Abstract: A method of manufacturing a laminate microfluidic device is described herein. Also described is the microfluidic device manufactured via the method of the disclosure, as well as use of the device to perform an assay. The laminate device includes a substrate layer, an adhesive layer having a cured adhesive with one or more channels or recesses formed therein, and a top layer.

Abstract: A device for separating blood plasma from whole blood includes a first reservoir and a second reservoir. The first reservoir is configured to receive a sample of whole blood including red blood cells and includes a collection region and a constricted region. The second reservoir is fluidically connected to the constricted region of the first reservoir, such that, responsive to centrifugal force applied to the device, the sample of whole blood disposed within the first reservoir separates into a first fraction and a second fraction. The first fraction is located in the collection region and includes blood plasma from which substantially all red blood cells have been removed. The second fraction is located in the second reservoir and includes blood plasma and red blood cells that have been removed from the first fraction by the centrifugal force. The constricted region inhibits the second fraction from entering the collection region.

Abstract: An assay device includes a first flow channel of a first size and a second flow channel of a second size disposed within a planar substrate, the second size being larger than the first size. The first flow channel is configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer. The second flow channel is configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer. The first analyte has higher population density within the liquid sample compared to the second analyte.

Abstract: A device for separating blood plasma from whole blood includes a first reservoir and a second reservoir. The first reservoir is configured to receive a sample of whole blood including red blood cells and includes a collection region and a constricted region. The second reservoir is fluidically connected to the constricted region of the first reservoir, such that, responsive to centrifugal force applied to the device, the sample of whole blood disposed within the first reservoir separates into a first fraction and a second fraction. The first fraction is located in the collection region and includes blood plasma from which substantially all red blood cells have been removed. The second fraction is located in the second reservoir and includes blood plasma and red blood cells that have been removed from the first fraction by the centrifugal force. The constricted region inhibits the second fraction from entering the collection region.

Abstract: A device for separating blood plasma from whole blood includes a first reservoir and a second reservoir. The first reservoir is configured to receive a sample of whole blood including red blood cells and includes a collection region and a constricted region. The second reservoir is fluidically connected to the constricted region of the first reservoir, such that, responsive to centrifugal force applied to the device, the sample of whole blood disposed within the first reservoir separates into a first fraction and a second fraction. The first fraction is located in the collection region and includes blood plasma from which substantially all red blood cells have been removed. The second fraction is located in the second reservoir and includes blood plasma and red blood cells that have been removed from the first fraction by the centrifugal force. The constricted region inhibits the second fraction from entering the collection region.

Abstract: The invention provides seminal computational approaches utilizing data from non-rare cells to detect rare cells, such as circulating tumor cells (CTCs). The invention is applicable at two distinct stages of CTC detection; the first being to make decisions about data collection parameters and the second being to make decisions during data reduction and analysis. Additionally, the invention utilizes both one and multi-dimensional parameterized data in a decision making process.

Abstract: The disclosure provides a method of detecting heterogeneity of disease in a cancer patient comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characteristization of nucleated cells in a blood sample obtained from the patient to identify and enumerate circulating tumor cells (CTC); (b) isolating the CTCs from the sample; (c) individually characterizing genomic parameters to generate a genomic profile for each of the CTCs, and (d) determining heterogeneity of disease in the cancer patient based on the profile. In some embodiments, the cancer is prostate cancer. In some embodiments, the prostate cancer is hormone refractory.

Abstract: The disclosure provides methods for analyzing rare circulating cells (RCCs) at cellular and molecular level following their detection in non-enriched blood samples, methods of this disclosure serve as diagnostic methods for several disease conditions, including cardiovascular diseases and cancer.

Abstract: An assay device as well as a method of use thereof is described. The assay device includes a planar substrate having a top surface and a bottom surface. The assay device further includes one or more flow channels disposed within the planar substrate and extending along a dimension of the planar substrate between the top surface and the bottom surface. The assay device further includes an inlet fluidly coupled to the one or more flow channels and one or more vents fluidly coupled to the one or more channels which are operable to facilitate flow of a liquid sample, such as whole blood through the one or more channels. The one or more flow channels are configured to receive a liquid sample from the inlet and allow flow of the liquid sample.

Abstract: The disclosure provides a method of detecting heterogeneity of disease in a cancer patient comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characteristization of nucleated cells in a blood sample obtained from the patient to identify and enumerate circulating tumor cells (CTC); (b) isolating the CTCs from the sample; (c) individually characterizing genomic parameters to generate a genomic profile for each of the CTCs, and (c) determining heterogeneity of disease in the cancer patient based on the profile. In some embodiments, the cancer is prostate cancer. In some embodiments, the prostate cancer is hormone refractory.

Abstract: Methods are provided for detecting circulating tumor cells in a mammalian subject. Methods of diagnosing cancer in a mammalian subject are provided. The methods of detection or diagnosis indicate the presence of metastatic cancer or early stage cancer.

Abstract: The invention provides seminal computational approaches utilizing data from non-rare cells to detect rare cells, such as circulating tumor cells (CTCs). The invention is applicable at two distinct stages of CTC detection; the first being to make decisions about data collection parameters and the second being to make decisions during data reduction and analysis. Additionally, the invention utilizes both one and multi-dimensional parameterized data in a decision making process.

Abstract: The disclosure provides methods for analyzing rare circulating cells (RCCs) at cellular and molecular level following their detection in non-enriched blood samples, methods of this disclosure serve as diagnostic methods for several disease conditions, including cardiovascular diseases and cancer.

Abstract: The invention provides methods for diagnosing prostate cancer. The invention also provides methods for determining the prognosis and efficacy of STEAP1-ADC therapy in patients with prostate cancer, specifically metastatic castration resistant prostate cancer (mCRPC).

Abstract: The invention provides seminal computational approaches utilizing data from non-rare cells to detect rare cells, such as circulating tumor cells (CTCs). The invention is applicable at two distinct stages of CTC detection; the first being to make decisions about data collection parameters and the second being to make decisions during data reduction and analysis. Additionally, the invention utilizes both one and multi-dimensional parameterized data in a decision making process.