Antigene und Zugehöriger Test zum Nachweis und zur Messung von Autoantikörpern bei einer Person mit sich Entwickelnder Diabetes Typ 1 (T1D)

Details

Veröffentlichungs-Nr.

EP4768595

Anmeldetag

24. Dezember 2024

Veröffentlichung

1. Juli 2026

Rechtsraum

EP

Abstract

The present invention relates to a test kit for performing an assay to detect and measure at least one autoantibody molecule in a subject developing type 1 diabetes (T1D). The invention more specifically relates to a recombinant antigen molecule fused to a bioluminescent reporter protein to detect an autoantibody molecule against a self-antigen. Said self-antigen is preferably expressed by pancreatic islet beta cells and include insulin, proinsulin, Glutamate decarboxylase 65, islet antigen 2, and Zinc transporter 8. More specifically, the present invention relates to an assay comprising a set of at least three recombinant antigen molecules in a single composition, the antigen molecules being selected from the list comprising recombinant human Glutamate decarboxylase 65, recombinant human islet antigen 2, recombinant human Zinc transporter 8, recombinant human insulin, and recombinant human proinsulin. The invention further relates to methods for determining the presence and/or level of at least one autoantibody molecule in a sample from a human subject developing T1D using said recombinant antigen molecules. According to the invention, the presence, absence, or amount of one or more autoantibody molecules against said self-antigens is determined with a luciferase immune precipitation system (LIPS) assay or a modified version of a LIPS assay, i.e., a solid phase capture LIPS (scLIPS) assay.

Anmelder

Firmen

Fondazione Centro San Raffaele
Ospedale San Raffaele S.r.l.
Università Vita-Salute San Raffaele

Land

🇮🇹 Italien