A method for identifying and enumerating candidate target cells within a biological fluid specimen is described. The method includes obtaining a biological fluid specimen, preparing the biological fluid specimen by staining cell features in the biological fluid specimen, capturing a digital image having a plurality of color channels of the biological fluid specimen, and applying image analysis to the digital image. A computer program product for identifying candidate target cells within a biological fluid specimen is also described. The computer program comprises instructions to cause a processor to carry out the image analysis.

The present disclosure provides devices and systems for diagnosing and characterizing cancer in a subject. Devices include microfilters and microfiltration systems useful for the isolation and characterization of cells from a subject.

Disclosed is an isolated monoclonal antibody comprising a heavy chain and a light chain, wherein the heavy chain comprises CDR1, CDR2 and CDR3 consisting of amino acid sequences set forth in SEQ ID NOs: 1, 2 and 3, respectively, and the light chain comprises CDR1, CDR2 and CDR3 consisting of amino acid sequences set forth in SEQ ID NOs: 4, 5 and 6, respectively.

The current disclosure provides for specific peptides, and derived ionization characteristics of the peptides, from the KRT5, KRT7, NapsinA, TTF1, TP63, and/or MUC1 proteins that are particularly advantageous for quantifying the KRT5, KRT7, NapsinA, TTF1, TP63, and/or MUC1 proteins directly in biological samples that have been fixed in formalin by the method of Selected Reaction Monitoring (SRM) mass spectrometry, or what can also be termed as Multiple Reaction Monitoring (MRM) mass spectrometry. Such biological samples are chemically preserved and fixed wherein said biological sample is selected from tissues and cells treated with formaldehyde containing agents/fixatives including formalin-fixed tissue/cells, formalin-fixed/paraffin embedded (FFPE) tissue/cells, FFPE tissue blocks and cells from those blocks, and tissue culture cells that have been formalin fixed and or paraffin embedded. A protein sample is prepared from said biological sample using the Liquid Tissue™ reagents and protocol and the KRT5, KRT7, NapsinA, TTF1, TP63, and/or MUC1 proteins are quantitated in the Liquid Tissue™ sample by the method of SRM/MRM mass spectrometry by quantitating in the protein sample at least one or more of the peptides described. These peptides can be quantitated if they reside in a modified or an unmodified form. An example of a modified form of a KRT5, KRT7, NapsinA, TTF1, TP63, and MUC1 fragment peptide is phosphorylation of a tyrosine, threonine, serine, and/or other amino acid residues within the peptide sequence.

The disclosure provides a method for detecting prostate specific membrane antigen (PSMA) on circulating tumor cells (CTCs) obtained from a patient afflicted with prostate cancer comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to detect circulating tumor cells (CTC), and (b) determining the number of CTCs expressing PSMA. The disclosure also provides a provides a method for identifying a patient afflicted with prostate cancer as a candidate for PSMA targeted therapy comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to detect circulating tumor cells (CTC), (b) determining prevalence of a CTC subpopulation expressing PSMA, and (c) comparing the prevalence of the CTC subpopulation expressing PSMA to a reference value, wherein the prevalence of the CTC subpopulation expressing PSMA above the reference value identifies the patient as a candidate for PSMA targeted therapy. The disclosure further provides a provides a method for predicting resistance to androgen receptor (AR) targeted therapy a patient afflicted with prostate cancer comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to detect circulating tumor cells (CTC), (b) determining prevalence of a CTC subpopulation expressing PSMA, and (c) comparing the prevalence of the CTC subpopulation expressing PSMA to a reference value, wherein the prevalence of the CTC subpopulation expressing PSMA above the reference value is indicative of resistance to androgen receptor (AR) targeted therapy.

The disclosure provides methods for detecting circulating endothelial cells (CECs) that mimic CTCs with respect to aspects of their immuno fluorescent staining and with respect to aspects of their morphological characteristics (CTC mimics). The present disclosure is based, in part, on the unexpected discovery that CTC mimics can be detected in non-enriched blood samples among CTC candidate cells. The present disclosure is further based, in part, on the discovery that CTC mimics can be detected in non-enriched blood samples by combining the detection of one or more immunofluorescent markers in the nucleated cells of a non-enriched blood sample with an assessment of the morphology of the nucleated cells.

The present invention concerns enriched heterogeneous mammalian renal cell populations characterized by biomarkers, and methods of making and using the same.

The purpose of the present invention is to provide a method for accurately predicting a cancer patient prognosis based on a count of desired cells for which expression of a leukocyte marker and an epithelial marker is hardly exhibited by detecting those cells. Provided is a method for diagnosing an overall survival prognosis for a patient suffering from cancer, the method including: a step of obtaining a concentrated solution containing desired cells by pre-treating a biological sample obtained from the patient; a step of optically detecting the concentrated cells; and a step of detecting the desired cells from the detected image, wherein an association is made with the overall survival prognosis diagnosis by counting the detected desired cells, and wherein the desired cells are cells confirmed by the existence of a cell nucleus and in which expression of a leukocyte marker and an epithelial marker is hardly exhibited.

The current disclosure provides methods for detecting and analyzing K17 expression in a bladder sample obtained from a subject. The current disclosure also pertains to methods and kits for identifying a mammalian subject with bladder cancer by detecting the expression of K17 in a sample. The present methods include both cell-based and cell-free methods for determining the level of keratin 17 in a sample obtained from the bladder of a subject.

Disclosed herein are methods, uses and compositions for the treatment or prophylaxis of cancer in a mammalian subject comprising administering to the subject an amount of an agent which targets an extracellular portion of KRT14 or its functional homolog or variant thereof resident on cancer cells or an agent which induces production of an antagonist of the extracellular portion of KRT14 or its functional homolog or variant on cancer cells. The present disclosure also extends to methods of monitoring and/or diagnosing cancer in a subject.