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Updated: Apr 22, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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CD19 mRNA quantification improves rituximab treatment-to-target approach: a proof of concept study
Fabiana Marnetto1, Letizia Granieri1, Paola Valentino1
1Clinical Neurobiology Unit, Regional Referring Multiple Sclerosis Centre (CRESM), Neuroscience Institute Cavalieri Ottolenghi (NICO), University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy; Clinical Neurology Unit, Regional Referring Multiple Sclerosis Centre (CReSM), University Hospital San Luigi Gonzaga,Orbassano, Turin, Italy.
Abstract:
We compared pre-amplification (PA) RT-PCR blood CD19 mRNA quantification with flow cytometry (FC), to personalize rituximab re-treatment in neuromyelitis optica spectrum disorders (NMOSDs) patients. 47 blood samples from 3 NMOSDs patients were studied. PA-RT-PCR quantified CD19 in all samples, and a positivity threshold was defined, whereas CD19+ B cells were under threshold in 31/47 samples by FC. In all samples where CD19+ B cells were above FC threshold, they resulted above the PA-RT-PCR threshold. CD19 mRNA was above threshold in 8 other samples, resulted negative by FC, and preceded the FC positivity in 7/8 samples by 1-3 months, showing major sensitivity.
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