This disclosure describes methods and compositions for detecting the presence of autoantibodies associated with autoimmune polyglandualar syndrome 1 (APS1) in a biological sample. In particular, detection of APS1-specific autoantibodies that specifically bind to certain APS1 associated autoantigens in such methods is described. Also provided are methods of treating subjects with APS1 or at risk of developing APS1 associated conditions. Also provided are devices and kits useful for the diagnosis and prognostic assessment of subjects having APS1 and for assessing subject risk at developing particular APS1-associated conditions.

Disclosed herein are devices, systems, methods and kits for performing immunoassay tests on a sample. The immunoassay devices may be used in conjunction with diagnostic reader systems for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices may be especially suited for the detection of at least a first analyte and a second analyte in a sample. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect analytes in a sample.

This application provides a method for staging bacterial vaginosis (BV), i.e., determining whether a subject does not have BV, has Stage I BV, or has Stage II BV. The method relies on testing for the number and maturity of shed epithelial cells from a sample of vaginal secretion from the subject. Specific diagnosis of Stage I or Stage II BV allows the clinician to provide a targeted and appropriate treatment or treatment course for the subject.

Hedgehog pathway modulators, such as hedgehog pathway activators or inhibitors, and the use of such modulators to modulate FSH signaling are described.

The present invention relates to a method of determining the outcome of a pregnancy. More particularly, the invention relates to a method of profiling lipids in a fluid sample obtained from a female subject to assess parameters associated with a positive pregnancy outcome.

A method of determining fetal lung development, by taking a sample from a pregnant subject, applying the sample to a panel including at least one biomarker for fetal lung maturity, measuring a response of the sample to the biomarker, and determining fetal lung maturity. A panel including an assay with at least one biomarker for fetal lung maturity on a solid support.

The present invention relates to methods of predicting endometrial receptivity for embryo implantation in a subject, the method comprising determining a level of podocalyxin in endometrial epithelial cells in the subject. The present invention also relates to methods of monitoring epithelial receptivity and improving epithelial receptivity.

The present disclosure is related to the field of ovarian cancer diagnostics. It introduces novel biomarkers that can be used to detect presence of ovarian cancer and to provide a prognosis of the disease.

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.

The technology described herein is directed to the diagnosis and treatment of sex hormone disorders and/or deficiencies, such as estrogen and/or testosterone disorders and/or deficiencies.