Her2 diagnostic methods
First Claim
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1. A method of quantitating an amount of HER-2 protein in a sample of a cancer from a subject, the method comprising:
- (a) measuring the amount of HER-2 protein in a sample of cancer from a subject, wherein the sample is deposited on a solid support, wherein the sample on the solid support comprises viable tumor tissue, necrotic tumor tissue and non-tumor tissue, and wherein the measuring is performed using an immunoassay comprising the steps of;
(i) contacting the sample with a first antibody that binds specifically to HER-2 and comprises a molecular tag attached thereto via a cleavable linkage,(ii) cleaving the cleavable linkage thereby releasing the molecular tag in a buffer volume, and(iii) quantifying the amount of released molecular tag in the buffer volume;
(b) after step (a), performing immunohistochemistry staining on the sample to distinguish viable tissue from non-viable tissue;
(c) defining a total tumor surface area on the sample on the solid support based on imaging of the immunohistochemistry staining of step (b), wherein the total tumor surface area includes all areas of viable tumor and excludes necrotic tissue and non-tumor tissue in the sample on the solid support;
(d) quantifying the size of the total tumor surface area; and
(e) determining the amount of HER-2 protein in the sample based on the amount of released molecular tag in the buffer volume normalized to the size of the total tumor surface area.
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Abstract
In certain aspects, the present invention provides methods for determining whether a Her-2 positive cancer is likely to respond to treatment with a Her2-acting agent and/or whether a patient with a Her-2 positive cancer is likely to have a slow disease progression. In other aspects, the present invention is drawn to methods for determining whether a subject with a Her-2 positive cancer is unlikely to respond to treatment with at least one chemotherapeutic agent in addition to a Her2-acting agent and/or whether a patient with a Her-2 positive cancer is likely to have a fast disease progression.
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Citations
21 Claims
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1. A method of quantitating an amount of HER-2 protein in a sample of a cancer from a subject, the method comprising:
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(a) measuring the amount of HER-2 protein in a sample of cancer from a subject, wherein the sample is deposited on a solid support, wherein the sample on the solid support comprises viable tumor tissue, necrotic tumor tissue and non-tumor tissue, and wherein the measuring is performed using an immunoassay comprising the steps of; (i) contacting the sample with a first antibody that binds specifically to HER-2 and comprises a molecular tag attached thereto via a cleavable linkage, (ii) cleaving the cleavable linkage thereby releasing the molecular tag in a buffer volume, and (iii) quantifying the amount of released molecular tag in the buffer volume; (b) after step (a), performing immunohistochemistry staining on the sample to distinguish viable tissue from non-viable tissue; (c) defining a total tumor surface area on the sample on the solid support based on imaging of the immunohistochemistry staining of step (b), wherein the total tumor surface area includes all areas of viable tumor and excludes necrotic tissue and non-tumor tissue in the sample on the solid support; (d) quantifying the size of the total tumor surface area; and (e) determining the amount of HER-2 protein in the sample based on the amount of released molecular tag in the buffer volume normalized to the size of the total tumor surface area. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification