Diagnostic methods involving determining gene copy numbers...

C - Chemistry – Metallurgy – 12 – Q

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C12Q 1/68 (2006.01)

Patent

CA 2634692

The invention relates to diagnostic methods to predict whether a subject is predisposed for acquiring a disease or to predict the therapy responsiveness of an individual patient. Provided is a method for determining whether a subject is predisposed for developing an autoimmune disease, comprising determining in a sample isolated from said subject the amount of intact genes, or gene products thereof, of the Fc.gamma.RII/Fc.gamma.RIII gene cluster, said gene cluster comprising the FCGR2C, FCGR3A, FCGR2A and FCGR3B genes encoding an activating Fc.gamma.R, and FCGR2B encoding an inhibitory Fc.gamma. R; and correlating said amount to the amount observed in a healthy population. Also provided is a method to predict the responsiveness of a subject to therapy with intravenous immunoglobulin (IVIg) therapy or a monospecific biological, such as a humanized or human monoclonal antibody or a chimeric molecule, comprising the C-terminal Fc-tail of IgG.

La présente invention concerne des procédés de diagnostics pour prédire si un sujet est prédisposé à une maladie ou pour prédire la capacité de réponse à un traitement d~un patient individuel. Il s~agit d~un procédé pour déterminer si un sujet est prédisposé à développer une maladie auto-immunitaire, y compris la détermination dans un échantillon isolé dudit sujet, de la quantité de gènes intacts, ou des produits de la famille de gènes Fc.gamma.RII/Fc.gamma.RIII, ledit gène comprenant les gènes FCGR2C, FCGR3A, FCGR2A et FCGR3B encodant un Fc.gamma.R d~activation, et FCGR2B encodant un Fc.gamma. R inhibiteur, et mettant en corrélation ladite quantité à la quantité observée dans une population saine. Est également fourni un procédé de prédiction de la réponse d~un sujet à une thérapie d~immuglobulines intraveineuse (IVIg) ou biologique monospécifique, tel qu~un anticorps monoclonal humain ou humanisé ou une molécule chimérique, comprenant l~extrémité Fc de terminal C d~IgG.

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