Abstract: Disclosed herein are embodiments of a signaling conjugate, embodiments of a method of using the signaling conjugates, and embodiments of a kit comprising the signaling conjugate. The disclosed signaling conjugate comprises a latent reactive moiety and a chromogenic moiety that may further comprise a linker suitable for coupling the latent reactive moiety to the chromogenic moiety. The signaling conjugate may be used to detect one or more targets in a biological sample and are capable of being covalently deposited directly on or proximally to the target. Particular disclosed embodiments of the method of using the signaling conjugate comprise multiplexing methods.

Abstract: Fusobacterium is a genus of gram-negative, filamentous, anaerobic bacteria found as normal flora in the mouth and large bowel, and often in necrotic tissue. A comparison of microbial ribonucleic acids (RNA) between colorectal carcinoma (CRC) tissue and adjacent normal control tissue found the over-representation of F. nucleatum in CRC tissue. RNA abundance was measured by polymerase chain reaction (PCR)-amplifying RNA from the tissue, constructing libraries, sequencing the RNA in the libraries, pairing sequences from CRC and normal tissue, and quantifying RNA abundance. Detection of Fusobacterium in a gastrointestinal sample is indicative of gastrointestinal cancer.

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 of hyaluronic acid (HA) as diagnostic and prognostic biomarker assays in renal injuries.

Abstract: The fusion protein comprising (1) a first region comprising the amino acid sequence of SEQ ID NO: 18 and (2) a second region comprising an amino acid sequence for a polypeptide containing at least one cysteine residue for binding to other useful compound via the thiol group can be modified by chemical modification, and thus has a high catalytic ability for a luminescence activity and is highly available for general purposes.

Abstract: The present application relates to methods of treating HIV-associated nephropathy (HIVAN) and/or focal segmental glomerulosclerosis (FSGS) using endothelin-1 (ET-1) antagonists. The application further relates to a composition for the treatment of HIVAN and/or FSGS. A kit for detecting the presence of ET-1 or ET-1-associated biomarker in a biological sample is also disclosed.

Abstract: The present invention relates to immunoassays for serologically differentiating animals naturally infected with PRRS virus from animals vaccinated against PRRS. The immunoassays provide detection of at least a portion of the N terminal region of the 2b portion of PRRSV. The immunoassay is preferably an enzyme-linked immunosorbent assay (ELISA).

Abstract: Testing systems and methods are disclosed for detecting a pregnancy marker of an animal. A test kit may include a first standard with a first concentration of the marker, a second standard with a second concentration of the marker lower than the first concentration, and at least three test surfaces coated with a biomolecular recognition element selected to bind with the marker. The test may also include a reagent solution with a conjugated biomolecular recognition element that binds with the marker, and a visual indicator that produces a visually detectable change when reacting with the conjugated biomolecular recognition element bound to each test surface. A detectable change generated by the marker from the sample with an intensity greater than the first concentration yields a pregnant result, lower than the second concentration yields a not pregnant result, and between the first and second concentrations yields a retest result.

Abstract: The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.

Abstract: Provided herein are methods of staining biological material for the purpose of detecting, and in some examples also identifying, microorganisms. Methods of Gram staining bacteria using a slow-acting decolorizing formulation, such as one that includes 1,2-propandiol or ethylene glycol, can be used to extend the time of the decolorizing step, and thus permit automation of the Gram staining method. Also provided are compositions and kits for performing automated Gram staining on microscope slides.

Abstract: The present invention, in various embodiments, relates to methods of inhibiting NNMT production or activity in a cell, and methods of treating or preventing obesity or a related metabolic condition in a subject in need thereof, comprising administering a nicotinamide N-methyltransferase (NNMT) antagonist. The invention further provides methods of identifying NNMT antagonists useful for treating obesity and related metabolic disorders.

Abstract: An object is to provide a compound capable of inhibiting activation of TGF-? receptors due to HCV, and a screening method for the compound. It has been found that a HCV-derived NS3 protease binds to type I TGF-? receptor, and this binding results in activation of TGF-? receptors. Moreover, binding sites between the NS3 protease and type I TGF-? receptor were identified, and it has been found that antibodies recognizing these binding sites inhibit activation of TGF-? receptors due to NS3 protease. Furthermore, it has been also found that screening for a compound capable of inhibiting activation of TGF-? receptors can be performed by using the inhibition of the binding between NS3 protease and type I TGF-? receptor or the like as an index.

Abstract: Compositions, methods, and devices for the detection of multiple analytes with a single signal are provided.

Abstract: In a method for testing a patient with a test apparatus for a plurality of diseases using a specimen collected from the subject, if the subject is determined to be positive for one of the plurality of diseases, a test result indicating the positive is outputted from the test apparatus without waiting for completion of the testing of the other diseases.

Abstract: The present invention is directed to electronic methods of detecting target analytes such that upon binding of the target analyte a shift in electrochemical potential is seen. This assay relies on the use of an electroactive moiety (“EAM”) that is attached to an electrode and comprises a self-immolative moiety, whose presence gives the EAM a first E0, and whose absence, upon irreversible cleavage gives the EAM a second E0. This difference is detected, and if such change occurs, it is an indication of the presence of a target analyte.

Abstract: The present invention is directed to electronic methods of detecting target analytes such that upon binding of the target analyte a shift in electrochemical potential is seen. This assay relies on the use of an electroactive moiety (“EAM”) that is attached to an electrode and comprises a self-immolative moiety, whose presence gives the EAM a first E0, and whose absence, upon irreversible cleavage gives the EAM a second E0. This difference is detected, and if such change occurs, it is an indication of the presence of a target analyte.

Abstract: Protein recognized by an antibody used as an active ingredient of an antibody medicine such as trastuzumab or an antibody used for targeting a target site of an active ingredient is highly accurately quantitatively determined by employing a quantitative tissue staining method of biological tissues, thereby providing a method for determining therapeutic effectiveness of a medicine containing such an antibody as a component.

Abstract: A lateral flow device includes a sample compressor and a test strip comprising a diverting zone. The diverting zone, which may include a barrier and/or a gap or ditch, stops or impedes flow. Flow is reinitiated and diverted into an alternate plane by compression of a sample compressor. Flow returns to the original, lateral plane, at the end of the diverting zone.

Abstract: The present invention relates to methods of identifying candidate compounds for the treatment of leukemia and diagnostic methods based on histone methylation and HoxA5 promoter activity.

Abstract: The present invention provides nucleotide and amino acid sequences that identify and encode novel expressed chemokines (PANEC-1 and PANEC-2) from human pancreas cells. The present invention also provides for antisense molecules to the nucleotide sequences which encode PANEC-1 and PANEC-2, expression vectors for the production of purified PANEC-1 and PANEC-2, antibodies capable of binding specifically to PANEC-1 and PANEC-2, hybridization probes or oligonucleotides for the detection of PANEC-1- or PANEC-2-encoding nucleotide sequences, genetically engineered host cells for the expression of PANEC-1 and PANEC-2, diagnostic tests for chemokine activation based on PANEC-1- and PANEC-2-encoding nucleic acid molecules and antibodies capable of binding specifically to the protein.

Abstract: Prostate cancer (PC) is an entity that encompasses different types of tumors, including adenocarcinomas and non-adenocarcinomas. Adenocarcinomas and non-adenocarcinomas respond to, and therefore should be treated, with different treatments. Even within the adenocarcinomas, the lethality of tumors is highly variable, from low risk/indolent/non-life threatening to high risk/lethal. The inability to accurately predict the behavior of a particular cancer makes treatment decisions difficult and highly inexact. Elevated expression of prostate specific membrane antigen (PSMA) expression is a molecular hallmark of lethal prostate adenocarcinoma. Assessment of PSMA expression levels to predict the behavior of a particular cancer will be useful in the diagnosis and treatment of PC.

Abstract: The compositions described include an antibody diluent buffer that minimizes the amount of antibody required for immunoassays and further improves the performance of antibody-based assays. The claimed antibody diluent buffer comprises a high-molecular weight neutral polymer and an antibody that specifically binds to an antigen of interest, wherein the antibody remains in solution in the presence of the polymer. Methods for the use of the antibody diluent buffer to detect an antigen, even trace amounts of an antigen, in an antibody-based assay are also disclosed herein.

Abstract: The present invention provides a method of examining polycystic kidney disease or a complication of polycystic kidney disease using a gene(s) selected from the group consisting of NTNG1, POSTN, TNC, KAL1, BST1, ACAT2, INSIG1, SCD, HSD3B1, KRT7, USP40, SULT1E1, BMP6, CD274, CTGF, E2F7, EDN1, FAM43A, FRMD3, MMP10, MYEOV, NR2F1, NRCAM, PDCK1, PLXNA2, SLC30A3, SNAI1, SPOCD1, MMP1, TFPI2, HMGA2, KRTAP4-7, KRTAP4-8, KRTAP4-9, MYPN, RPPH1, and SIAE, and a method of screening for a therapeutic agent or a preventive agent therefore, and further vascular endothelial cells or vascular mural cells obtained via differentiation induction from iPS cells formed from a somatic cell of a subject suffered from polycystic kidney disease and having cerebral aneurysm as a complication.

Abstract: The application provides methods for the detection of an analyte in a sample by electrochemiluminescence using certain reagent compositions. Reagent compositions, reagent kits for measuring electrochemiluminescence (ECL) and electrochemiluminescence detection methods using the reagent compositions are disclosed. In particular, the application relates to the use of novel combinations of compounds, which can be used in said measurements to provide improved ECL assay performance.

Abstract: A system for detecting presence of an organism having an enzyme in a sample, comprising: a cartridge for containing the sample and a substrate such that the enzyme can react with the substrate to produce a biological molecule; a partitioning element mounted in a recess in a base of the cartridge, the partitioning element allowing partitioning of the biological molecule thereinto; a light source for irradiating the biological molecule partitioned into the partitioning element; and, a detector for detecting fluorescence of the biological molecule partitioned into the partitioning element, the detected fluorescence being indicative of presence of the organism in the sample; wherein the light source is in a raised cartridge mount of the system that mates with the recess in the base of the cartridge. Also provided is a method for calibrating said system and quality control cartridges for use in same.

Abstract: The present invention relates in particular to methods of detecting predisposition to or diagnosis and/or prognosis of Charcot-Marie-Tooth (CMT) and related disorders. More specifically, the invention relates to development, validation and application of new biomarkers, which can be used for detecting the presence or risk of CMT disease and related disorders. In particular, the present invention relates to metabolite, lipid, carbohydrate and proteinaceous biomarkers that can be measured in biological body fluids and easily available extracts of biopsies, which can be used to aid in the detection, prediction of drug treatment and follow up of this treatment of neurodegenerative disorders, including CMT disease. The present invention also relates to methods for identification of CMT disease subtypes, assessing the responsiveness to the treatments and the efficacy of treatments in subjects having CMT or a related disorder.

Abstract: Methods are described for producing enteroendocrine cells that make and secrete insulin in a mammal by blocking the expression or biological activity of one or more Foxo proteins or biologically active fragments or variants thereof.

Abstract: A method for determining a prognosis for survival for a patient with leukaemia is described. Also described is a method for monitoring the effectiveness of a course of treatment for a patient with leukaemia, and the use of such a method in a kit. A kit determining the level of RINF is also described.

Abstract: Methods for screening compounds for their capability to inhibit CYP1B1-mediated proliferation and motility of and/or to reverse estrogen-induced reduction in apoptosis of premalignant or malignant cells are provided. Kits for practicing the screening methods are also provided.

Abstract: The present invention relates generally to the fields of molecular biology and growth factor regulation. The invention concerns methods and compositions useful for diagnosing and treating human lung cancer associated with mutated c-CBL.

Abstract: Specific, targetable molecules mediating acquired resistance of B-RAF-mutant melanomas to a B-RAF inhibitor, thereby providing materials and methods for the treatment and detection of B-RAF inhibitor resistant cancers, such as melanoma. A method of identifying a patient to be treated with an alternative to B-RAF inhibitor therapy is described. Also described is a method of treating a patient having cancer. The patient is administered a MEK inhibitor, optionally in conjunction with vemurafenib therapy, or an inhibitor of the MAPK pathway (RAF, MEK, ERK) in conjunction with an inhibitor of the RTK-PI3K-AKT-mTOR pathway.

Abstract: Compositions for use in diagnostic screens for Mycoplasma haemofelis are provided. In one embodiment an immunogenic peptide selected from SEQ ID NO: 1 to SEQ ID NO: 60, or a fragment thereof, is immobilized on a solid support and is used to detect the presence of Mycoplasma haemofelis antibodies in a patient bodily fluid. In accordance with one embodiment a method for detecting a Mycoplasma haemofelis infection in a feline species, is provided.

Abstract: The disclosed invention comprises methods and materials for screening cells for genetic profiles associated with autism spectrum disorders. The methods typically involve isolating a cell from an individual and then observing the expression profile of one or more genes in the cell, wherein certain expression patterns of the genes observed are associated with autism spectrum disorders.

Abstract: The present invention relates to methods for determining the presence of an unstable atherosclerotic plaque in an individual, comprising the steps of measuring the presence and/or level of at least one biochemical marker in a biological sample obtained from said individual, and, based on the result of this measurement, determining the presence of an unstable atherosclerotic plaque in the individual. The present invention also relates to a method for diagnosing a vascular or metabolic disease or an increased predisposition to an adverse outcome in an individual comprising determining the presence of an unstable atherosclerotic plaque in the individual. The present invention also relates to an in vitro method for identifying markers of the presence of an unstable atherosclerotic plaque in a subject, using depleted protein extracts obtained from proteins extracts from biological samples representative of stable and unstable atherosclerotic plaques.

Abstract: The present invention aims to provide a novel reagent for tumor testing and a novel pharmaceutical composition for tumor prevention. The present invention provides a reagent for tumor detection, which comprises a probe for the FEAT gene or amplification primers for the FEAT gene, or an antibody against the FEAT protein or a fragment of the antibody. Moreover, the present invention also provides a pharmaceutical composition for tumor prevention, which is configured to use the FEAT gene or the FEAT protein as a tumor marker to thereby recognize tumor cells.

Abstract: The present invention provides novel methods of inhibiting fibrosis, as well as methods of treating or inhibiting fibrotic disorders, using BMP9 and/or BMP10 antagonists. The present invention also provides methods of assessing whether a subject has or is at risk of developing a fibrotic disorder by detecting levels of BMP9 and/or BMP10. Further provided are methods of assessing the efficacy of a treatment regimen for treating a fibrotic disorder by detecting and comparing pre-treatment levels of BMP9 and BMP10 with post-treatment levels of BMP9 and BMP10.

Abstract: The present disclosure is generally related to pulmonary autoantigens. The disclosure provides methods and kits for assessing whether a subject has or is predisposed to interstitial lung disease. Additionally the present disclosure provides methods of treatment and animal models of interstitial lung disease.

Abstract: It has been discovered that STAT5 phosphorylation and CD150 are effective biomarkers for detecting, diagnosing, and monitoring hematological malignancies, including for example lymphomas. Compositions and methods for identifying therapeutic agents for the treatment of hematologic malignancies using p-STAT5, CD150 or both as biomarkers are described.

Abstract: We provide a novel technological approach for quantitation of c-terminal fragment of uTF for the purpose of quantitation, diagnosis and population screening of cancer. We provide a rationale for measuring c-terminal fragment, methods for making assays, monoclonal and polyclonal antibodies, together with accepted methods of sample preparation. Taken together these proposals and ideas constitute a novel approach for diagnosis and population screening for cancers using urine from cancer patients. In addition we believe that our approach may be useful in the diagnosis of other pathological conditions.

Abstract: A method of quantifying non-transferrin bound iron (NTBI) in a biological fluid is provided, the method comprising: (a) contacting a sample of the biological fluid with a reducing agent to obtain redox-active iron; (b) contacting the sample of the biological fluid with a nitrilotriacetate (NTA) at a concentration of 0.4-2 mM to mobilize non-transferrin bound iron including redox inactive and the redox active iron in the sample; (c) contacting the sample of the biological fluid of step (b) with an indicator including an iron binding moiety and fluorophore; and (d) detecting and quantifying a fluorescent signal of the fluorophore thereby quantifying the NTBI in the biological sample.

Abstract: Methods and reagents are disclosed for conducting assays for EDDP. The reagents include a moiety selected from the group consisting of poly(amino acid) label moieties, non-poly(amino acid) label moieties, poly(amino acid) immunogenic carriers, non-poly(amino acid) immunogenic carriers, non-label poly(amino acid) moieties, and non-immunogenic carrier poly(amino acid) moieties linked to 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine at the 3-position of one of the phenyl rings. Antibodies produced from immunogenic EDDP conjugates and labeled EDDP conjugates are employed in assays for determining the presence and/or amount of EDDP in samples suspected of containing EDDP.

Abstract: The present disclosure relates to methods for determining a wavefront position of a liquid on a surface of an assay test strip placing a liquid on the surface of the test strip; and acquiring one or more signals from the surface of the test strip at one or more times, comparing the one or more acquired signals to a threshold, wherein the wavefront position is a position on the surface of the test strip where a signal is greater than or less than a threshold (e.g., fixed or dynamic threshold). Such methods may be used to determine the wavefront velocity of a liquid on a surface of an assay test strip and the transit time of a liquid sample to traverse the one or more positions on the surface of the assay test strip.

Abstract: The present invention relates to novel compositions and therapeutic methods for the treatment of cancer, in particular malignant glioma. The compositions include antisense oligonucleotides or RNAs or vectors encoding them which reduce expression of downregulated in renal cell carcinoma (DRR) in tumor cells, and inhibit malignant glioma cell invasion.

Abstract: The disclosure provides methods for characterizing a prostate cancer sample by detecting expression of ERG, PTEN or both, changes in which relative to a normal control are shown herein to be correlated with prostate cancer capsular penetration and more aggressive forms of prostate cancer. Such methods are useful for the prognosis of prostate cancer capsular penetration and for making treatment decisions in patients with prostate cancer that has penetrated the capsule. Also provided are kits that can be used with such methods.

Abstract: A sample receiving chip comprising a substrate that receives an aliquot volume of a sample fluid and a sample region of the substrate, sized such that the volume of the sample fluid is sufficient to operatively cover a portion of the sample region. The energy imparted into the sample fluid is transduced by the sample region to produce an output signal that indicates energy properties of the sample fluid. The sample receiving chip also includes a channel formed in the substrate, the channel configured to collect the aliquot volume of a sample fluid and transfer the aliquot volume of sample fluid to the sample region.

Abstract: Herewith disclosed is a sample analyzer comprising: a measurement section configured to perform a measurement on a sample and generate a measurement value according to the concentration of an analyte in the sample; a memory storing a calibration curve; an analysis section; an output section; and an instruction receiver. When the instruction receiver receives an instruction to perform a diluting measurement on a calibration sample, the measurement section dilutes the calibration sample by a predetermined ratio and performs a measurement on the diluted calibration sample, and the analysis section determines the concentration of the analyte in the diluted calibration sample by applying a measurement value obtained from the diluted calibration sample to the calibration curve. Information generated based on the determined concentration and the known concentration is output.

Abstract: Disclosed embodiments concern a composition comprising DAB chromogen, and/or derivative thereof, a stabilizer, and polymer capable of preventing or reducing DAB precipitation relative to a composition that does not comprise the polymer. Also disclosed herein is a method for using the disclosed composition and embodiments of a kit.

Abstract: A sample compressor applies pressure to a sample collector and a sample application zone of a test strip to transfer a sample from the sample collector and a binding partner of an analyte to the sample application zone in a lateral flow device. At least one of the binding partners of the analyte is not located on the test strip prior to use of the lateral flow device. The test strip may be a universal test strip with no molecule that specifically binds the analyte is located on the test strip. The sample compressor may be a universal sample compressor also with no molecule that specifically binds the analyte on the sample compressor. The lateral flow device may also include one or more enhancement elements, where the enhancement elements bind to the analyte sandwich to increase a detection signal in the test zone.

Abstract: The present invention identifies biomarkers that are diagnostic of nerve cell injury and/or neuronal disorders. Detection of different biomarkers of the invention are also diagnostic of the degree of severity of nerve injury, the cell(s) involved in the injury, and the subcellular localization of the injury.

Abstract: The receptor for Interleukin 35 (IL-35) is provided. The Interleukin 35 Receptor (IL-35R) comprises a heterodimeric complex of the Interluekin12R?2 receptor and the gp130 receptor. Various compositions comprising the IL-35R complex, along with polynucleotides encoding the same and kits and methods for the detection of the same the same are provided. Methods of modulating the activity of IL-35R or modulating effector T cell functions are also provided. Such methods employ various IL-35R antagonists and agonists that modulate the activity of the IL-35R complex and, in some embodiments, modulate effector T cell function. Further provided are methods for screening for IL-35R binding agents and for IL-35R modulating agents. Various methods of treatment are further provided.

Abstract: Described herein are antibodies, and antigen-binding fragments thereof, that are specific for folate receptor alpha, related polynucleotides, expression vectors, and cells that express the described antibodies. Also provided are methods of using the described antibodies, and antigen-binding fragments thereof, and related kits. Provided herein are also methods for diagnosing cancers, such as breast cancer, thyroid cancer, colorectal cancer, endometrial cancer, fallopian tube cancer, ovarian cancer, or lung cancer, using the described antibodies, and antigen-binding fragments thereof. The methods involve determining the amount of folate receptor alpha in a sample derived from a subject and comparing this level with the level of folate receptor alpha in a control sample or reference sample.