Disclosed herein are compositions and methods useful for the diagnosis, assessment, and characterization of endometriosis in a subject in need thereof, based upon the expression level of at least one miRNA that is associated with endometriosis.

Methods for diagnosing or monitoring endometriosis in a mammal are provided. The methods include the steps of determining the expression levels of BDNF, glycodelin and optionally ZAG, in a biological sample from the mammal, and determining that the mammal has endometriosis when the biomarker expression levels in the sample are elevated.

Disclosed is a method for non-invasive diagnosis of endometriosis on the basis of the measurement of the level of acellular DNA in a biological sample from an individual, wherein a measured level of acellular DNA lower than the reference threshold can be used to rule out an endometriosis diagnosis. When the measured level of acellular DNA is greater than the reference threshold, a step of measuring the methylation level of at least 15 genes involved in endometriosis enables the diagnosis of endometriosis to be made in the patient tested.

The present invention is a cytocidal agent including a peptide consisting of an amino acid sequence represented by SEQ ID NO: 1 and a site selectively binding to a target molecule, in which the peptide consisting of an amino acid sequence represented by SEQ ID NO: 1 is a peptide exclusively consisting of L-amino acids, a peptide in which, in amino acid sequences represented by SEQ ID NO: 1, the first to the 14.sup.th amino acids are D-amino acids, and the 15.sup.th to 19.sup.th amino acids are L-amino acids, a peptide in which, in amino acid sequences represented by SEQ ID NO: 1, the first to 14.sup.th amino acids are L-amino acids, and the 15.sup.th to the 19.sup.th amino acids are D-amino acids, or a peptide exclusively consisting of D-amino acids.

Aberrant mitochondrial DNA (mtDNA) molecules having specific large-scale deletions and having an association with endometriosis are provided. The aberrant, or mutated, mtDNA may comprise the parent nucleic acid (i.e. the large sublimon), particularly when re-circularized, wherein adjacent nucleotides are fused following the deletion to form a junction site. Alternatively, the mtDNA may comprise the deleted strand (i.e. the small sublimon), also particularly when re-circularized to create a junction site. In addition, fusion transcripts resulting from such mutated mtDNA, and their putative protein products, are provided, where such transcripts and proteins are also associated with endometriosis. Hybridization probes and amplification primers and kits containing same are provided for detecting, diagnosing, or monitoring endometriosis.

An in vitro test method for early detection of endometriosis and/or uterine adenomyosis in a female patient, comprising the following steps: a) providing menstrual blood of the patient to be tested, b) determining expression of the genes ESR2 and/or CXCL12 and/or CXCR4 in comparison with at least one control sample, wherein an increased expression of one or more of the genes indicates endometriosis and/or uterine adenomyosis.

A method for treating chronic inflammatory conditions in the lower urinary tract, the method comprising administering to a patient in need thereof, an effective amount of a reagent selected from the group consisting of IL-1β inhibitors and MMP inhibitors, or proteins selected from ASC or NLRP-3 is provided. Diagnostic methods are also described and claimed. The present disclosure further relates to an IL-1 inhibitor for use in a method of treating, alleviating or reducing pain and pain related symptoms of chronic pelvic pain syndrome. The IL-1 inhibitor may be an IL-1 receptor antagonist. The IL-1 inhibitor may be anakinra. The chronic pelvic pain syndrome may be a urological pain syndrome, a gynecological pain syndrome of the external genitalia, an internal pelvic pain syndrome and a gastrointestinal pelvic pain syndrome.

It has been discovered that plasma samples from endometriosis patients contain a number of markers whose abundance is different from those in healthy individuals. It has also been discovered that, by measuring the abundance of those markers, whether or not a subject is affected by endometriosis can be diagnosed, the extent of endometrial fibrosis or adhesion in a subject can be determined, pain of a patient affected or suspected of being affected by endometriosis can be predicted, and pathological conditions of the patient can be monitored.

The present application relates to a method for diagnosis of endometriosis in a subject, comprising the steps of (i) determining the level of β2-Microglobulin protein (β2M) as a biomarker in a sample of said subject to be diagnosed; (ii) comparing the biomarker level as determined in steps (i) to a respective control level derived from one or more subject without endometriosis;
wherein a reduced level as compared to the respective control level of β2M is indicative for the presence of endometriosis in said subject to be diagnosed. In particular, the application relates to a diagnostic classifier comprising a combination of a plurality of biomarkers selected from the group consisting of β2M protein level, CA19-9 level, CA125 protein level, PON-1 activity, MMP1 protein level and MMP2 protein level.

The present invention relates to monoclonal antibodies against MELK. Furthermore, the present invention provides methods for diagnosing MELK-associated diseases using the antibodies, methods for detecting the MELK protein, methods for determining the drug efficacy following treatment with a MELK inhibitor, methods of screening for subjects to whom a MELK inhibitor has a high therapeutic effect, and diagnostic reagents containing the antibodies.