SAN DIEGO, CA, United States
SAN DIEGO, CA, United States
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The disclosure provides a method of predicting de novo resistance to androgen receptor (AR) targeted therapy in a tumor of a prostate 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 generate circulating tumor cell (CTC) data, wherein the analysis comprises determining a measurable feature of a panel of traditional and non-traditional CTC biomarkers for de novo resistance to androgen receptor (AR) targeted therapy, and ( b) evaluating the CTC data to determine the probability of de novo resistance to the AR targeted therapy in the tumor of the prostate cancer patient. Further disclosed are the panel of traditional and non-traditional CTC biomarkers for the methods.


Patent
Epic Sciences, Inc. | Date: 2017-08-23

The disclosure provides a method for determining if a subject afflicted with cancer is a candidate for Programmed Death Ligand-1 (PD-Ll) targeted immunotherapy, which method comprises (a) providing a liquid biopsy sample obtained from the subject afflicted with cancer; (b) detecting CTCs in the liquid biopsy sample; (c) calculating what proportion of CTCs in the liquid biopsy express PD-Ll; and (c) identifying the subject as a candidate for PD-Ll targeted immunotherapy based on an assessment that the proportion of the CTCs in the liquid biopsy that express PD-Ll exceeds a pre-determined threshold level.


Patent
Epic Sciences, Inc. | Date: 2016-12-28

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.


The present invention describes a method for detecting NEPC in 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 presence or absence of a CTC subpopulation associated with NEPC comprising detecting a measurable feature of each biomarker in a panel of morphological and protein biomarkers, wherein the presence of the CTC subpopulation associated with NEPC is indicative of NEPC. In other embodiments, the biomarkers for the CTC subpopulation associated with NEPC comprise small size, absence of Androgen Receptor (AR^()), and presence of nucleoli (nucleoli^(+)). In additional embodiments, the methods of the invention further comprise molecular analysis of the CTCs.


Patent
Epic Sciences, Inc. | Date: 2015-01-26

The present invention describes a method for detecting castration-resistant prostate cancer (CRPC) in 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 associated with CRPC comprising detecting a measurable feature of each biomarker in a panel of morphological and protein biomarkers, and (c) comparing the prevalence of said CTC subpopulation to a predetermined threshold value, wherein the prevalence of the CTC subpopulation associated with CRPC above said predetermined threshold value is indicative of CRPC. In some embodiments, the CTC subpopulation associated with CRPC comprises CK CTCs. In some embodiments, the CTC subpopulation associated with CRPC comprises small CTCs. In additional embodiments, the methods of the invention further comprise molecular analysis of the CTCs.


Patent
Epic Sciences, Inc. | Date: 2015-02-19

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.


The disclosure provides a method of predicting resistance to androgen receptor (AR) targeted therapy in a prostate cancer patient comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to identify circulating tumor cells (CTCs), and (b) based on said direct analysis further determining the presence of a biomarker signature that is predictive of resistance to AR targeted therapy in the prostate cancer patient, wherein the biomarker signature comprises CK+, AR+, nucleoli+ CTCs in a subpopulation of said CTCs. The present disclosure also provides a method of predicting resistance to taxane-based chemotherapy in a prostate cancer patient comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to identify circulating tumor cells (CTCs), and (b) based on said direct analysis further determining the presence of a biomarker signature that is predictive of resistance to taxane-based chemotherapy in the prostate cancer patient, wherein the biomarker signature comprises CK+, AR, nucleoli+, small size in a subpopulation of said CTCs.


Patent
Scripps Research Institute and Epic Sciences, Inc. | Date: 2016-07-20

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.


The disclosure provides methods for detecting circulating endothelial cells (CECs) that mimic CTCs with respect to aspects of their immunofluorescent 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 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.

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