Tue, Feb 16, 2021 9:00 AM

Clinical Performance Evaluation

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

Clinical Performance Evaluation

The successful clinical performance evaluation, which proves the efficacy and safety of the PREDYSTIC® Infliximab RA Kit is essential for the EU IVD MD registration.
Tue, Feb 16, 2021 9:00 AM
Tue, Feb 16, 2021 9:00 AM

The clinical performance evaluation confirms the efficacy and safety of the test. In case of a device such as the innovative PREDYSTIC® Infliximab RA Kit, the clinical performance test is the base of the clinical performance evaluation. For the clinical performance test, Egis conducted an international multicentric clinical study with the enrollment of 217 patients.

In addition to specificity and sensitivity, the test even predicts the Disease Activity Score (DAS28 CRP) prediction for the 6th months of the treatment.

For the Clinicians, the clinical performance characteristic is a simple reference for a complementary diagnostic such as the PREDYSTIC® Infliximab RA Kit.

In addition to specificity and sensitivity, the test even predicts the Disease Activity Score (DAS28 CRP) prediction for the 6th months of the treatment.

 For more information on the PREDYSTIC® Infliximab RA Kit please visit the Personalized Medicine / Clinical need / Development sections.

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