Method and kit for predicting the therapeutic response of a...

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G01N 33/554 (2006.01) G01N 33/50 (2006.01) G01N 33/569 (2006.01)

Patent

CA 2215627

The present invention relates to a method of predicting the therapeutic response of a drug against a malignant tumour in a human patient, using a sample of a fine needle aspirate of the tumour from the patient. The method comprises the steps of identifying and estimating in the sample the number of cells belonging to one class of cells in relation to other cells in the sample, and comparing the estimation with a previously made analysis demonstrating correlation between the number of the cells and parameters of the therapeutic response of the drug directed towards the tumour in human patients, the results of the comparison being indicative of the therapeutic response of the drug in human patient. A diagnostic kit comprises a mixture of enzymes rendering the sample of the tumour a single cell suspension, a first mixture of monoclonal antibodies directed towards tumour associated antigens on tumour cells in the single cell suspension, said antibodies having a first label, and a second mixture of two types of monoclonal antibodies directed towards two specific antigens on lymphocytes, said antibodies having a second and a third label, respectively.

Procédé permettant de prédire la réponse thérapeutique d'un médicament contre une tumeur maligne chez un patient humain à partir d'un échantillon prélevé par aspiration à l'aide d'une aiguille fine dans ladite tumeur sur le patient. Ledit procédé consiste à identifier et à estimer dans l'échantillon le nombre de cellules appartenant à une classe de cellules en relation à d'autres cellules de l'échantillon et à comparer ladite estimation à une analyse préalable démontrant une corrélation entre le nombre de cellules et des paramètres de réponse thérapeutique du médicament dirigé contre la tumeur chez des patients humains, le résultat de ladite comparaison indiquant la réponse thérapeutique du médicament chez le patient humain. Un kit de diagnostic comprend un mélange d'enzymes faisant de l'échantillon de tumeur une suspension unicellulaire, un premier mélange d'anticorps monoclonaux dirigés contre des antigènes associés à des tumeurs sur des cellules tumorales se trouvant dans la suspension unicellulaire, lesdits anticorps ayant une première étiquette, et un second mélange de deux types d'anticorps monoclonaux dirigés contre deux antigènes spécifiques sur des lymphocytes, lesdits anticorps ayant des deuxième et troisième étiquettes, respectivement.

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