The PREDYSTIC® Infliximab RA Kit is a first-in-class, CE IVD labelled, molecular biomarker diagnostic system, suitable for predicting infliximab responsiveness in rheumatoid arthritis patients, before the first biological treatment initiation. This novel tool supports the decision making of stakeholders including rheumatologists, patients, payors, and drug developers.
Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disorder affecting around 1% of the worldwide population. Clinical therapeutic options are still limited in their efficacy. A large portion of patients fail to achieve low-disease activity using TNFα inhibitor biological treatments such as infliximab. This problem represents an unmet medical need of efficacy prediction.
Altogether, 217 biological drug-naïve RA patients were enrolled under rigorous clinical protocols in the supporting clinical studies, complying with the effective In Vitro Diagnostic Medical Device Directive (IVDD) and also in line with the future In Vitro Diagnostic Regulation (IVDR) requirements. Clinical and analytical data of patients with moderate-high disease activity RA (DAS28-CRP >3.2), who have not responded adequately to DMARDs (including methotrexate), were used for the development. It has successfully been demonstrated that gene expression profiles of a selected gene set (as genomic biomarkers) and Egis’ proprietary algorithm with selected clinical data for data analysis can predict therapeutic responsiveness to infliximab before treatment initiation.
The PREDYSTIC® Infliximab RA Kit utilizes the Applied Biosystems™ Gene Expression TaqMan® Array Card (TAC) platform, developed by Thermo Fisher Scientific and custom manufactured for Egis’ diagnostic purposes. The TAC card is an outstanding tool for quantitative gene expression profiling, that allows quick and robust diagnostic characterization on the Applied Biosystems™ QuantStudio™ Dx instrument.
The PREDYSTIC® Infliximab RA Kit is manufactured as a CE IVD Medical Device by Egis.
"An economical therapy which is effective from day one has been a long-awaited goal for rheumatoid arthritis,” - commented Dr. Zsolt Holló, head of the Center of Biological Business Development and Technology at Egis Pharmaceuticals PLC.
Dr. Holló added, “development of the PREDYSTIC® Infliximab RA Kit is a significant step towards personalized therapy in RA.
The genetic classifier of the PREDYSTIC® Infliximab RA Kit has predictive power that compare well with prognostic biomarkers used in oncology to guide targeted treatment selection, serving as a complementary diagnostic. The registration of the Kit is the completion of a 5-year-long development process involving several research partners participating in biomarker discovery, clinical trials, statistical analysis, machine learning and product development.
This diagnostic development has also introduced a completely new and innovative business and scientific direction into the generic drug developer company, Egis. The PREDYSTIC® Infliximab RA Kit solution will be available both as Product and Service provided by partner diagnostic laboratories. Egis is currently looking for licensing collaborations for worldwide coverage.”
“We are proud to have collaborated with Egis in achieving this successful IVD development by lending key support from our genomics and biostatistical teams in the early biomarker discovery phase of this program,” - commented Dr. Brian Lockhart (head of Companion Diagnostics, Servier).
“We are pleased that our TAC platform has been selected by Egis, and our collaboration has contributed to the development of their CE IVD Medical Device,”- commented Dr. Michelle Collins, Director, MDx License and Commercial Supply with Thermo Fisher Scientific.
About Egis Pharmaceuticals PLC
Egis (member of the Servier Group) headquartered in Budapest, Hungary, is one of the leading generic pharmaceutical companies in Central and Eastern Europe. The company’s activities extend to every field of the pharmaceutical value chain: from Research and Development through the production of Active Pharmaceutical Ingredients and Finished Drug Products to sales and marketing. Egis products are available in 60 countries through its network of subsidiaries and representative offices or partners. Egis launched the first biosimilar infliximab for the treatment of rheumatoid arthritis in Central and Eastern Europe in 2013.
Zsolt Holló, MD, PhD, MBA
Head, Center of Biological Business Development and Technology
Egis Pharmaceuticals PLC