Disclosed herein are devices, systems, methods and kits for performing immunoassay tests to detect for at least progesterone or analytes of progesterone on a sample in association with diagnosing problems and issues associated with corpus luteum functionality. The immunoassay devices and methods may be used in conjunction with diagnostic reader systems and/or a base unit for obtaining a sensitive readout of the immunoassay results. The methods disclosed herein may also incorporate steps associated with evaluating the urine of a sample for the presence of an estrogen metabolite and/or luteinizing hormone.

Pharmaceutical compositions and methods for the treatment of DENND1A.V2 related disorders, such as PCOS, are provided. In particular, humanized and mouse monoclonal antibodies specific for DENND1A.V2 and methods for using the same are provided.

A method of treating or preventing gonadal or uterine toxicity induced by an agent in a subject is provided. Accordingly there is provided a method comprising administering to a subject a therapeutically effective amount of pigment epithelium-derived factor (PEDF), thereby treating or preventing the gonadal toxicity induced by the agent. Also provided is, a method comprising determining gonadal function in a subject; and administering to the subject a therapeutically effective amount of PEDF, thereby treating or preventing the gonadal toxicity induced by the agent. Also provided is a PEDF for use in the treatment or prevention of gonadal toxicity induced by an agent in a subject. Also provided are cell culture, a medium, a kit and method for improving oocyte quality ex-vivo.

Pharmaceutical compositions and methods for the treatment of DENND1 A. V2 related disorders, such as PCOS, are provided. In particular, humanized and mouse monoclonal antibodies specific for DENND1 A. V2 and methods for using the same are provided.

Disclosed herein is a method for assessing the probability of embryo implantation success during the in vitro fertilization process. A method of the disclosure can predict embryo implantation success based on, for example, the amount of specific metabolites present in embryo conditioned culture media.

A diagnostic device for and method of detecting the presence of head and neck squamous cell carcinoma (HNSCC) in a patient including a detector device for detecting a presence of at least one marker indicative of HNSCC, the detector device including a panel of markers for HNSCC. A diagnostic device for and method of staging HNSCC in a patient including a detector device for detecting a presence of at least one marker indicative of stages of HNSCC, the detector device including a panel of markers for HNSCC. Markers for head and neck squamous cell carcinoma selected from the markers listed in Table 5. Methods of personalized immunotherapy, making a personalized anti-cancer vaccine, and predicting a clinical outcome in a HNSCC patient. A method of making a panel of HNSCC markers.

The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

A system, apparatus and method for diagnosis of vaginal disorders, comprising a collection apparatus for collecting and sampling vaginal discharge or fluid and a sensing device for processing the sampling vaginal discharge or fluid, said sensing device comprising at least two lateral flow assays (LFAs).

Vaginal dysbiotic conditions accompanied by elevated levels of calprotectin, such as bacterial vaginosis and preliminary conditions that can lead to bacterial vaginosis, are treated with intravaginal administration of essential metal of manganese, zinc or manganese and zinc. to partially or fully counteract binding capacity for those metals by the calprotectin, permitting manganese to become more available to support establishment of a healthy vaginal microbiome dominated by beneficial lactobacilli to correct the dysbiotic condition.