The present invention provides methods for identifying biomarker proteins that exhibit differential expression in subjects with a first lung condition versus healthy subjects or subjects with a second lung condition. The present invention also provides compositions comprising these biomarker proteins and methods of using these biomarker proteins or panels thereof to diagnose, classify, and monitor various lung conditions. The methods and compositions provided herein may be used to diagnose or classify a subject as having lung cancer or a non-cancerous condition, and to distinguish between different types of cancer (e.g., malignant versus benign, SCLC versus NSCLC).

The invention described herein provides biological markers for the diagnosis, prognosis, and monitoring of prostate cancer.

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

The present invention is directed to a method for identifying an individual who is at risk for developing metastatic liver disease that involves measuring, in a sample isolated from the individual, exosomal levels of one or more markers of metastatic liver disease. Kits for carrying out this method are also disclosed. The present invention also relates to a method of preventing metastatic liver disease in an individual who are at risk for developing the disease that involves administering one or more inhibitors of liver premetastatic niche formation.

The purpose of the present invention is to provide: a detection agent for specifically detecting a cancer stem cell; a tumor antigen peptide specifically presented by cancer stem cells; a medicinal composition useful in preventing and/or treating cancer, said medicinal composition comprising the aforementioned tumor antigen peptide as an active ingredient; a method for screening the tumor antigen peptide; etc. To achieve the above-mentioned purpose, provided are: peptides represented by Y.sub.O-X.sub.O-Z.sub.O; a polyepitope peptide consisting of a plurality of epitope peptides connected together, said polyepitope peptide containing at least one of the above-mentioned peptides as one of the epitope peptides; a polynucleotide encoding the aforementioned peptides and/or polyepitope peptide; a medicinal composition comprising the same as an active ingredient; a prophylactic and/or therapeutic agent for cancer characterized by inducing CTL; etc.

A method including detecting a presence of at least one analyte in a sample from a subject wherein the at least one analyte is selected from the group consisting of: mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1, and determining the subject has hydrosalpinx if the sample comprises an increased level of mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, and/or Mucin-16 relative to a control, and/or a decreased level of GSTP1, PRDX5, TXN, PRDX6, and/or SOD1, relative to the control, is provided herein. The method may further include if the subject is determined to have hydrosalpinx, administering a hydrosalpinx therapy to the subject.

Provided herein are compositions and methods for treating or preventing fibrosis.

The invention relates to the new application of medicine, in particular to the laboratory cancer diagnostics. It describes a set of reagents for detecting the marker for epithelial carcinomas CA-62 in patients' blood serum for early detection of cancer, detecting cancer recurrences and monitoring cancer treatment of human epithelial tumors using immunochemical analysis. The main difference between the CA-62 cancer marker and other well-known markers comprises of the fact that the maximum peak of its expression falls on the very beginning of cancer development. This makes it possible to detect the early stages of tumor growth with high sensitivity and specificity when the cure rate is at maximum. The dynamics of the CA-62 marker level also show high efficacy in detecting tumor recurrences and monitoring the treatment of patients with advanced cancer. The set of reagents includes a microplate with immobilized antibodies to a CA-62 cancer antigen, CA-62-Acridinium conjugate, CA-62 standard calibrators in the measurement range from 10 to 30000 U/ml, CA-62 positive control, working buffer solution (pH 2.0-8.0) containing Tween-80.

Methods of selecting a subject for treatment of amyotrophic lateral sclerosis (ALS) and methods of treatment for subjects having ALS or at risk of developing ALS are provided. The method of selecting subjects for treatment includes obtaining a biological sample from the subject, where the sample is obtained from the subject's gastrointestinal tract or skeletal muscle. The method further includes measuring a biomarker in the subject's sample and selecting the subject for treatment of ALS when the biomarker measurement in the subject's sample is lower or higher relative to a control measurement.

Methods, devices, kits and systems for diagnosing inclusion body myositis (IBM) are provided. Methods, devices, kits and systems involves detecting the presence and/or level of autoantibodies that are reactive against at least a ˜43 kilodalton (kDa) protein or ˜43 kDa protein band from a muscle lysate or a mammalian cell lysate, or autoantibodies that are reactive against a cytosolic 5′-nucleotidase 1A protein (NT5C1A), or a cytosolic 5′-nucleotidase 1B protein (NT5C1B), or a NT5C1B isoform thereof, or a peptide fragment thereof, an isolated peptide thereof or a fusion protein comprising an isolated peptide of NT5C1A or NT5C1B. Such autoantibodies are only found in IBM patients and not in patients with other myopathies.