Abstract: Antibody molecules that specifically bind to CD138 are disclosed. The antibody molecules can be used to treat, prevent, and/or diagnose disorders, such as multiple myeloma.

Abstract: Bioconjugates and methods of making bioconjugates are provided, wherein the bioconjugates comprise glucose oxidase and nanoparticles that can kill tumor cells. For example, glucose oxidase-iron oxide bioconjugates can produce reactive oxygen species from blood glucose, causing cell death. The use of superparamagnetic iron oxide nanoparticles can provide magnetic resonance imaging guidance to facilitate imaging-guided drug delivery and combine diagnostics with therapy.

Abstract: Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer. In some embodiments, the disclosure provides improved prostate antigen standards for quantifying levels of prostate antigens.

Abstract: Methods are provided for assessing risk of developing esophageal adenocarcinoma in a subject using one or more of the following marker genes/proteins: ISG15, LTF, CNDP2, DAD1, SET, UBE2N, S100P, and GPI. Methods are also provided for determining expression of one or more esophageal adenocarcinoma risk factors in a subject. Methods are also provided for treating esophageal adenocarcinoma in a subject, for preventing esophageal adenocarcinoma in a subject, for inhibiting or decreasing proliferation of esophageal adenocarcinoma cells, for inhibiting or decreasing migration of esophageal adenocarcinoma cells, or for increasing susceptibility to cytotoxicity or inducing cell death of esophageal adenocarcinoma cells.

Abstract: The present invention encompasses filamin A (FLNA) binding proteins. Specifically, the invention relates to antibodies to FLNA. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Methods of making and methods of using the antibodies of the invention in methods of diagnosis, monitoring and prognosis of prostate cancer are also provided.

Abstract: Systems and methods for automated, non-supervised, parameter-free segmentation of single cells and other objects in images generated by fluorescence microscopy. The systems and methods relate to both improving initial image quality and to improved automatic segmentation on images. The methods will typically be performed on a digital image by a computer or processor running appropriate software stored in a memory.

Abstract: Methods for determining treatments for cancer patients are disclosed.

Abstract: From gene expression analysis with a long-term recurrence-free group and a recurrence metastasis group of stomach cancer, CHRNB2 and NPTXR were identified as drug discovery targets. Tumor growth was successfully inhibited by an antibody medicine or a nucleic acid medicine targeting CHRNB2 or NPTXR. Furthermore, a polyclonal antibody and a monoclonal antibody linking to CHRNB2 or NPTXR are provided. Since these receptor molecules are novel molecular targets, treatment of cases which the existing therapeutic drugs have no effect on is made possible.

Abstract: The present invention relates, in part, to methods of treating a cancer in a subject comprising administering to the subject a therapeutically effective amount of an agent that inhibits one or more biomarkers listed in Table 1 in combination with an immunotherapy.

Abstract: The present invention is based, in part, on the discovery that galectin-1 (Gal1) plays a role in viral-associated PTLD, e.g., EBV-associated PTLD and hypoxia associated angiogenesis disorders. Accordingly, the invention relates to compositions, kits, and method for diagnosing, prognosing, monitoring, treating and modulating viral-associated PTLD, e.g., EBV-associated PTLD and hypoxia associated angiogenesis disorders.

Abstract: An object of the present invention is to provide: an anti-GPC3 antibody that recognizes an epitope different from that for existing antibodies (e.g., GC33 and GC199) and can specifically bind, even in the form of single chain antibody, to GPC3 localized on a cell membrane; CAR comprising the anti-GPC3 single chain antibody; an immunocompetent cell expressing the CAR; a gene of the anti-GPC3 antibody or a gene of the CAR; a vector comprising the anti-GPC3 antibody gene or the CAR gene; a host cell in which the vector has been introduced; a method for specifically detecting GPC3; and a kit for specifically detecting GPC3. An antibody comprising particular heavy chain CDR1 to CDR3 and particular light chain CDR1 to CDR3 defined in claim 1, and specifically binding to a human-derived GPC3 polypeptide specifically binds to GPC3 localized on a cell membrane. CAR-immunocompetent cells prepared on the basis of CAR comprising such single chain antibody are useful for cancer immunotherapy.

Abstract: A method of diagnosing a cancer or a pre-malignant lesion is disclosed. The method comprising determining a level of expression of CD24 on leukocytes comprised in a biological sample of a subject, wherein a level of CD24 on small leukocytes and not on large leukocytes above a predetermined threshold is indicative of the cancer or the pre-malignant lesion. A method of monitoring efficacy of cancer therapy and a kit for diagnosing a cancer or a pre-malignant lesion are also disclosed.

Abstract: Methods for detecting the presence of proteins in a subject are described. The proteins detected can be indicative of acute myeloid leukemia (AML). The proteins can be particularly useful for monitoring minimal residual disease (MRD) in AML.

Abstract: This invention is directed to vaccine compositions and methods of using the same to prevent infection.

Abstract: Methods for treating, preventing and predicting a subject's risk of developing breast cancer are provided.

Abstract: Embodiments of the present invention relate generally to non-invasive methods and tests that measure biomarkers (e.g., tumor antigens) and collect clinical parameters from patients, and computer-implemented machine learning methods, apparatuses, systems, and computer-readable media for assessing a likelihood that a patient has a disease, relative to a patient population or a cohort population. In one embodiment, a classifier is generated using a machine learning system based on training data from retrospective data and subset of inputs (e.g. at least two biomarkers and at least one clinical parameter), wherein each input has an associated weight and the classifier meets a predetermined Receiver Operator Characteristic (ROC) statistic, specifying a sensitivity and a specificity, for correct classification of patients.

Abstract: Aspects of the present disclosure provide methods for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent based on a Combined Positive Score (CPS) for a tumor tissue sample from the subject. Compositions and kits or performing the disclosed methods are also provided.

Abstract: Disclosed are methods for diagnosing CAT1-related diseases, wherein the methods include detecting CAT1 in a cell by a BLV.RBD ligand, or a variant or a fragment thereof. Also disclosed is a BLV.RBD ligand, or a variant or a fragment thereof for use in the treatment of CAT1-related diseases and/or BLV infections.

Abstract: Provided herein are compositions and methods for detecting and/or targeting dysfunctional tumor antigen-specific CD8+ T cells in the tumor microenvironment for diagnostic, therapeutic and/or research applications. In particular, dysfunctional tumor antigen-specific CD8+ T cells are detected and/or targeted via their expression of cell surface receptors described herein, such as 4-1BB, LAG-3, or additional markers that correlate with 4-1BB and LAG-3 expression, such as markers differentially expressed on the surface of the T cells.

Abstract: Microscale and/or mesoscale condenser arrays that can facilitate microfluidic separation and/or purification of mesoscale and/or nanoscale particles and methods of operation are described herein. An apparatus comprises a condenser array comprising pillars arranged in a plurality of columns, wherein a pillar gap greater than or equal to about 0.5 micrometers is located between a first pillar of the pillars in a first column of the columns and a second pillar of the plurality of pillars in the first column, and wherein the first pillar is adjacent to the second pillar. The first ratio can be characterized by Dx/Dy is less than or equal to a first defined value, wherein Dx represents a first distance across the lattice in a first direction, wherein Dy represents a second distance across the lattice in a second direction, and wherein the first direction is orthogonal to the second direction.

Abstract: The invention described herein relates to methods of monitoring genotoxic stress in a test subject, specifically by detecting the expression level of microvesicle-associated H2AX from a biological sample.

Abstract: The present invention relates to a method of diagnosing Head and Neck Squamous Cell Carcinoma (HNSCC) in an individual. In addition, the present invention relates to a method of providing a survival prognosis to an individual suffering from Head and Neck Squamous Cell Carcinoma (HNSCC). Moreover, the present invention relates to a kit for performing the above-mentioned methods.

Abstract: This invention comprises compositions and methods to detect and treat gastrointestinal diseases.

Abstract: An immunoassay for the detection of an analyte in a sample includes a plurality of moieties capable of binding to the analyte. Capture moieties, which are not specific for the same epitope, are bound to a solid substrate, and at least one epitope-specific detection moiety is bound to a detectable marker. The detectable marker is a large particle marker having a particle size of ?50 nm and ?5000 nm.

Abstract: The state of protein phosphorylation and glycosylation can be key determinants of cellular physiology such as early stage cancer, but the development of phosphoproteins and/or glycoproteins in biofluids for disease diagnosis remains elusive. Here we demonstrate, for the first time, a strategy to isolate and identify phosphoproteins/glycoproteins in extracellular vesicles (EVs) from human plasma as potential markers to differentiate disease from healthy states. We identified close to 10,000 unique phosphopeptides in EVs by isolating from small volume of plasma samples. Using label-free quantitative phosphoproteomics, we identified 144 phosphoproteins in plasma EVs that are significantly higher in patients diagnosed with breast cancer than in healthy controls. Several novel biomarkers were validated in individual patients using Paralleled Reaction Monitoring for targeted quantitation. Similarly a group of glycoproteins in plasma EVs are identified.

Abstract: Described herein are methods for diagnosing high-risk cancer in a subject by detecting PolySialic Acid (polySia) in a biological sample obtained from the subject, or by detecting polySia and one or more tissue-specific markers in a biological sample obtained from the subject.

Abstract: Disclosed herein are monoclonal antibodies targeting specific tau epitopes, particularly, phosphorylated tau epitopes. Also disclosed are methods of detecting tau protein in a subject, comprising performing an assay using the antibodies or antigen binding fragments thereof on the subject or on a biological sample obtained from the subject. Assay kits containing the disclosed antibodies are also provided. Further, methods of treating or preventing a tauopathy in a subject by administering to the subject tau antibodies or antigen-binding fragments thereof are provided.

Abstract: Methods of testing tumor samples for mutational burden and/or for expression profiles permit the prediction of responsiveness of an individual to immunotherapy comprising PVSRIPO. Those predicted to respond are treated with PVSRIPO and those predicted not to respond are treated with other agents.

Abstract: The present invention relates to biomarkers of lung cancer, particularly to markers that enable distinguishing between subtypes of non-small cell lung cancer (NSCLC), particularly between adenocarcinoma (AC) and squamous cell carcinoma (SCC). In particular, the present invention relates to means and methods for diagnosing, assessing the level of severity and selecting methods of treating NSCLC.

Abstract: The instant disclosure provides biomarkers and methods for identifying subjects at risk of developing cytokine release syndrome (CRS), neurotoxicity, or both after adoptive immunotherapy to guide preemptive intervention, modified therapy, or the like. For example, adverse event biomarkers may be measured in a subject before pre-conditioning chemotherapy, before immunotherapy (e.g., adoptive immunotherapy infusion comprising a chimeric antigen receptor (CAR) modified T cell), or shortly after pre-conditioning chemotherapy and/or immunotherapy. Exemplary biomarkers include temperature, cytokine levels and endothelial activation biomarkers, such as angiopoietin 2, von Willebrand factor (vWF), ratio of angiopoietin 2 to angiopoietin 1, and ratio of ADAMTS13 to vWF. Also provided are methods of treating subjects identified as at risk of developing cytokine release syndrome (CRS), neurotoxicity, or both to minimize such potential adverse events.

Abstract: The present invention provides novel IgE antibodies useful for inhibiting or preventing metastatic cancer. Also provided are methods to inhibit tumor metastasis by modulating the activity of at least one non-tumor cell, treating a patient to inhibit or prevent tumor metastases of a primary solid tumor, treating metastatic carcinoma, reducing metastasis of carcinoma cells, and reducing the growth kinetics of a primary solid tumor or a metastasized cell or tumor.

Abstract: Disclosed herein are methods and devices for antigen-specific T cell identification or neoantigen identification. Also disclosed herein are devices for separating and isolating antigen-specific T cells or other particles of a certain size from a population of particles of different sizes. Also describe herein are methods and devices for the separation and isolation of barcoded T cells from other nanoparticles containing barcodes for subsequent analysis and further processing of a viable T cell.

Abstract: Methods of using detection of PD-L1 expression by circulating cancer cells in the screening, monitoring, treatment and diagnosis of cancer in subjects are disclosed. The methods are based on assaying one or more of circulating tumor cells (CTCs), epithelial to mesenchymal transition CTCs (EMTCTCs), cancer associated macrophage-like cells (CAMLs), and cancer associated vascular endothelial cells (CAVEs) isolated from a subject having cancer for PD-L1 expression.

Abstract: Described herein are methods of identifying immunologically protective neo-epitopes from the cancer tissue DNA of cancer patients using biophysical principles as well as bioinformatics techniques. The identification of immunologically protective neo-epitopes provides pharmaceutical compositions with a limited number of tumor-specific peptides suitable for personalized genomics-driven immunotherapy of human cancer. Specifically disclosed herein is a method of using the conformational stability of an epitope in an MHC protein-binding groove to predict immunogenicity of peptides in a putative neo-peptide set from a tumor from a cancer patient. Pharmaceutical compositions and methods of administration are also included.

Abstract: Herein are described methods of treating a human subject having acute myeloid leukemia (AML) that is refractory to induction therapy, wherein an MDM2 inhibitor is administered before or concurrently with chemotherapy, which may comprise induction therapy. Refractory AML may be predicted based on decreased expression of MTF2 in cells from a hematological sample obtained from the subject. Also provided are methods of predicting and treating AML responsive to MDM2/HDM2 inhibitors, based on MTF2 expression. One set of additional biomarkers useful in the predictions comprise one or more of H3K27me3, CD84, CD92, MDM2, NPM1, PRICKLE1, SET, ABCB6, POLQ, POLK, POLH, ARTIMIS, MCM6, CD327, CD90 and PARP1. Another set of additional biomarkers useful in the predictions include at least one of H3K27me3, MDM2, NPM1, SET, CD84 and PRICKLE1. Methods of selecting a patient for treatment with an MDM2 inhibitor before or concurrently with chemotherapy are also provided, along with kits and uses.

Abstract: Disclosed herein are biomarkers for hepatocellular carcinoma and pancreatic cancer. The biomarkers may be laminin gamma 2 monomer, PIVKA-II, AFP, CEA, CA19-9, or combinations thereof. Also disclosed herein are methods of diagnosing, prognosing, classifying risk, and monitoring progression of hepatocellular carcinoma or pancreatic cancer by the detecting the level of laminin gamma 2 monomer, PIVKA-II, AFP, CEA, CA19-9, or combinations thereof.

Abstract: Providing a method of estimating the number of microparticles such as microorganisms in a sample, without performing complicated operations. The method comprises counting by constant flow the number of target microorganisms contained in the sample at a predetermined flow rate, sectioning measurement data obtained as a result of the constant flow counting into a predetermined number of sections by a predetermined unit time for a section, counting the number of sections in which microorganisms are detected and the number of sections in which they are not detected, in the predetermined number of sections; and estimating the number of microorganisms in the sample, by a statistical method from the flow rate of the sample in the constant flow counting step, the predetermined number of sections and the predetermined unit time in the sectioning step, and the number of sections in which microorganisms are detected in the counting step.

Abstract: An analysis chip for determining an efficient anticancer drug or anticancer drug combination for cancer cells, according to an embodiment of the present disclosure, includes a chamber which is a unit for analyzing single cancer cells, and a plurality of valves configured to regulate a fluid to be injected into the chamber, wherein the chamber includes a channel through which a fluid including an anticancer drug and a cell lysis buffer flows, a cell sorting part configured to focus cancer cells flowing along the channel, a cell capturing part configured to focus the cancer cells focused by the cell storing sorting part, and an antibody array configured to capture proteins secreted from the captured cancer cells and intracellular protein through cell lysis.

Abstract: The present invention provides a method of producing dye-containing thermosetting resin particles, the method including: dispersing seed particles formed from a thermosetting resin in a dispersion medium; and polymerizing a monomer for thermosetting resin synthesis in the thus obtained dispersion in the presence of a dye and an acid catalyst. By the method of producing dye-containing thermosetting resin particles according to the present invention, dye-containing thermosetting resin particles whose particle size variation coefficient is small at, for example, 8% or less, can be produced without performing a post-treatment such as centrifugation. Therefore, when immunological observation is performed by a fluorescent labeling method using fluorescent dye-containing resin particles produced by the method of producing dye-containing thermosetting resin particles according to the present invention, a high bright spot detection accuracy can be attained.

Abstract: The object of the present invention is to provide an evaluation method capable of accurately determining a metastasis of cancer, the stage of cancer progression, or the malignancy of cancer.

Abstract: Antigen binding proteins specific for an HLA-A2 restricted Ras peptide are disclosed. The antigen binding proteins encompass antibodies in a variety of forms, including full-length antibodies, substantially intact antibodies, Fab fragments, F(ab?)2 fragments, and single chain Fv fragments. Fusion proteins, such as scFv fusions with immunoglobulin or T-cell receptor domains, and bispecific antibodies incorporating the specificity of the antigen binding region for each peptide are also contemplated by the disclosure. Furthermore, immunoconjugates may include antibodies to which is linked a radioisotope, fluorescent or other detectable marker, cytotoxin, or other molecule are also encompassed by the disclosure. Among other things, immunoconjugates can be used for delivery of an agent to elicit a therapeutic effect or to facilitate an immune effector function.

Abstract: A compact device compact analytical device to perform main steps of analytical procedures comprises a driving part configured to be attached to a stirrer part or a centrifuge part, wherein the stirrer part is configured to mix at least one sample and the centrifuge part is configured to separate a component. Furthermore, an analyzer part is configured to produce analytical data.

Abstract: Provided are methods for detecting chromogranin A by mass spectrometry. In another aspect, provided herein are methods for quantitating chromogranin A by mass spectrometry. In another aspect, provided herein are methods for prognosis of or measuring the size of neuroendocrine tumors by mass spectrometry.

Abstract: In various embodiments various cancer specific antibodies and immunoconjugates are provided. In certain embodiments the antibodies specifically bind and are internalized into a prostate cancer cell, where the antibodies specifically binds cells that express or overexpress a CD46, and where the antibodies specifically bind sushi domain 1 of said CD46 (CD46 CPP1).

Abstract: The present invention provides a modified eukaryotic cell wherein the modified eukaryotic cell is not able to provide an SSN6-like protein that exerts its wildtype function and/or wildtype activity, the amount of SSN6-like protein being present in the modified eukaryotic cell differs from the amount of SSN6-like protein being present in its wildtype form, and/or essentially no SSN6-like protein is present in the modified cell. Additionally, the present invention provides a polynucleotide sequence comprising a modified ssn6-like gene, and a vector comprising said polynucleoptide. Additionally provided is an expression vector comprising a promoter that is repressed in the presence of SSN6-like protein, and a host cell comprising said vectors. The present invention further refers to a method for determining the purity of a composition by using the modified eukaryotic cell, to a method of expressing gene(s) of interest, and eukaryotic cells comprising modified ssn6-like gene.

Abstract: The present disclosure provides processes for describing and quantifying the expression of human programmed death ligand-1 (PD-L1) in tumor tissue sections as detected by immunohistochemical assay using an antibody that specifically binds to PD-L1. The results generated using these processes have a variety of experimental, diagnostic and prognostic applications.

Abstract: Herein disclosed is a method for the normalization of an immunological test, characterized in that the presence of a comparable amount of cells is determined by a sandwich ELISA test in which the capture antibody includes at least one antibody that binds to at least one keratin selected from among keratin 4, 5, 6, 8, 10, 13 and 18 and the detection antibody includes at least one antibody that binds to the selected keratin.

Abstract: A microchannel (1) having a spiral geometry structured with asymmetrical curls (2) that enables separation of metastasis cancer cells rarely found in blood from the blood cells and enrichment thereof, which forces the particles or the cells to focus quicker and where high-quality particle focusing in a wider flow rate range can be performed.

Abstract: The present invention relates to a method for discrimination of p16INK4a overexpressing metaplasias from neoplastic or preneoplastic p16INK4a overexpressing lesions by determination of the level of high risk HPV encoded gene-products such as e.g. HPV E2 and/or HPV E7 molecules in biological samples in the course of cytological testing procedures. The method thus enables for reduction of false positive results in the p16INK4a based detection of anogenital lesions in cytological testing procedures.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect one or more markers selected from the group consisting of soluble p-selectin, protein NOV homolog, soluble epidermal growth factor receptor, netrin-4, haptoglobin, heat shock protein beta-1, alpha-1-antitrypsin, leukocyte elastase, soluble tumor necrosis factor receptor superfamily member 6, soluble tumor necrosis factor ligand superfamily member 6, soluble intercellular adhesion molecule 2, active caspase-3, and soluble platelet endothelial cell adhesion molecule as diagnostic and prognostic biomarkers in renal injuries.