Whole cell assays and methods
First Claim
1. A method of treating a human subject diagnosed with cancer, the method comprising:
- administering to the subject a first agent that is a targeted therapeutic that has been determined to be therapeutically active in the signaling pathway it is intended to address in the subject'"'"'s cancer cells by a method comprising;
culturing a sample consisting essentially of viable primary or metastatic cancer cells obtained from the subject in a media free of serum;
contacting the sample with the first agent and with a second agent that is known to selectively affect the same signaling pathway the first agent is intended to address, so as to upregulate or downregulate the signaling pathway as measured by an effect on cell adhesion or attachment, to produce a sample contacted with both the first agent and the second agent;
continuously measuring cell adhesion or attachment of viable primary or metastatic cancer cells in the sample contacted with both the first agent and the second agent, relative to a sample of viable primary or metastatic cancer cells obtained from the subject which sample is contacted with the first agent or the second agent alone;
determining by mathematical analysis of the continuous measurements an output value, expressed as a percentage, that characterizes whether a change in cell adhesion or attachment has occurred in the sample contacted with both the first agent and the second agent, as compared to the sample contacted with the first agent or the second agent alone; and
administering the first agent to the subject wherein the output value that characterizes the change in cell adhesion or attachment is equal to or greater than 50%, indicating the first agent is therapeutically active in the cell signaling pathway of the subject'"'"'s cancer cells.
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Accused Products
Abstract
The disclosure provides methods for analysis of disease cell response to a therapeutic agent. In embodiments, a method comprises administering the therapeutic agent to a disease cell sample from the subject in a device that measures at least one physiological parameter of a cell; determining whether a change occurs in the physiologic parameter of the disease cell sample in response to the therapeutic agent as compared to a baseline measurement or the physiological parameter before administration of the therapeutic agent, and selecting the therapeutic agent that results in the change in the at least one physiologic parameter. In embodiments, the disease cells are whole, viable, and/or label free.
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Citations
21 Claims
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1. A method of treating a human subject diagnosed with cancer, the method comprising:
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administering to the subject a first agent that is a targeted therapeutic that has been determined to be therapeutically active in the signaling pathway it is intended to address in the subject'"'"'s cancer cells by a method comprising; culturing a sample consisting essentially of viable primary or metastatic cancer cells obtained from the subject in a media free of serum; contacting the sample with the first agent and with a second agent that is known to selectively affect the same signaling pathway the first agent is intended to address, so as to upregulate or downregulate the signaling pathway as measured by an effect on cell adhesion or attachment, to produce a sample contacted with both the first agent and the second agent; continuously measuring cell adhesion or attachment of viable primary or metastatic cancer cells in the sample contacted with both the first agent and the second agent, relative to a sample of viable primary or metastatic cancer cells obtained from the subject which sample is contacted with the first agent or the second agent alone; determining by mathematical analysis of the continuous measurements an output value, expressed as a percentage, that characterizes whether a change in cell adhesion or attachment has occurred in the sample contacted with both the first agent and the second agent, as compared to the sample contacted with the first agent or the second agent alone; and administering the first agent to the subject wherein the output value that characterizes the change in cell adhesion or attachment is equal to or greater than 50%, indicating the first agent is therapeutically active in the cell signaling pathway of the subject'"'"'s cancer cells. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of treating a human subject diagnosed with cancer, the method comprising:
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administering to the subject a HER targeted therapeutic that has been determined to be therapeutically active in a HER family signaling pathway of the subject'"'"'s cancer cells by a method comprising; culturing a sample consisting essentially of viable primary or metastatic cancer cells obtained from the subject in a media free of serum; contacting (1) a first portion of the sample with the HER targeted therapeutic and with neuregulin, and/or (2) contacting a second portion of the sample with the HER targeted therapeutic and with an epidermal growth factor; continuously measuring cell adhesion or attachment of viable primary or metastatic cancer cells (1) in the first portion of the sample contacted with both the HER targeted therapeutic and neuregulin, relative to a sample of viable primary or metastatic cancer cells obtained from the subject which sample is contacted with the HER targeted therapeutic or neuregulin alone, and/or (2) in the second portion of the sample contacted with both the HER targeted therapeutic and an epidermal growth factor, relative to a sample of viable primary or metastatic cancer cells obtained from the subject which sample is contacted with the HER targeted therapeutic or an epidermal growth factor alone; determining by mathematical analysis of the continuous measurements an output value, expressed as a percentage, that characterizes whether a change in cell adhesion or attachment has occurred (1) in the first portion contacted with both the HER targeted therapeutic and neuregulin, as compared to the sample contacted with the HER targeted therapeutic or neuregulin alone, and/or (2) in the second portion contacted with both the HER targeted therapeutic and an epidermal growth factor, as compared to the sample contacted with the HER targeted therapeutic or an epidermal growth factor alone; and administering the HER targeted therapeutic to the subject wherein the output value that characterizes the change in cell adhesion or attachment is equal to or greater than 50%, indicating the HER targeted therapeutic is therapeutically active in the HER family signaling pathway of the subject'"'"'s cancer cells. - View Dependent Claims (18, 19, 20, 21)
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Specification