Abstract: Methods of identifying, diagnosing, and prognosing rheumatoid arthritis are provided, as well as methods of treating rheumatoid arthritis. Also provided are methods for identifying effective rheumatoid arthritis therapeutic agents and predicting responsiveness to rheumatoid arthritis therapeutic agents.

Abstract: A method for the detection of at least one analyte in a sample is disclosed, wherein it comprises the steps of: a) providing a layer comprising a porous matrix having at least one ligand bound thereto above a filter constituting the bottom of at least one well of an assay plate, wherein said filter does not allow passage of said porous matrix having a ligand bound thereto, b) adding a sample containing said at least one analyte to be detected, said at least one analyte having the ability to specifically bind to said at least one ligand, c) adding a wash solution with a view to washing out non-bound sample components from the assay plate through the filter, d) adding enzyme-linked antibodies or antigens having the ability to specifically bind to said at least one analyte, e) adding a wash solution with a view to washing out non-bound enzyme-linked antibodies or antigens from the analysis plate through the filter, f) adding a substrate specific for the enzyme, wherein a product is formed by a reaction between t

Abstract: The present invention relates to a method, composition and a kit for verifying the source of biological samples when collected for testing, e.g., for the presence of drugs of abuse. The method generally involves providing a subject with a composition comprising at least one detectable consumable marker and optionally at least one metabolizable detectable consumable marker; obtaining a biological sample from the subject after consumption of the composition; and detecting the presence or absence of the detectable consumable marker in the sample; wherein the presence of the detectable marker indicates that the subject is the source of the sample, and wherein the absence of the detectable marker indicates that the subject is not the source of the biological sample.

Abstract: The disclosure provides a method of identifying a subject as having B-cell non-Hodgkin lymphoma (NHL) such as testing a sample from a subject for a mutation in one or more biomarkers. Also described are methods of classifying or monitoring a subject having, or suspected of having, B-cell non-Hodgkin lymphoma comprising testing the same for a mutation in one or more biomarkers.

Abstract: MicroRNA-31 (miR-31), targets of miR-31, the role of miR-31 in inhibiting tumor metastasis, and the role of miR-31 target genes in promoting tumor metastasis are disclosed.

Abstract: Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample vessel for receiving the bodily fluid sample collected in the sample collection channel, the sample vessel operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessel and/or another source provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessel.

Abstract: The present invention relates to an exemplary in vitro diagnostic (IVD) device used to detect the presence of and/or severity of neural injuries or neuronal disorders in a subject. The IVD device relies on an immunoassay which identifies biomarkers that are diagnostic of neural injury and/or neuronal disorders in a biological sample, such as whole blood, plasma, serum, cerebrospinal fluid (CSF). The inventive IVD device may measure one or more of several neural specific markers in a biological sample and output the results to a machine readable format wither to a display device or to a storage device internal or external to the IVD.

Abstract: Methods for identifying and evaluating biochemical entities useful as biomarkers for kidney cancer, target identification/validation, and monitoring of drug efficacy are provided. Also provided are suites of small molecule entities as biomarkers for kidney cancer.

Abstract: A kit and method for evaluating in vitro the effect of a xenobiotic (e.g., a biologic drug) on drug metabolism in hepatocytes. The kit comprises a first culture of hepatocytes, a portion of in vitro xenobiotic-stimulated biological sample, and instructions for incubating the first culture of hepatocytes with the portion of in vitro xenobiotic-stimulated biological sample, and analyzing the activity, expression, or a combination thereof of a biomarker in the hepatocytes to evaluate the effect of the xenobiotic on drug metabolism in the hepatocytes.

Abstract: Herein is reported a method for the detection of free antigen of a multispecific antibody in a sample, whereby the antigen to be detected can be specifically bound by a first binding site of the multispecific antibody, comprising the step of incubating a sample comprising free antigen and multispecific antibody with an anti-idiotypic antibody, which specifically binds to a second binding specificity of the bispecific antibody, which is different from the first binding specificity, whereby the anti-idiotypic antibody is bound to a solid phase.

Abstract: The invention relates to a method of identifying a specific fungal species in patient tissue or body fluid. The method comprises the steps of extracting and recovering DNA of the fungal species from the patient tissue or body fluid, amplifying the DNA, hybridizing a probe to the DNA to specifically identify the fungal species, and specifically identifying the fungal species. The invention also relates to a method of identifying a mycotoxin in patient tissue or body fluid. The method comprises the steps of extracting and recovering the mycotoxin from the patient tissue or body fluid, contacting the mycotoxin with an antibody directed against the mycotoxin, and identifying the myocotoxin. Both of these methods can be used to determine if a patient is at risk for or has developed a disease state related to a fungal infection, and to develop an effective treatment regimen for the patient.

Abstract: The invention relates to a peptide derived from an antigen recognized by autoantibodies, which peptide is reactive with autoimmune antibodies from a patient suffering from rheumatoid arthritis. The peptide according to the invention possesses a modified arginine residue. The invention also relates to antibodies against the peptide and a method of detecting autoimmune antibodies.

Abstract: The present invention concerns a microfluidic system comprising: a microchannel containing several elements of two non-miscible fluids, the microchannel comprising a droplet (30) containing magnetic particles (M), and a device for generating inside the microchannel magnetic field, said device comprising an activable magnetic element, the activable magnetic element comprising a tip (5,6), the microfluidic system being configured to transport the droplet by flow or by pressure difference.

Abstract: The present invention relates to a composition for enhancing an immune response, an epitope having immunogenicity, screening and preparing method thereof, a antibody to peptide antigen and screening and preparing method thereof. The composition of the present invention may be effectively used for preventing or treating diverse immune-deficiency diseases such as cancer, influenza virus, hepatitis C virus and RSV (respiratory syncytial virus) by enhancing immune responses.

Abstract: A homogeneous method of determining inhibitors of proteolytically active coagulation factors (anticoagulants) in a sample, in particular direct thrombin and factor Xa inhibitors, and also a test kit to be used in such a method. Use is made of ligands which bind to the proteolytically active coagulation factor but are not cleaved by the latter and compete with the anticoagulant to be determined.

Abstract: Systems and methods are provided for collecting, preparing, and/or analyzing a biological sample. A sample collection site may be utilized with one or more sample processing device. The sample processing device may be configured to accept a sample from a subject. The sample processing device may perform one or more sample preparation step and/or chemical reaction involving the sample. Data related to the sample may be sent from the device to a laboratory. The laboratory may be a certified laboratory that may generate a report that is transmitted to a health care professional. The health care professional may rely on the report for diagnosing, treating, and/or preventing a disease in the subject.

Abstract: Isolated transduced cells exhibiting FRDA characteristics in an inducible fashion are disclosed. Isolated transduced cells comprise an expression vector having a nucleic acid sequence encoding an shRNA for frataxin protein knockdown and a heterologous expression control sequence. Additionally, methods of screening for a candidate therapeutic agent for treating Friedreich's Ataxia using isolated transduced cells are disclosed. Further, a recombinant nucleic acid construct for frataxin knockdown is disclosed that comprises a nucleic acid encoding an shRNA operably linked to a heterologous expression control sequence and expressing an shRNA molecule in a dose-responsive fashion.

Abstract: The invention relates to assays for testing the therapeutic effectiveness of mesenchymal stromal cell (MSC) populations and methods of treating pathologies with passaged and/or frozen and thawed MSC populations.

Abstract: Provided herein are antigenic molecules that can be used to generate antibodies capable of binding to a vitamin D derivative, such as 25-hydroxyvitamin D2 and/or 25-hydroxyvitamin D3, or a 25-hydroxyvitamin D analog, such as a vitamin D-C22 immunogenic molecule or compound. Antibodies produced using these antigenic molecules, and related antigenic compounds, are also described. In addition, disclosed herein are methods for detecting vitamin D deficiency in a subject, methods for treating a subject suspected of having a vitamin D deficiency, methods for monitoring progression of vitamin D deficiency in a subject, and methods for monitoring treatment of vitamin D deficiency in a subject in need thereof. The methods involve the detection or quantification of 25-hydroxyvitamin D2 and D3.

Abstract: Provided is a novel method of isolating and producing human antibodies with desired specificity from human B cells. In particular, a method of isolating human antibodies from memory B cells obtained from patients which suffer from a disease which is caused by or involves activation of the immune system, for example autoimmune and inflammatory disorders is described.

Abstract: Methods are provided herein for enhancing the effectiveness of medical therapies by administering agents that suppress a biological damage response that is inducible by the medical therapy administered to a subject. In certain embodiments, a method is provided for administering an anti-senescent cell agent that suppresses a biological response comprising cellular senescence that is induced by the medical therapy.

Abstract: The present invention relates to the discovery that of a panel of serum or plasma markers may be used to diagnose Idiopathic Pulmonary Fibrosis (“IPF”) and distinguish this condition from other lung ailments. It further relates to the identification of markers associated with IPF disease progression.

Abstract: A device for calculating risk of a patient developing a serious infection, the device comprising: a controller; storage storing electronic program instructions for controlling the controller; a display for displaying a user interface; and input means; wherein the controller is operable, under control of the electronic program instructions, to: receive input via the input means, the input comprising one or more values representing respective measures of one or more risk factors associated with biological sample(s) obtained from the patient; process the input to calculate the risk; and display an indication of the calculated risk via the display.

Abstract: The present invention relates to the field of cell differentiation. In particular, the present invention relates to a method for preparing improved cardiomyocyte-like cells differentiated from at least one multipotent or pluripotent cell, comprising a step of contacting the cardiomyocyte-like cell(s) with at least one agent to promote and/or induce integrin subunit alpha-V (integrin ?v) activity, thereby modulating expression of at least one cardiac gene of said cardiomyocyte-like cells. It also relates to a method for screening for an agent capable of improving cardiomyocytes differentiated from at least one multipotent or pluripotent cell.

Abstract: A method for determining the sensitivity and/or resistance of a patient suffering from a cancer disease to Aurora kinase inhibitor therapy, which comprises determining in vitro in the cancer cells or body fluids taken from the patient the expression of at least one gene selected from a particular group and/or determining in vitro in the cancer cells or body fluids taken from the patient the level of at least one protein selected from a particular group.

Abstract: This invention features methods and compositions useful for treating and diseases caused by a dysregulation of the BMP/GDF branch of the TGF-? signaling pathway. Also disclosed are methods for identifying compounds useful for such therapy.

Abstract: The invention relates to an epitope protection assay for use in diagnosis, prognosis and therapeutic intervention in diseases, for example, involving polypeptide aggregation, such as prion infections. The methods of the invention first block accessible polypeptide target epitope with a blocking agent. After denaturation of the polypeptide, a detecting agent is used to detect protein with target epitope that was inaccessible during contact with the blocking agent. The invention also relates to novel amyotrophic lateral sclerosis-specific epitopes and their uses to make antibodies, and to the novel antibodies and uses thereof.

Abstract: The present invention provides an expression vector for cell-surface expression of proteins.

Abstract: The disclosure relates to methods and compositions effective in the diagnosis, prognosis and treatment of human hematopoietic cancers. In particular, the disclosure provides tumor-associated genes that encode for cytokine receptors that are differentially expressed in hematopoietic tumor cells of myeloid origin compared with other cells, e.g., normal stem cells.

Abstract: Peptides useful in determining the presence of autoantibodies in patients suffering from rheumatoid arthritis are disclosed.

Abstract: The invention refers to a method to evaluate the sulfoxidizing activity in a microbiologic process detecting the presence of the spermidine biomarker produced by the micro organisms that participate in such process.

Abstract: The invention quantifies HA using a process which comprises two key steps: HA is captured using a lectin, such as snowdrop lectin; and captured HA is quantified using an immunoassay. This assay can conveniently be performed in an ELISA format. The process is specific, is robust in the face of contaminants, and is more rapid and more sensitive than the standard SRID assay.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.

Abstract: The invention concerns a method for assaying soluble fibrin in a sample, in which said sample is brought into the presence of a plasminogen activator with a high specificity for soluble fibrin (PA-Fb sp) and the soluble fibrin count in the sample is measured by measuring the difference between the count of fibrin degradation products obtained after degrading soluble fibrin with PA-Fb sp and the base count of fibrin degradation products determined before bringing the sample into the presence of PA-Fb sp.

Abstract: This invention relates to a method of predicting progression of an inflammatory condition in a subject, which involves providing a medium comprising hyaluronan or a fragment thereof; contacting the medium with a fluid sample from a subject with an inflammatory condition, where the fluid sample comprises proteins or proteoglycans and a transfer agent; incubating the fluid sample with the medium under conditions effective for the transfer agent in the fluid sample to mediate transfer of heavy chains from the proteins or proteoglycans to the hyaluronan or a fragment thereof to form a complex; detecting, using an antibody, occurrence levels of the complex; and comparing occurrence levels of the complex from said detecting to a reference standard to predict progression of an inflammatory condition in the subject. Also disclosed are methods of tailoring treatment of an inflammatory condition and quantifying local inflammatory activity in a body fluid.

Abstract: Provided herein are compositions and methods for examining the progression, regression or risk of individuals at risk for developing coronary artery disease (CAD).

Abstract: A process for the characterization of rosacea is disclosed. The process can include identifying for the first time new markers in leukocyte recruitment as well as the therapeutic applications targeting rosacea.

Abstract: The present invention relates to agent selected from the group consisting of an anti-S100B antibody, an anti-S100B aptamer or an inhibitor of S100B gene expression for use in a method for reducing airway hyperresponse in a subject in need thereof. The present invention also relates to a method for determining whether a subject is at risk of having or developing an airway hyperresonse comprising determining the level of S100B protein in a biological sample obtained from said subject.

Abstract: An assay of identifying the responsiveness of a HER2-positive cancer in a patient to a HER2 targeted drug, the method comprising the step of comparing a level of NeuromedinU in a biological sample obtained from the patient with a reference level of NeuromedinU, wherein detection of a level of NeuromedinU that is increased compared to the reference level of NeuromedinU indicates that the HER2-positive cancer has reduced responsiveness to a HER2 targeted drug.

Abstract: The present invention provides novel methods for determining the presence or amount of a hydrolytic enzyme in a sample, based on novel substrates for the enzymes, and also provides compositions and methods that provide highly sensitive assay methods for such hydrolytic enzymes.

Abstract: The invention relates to an immunogenic peptide of eight amino acids that is generated naturally in the intestine of celiac patients by means of the hydrolysis of ingested gluten. In addition, the invention relates to the use of the peptide, or antibodies generated against same, for the in vitro monitoring and/or diagnosis of celiac disease, as well as to the use of such antibodies for the detection of gluten in food. The invention further relates to the use of the aforementioned peptide as a therapeutic target for the development of compounds or compositions for use in the diagnosis, treatment and/or prevention of this pathological condition, as well as to the use of the peptide and the antibodies against same for the prevention and/or treatment of celiac disease.

Abstract: There exist in the art methods of detecting simple peptides. However, methods to determine the effective plasma concentration of mixtures of peptides as a group, rather than for individual peptides with a defined amino acid sequence, are complicated by the heterogeneity of the peptides to be detected. This application provides improved methods of detecting and assessing random sequence polymer (RSP) compositions, methods for the detection and quantitation of RSP compositions, means to determine and enrich a subset of peptides in an RSP composition based on the subset's interactions with certain capture polypeptides, and methods for administering RSP compositions to a subject in need thereof, wherein the dosage regimen and quantity may be determined or evaluated based on the above-mentioned methods for detection and quantitation.

Abstract: This invention is related to the field of the prevention and treatment of kidney disease. The treatment of kidney disease may be tailored depending upon the need for, or expectation of, long-term dialysis. For example, prediction of long-term dialysis treatment can be determined by monitoring urine biomarkers related to the development of chronic kidney disease. For example, a normalized time course of hyaluronic acid can be used to determine whether a patient having suffered acute kidney injury will require long-term dialysis.

Abstract: Provided herein is an all-in-one saliva collection apparatus that collects saliva to allow for the filtration of saliva in order to separate saliva components, such as extracellular proteins and nucleic acids that are not present in intact cells, from the intact cells and debris remaining in the extracted sample. The filtered saliva samples can be aliquoted into two fractions for protein and/or nucleic acid analysis. The present invention further describes long term storage at ambient temperatures of filtered salivary nucleic acids, and long term storage at ambient temperatures of filtered salivary proteins added to an ethanol solution. The filtered cell-free saliva samples have diagnostic usefulness.

Abstract: Provided herein are methods for predicting efficacy of a DNA (cytosine-5)-methyltransferase 1 (DNMT1) inhibitor treatment in a subject having a cancer, methods of identifying a subject having a cancer that is more likely to respond to a DNMT1 inhibitor treatment, and methods of selecting a treatment for a subject having a cancer that include determining a level of SOX9 in a sample containing cells from a subject having a cancer. Also provided are methods of treating a subject having a cancer that include selectively administering a DNMT1 inhibitor to a subject having cancer determined to have an elevated level of SOX9 in a sample containing cells from the subject compared to a reference level. Also provided are antibodies and antigen-binding antibody fragments that specifically bind to SOX9, and nucleic acid sequences that contain at least 10 nucleotides complementary to a contiguous sequence present in a SOX9 nucleic acid for use in these methods.

Abstract: This disclosure relates to apelin antigen-binding proteins and methods of using the apelin antigen-binding proteins. The antigen-binding protein may comprise an antibody to apelin and can be used to treat pathological conditions involving angiogenesis. The pathological conditions can comprise cancer or retinopathy and/or retinopathy-related complications.

Abstract: The present invention provides a method of treating, delaying the onset, delaying progression of, reducing the incidence of or reducing the severity of amyotrophic lateral sclerosis in a subject, the method comprising administering to a subject an agent, which interferes with IgG-A2BG2 expression, IgG-A2BG2 function or IgG-A2BG2 interaction with CD16 in said subject.

Abstract: The invention features methods and devices for the detection of biomarker complexes and their components and for the sequential detection of multiple epitopes of a biomarker. The invention also features methods for diagnosing disease and evaluating the efficacy of treatment of a subject with a disease.

Abstract: The present invention provides methods for diagnosing a venous thromboembolism or intracardiac thrombi in an individual in need of such treatment. A representative method of the present invention comprises the steps of: obtaining a plasma sample from said individual; determining the baseline level of D-dimer in said sample; contacting said sample with a compound that catalyzes the conversion of plasminogen into plasmin; and measuring the level of D-dimer is said sample after administering or contacting said sample with a compound that catalyzes the conversion of plasminogen into plasmin, wherein a significantly greater concentration of D-dimer after contact with a compound that catalyzes the conversion of plasminogen into plasmin than prior to contact with a compound that catalyzes the conversion of plasminogen into plasmin indicates that said individual has pulmonary embolism or venous thromboembolism.

Abstract: The present invention is directed to the field of cancer diagnosis, specifically to the diagnosis of bladder cancer (BC) and prostate cancer (CaP). More specifically, the invention provides simple, non-invasive urinary tests characterized by high sensitivity and specificity, wherein urinary levels of heat shock proteins and anti-inflammatory cytokines are used as biomarkers.