CENTIVIS AG's 5 most read blog entries in 2021: the interview with Zsolt Holló MD, PhD, MBA introducing the PREDYSTIC® Infliximab RA Kit development is among the most popular topics. Thank you CENTIVIS AG, and especially Norbert Farkas (a seasoned Diagnostics Access Consultant), for all support in our diagnostics licensing journey. https://lnkd.in/gX9_JnpX #rheumatoidarthritis #responseprediction #predystic #infliximab #personalizedmedicine
PREDYSTIC® Infliximab RA Kit
Medical Equipment Manufacturing
PREDYSTIC® test identifies those bio-naive patients with RA who are likely responders or non-responders to infliximab
Rólunk
The PREDYSTIC® Infliximab RA Kit is a highly innovative diagnostics system suitable for predicting biological drug (infliximab) response in Rheumatoid Arthritis (RA) patients before treatment initiation. An unmet medical need and a complex problem to be tackled by in vitro gene expression testing. Altogether 217 biological drug-naïve patients were enrolled under rigorous clinical protocols (complying with the effective European In vitro Diagnostic Directive (IVDD, 98/79/EC) and ISO 13485:2016 standard’s requirements for a quality management system and in line with the future In Vitro Diagnostic Medical Device Regulation (IVDR, EU 2017/746) in our clinical studies. Clinical and analytical data of 110 bio-naive RA patients with moderate-high activity RA (DAS28-CRP >3.2), who have responded inadequately to DMARDs (including methotrexate) were used for the performance evaluation: data of 80 patients for model building, which was followed by the verification phase based on the data of 30 patients. It has successfully been demonstrated that gene expression profiles of a selected gene set (as genomic biomarkers) and our proprietary algorithm for data analysis can predict month 6 (M6) therapeutic response to infliximab and can discriminate between infliximab responder and non-responder patients. The final clinical validation based on the data of 52 patients has also been completed. The PREDYSTIC® Infliximab RA Kit has been developed and manufactured as a CE IVD Medical Device by Egis Pharmaceuticals. The PREDYSTIC® Infliximab RA Kit complies with the applicable requirements set in Directive 98/79/EC. The product received the “Certificate of Registration” document issued by the National Institute of Pharmacy and Nutrition (Hungary) on the 21st of December 2020. For more informaton visit https://hu.egis.health/personalized-medicine
- Weboldal
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https://hu.egis.health/personalized-medicine
Külső hivatkozás PREDYSTIC® Infliximab RA Kit
- Ágazat
- Medical Equipment Manufacturing
- Vállalat mérete
- 1.001-5.000 alkalmazott
- Központ
- Budapest