Abstract: A microfilter having a hydrophilic surface and suited for size-based capture and analysis of cells, such as circulating cancer cells, from whole blood and other human fluids is disclosed. The filter material is photo-definable, allowing the formation of precision pores by UV lithography. Exemplary embodiments provide a device that combines a microfilter with 3D nanotopography in culture scaffolds that mimic the 3D in vivo environment to better facilitate growth of captured cells.

Abstract: A microfilter comprising a polymer layer formed from epoxy-based photo-definable dry film, and a plurality of apertures each extending through the polymer layer. A method of forming a microfilter is also disclosed. The method includes providing a first layer of epoxy-based photo-definable dry film disposed on a substrate, exposing the first layer to energy through a mask to form a pattern, defined by the mask, in the first layer of dry film, forming, from the exposed first layer of dry film, a polymer layer having a plurality of apertures extending therethrough, the plurality of apertures having a distribution defined by the pattern, and removing the polymer layer from the substrate.

Abstract: Methods of using detection of PD-L1 expression by circulating cancer cells in the screening, monitoring, treatment and diagnosis of cancer in subjects are disclosed. The methods are based on assaying one or more of circulating tumor cells (CTCs), epithelial to mesenchymal transition CTCs (EMTCTCs), cancer associated macrophage-like cells (CAMLs), and cancer associated vascular endothelial cells (CAVEs) isolated from a subject having cancer for PD-L1 expression.

Abstract: Methods of using detection of PD-L1 expression by circulating cancer cells in the screening, monitoring, treatment and diagnosis of cancer in subjects are disclosed. The methods are based on assaying one or more of circulating tumor cells (CTCs), epithelial to mesenchymal transition CTCs (EMTCTCs), cancer associated macrophage-like cells (CAMLs), and cancer associated vascular endothelial cells (CAVEs) isolated from a subject having cancer for PD-L1 expression.

Abstract: Means for predicting overall survival (OS) and progression free survival (PFS) of subjects having cancer are disclosed, where the predictions are based on the number of CCR5 pools in circulating cells, such as circulating cancer associated macrophage-like cells (CAMLs) and circulating tumor cells (CTCs) found in a biological sample, such as blood, from the subject. CCR5 expression can also be used for companion or complementary diagnostics.

Abstract: A microfilter having a hydrophilic surface and suited for size-based capture and analysis of cells, such as circulating cancer cells, from whole blood and other human fluids is disclosed. The filter material is photo-definable, allowing the formation of precision pores by UV lithography. Exemplary embodiments provide a device that combines a microfilter with 3D nanotopography in culture scaffolds that mimic the 3D in vivo environment to better facilitate growth of captured cells.

Abstract: A new sensitive cell biomarker of solid tumors is identified in blood. This biomarker can be used to determine presence of solid tumors, rapid determination of treatment response, early detection of cancer, early detection of cancer recurrence, and may be used to determine therapy.

Abstract: Circulating tumor cells (CTCs) are associated with metastasis of malignant solid tumors in a patient. Presented here is evidence that CTCs exhibit cell cycle phase variability and that there is a strong correlation between the number of CTCs in a mitotic cell cycle phase and the prospects for long term survival of the subject from which the cells were obtained. Also presented herein are methods of determining the mitotic cell cycle phase of CTCs from a patient having cancer and using the information in grading malignant solid tumors and predicting the likelihood of survival of the patient.

Abstract: A microfilter having a hydrophilic surface and suited for size-based capture and analysis of cells, such as circulating cancer cells, from whole blood and other human fluids is disclosed. The filter material is photo-definable, allowing the formation of precision pores by UV lithography. Exemplary embodiments provide a device that combines a microfilter with 3D nanotopography in culture scaffolds that mimic the 3D in vivo environment to better facilitate growth of captured cells.

Abstract: A new sensitive cell biomarker of solid tumors is identified in blood. This biomarker can be used to determine presence of solid tumors, rapid determination of treatment response, early detection of cancer, early detection of cancer recurrence, and may be used to determine therapy.

Abstract: Circulating tumor cells (CTCs) are associated with metastasis of malignant solid tumors in a patient. Presented here is evidence that CTCs exhibit cell cycle phase variability and that there is a strong correlation between the number of CTCs in a mitotic cell cycle phase and the prospects for long term survival of the subject from which the cells were obtained. Also presented herein are methods of determining the mitotic cell cycle phase of CTCs from a patient having cancer and using the information in grading malignant solid tumors and predicting the likelihood of survival of the patient.

Abstract: A new sensitive cell biomarker of solid tumors and viral infection is identified in blood. This biomarker can be used to determine presence of carcinomas, sarcomas, and viruses, rapid determination of treatment response, early detection of cancer, early detection of cancer recurrence, and may be used to determine therapy.

Abstract: Means for monitoring treatment response and disease progression in subjects are disclosed, where the predictions are based on the change of number and/or size of circulating cancer associated macrophage-like cells (CAMLs) found in a biological ample, such as blood, from the subject.

Abstract: A new sensitive cell biomarker of solid tumors and viral infection is identified in blood. This biomarker can be used to determine presence of carcinomas, sarcomas, and viruses, rapid determination of treatment response, early detection of cancer, early detection of cancer recurrence, and may be used to determine therapy.

Abstract: The characterization of nucleic acids obtained from cancer-associated cells circulating in the blood of a subject, and the use of such characterizations in cancer screening, diagnostics, treatment, and recurrence, are disclosed.

Abstract: Means for predicting overall survival (OS) and progression free survival (PFS) of subjects having cancer are disclosed, where the predictions are based on the number arid size of circulating cancer associated macrophage-like cells (CAMLs) found in a biological sample, such as blood, from the subject.

Abstract: A microfilter having a hydrophilic surface and suited for size-based capture and analysis of cells, such as circulating cancer cells, from whole blood and other human fluids is disclosed. The filter material is photo-definable, allowing the formation of precision pores by UV lithography. Exemplary embodiments provide a device that combines a microfilter with 3D nanotopography in culture scaffolds that mimic the 3D in vivo environment to better facilitate growth of captured cells.

Abstract: A preservative reagent for urine is disclosed that increases the stability of cells, such as tumor cells, in urine for a period of several weeks. The preservative reagent comprises polyethylene glycol (PEG), ethanol, paraformaldehyde (PFA), and ethylenediaminetetraacetic acid (EDTA), and optionally pH stabilizing reagents.

Abstract: A microfilter comprising a polymer layer formed from photo-definable dry film, and a plurality of apertures each extending through the polymer layer. A microfilter comprising two or more polymer layers formed from photo-definable dry film, and a plurality of apertures or open areas each extending through the polymer layer. Methods of forming apertures in one or more layers of photo-definable dry film are also disclosed. Filter holder designs and methods appropriate to hold microfilters to collect the rare cells and to perform of assays in the filter holder are provided. Microfiltration chip designs and methods appropriate to collect the rare cells and to perform assays in the microfluidic chips are provided. The invention also describes the use of the microfilter, filter holder and microfilter chips to collect rare cells from body fluids and perform assays, and these rare cells can be used for medical and biological research applications.

Abstract: Micro- and nanofilters with precision pore sizes and pore layout have applications in many fields including capturing circulating tumor cells and fetal cells in blood, water treatment, pathogen detection in water, etc. Methods to fabricate micro- and nanofilters not using track etching or reactive ion etching are provided, allowing easy fabrication of single layer or stack of films simultaneously, and/or stack of films on rolls. Microfilter can be made using one or more layers of material. Invention enables mass production of microfilters with lithographic quality at low cost. Isolation, enumeration and characterization of circulating tumor cells using microfilters provides (i) guides to cancer treatment selection and personalize dosage, (ii) low cost monitoring for treatment response, disease progression and recurrence, (iii) assessment of pharmacodynamic effects, (iv) information on mechanisms of resistance to therapy, and (v) cancer staging.