The current disclosure provides methods for detecting and analyzing KRT4 and KRT17 expression in a sample obtained from a test subject. The current disclosure pertains to methods and kits for identifying a mammalian subject with cervical cancer or non-cancerous lesions of the cervix. The current disclosure further provides methods and kits for determining the likelihood of survival or treatment outcome of a subject having cervical cancer by determining the expression level of KRT17 in a sample.

The current disclosure provides methods for detecting and analyzing KRT17 expression in a sample obtained from a subject. The current disclosure also pertains to methods and kits for identifying a mammalian subject with head and neck squamous cell carcinoma. The current disclosure further provides methods and kits for determining the likelihood of survival of a subject having head and neck squamous cell carcinoma.

Devices and methods for labeling and mounting suspended cells in a controllable area are disclosed. The devices and methods utilize polycarbonate filters. The filters are employed both to capture the cells and as a substrate for labeling. This disclosure provides a device for cell capture and staining. This device utilizes a stack comprising a filter sandwiched between two o-rings (an “OFO stack”) in which the o-rings both seat the device and, based on their outer diameter and cross-section, determine the cell capture area. In one embodiment, an alignment plate is affixed to an output head of the device, the alignment plate having one or more through holes, a diameter of the one or more through holes matching an outer diameter of the OFO stack.

The present invention provides uses of cytokeratins as markers for diagnosing epithelium derived cancers. The present invention provides cancer-related epitopes of cytokeratins and monoclonal antibodies which specifically recognize the epitopes. The present invention also provides methods for the early screen, diagnosis or prognosis of epithelium derived cancers in subjects, methods for the evaluation of therapeutic effect of related medicaments or therapies, and kits for accomplishing the methods.

Provided are methods for detecting or isolating circulating tumor cells (CTCs) in a subject. The methods may include detecting the expression of at least one epithelial mesenchymal transition (EMT) biomarker. Further provided are kits for detecting or isolating CTCs. The kits may include antibodies to at least one EMT biomarker. Further provided are methods of predicting the responsiveness of a subject to a cancer drug, methods of targeting delivery of a cancer drug in a subject, methods of providing a cancer prognosis to a subject, and methods for following the progress of cancer in a subject.

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

The invention provides method for diagnosis, monitoring, and prognosis of prostate cancer using one or more of keratin 4, keratin 7, keratin 8, keratin 15, keratin 18, keratin 19, tubulin-beta 3, filamin B, and LY9, and PSA. The invention provides kits for practicing the methods of the invention.

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

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.

The present invention relates to a composition comprising at least three primary antibodies or fragments thereof, wherein the at least three antibodies or fragments thereof binds specifically to at least three different proteins, and wherein the at least three different proteins are AMCAR, CK 5/6, and HMWC. Methods for using the composition in diagnosis, prognosis, and assessing efficacy of treatment is further included as well as kits comprising said composition, and optionally, instructions of its use.