Personalized Medicine
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Personalized Medicine

PREDYSTIC® Infliximab RA Kit

Future therapies rely on the development of Personalized Medicine, when the therapy is tailored to the patient’s anatomy, metabolism, biochemistry ultimately their genetic background.

The core of Personalized Medicine is the observation of understanding the unique nature of the actual patient based on genetic, epigenetic, and clinical information. Thus, we can predict, diagnose or cure them tailored to their individual needs.

The keys to personalized medications are reliable and cost-effective diagnostic procedures shedding light on the individual drug-patient interactions, facilitating the selection of the effective therapy, reducing side-effects thus supporting the realization of a cost-effective therapy.

Egis Pharmaceuticals PLC has started its journey in the Personalized Medicine space by developing a novel innovative diagnostic method, the PREDYSTIC® Infliximab RA Kit 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 Regulation (IVDR EU 2017/746) requirements.

In rheumatoid arthritis (RA) disease heterogeneity and interpatient variability contribute to differences in drug efficacy and safety. Since the therapeutic response shows significant differences between individuals it is an unmet medical need in everyday clinical therapy to eliminate the trial-and-error method by incorporating predictive biomarkers into therapeutic decision making.

The development of a complementary diagnostic (CLDx) PREDYSTIC® Infliximab RA Kit has covered the complete cycle from biomarker discovery through in-process manufacturing and successful clinical performance testing to EU IVDD registration. According to the definition complementary diagnostics identify a biomarker-defined subset of patients that respond particularly well to a drug and aid risk/benefit assessments for individual patients, but that are not pre-requisites for receiving the drug.

The PREDYSTIC® Infliximab RA Kit identifies those bio-naïve patients with RA, who are likely responders or non-responders to infliximab treatment based on biomarker analysis from peripheral blood sample collected before the treatment initiation.

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.

The PREDYSTIC® Infliximab RA Kit is manufactured as a CE IVD Medical Device at the Körmend site of Egis Pharmaceuticals PLC.

The PREDYSTIC® Infliximab RA Kit will be available from as a Product and as a Service via our official partners. Please send your questions and inquiries to the predystic@egis.hu e-mail address.

For more information on the PREDYSTIC® Infliximab RA Kit please scroll down and visit the 1.1. Clinical need / 1.2. Development / 1.3. Clinical Performance Evaluation sections.

For the latest information, visit the Linkedin page of the PREDYSTIC® Infliximab RA Kit.

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Clinical need

In rheumatoid arthritis (RA), the therapeutic response shows significant differences between individuals, thus it would be helpful to have a complementary diagnostic tool for predicting the therapeutic response before treatment initiation.
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Development

From the biomarker discovery to the successful clinical validation.
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Clinical Performance Evaluation

The successful clinical performance evaluation is essential for the EU IVD MD registration, which proves and confirms the efficacy and safety of the PREDYSTIC® Infliximab RA Kit.
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Quick news
Oct 12

Genedata has Successfully Collaborated with Egis Pharmaceuticals PLC to Develop a Precision Medicine Tool for Rheumatoid Arthritis

A novel approach to guide infliximab therapy selection for rheumatoid arthritis patients.
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Sep 09

CENTIVIS Interview: Personalised Drug Therapy For Rheumatoid Arthritis Patients – Lessons Learnt From Diagnostic Development

Diagnostic algorithms are increasingly helping to tailor therapies for patients. What are the key learnings in building a diagnostic algorithm to personalise therapy for rheumatoid arthritis patients? We talk to Zsolt Hollo, MD, PhD, MBA, Head of the Center of Biological Business Development and Technology at Egis Pharmaceuticals PLC.
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Mar 16

Egis Pharmaceuticals PLC Announces Registration of the First Blood-based CE IVD Precision Medicine Tool for Therapy Selection in Rheumatoid Arthritis

Budapest, Hungary – March 16, 2021. Egis Pharmaceuticals PLC (Egis) received the CE In vitro Diagnostic (IVD) Medical Device Certificate of its PREDYSTIC® Infliximab RA Kit on December 21st, 2020.
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