Cell response assay for cancer and methods of producing and using same

Abstract

A cell response assay for cancer is provided. In the assay, the levels of a cancer cell type biomarker, a chemo resistance biomarker and a metastatic potential biomarker are simultaneously measured in a biological sample.

Description

[0001]CROSS REFERENCE TO RELATED APPLICATIONS / INCORPORATION BY REFERENCE STATEMENT[0002]The present application is a continuation of U.S. Ser. No. 14 / 346,638, filed Mar. 21, 2014; which is a U.S. national stage application filed under 35 USC §371 of international application No. PCT / US12 / 56668, filed Sep. 21, 2012; which claims priority to U.S. Ser. No. 61 / 538,302, filed Sep. 23, 2011. The entire contents of each of the above-referenced patent applications are hereby expressly incorporated by reference.[0003]STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0004]Not Applicable.BACKGROUND[0005]1. Technical Field[0006]The presently disclosed and / or claimed inventive concept(s) generally relates to cellular assays. More particularly, but not by way of limitation, the presently disclosed and / or claimed inventive concept(s) relates to methods of assaying biological samples to determine the cellular response to treatment / therapy and / or monitor progression of a disease state....

AI Technical Summary

Benefits of technology

The patent text discusses the use of cellular assays for analyzing biomarkers and monitoring disease progression and treatment. These assays require high sensitivity detection methods, especially for rare cell analysis. The technical effect of the patent is to provide a method for detecting biomarkers using fluorescent labels with improved sensitivity, even for rare cells. This is achieved by using enzymes to catalytically increase the number of fluorescent labels and avoiding the need for excess affinity molecules.

Problems solved by technology

The sensitivity of traditional fluorescent labels for detecting biomarkers is generally poor for rare cell analysis.

However, enzymatic amplification involves multiple lengthy steps that increase the difficulty of the measurements.

However, multiple affinity molecules must also be attached to the nanoparticles, and adsorption of organic compounds onto nanoparticles also decreases the fluorescence signals.

As a result, the nanoparticles with fluorescent labels (such as FITC) are no more sensitive than directly conjugated fluorescent labels.

Additional problems with nanoparticles are that the size and coating must be carefully controlled for the particles to cross the cell walls (see, for example, Goodman et al., 2007).

As a result, the selection of biomarkers to test is a difficult choice; the expression level, number of epitopes, expression on cancer stem cells, cellular location of expression, and the number of patients with antigen positive cancers all must be considered.

However, all three of these methods also rely on “picking” the right antigen and fail to give good information for all patients.

Thus the current field lacks a comprehensive measure of the metastatic potential of a cancer cell / tissue.

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