Methods and devices for cellular analysis

Inventors

Clark, Douglas P. • SCHAYOWITZ, Adam • Murphy, Kathleen M. • Diamond, Scott

Assignees

Biomarker Strategies LLC

Abstract

Embodiments of the present invention are directed to improved methods and devices for analyzing a cell, aggregated cells, or a solid tumor. Such methods and devices are, for example, useful in the field of pathology and can provide improved cell processing and analytical results.

Core Innovation

The invention provides a method for processing cancer cells from a solid tumor sample by disaggregating and dispersing an aqueous solution containing live aggregated cancer cells into at least one test aliquot in a first isolated chamber. The method uses a predetermined amount of laminar fluid shear force to disrupt aggregates of the cancer cells without killing the cancer cells and triggering only a minimal stress response or no stress response in the cancer cells.

After dispersing, the method optionally purifies the aliquot to increase the percentage of target cancer cells relative to other contaminating cell types by removing contaminating cells. The method then distributes the live cancer cells into one or more second isolated chambers for analysis and contacts them ex vivo with at least one agent to produce a measurable quantitatively or qualitatively effect on a target ex vivo biomarker or biomolecules in a cellular pathway.

The invention further stabilizes the target ex vivo biomarker or biomolecule within about one to four hours by lysing or fixing the cancer cells on a solid support using a solution comprising a polymer, thereby killing the cancer cells. Finally, the method measures changes in levels of the target ex vivo biomarker or biomolecule to assess the response of the target cancer cells to the at least one agent.

Claims Coverage

The document provides one independent claim defining a sequential ex vivo workflow with laminar shear disaggregation, optional purification, isolated-chamber distribution, agent-driven pathway biomarker effects, polymer-based stabilization within a time window, and measurement of biomarker changes. The dependent claims refine the workflow with quantification constraints, agent classes, biomarker types, and chamber cell-loading limits.

Overall, claim coverage centers on preserving live aggregated cancer cells through laminar fluid shear disaggregation with minimal or no stress response, optionally enriching target cancer cells, analyzing them in isolated chambers after ex vivo agent exposure, and stabilizing target biomarkers on a solid support using a polymer solution within about one to four hours before measuring pathway biomarker changes to assess response.

Stated Advantages

Documented Applications