Abstract: The invention disclosed concerns a fixed dose combination (FDC) of pertuzumab, trastuzumab, and, optionally, recombinant human hyaluronidase (rHuPH20), which is administered subcutaneously to patients. The final efficacy and safety data for the FeDeriCa clinical trial, United States Prescribing Information (USPI) (including home-use) methods, and primary analysis of the PHranceSCa clinical trial are disclosed and claimed.

Abstract: The present invention discloses an assay method for the detection of viable microbial cells in a sample, the assay method comprising the steps of: i) adding an ATP degrading enzyme to a sample suspected of containing viable microbial cells to substantially degrade any extracellular ATP in the sample; ii) adding a phosphate containing compound to the sample to substantially halt action of the ATP degrading enzyme; and iii) subjecting the sample to a detection assay to establish the level of undegraded ATP in the sample to provide an indication of the level of viable microbial cells in the sample.

Abstract: The instant disclosure provides aquaporin DNA tolerizing vaccines and methods of using such vaccines for treating individuals having neuromyelitis optica (NMO) and NMO spectrum disorders. Aspects of the methods include administering to the individual, in need thereof, an effective amount of an aquaporin DNA tolerizing vaccine to reduce one or more symptoms of NMO or an NMO spectrum disorder. Compositions and kits for practicing the methods of the disclosure are also provided.

Abstract: The invention provides methods for detection in stored biological samples of PrPsc and other analytes that are present in exosomes.

Abstract: The invention relates to an analysis method for determining a functional parameter of an organ of a human or animal individual by measuring the 13CO2 content in the air exhaled by the individual to which a substrate has been administered the reaction of which in the body of the individual enriches the air exhaled by the individual with 13CO2. The method is characterized by using a measuring device, the maximum reaction rate of the substrate in the body of the individual being determined via a change of the measured 13CO2 content in the air exhaled by the individual using zero-order enzyme kinetics. The invention also relates to an aqueous methacetin solution for use in said analysis method, the pH of the solution being greater 7.0. The invention also relates to a face mask (1) for use in the inventive method for separating the exhaled air from the air inhaled by an individual. Said face mask comprises a face mask body (2) and an air cushion (3) encircling the face mask body.

Abstract: The present invention provides for methods and materials for diagnosing and treating neuromyelitis optica (NMO).

Abstract: The present invention relates to compositions and methods for the reduction of atherosclerotic plaques and the decrease in the level of total serum cholesterol, triglycerides, serum LDL cholesterol, and serum HDL cholesterol. The present invention also relates to methods for the diagnosis, prevention and treatment of atherosclerosis and mycoplasma associated diseases.

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

Abstract: The present invention pertains to a method for in vitro prognosticating and/or diagnosing cerebral cerebral malaria, wherein said method comprises a step of detecting non-erythroid spectrin or fragments thereof, and/or antibodies directed against non-erythroid spectrin, in a biological sample. Reagents and kits for performing this method are also disclosed.

Abstract: Nanosubstrates as biosensors, methods of making such nanosubstrates, and methods of using such nanosubstrates to detect biomarkers are described.

Abstract: The present invention provides methods of treating a subject diagnosed with, or at risk for developing, pathogenic fibrosis, particularly pulmonary fibrosis. The method of the invention comprises administering to the subject a compound or composition which inhibits semaphorin (SEMA) 7A, SEMA 7A receptors, or downstream effectors. A SEMA 7A inhibitor comprises an antibody, a soluble SEMA 7A receptor, an siRNA, a ribozyme, an antisense, an aptamer, a peptidomimetic, a small molecule, a soluble receptor, or any combinations thereof.

Abstract: The present invention relates to compositions and methods for prevention and treatment of diseases and conditions, particularly ocular diseases and conditions, characterized by aberrant fibrogenesis or scarring, inflammation, and/or aberrant neovascularization or angiogenesis. The compositions and methods of the invention utilize immune-derived moieties that are specifically reactive against the bioactive lipid, sphingosine-1-phosphate, and its variants, which moieties are capable of decreasing the effective concentration of bioactive lipid being targeted. In one embodiment, the immune-derived moiety is a humanized monoclonal antibody that is reactive against sphingosine-1-phosphate.

Abstract: The present invention provides, as a novel diagnosis marker for type 1 diabetes mellitus, a type 1 diabetes mellitus diagnostic composition comprising alanyl-tRNA synthetase, glycyl-tRNA synthetase, asparaginyl-tRNA synthetase, or tryptophanyl-tRNA synthetase, a diagnostic kit comprising the same, and a diagnostic method using the same. The composition, the kit, and the method, according to the present invention, may be used for early diagnosis and confirmed diagnosis of type 1 diabetes mellitus because type 1 diabetes mellitus can be easily diagnosed from a patient sample.

Abstract: The present invention provides for methods and materials for diagnosing and treating neuromyelitis optica (NMO).

Abstract: Monoclonal antibodies, synthetic and biotechnological derivatives thereof (ScFv or others) are able to recognise the NGF high affinity receptor, TrkA, and act as NGF-antagonist molecules. Pharmacological compositions for therapy, gene therapy, diagnostics of neurological pathologies are also described. Transgenic animal models to study such pathologies are also described.

Abstract: 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. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.

Abstract: By detecting an antibody which immunologically reacts with amylase ?2-A in a sample, AIP or FT1DM is examined or the possibility of developing FT1DM is determined. For instance, detection of this antibody is carried out by an immunological method using an antigen which immunologically reacts with this antibody. The antigen is preferably a partial fragment containing the amino acid sequence of amino acid numbers 299 to 511 of human amylase ?2-A (SEQ ID NO: 1).

Abstract: The present invention is to present an analyzing method for analyzing a target substance contained in a sample using a reagent containing magnetic particles. The method comprises steps of: (a) magnetically capturing magnetic particles in a container with a first magnetic force generating member arranged on a lower side of the container accommodating a liquid specimen containing the magnetic particles; (b) transferring the container to a target substance separating section after the step (a); and (c) in the target substance separating section, discharging a cleaning liquid into the container and aspirating a liquid in the container while magnetically capturing the magnetic particles in the container with a second magnetic force generating member.

Abstract: The present invention pertains to methods of inhibiting angiogenesis in an individual in need thereof comprising administering to the individual an agent that inhibits one or more CEP protein adducts wherein the angiogenesis is the result of oxidative peptide modification of polyunsaturated fatty acids (PUFA) in the individual, and administration of the agent inhibits angiogenesis in the individual. In one embodiment, the invention is directed to methods of inhibiting ocular angiogenesis in an individual in need thereof comprising administering to the individual an agent that inhibits the angiogenic activity of one or more CEP protein adducts wherein administration of the. agent inhibits ocular angiogenesis in the individual.

Abstract: Methods useful for human adapting non-human monoclonal antibodies are disclosed. The methods select candidate human antibody framework sequences from a human germline framework database.

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 invention relates to the use a BD16 and/or BB18 anti-CD100 antibody or of a chimeric or humanized or human form thereof, or a fragment thereof, for the therapy or diagnosis of a central nervous system disorder, more particularly a myelin disorder or a disease that affects oligodendrocytes, such as multiple sclerosis or HTLV-1 associated myelopathy or peripheral myelinating cells.

Abstract: A diagnostic composition to detect antibodies in a sample obtained from an animal or human being infected by Trichinella, comprising at least one peptide containing a series of amino acids that form a continuous or discontinuous epitope recognized by sera from pigs infected with Trichinella.

Abstract: 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. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.

Abstract: 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. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.

Abstract: The invention relates to method of detecting autoantibodies from patients suffering from rheumatoid arthritis. To this end, according to the invention, at least two peptide units are used of which at least one peptide unit comprises a part not derived from (pro)filaggrin, fibrin, fibrinogen, vimentin, cytokeratin 1 and cytokeratin 9, and which peptide unit comprises the motif XG, and a peptide unit comprising the motif XnonG, wherein X is a citrulline or an analogue thereof, and nonG is an amino acid other than glycine.

Abstract: An antibody which reacts with N-acetylheparosan and heparan sulfate that is derived from bovine kidney but does not substantially react with heparan sulfate derived from a murine Engelbreath-Holm-Swarn tumor tissue, the antibody being produced with a hybridoma which is prepared using a substance composed of a protein and N-acetylheparosan bound to the protein.

Abstract: A protein utilizing an anti-gold antibody and a gold-binding side which is a part of the anti-gold antibody is constructed. This protein is capable of specifically binding to gold. This protein or a complex protein containing such a protein can be used for the detection of a target substance.

Abstract: The invention relates to ultrasensitive bioanalytical assays based on the use of high-gain catalytic chemical amplification methods. The ultrasensitive bioanalytical assays of the invention utilize high gain catalytic chemical amplification methods to detect the presence and to quantify the concentrations of target analytes labeled with specific binding reagents or biomarkers comprising a catalyst or a catalyst precursor.

Abstract: The invention provides a method to efficiently express high levels of a recombinant untagged NT-proBNP for use as a calibrator in NT-proBNP immunoassays.

Abstract: Provided is a method for characterizing an analyte by matrix assisted laser desorption ionization (MALDI) mass spectrometry, which method comprises: (a) labelling the analyte with a light-absorbing label that absorbs light at a pre-determined frequency, to form a labelled analyte; (b) embedding the labelled analyte in a matrix formed from at least one compound that absorbs light, to form an embedded labelled analyte; (c) desorbing the embedded labelled analyte by exposing it to light having the pre-determined frequency, to form a desorbed analyte; and (d) detecting the desorbed analyte by mass spectrometry to characterize the analyte.

Abstract: Methods for (1) evaluating feline kidney function by determining ghrelin level in feline tissue or biofluid and correlating the ghrelin level directly to kidney function and (2) diagnosing kidney disease in a feline comprises determining an observed ghrelin level in a tissue or biofluid of the feline and comparing the observed ghrelin level to a reference ghrelin level indicative of normal kidney function, wherein an observed level lower than the reference level is indicative of kidney disease or susceptibility thereto.

Abstract: Methods for detecting and quantifying phosphoinositide lipids in a sample are provided, together with novel SidC- and SdcA-derived polypeptide fragments, or fusion proteins comprising such fragments that may be effectively employed as PI(4)P probes in biochemical and cell biological assays. Applications of the disclosed probes include: (i) detection and quantification of PI(4)P in vitro; and (ii) staining of intracellular compartments in live or fixed eukaryotic cells.

Abstract: To enable successive measurement of samples by using one piezoelectric sensor. An adsorption layer provided in a piezoelectric sensor is an adsorption layer in which protein and an immunoglobulin are stacked in this order from the bottom. The immunoglobulin has a property of separating from protein when coming into contact with an acid liquid, and therefore, when the immunoglobulin as the adsorption layer is brought into contact with the acid liquid after capturing a substance to be sensed, the immunoglobulin is separated from the protein. Then, the adsorption layer is again formed by the supply of a new immunoglobulin, which enables the successive measurement of samples.

Abstract: Methods for (1) evaluating feline kidney function by determining ghrelin level in feline tissue or biofluid and correlating the ghrelin level directly to kidney function and (2) diagnosing kidney disease in a feline comprises determining an observed ghrelin level in a tissue or biofluid of the feline and comparing the observed ghrelin level to a reference ghrelin level indicative of normal kidney function, wherein an observed level lower than the reference level is indicative of kidney disease or susceptibility thereto.

Abstract: The present invention provides an assay for detection of M. bovis-infected animals. A tracer, comprising a peptide of M. bovis protein MPB70 conjugated to a fluorophore, is added to a serum sample from an animal to form a mixture. The fluorescence polarization of the mixture in then measured and compared to the fluorescence polarization of a control. The present invention further provides a tracer for use in fluorescence polarization assay to detect antibodies specific for M. bovis. The tracer comprises a peptide of M. bovis protein MPB70 conjugated to a fluorophore, such that the tracer is able to bind to antibodies specific for M. bovis to produce a detectable change in fluorescence polarization.

Abstract: There is provided a method for the identification of antigens recognized by a given antibody. In particular the method provides for characterization of the epitope recognized by the antibody and for purification based on the physico-chemical properties of the antigen. The characterization facilitates subsequent analysis of the antigen for identification purposes.

Abstract: The invention pertains to bioconjugation systems comprising sterically constrained cis-diols and borates.

Abstract: A sandwich immunoassay kit for detecting ciguatoxins based on a combination of two anti-ciguatoxin CTX3C monoclonal antibodies produced by hybridomas, 3D11 (deposited at IPOD, AIST under accession number FMRM PB-8293) and 10C9 (FMRM PB-8292). In particular, one of the antibodies is labeled and each of them binds specifically to a different site of ciguatoxin CTX3C.

Abstract: An assay method for determining presence of a target antibody or antigen in a specimen qualitatively or quantitatively by mixing the specimen with an antigen or antibody immunologically reactive with the target antibody or antigen, and assaying the level of the immunological agglutination reaction, wherein the reactive antigen or antibody is effectively immobilized on the carrier via an amino acid sequence capable of binding to the carrier.

Abstract: The present invention relates to a novel allergen from timothy grass (Phleum pretense) pollen, Phl p11 as disclosed in SEQ ID NO:2, and use thereof as a reagent and in a diagnositic kit as well as for immunotherapy.

Abstract: The invention provides derivatives of efavirenz and methods of making derivatives of efavirenz. The derivatives include immunogenic compounds for producing antibodies to efavirenz and labeled efavirenz tracers. These compounds are useful in immunoassay methods for determining efavirenz.

Abstract: Novel hapten-carrier conjugates are capable of inducing the production of antibodies, in vivo, that specifically bind to nicotine. These conjugates comprise a nicotine hapten conjugated to an immunogenic carrier protein. The novel conjugates preserve the chirality of nicotine in its native (S)-(?) state, and have good stability properties. The conjugates are useful in formulating vaccines for active immunization, that are used to prevent and treat nicotine addiction. The antibodies raised in response to the nicotine hapten-carrier conjugate are used for passive immunization. These antibodies are administered for prevention and treatment of nicotine addiction.

Abstract: The invention concerns lactic acid bacteria strains capable of regulating the production of NO and inflammatory cytokines by enterocytes, depending on the inflammatory condition of said enterocytes. The strains can also be incorporated in food supplements such as fermented dairy products used for regulating inflammatory response and non-specific immunity.

Abstract: A microscale binding assay, analyte binding array, and kits are disclosed, which exploit the mass action law to harvest analyte from a liquid sample. This is achieved by fabrication of sorbent zones having up to ten times the binding capacity per unit area generally obtained on polystyrene microtiter plates. The resulting arrays substantially deplete the liquid solution of analyte during incubation. Accordingly, the assays respond to total mass of analyte in the sample, not analyte concentration. This approach, coupled with direct fluorescence detection in the NIR, yields maximal signal intensity and low background for optimal sensitivity.

Abstract: Conjugates of nonimmunogenic valency platform molecules and analogs of immunogens that possess the specific B cell binding ability of the immunogen but lack T cell epitopes and which, when introduced into individuals, induce humoral anergy to the immunogen are disclosed. Accordingly, these conjugates are useful for treating antibody-mediated pathologies that are caused by foreign or self immunogens.

Abstract: The invention provides methods and compositions for azide tagging of biomolecules. In one embodiment of the invention, proteins are tagged by metabolic incorporation of prenylated azido-analog substrates. Examples of such analogs are azido farnesyl diphosphate and azido farnesyl alcohol. The azido moiety in the resulting modified proteins provides an affinity tag, which can be chemoselectively captured by an azide-specific conjugation reaction, such as the Staudinger reaction, using a phosphine capture reagent. When the capture agent is biotinylated, the resulting conjugates can be detected and affinity-purified by streptavidin-linked- HRP and streptavidin-conjugated agarose beads, respectively. The invention allows detection and isolation of proteins with high yield, high specificity, and low contamination without harsh treatment of proteins.

Abstract: A pretreatment kit and a pretreatment kit for saliva in identification and quantitative determination of mutans streptococci by immunochromatography utilizing an antigen-antibody reaction, which can remove aggregation caused by mucin and chain formation of mutans streptococci in saliva in a simple operation and can efficiently flow out a complex of a labeled antibody and mutans streptococci from a porous membrane retaining the labeled antibody, contains (A) a 0.01 to 10 mol/L aqueous solution of sodium hydroxide, (B) a 0.01 to 3 mol/L aqueous solution of tartaric acid and/or citric acid, and (C) a nonionic surface active agent and/or an amphoteric surface active agent, in which the component (C) is mixed with the components (A) and/or (B), or is provided separately, and at least one substance selected from the particular metallic salts is contained in at least one of the components (A), (B) and (C) in an amount of 5 to 25% by weight.

Abstract: The present invention provides an assay for detection of serum antibodies to M. paratuberculosis. A tracer, comprising a carbohydrate antigen isolated from M. paratuberculosis that is conjugated to a fluorophore, is added to a serum sample from an animal to form a mixture. The fluorescence polarization of the mixture is then measured. The presence of serum antibodies to M. paratuberculosis is indicated by a fluorescence polarization value of the mixture that is higher than the fluorescence polarization value of a control. The present invention further provides a tracer for use in a fluorescence polarization assay for antibodies specific for M. paratuberculosis. The tracer comprises a carbohydrate antigen isolated from M. paratuberculosis and conjugated to a fluorophore, such that the tracer is able to bind to antibodies specific for M. paratuberculosis to produce a detectable change in fluorescence polarization.

Abstract: An antibody is provided which specifically recognizes and binds to INGAP protein. The antibody is used in competitive binding assays for quantitation of INGAP in biological samples. The assay can be performed on a solid support or in a suspension.