We describe a method of monitoring the state of a cell, tissue, organ or organism. The method comprises establishing, for a sample of micro-particles from the cell, tissue, organ or organism, a ratio. The ratio is of a selected polypeptide in microparticles which comprise GM1 gangliosides, preferably which bind to Cholera Toxin B (CTB) (GM1 ganglioside microparticle polypeptide) to the selected polypeptide in microparticles which comprise exposed phosphotidylserine, preferably which bind to Annexin V (Annexin V microparticle polypeptide). The GM1 ganglioside microparticle polypeptide to Annexin V microparticle polypeptide ratio so established may be indicative of the state of the cell, tissue, organ or organism.

The present invention provides a panel of at least five clinical analyses or tests (using serum samples) to determine the risk of pediatric acute-onset neuropsychiatric syndrome (PANS) and/or pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS) in an individual. These include enzyme linked immunosorbent assays (ELISAs) to measure antibody titers against neuronal antigens present in the brain; the neuronal antigens include lysoganglioside, tubulin, dopamine receptor D1, dopamine receptor D2, serotonin receptor 5HT2A, and serotonin receptor 5HT2C. Antibody titers against at least four of these neuronal antigens are required in the present methods; preferably antibody tiers against all of these neuronal antigens are measured. A final assay is used to quantify calcium/calmodulin-dependent protein kinase activity using a neuronal cell line. The results of these analyses or tests are then combined using an algorithm to determine whether a PANS or PANDAS diagnosis is appropriate for the individual. Depending on the diagnosis, an appropriate treatment can be determined.

Disclosed herein is a compound and its use for the prognosis or diagnosis of neurodegenerative diseases. The compound has the structure of formula (I),

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According to embodiments of the present disclosure, the neurodegenerative disease may be an Alzheimer's disease (AD), Parkinson disease (PD), Huntington's disease (HD), frontotemporal dementia (FTD), Friedreich's ataxia, age-related macular degeneration, or Creutzfeldt-Jakob disease.

The present invention provides compositions for the production of an antibody or functional fragment thereof directed against disialoganglioside-GD2. The compositions of the invention include polynucleotides encoding a heavy chain and/or a light chain variable domain that binds to GD2. The invention also provides an isolated antibody or functional fragment thereof and methods of treating or preventing a disease, such as cancer or tumor formation, wherein the antibody or functional fragment includes a variable heavy chain domain and a variable light chain domain that has an amino acid sequence provided herein. The invention further provides a conjugate of an antibody or functional fragment thereof conjugated or recombinantly fused to a diagnostic agent, detectable agent or therapeutic agent, and methods of treating, preventing or diagnosing a disease in a subject in need thereof.

Provided are methods for assessing aberrant glycosphingolipid processing, and methods for determining the severity and/or progression of diseases associated therewith. Also provided are methods for assessing the likely therapeutic response of a subject to treatment with agents that can modulate glycosphingolipid processing, as well as therapeutic methods which benefit from assessing the patient in accordance with the disclosure. The methods of the disclosure employ an agent (e.g., conduritol- epoxide) which can challenge the glycosphingolipid pathway in a cell, followed by monitoring the recovery of the cell, e.g., monitoring the restoration of glycosphingolipid flux in the cell.

A novel 11-lipid biomarker panel, consisting of or comprising at least one ceramide, at least one sphingomyelin, at least one glycosphingolipid, and at least one free fatty acid, capable of assessing the risk of breast cancer is described.

The present disclosure provides monoclonal antibodies and antigen-binding fragments thereof that specifically bind to gangliosides (e.g., GD2 or GD3), as well as compositions comprising same and methods of using same for diagnostic and prognostic purposes. In addition, the present disclosure provides mass spectrometry-based methods for detecting various gangliosides and their lipid length, the changes of which are useful for the cancer diagnostic and prognostic methods described herein. The present disclosure further provides compounds comprising modified versions of gangliosides.

The present disclosure relates to methods of diagnosing and treating breast cancer in a subject that include determining a level of one or more lipid biomarkers in a biological sample obtained from the subject. Systems and kits for use in such methods are also provided.

The present invention concerns a method for the in vitro diagnosis of neurodegenerative metabolic diseases able to simultaneously identify biomarkers characteristic of a large number neurodegenerative metabolic diseases.

Methods and reagents suitable for in vitro diagnostic assay comprising a qualitative immunohistochemical assay using anti-Globo H antibodies and/or binding fragments thereof are provided. The method comprises the detection of Globo-H expression levels in formalin-fixed, paraffin-embedded (FFPE) cancer tissue using a visualization system. The Globo-H expression can be determined by using tumor scoring showing partial or complete staining at any intensity.