diagnostic provider to the clinical laboratory market. IDS develops, manufactures and markets innovative immunoassays and automated immuno-analyser technologies to provide improved diagnostic outcomes for patients.

IDS is headquartered in Boldon, UK, and listed on the Alternative Investment Market of the London Stock Exchange.

About Theradiag

Theradiag is the market leader in biologics monitoring and pioneered "Theranostics" testing (combining therapy with diagnosis), measuring the efficacy of biologics in the treatment of chronic inflammatory diseases. Going beyond mere diagnosis, theranostics aims to help clinicians set up "customized treatment" for each patient. This method favors the individualization of treatment, evaluation of its efficacy and the prevention of drug resistance. In response to this challenge, Theradiag develops and markets the CE-marked TRACKER® range, a comprehensive solution of inestimable medical value.

Theradiag is based in Marne-la-Vallée, near Paris, markets its products in over 70 countries and employs over 60 people.

For further information:

Immunodiagnostic Systems Holdings plc Tel: +44 (0) 191 519 6111

Jaap Stuut, Chief Executive Officer

Paul Martin, Group Finance Director

Peel Hunt LLP Tel: +44 (0) 20 7418 8900

James Steel

Oliver Jackson