Abstract: A method of diagnosing fibrosis in a subject is provided, comprising the steps of: determining a level of PCPE in a body fluid sample obtained from said subject; and detecting an increased level of PCPE in said body fluid sample relative to a normal control level of PCPE, wherein said increased level of PCPE relative to normal control is indicative of fibrosis in said subject. Furthermore, methods for evaluating the pharmacological efficacy of a drug or a drug candidate in treatment of fibrosis in a patient and for monitoring change of fibrosis in a subject are provided.

Abstract: The present invention relates to a method for detecting an analyte (10) in a sample, comprising the steps of: providing a transducer comprising a pyroelectric or piezoelectric element and electrodes which is capable of transducing a change in energy to an electrical signal, a first reagent immobilised on the transducer, and a second reagent (11) releasably bound to the first reagent and having a label attached thereto which is capable of absorbing electromagnetic radiation to generate energy by non-radiative decay, wherein either the first or second reagent has a binding site which allows binding to the other and which is capable of preferentially binding to the analyte or a derivative of the analyte; exposing the transducer to the sample thereby allowing the analyte or a derivative of the analyte to bind to the binding site and displace the second reagent; irradiating the sample with electromagnetic radiation; transducing the energy generated into an electrical signal; and detecting the electrical signal.

Abstract: The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.

Abstract: The present invention relates to combinations of biomarkers and levels thereof that may be used, for example, in the determination of risk associated with the occurrence of a major adverse cardiac event (MACE) in a patient.

Abstract: The present invention relates to the treatment of pulmonary diseases. More specifically, the invention relates to new methods of detecting and treating chronic obstructive pulmonary disease (COPD). In particular, the invention relates to a method of measuring one or more lipid metabolites in human body fluids as an indicator/biomarker of the progress of chronic obstructive pulmonary disease. The present invention also relates to a method of detecting and/or monitoring chronic obstructive pulmonary disease in a subject, the method comprising measuring the level of at least one lipid metabolite in a sample from the subject, wherein said level is indicative of COPD. The present invention also relates to a method of assessing the efficacy of a COPD treatment in a subject, the method comprising a step of measuring the level of at least one lipid metabolite in a sample from the subject, wherein said level is indicative of COPD severity or status.

Abstract: The invention relates to a method for the determination of an MRM or SRM assay for a protein of interest, a peptide of interest, or a group of proteins/peptides of interest or a whole proteome. It essentially includes the following steps: (1) a list of proteins of interest is selected and for each member at least one or a list of candidate proteotypic peptides is derived (2) this at least one peptide is synthesized/generated essentially without subsequent purification; (3) this at least one unpurified peptide is analyzed by selected reaction monitoring (SRM) preferably coupled to liquid chromatography (LC-SRM) or analogous techniques; (4) validation and/or optimisation of the corresponding assay of the at least one peptide with determination of the SRM coordinates for a peptide/protein of interest and/or of a regulator of interest is achieved.

Abstract: Methods are described for measuring the amount of glucagon in a sample. More specifically, mass spectrometric methods are described for detecting and quantifying glucagon in a sample.

Abstract: This invention relates, e.g., to a method for determining if a subject has myocardial ischemia, comprising (a) providing a blood sample obtained from a subject suspected of having myocardial ischemia; (b) determining in the sample the amount of one or more of the following proteins: (i) Lumican and/or (ii) Extracellular matrix protein 1 and/or (iii) Carboxypeptidase N; and (c) comparing the amount(s) of the protein(s) to a baseline value that is indicative of the amount of the protein in a subject that does not have myocardial ischemia, wherein a statistically significantly increased amount of the protein(s) compared to the baseline value is indicative of myocardial ischemia. Other proteins indicative of myocardial ischemia are also described, as are methods for treating a subject based on a diagnostic procedure of the invention, and kits for carrying out a method of the invention.

Abstract: The method of the invention pertains to determining signal transduction activity in a tissue section by immunohistochemistry techniques. The expression level of the receptor of interest is determined as well as the expression levels of one or more effector molecules of the receptor signal transduction pathway. Furthermore a combined ratio of expression levels of effector molecules in subcellular compartments with the receptor expression was found to have prognostic significance.

Abstract: Disclosed is a fluidic assay device for assaying at least one property of a liquid sample comprising: a liquid sample application region; at least one test flow path in liquid flow communication with the sample application region; a reference flow path in liquid flow communication with the sample application region; and a junction region, at which the test flow path and the reference flow path contact one another, the junction region typically comprising an outlet, conduit, chamber or other portion which permits the onward flow of liquid; wherein a liquid flowing along the reference flow path, upon reaching the junction region, has the effect of preventing the flow of liquid along the test flow path. The invention relates to a fluidic device for the passage of a liquid and an assay device suitable for measurement of the amount and/or presence of an analyte in, or property of, a fluid sample.

Abstract: The invention relates to the detection and quantitation of cyclodextrins and cyclodextrin derivatives in solutions comprising a protein. The invention further relates to methods of evaluating pharmaceutical preparations for the presence of residual cyclodextrins.

Abstract: The invention provides methods of screening a mammalian subject to determine if the subject is at risk to develop or is suffering from, cardiovascular disease. In one embodiment, the method comprises detecting a measurable feature of at least two biomarkers in an HDL subfraction, or in a complex containing apoA-I or apoA-III isolated from a biological sample obtained from the subject, wherein the at least two biomarkers are selected from the group consisting of apoA-I, apoA-II, apoB-100, Lp(a), apoC-I, and apoC-III, combinations or portions and/or derivatives thereof, and comparing the measurable features of the at least two biomarkers from the biological sample to a reference standard, wherein a difference in the measurable features of the at least two biomarkers from the biological sample and the reference standard is indicative of the presence or risk of cardiovascular disease in the subject.

Abstract: The invention relates to the determination of the degree of membrane receptor binding by specific monoclonal antibodies. This method is notably beneficial for monoclonal antibodies that are used in targeted therapies in order to define a target effective dose (TED). Especially the invention relates to the determination of the saturation degree of receptor binding effected by an anti-EGFR antibody of interest.

Abstract: A method for identifying a subject being at risk for or having a chronic inflammatory disease, fibrillinopathy, atherosclerosis, or coronary artery disease is provided. The method may include determining the concentration of GrA and/or GrB in a blood or serum sample from said subject; and comparing the concentrations to the corresponding concentration in a control sample, wherein an elevated concentration of GrA and/or GrB may be indicative of a chronic inflammatory disease, fibrillinopathy, atherosclerosis, or coronary artery disease. The method may further include identifying concentrations of fibrinogen, elastin and/or fibrillin.

Abstract: System and methods for the detection of biomarkers. In at least one embodiment of a system for the detection of a diagnostic marker in a body fluid of the present disclosure, the system comprises a diagnostic device comprising a plurality of test wells, wherein each test well is capable of containing at least one detection agent, a detection device capable of interacting with the diagnostic device, wherein the detection device is capable of detecting an interaction between the at least one detection agent and a diagnostic marker in at least one of the plurality of test wells, and a stabilization agent contained within at least one of the plurality of test wells, the stabilization agent capable of completely or substantially preventing the degradation or inactivation of the detection agent or the diagnostic marker.

Abstract: Provided herein is an affinity media and the construction and use thereof. The affinity media may be used, for example, for the detection of differential proteins/peptides by depletion of proteins/peptides similar to those in a control sample from a test sample in the search for biologically and pathologically important proteins/peptides. The detected differential proteins/peptides provide vital information for biomarker discovery, drug target discovery, and personalized medicine and treatment.

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Abstract: The invention provides methods of screening a mammalian subject to determine if the subject is at risk to develop, or is suffering from, cardiovascular disease. The methods comprise detecting an amount of at least one biomarker in a biological sample, or HDL subfraction thereof, from the subject, and comparing the detected amount of the biomarker to a predetermined value, where a difference between the detected amount and the predetermined value is indicative of the presence or risk of cardiovascular disease in the subject. In some embodiments, the biomarker comprises at least one of ApoC-IV, Paraoxonase 1, C3, C4, ApoA-IV, ApoE, ApoL1, C4B1, Histone H2A, ApoC-II, ApoM, Vitronectin, Haptoglobin-related protein, and Clusterin, or combinations thereof.

Abstract: Disclosed herein are compositions and methods for measuring the level of MG53 found in a biological fluid as a biomarker for a disease or disorder, e.g., tissue damage, exercise capacity or a muscle-related disease or disorder. In addition, the invention relates to targeting the native MG53 found in the blood as a therapeutic approach.

Abstract: The present invention provides a method of testing the ability of a test compound to bind to and optionally modulate the activity of a protein of the JMJD2 subfamily of Jumonji proteins. The method comprises incubating a test compound with a protein of the JMJD2 subfamily of Jumonji proteins, a co-factor of said protein and, optionally, a substrate for demethylation. The method of the invention can be used for screening large numbers of compounds to identify a group of compounds that are candidate compounds for clinical use for treatment of certain cancers especially prostate cancers. Other compounds that do not have activity in the screening assays can be eliminated from further consideration as candidate compounds. The method of the invention therefore has utility in the pharmaceutical industry.