Abstract: The invention relates to compositions and methods for regulating hair growth. Specifically, the invention relates to regulating hair growth by regulating the activity one of the prostaglandin D2 (PGD2) receptors, DP-2 (GPR44). Compositions and methods for regulating hair growth include inhibiting hair growth by administering a DP-2 agonist, or stimulating hair growth by administering a DP-2 antagonist.

Abstract: The present invention relates to the use of N-linked glycan profiles of blood or blood component proteins as biomarkers for diagnosing diabetes mellitus and for monitoring the efficacy of anti-diabetic therapy. Specifically, the present invention relates to detecting changes in the amounts of N-linked glycans as diagnostic biomarkers for diabetes mellitus and as indicators of the efficacy of anti-diabetic therapy over time.

Abstract: Using NMR/MS based metabonomics and targeted lipidomics approaches the inventors have explored the metabolic phenotypes of aging and longevity in a cohort compromising centenarians, elderly and young adults. The inventors have identified biomarkers for a reduced risk of developing ageing related chronic inflammatory disorders and propose an in vitro method of diagnosing a lifestyle that allows delaying and/or avoiding ageing related chronic inflammatory disorders using phenylacetylglutamine (PAG) as biomarker.

Abstract: Methods are disclosed for predicting or diagnosing pulmonary artery hypertension (PAH) and for determining the efficacy of PAH therapy using biomarkers.

Abstract: The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. A first aspect of the invention relates to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titre of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points. A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titre of untreated patients increased by the double of the standard deviation of this control antibody titre.

Abstract: Embodiments herein relate to the field of screening tools for fetal/maternal wellness, and, more specifically, to biomarkers for gestational diabetes. In various embodiments, the methods may provide non-invasive and minimally-invasive screening tools for gestational diabetes that involve detection of changes in a proteomic profile of a test sample relative to a reference sample. In particular embodiments, the method may include determining whether a proteomic profile of a test sample from the subject includes at least one expression signature characteristic of gestational diabetes, wherein the proteomic profile comprises information on the expression of glycosylated fibronectin and glycosylated PSG, for example information on levels of fibronectin-SNA or a fibronectin-antibody complex, and PSG-AAL or a PSG-antibody complex.

Abstract: Embodiments of the invention include methods for detecting and determining the concentrations of macro and small molecules, including bio-molecules, in a liquid or gaseous sample.

Abstract: The present invention relates to methods and materials for more effectively treating patients with interferon. It is based on the discovery that clinical response to interferon (IFN) therapy is mediated in part by inhibition of activation of MDSC and such inhibition can be observed after a test dose of interferon; a significant decrease of reactive oxygen species (ROS) production by MDSC (as a measure of their activation) after IFN therapy is predictive of overall response to immunotherapy in cancer patients.

Abstract: A detection device and associated systems and methods for detecting analytes from a multiplex reaction are described. In particular, a device for conducting at least one detection reaction using a modified ELISA method including a surface with a detection region and a reference region, a detection sensor, and a light source. The detection device may include a complementary metal-oxide-semiconductor (CMOS) image sensor. The device may be used to measure and report discrete quantities or combinations of discrete analytes, providing information to aid in the prognosis and/or diagnosis of altered states of health in vertebrates.

Abstract: Definitive diagnosis and early start of treatment cannot be made for tuberculosis since conventional methods for detecting a Mycobacterium tuberculosis complex require a long time plus enormous labor and expense. Because detection is difficult to perform directly from a biological sample, if the biological sample contains no or a very small amount of MPT64, there is a risk infection with the Mycobacterium tuberculosis complex will be missed. The present method and a kit address these long-standing needs by more rapidly and conveniently detecting a Mycobacterium tuberculosis complex, without culturing a biological sample containing the Mycobacterium tuberculosis complex, in which a biological sample is subjected to a heat-treatment so as to extracellularly secrete a Mycobacterium tuberculosis complex-specific secretory protein, particularly, MPB64, and subjecting the resulting treated sample to an immunological measurement/assay.

Abstract: The invention relates to assessing the Fc?RIIIa-158 polymorphism in a subject in order to determine susceptibility of the subject to drug induced thrombocytopenia, as well as therapies and therapeutic compositions based on the use of this biomarker.

Abstract: The invention provides devices and methods for self-administered noninvasive retrieval of biological materials of the uterus and/or cervix. The cervical device comprises a receptacle with a variable volume receptacle cavity, a controller configured to change the volume of the receptacle cavity, a surface for collection of biological materials, and a flexible pouch for generation of suction to facilitate efficient retrieval of biological materials. The biological materials retrieved include various biomarkers of diseases and disorders of reproduction, are directly isolated from a site of pathology, and are not metabolized or diluted. Information generated by analyzing these biological materials permits early diagnosis and prognosis assessments of disease and disorders of the female reproductive organs, irregularities of pregnancy, anomalies of the fetus in utero, and microbial infections.

Abstract: This invention provides methods and kits for improved diagnosis of medically relevant conditions by solution based biochemical testing procedures performed in solutions of test samples. The invention provides a method to substitute the cell based morphological information contained within the cytological and/or histological data of the test sample by molecular information obtainable from the solution, wherein the original test sample is dissolved and thus enables for accurate and reproducible assessment of medically relevant diagnosis from dissolved test samples. The method according to the invention comprises the steps of determining the levels of one or more disease markers associated with the condition to be diagnosed, determining the level of one or more normalization markers suitable to substitute the information related to morphological aspects of the sample, comparing and/or combining the data of the disease and normalization markers, and assessing diagnosis of a medically relevant condition.

Abstract: The invention relates to a process for determining the susceptibility to nosocomical infections in a patient, comprising the measurement of the expression of sCD127 in a biological sample.

Abstract: Biomarkers relating to pancreatic Beta-cell function, pancreatic Beta-cell glucose sensitivity, insulin resistance, and/or pancreatic Beta-cell-related disorders are provided. Methods based on the same biomarkers are also provided.

Abstract: Ectoparasite infestation of a substrate like bedding is detected by contacting a sample from the substrate with a polyclonal ectoparasite antibody generated from a whole ectoparasite immunogen, under conditions wherein the antibody specifically binds ectoparasite antigen in the sample.

Abstract: Methods and devices for rapid assessment of the severity of injury not due to a natural disease based upon measurement of neutrophil gelatinase-associated lipocalin (NGAL) are provided.

Abstract: A chimeric polyvalent recombinant protein for use as a vaccine and diagnostic for Lyme disease is provided. The chimeric protein comprises epitopes of the loop 5 region and/or the alpha helix 5 region of outer surface protein C (OspC) types. The OspC types may be associated with mammaliran Borrelia infections.

Abstract: Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Abstract: A method of bioassay for the quantification of peptide fragments relevant to neurodegenerative conditions comprising a neo-epitope formed by cleavage of a Tau protein by a secretase such as ADAM10 comprises contacting a blood derived sample with an antibody specific for the neo-epitope and determining the level of binding of said immunological binding partner to peptide fragments in said sample. Neo-epitope containing peptide levels are found to be inversely correlated to cognitive function.

Abstract: A novel method that enables prostate cancer testing that is noninvasive and more accurate than conventional methods is disclosed. The present inventors intensively analyzed urine samples from prostate cancer patients, and non-cancer subjects, who are free of prostate cancer, and, as a result, newly discovered urinary peptides that can be used as indicators in prostate cancer testing. Use of these urinary peptides as indicators enables various prostate cancer-related tests including detection of prostate cancer, discrimination between prostate cancer and benign prostatic hyperplasia, monitoring of a therapeutic effect of prostate cancer therapy and monitoring of postoperative recurrence.

Abstract: This application relates to methods of increasing survival or progression-free survival in a patient with a solid tumor, wherein the patient has an elevated serum concentration of C-reactive protein (CRP), by administering a JAK inhibitor or an inhibitor of IL-6 signaling to the patient, as well as methods of predicting survival benefit in these patients from such therapy.

Abstract: Compositions and methods comprising proteins that bind specifically to adalimumab are disclosed herein. Adalimumab is a monoclonal antibody specific for the cytokine TNF-? and was developed to treat TNF-? mediated inflammatory diseases. In one aspect of the instant invention, the binding proteins are antibodies directed toward adalimumab. These antibodies, including binding fragments thereof, can be used in a clinical setting as well as for research and development. For example, these anti-adalimumab antibodies can be employed to neutralize adalimumab.

Abstract: Provided is a microanalysis method and system using a Field Effect Transistor (FET). The microanalysis method includes a channel region having a receptor molecule fixed; forming a nano-particle conjugate in the channel region by supplying a sample for test and the nano-particle conjugate to the FET; growing a probe material on the channel region; and measuring a current flowing through the channel region, wherein the receptor molecule is a material that is selectively bonded to a target molecule in the sample for test.

Abstract: The present application relates to extracellular vesicles (EVs) derived from gram-positive bacteria. In detail, the present application provides animal models of disease using extracellular vesicles derived from gram-positive bacteria, provides a method for screening an active candidate substance which is capable of preventing or treating diseases through the animal models of disease, provides vaccines for preventing or treating diseases caused by extracellular vesicles derived from gram-positive bacteria, and provides a method for diagnosing the causative factors of diseases caused by gram-positive bacteria using extracellular vesicles.

Abstract: The present invention relates to solution microarrays. In particular, the present invention relates to an aqueous 2-phase system for solution microarrays and uses thereof. The present invention further relates to systems and methods for performing assays within the solution microarrays (e.g., diagnostic assays).

Abstract: Provided is a derivative of 22-hydroxycholesterol, 24S-hydroxycholesterol, 25-hydroxycholesterol, 26-hydroxycholesterol or 27-hydroxycholesterol. Also provided is a protein conjugated to the above derivative. Further provided is an antibody composition comprising antibodies that specifically bind to 22-hydroxycholesterol, 24S-hydroxycholesterol, 25-hydroxycholesterol, 26-hydroxycholesterol or 27-hydroxycholesterol. Additionally, a method of making antibodies that specifically bind to 22-hydroxycholesterol, 24S-hydroxycholesterol, 25-hydroxycholesterol, 26-hydroxycholesterol or 27-hydroxycholesterol is provided. Also, a method of assaying for 22-hydroxycholesterol, 24S-hydroxycholesterol, 25-hydroxycholesterol, 26-hydroxycholesterol or 27-hydroxycholesterol is provided. Additionally provided is a kit for detecting 22-hydroxycholesterol, 24S-hydroxycholesterol, 25-hydroxycholesterol, 26-hydroxycholesterol or 27-hydroxycholesterol.

Abstract: The invention provides markers and methods for detecting head-and-neck precancers, (including OPLs), cancers and related disease conditions in a subject. The invention also provides localization and imaging methods for head-and-neck precancers (including OPLs) and cancers, along with kits for carrying out methods of the invention. The invention further provides therapeutic applications for head-and-neck precancers (including OPLs) and cancers which employ head-and-neck precancer and cancer markers, polynucleotides encoding the markers, and binding agents for the markers.

Abstract: The present invention provides antibodies that differentially react with allelic variants of a polymorphic protein, methods of identifying same, an antigen binding fragment comprised therein, proteins, cells, viral particles, compositions, and kits comprising same. The invention also provides methods for determining a haptoglobin type of a subject and methods for testing a subject for susceptibility to diabetic complications.

Abstract: A collection device for use in connection with off-device testing of collected samples. The device includes a first panel having one or more apertures for receiving samples, a second panel opposite the first panel, and a removable tab having a first portion and a second portion. The first portion is aligned with at least one of apertures on the first panel and constructed such that depositing the sample through the at least one aperture causes the sample to be directly deposited on the first portion of the tab, and the second portion includes a sample-free grasping area accessible from an exterior of the device for removing the tab. A method of obtaining a sample is also disclosed.

Abstract: The present invention is related to the anti-PAX8 antibodies, kits, cocktails, and use of anti-PAX8 antibodies for detection of cancer.

Abstract: The present invention provides a method for determining a breast cancer-associated disease state comprising the steps of: a) providing a sample to be tested; and b) determining a biomarker signature of the test sample by measuring the presence and/or amount in the test sample of one or more biomarker selected from the group defined in Table 1; wherein the presence and/or amount in the test sample of the one or more biomarker selected from the group defined in Table 1 is indicative of the breast cancer-associated disease state. The invention further provides arrays and kits fir use in the same.

Abstract: The present inventors discovered that by forming a large immune complex comprising antigens containing two or more antigenic binding units (epitopes) and two or more antigen-binding molecules (for example, antibodies), elimination from the plasma of the antigens containing two or more antigenic binding units can be accelerated. Moreover, they found that by using this characteristic and by further using antigen-binding molecules having an ion-dependent antigen-binding activity, elimination of the antigens can further be accelerated and the above problem can be solved.

Abstract: The invention provides methods and compositions to detect expression of one or more biomarkers for identifying and treating patients who are likely to be responsive to VEGF antagonist therapy. The invention also provides kits and articles of manufacture for use in the methods.

Abstract: The present invention provides devices and methods to separate and concentrate target protein species at a microliter scale and to generate reagents to those variants with exquisite selectivity for specific protein isoforms using only picograms of target material.

Abstract: Provided herein are antigen binding proteins, e.g., human and/or monoclonal antibodies that have affinity for heparin-binding epidermal growth factor-like growth factor (HB-EGF) and neutralize the biological functions of this growth factor.

Abstract: Methods and compositions are described for the diagnosis of primary biliary cirrhosis. Novel autoantigens are described for use in assays which employ test samples from individuals.

Abstract: An in vitro method aiding in the assessment of chronic obstructive pulmonary disease (COPD). The disclosure further relates to a method for assessing COPD from a sample, derived from an individual, by measuring the protein ARMET in said sample in vitro.

Abstract: Methods of detecting complement activation including steps of detecting in a sample from a subject a level of iC3b wherein the detecting involves specific interaction between the iC3b and a non-cross-reactive antibody thereto, comparing the detected level with a reference level, which reference level is within a range of about 10 ng/ml to about 5,000 ng/ml, wherein determination that the detected level is above the reference level indicates that the subject is suffering from or susceptible to undesirable and/or pathologic complement activation, and administering treatment to treat undesired complement activation if the detected level is above the reference level. Other methods of detecting complement activation with or without measuring iC3b are also provided.

Abstract: The present invention includes compositions and methods for the diagnosis and treatment of lung cancer with a recombinant tumor-associated antigen loaded antigen presenting cell that generates a cytotoxic T lymphocyte specific immune response to at least one of SP17, AKAP-4, or PTTG1 expressed by one or more lung cancer cells.

Abstract: Isolated human monoclonal antibodies which bind to and inhibit human CD25, and related antibody-based compositions and molecules, are disclosed. The human antibodies can be produced by a hybridoma, a transfectoma or in a nonhuman transgenic animal, e.g., a transgenic mouse, capable of producing multiple isotypes of human monoclonal antibodies by undergoing V-D-J recombination and isotype switching. Also disclosed are pharmaceutical compositions comprising the human antibodies, nonhuman transgenic animals, hybridomas and transfectomas which produce the human antibodies, and therapeutic and diagnostic methods for using the human antibodies.

Abstract: The invention encompasses methods and kits used in the detection of invasive glioblastoma based upon the expression of NHERF-1. The methods and kits also allow prediction of disease outcome as well as therapeutic outcome.

Abstract: The present invention provides a method of detecting dermatophyte, which does not require a complicated operation such as an enzyme treatment and a heat treatment. The present invention provides a method of detecting dermatophyte, including a step of extracting a dermatophyte component from a sample with a treatment liquid containing a non-ionic surfactant or a zwitterionic surfactant, and a kit for diagnosing dermatophyte infection, containing a treatment liquid comprising the above surfactant, and an antibody specifically recognizing a dermatophyte component, which are housed in separate containers.

Abstract: The present invention relates to the discovery of the human survival motor-neuron gene or SMD gene, which is a chromosome 5-SMA (Spinal Muscular Atrophy) determining gene. The present invention further relates to the nucleotide sequence encoding the SMN gene and corresponding amino acid sequence, a vector containing the gene encoding the SMN protein or a DNA sequence corresponding to the gene and transformant strains containing the SMN gene or a DNA sequence corresponding to the gene.

Abstract: The present invention relates to a method for determining the survival prognosis of patients suffering from non-small cell lung cancer. More specifically, the present invention provides methods which measure kinase activity by studying phosphorylation levels in response to a kinase inhibitor and profiles in samples obtained from patients diagnosed with non-small cell lung cancer. The present invention also provides methods for predicting the response of a patient diagnosed with non-small cell lung cancer to a medicament.

Abstract: Methods for producing a protein extract from cells, such as cells containing viral proteins, are provided. In general terms, the methods involve: increasing the pH of the cells to a pH of at least about pH 10.0 to produce an intermediate composition, and then, in the presence of a non-ionic detergent, neutralizing the pH of the intermediate composition to produce the protein extract. Kits and compositions for practicing the subject methods are also provided.

Abstract: The present invention relates to an anti-idiotypic polypeptide scaffold that includes two or more peptide sequences that mimic a discontinuous epitope of a pathogen that is recognized by or induces formation of a broadly neutralizing antibody. Using a fibronectin FNfn10 scaffold bearing two or more modified discontinuous loops, scaffolds that recognize broadly neutralizing antibodies in vitro and from patient serum have been identified. These scaffolds should induce an immune response or mobilize germline specificities to initiate their affinity maturation.

Abstract: The present invention relates to a method for determining or predicting the response of a patient diagnosed with non small cell lung cancer to targeted pharmacotherapy. The present invention also aims to provide methods and devices for predicting the response of patients diagnosed with non small cell lung cancer to specific medicaments. More specifically, the present invention provides methods which measure kinase activity by studying phosphorylation levels and profiles and inhibitions thereof by drugs in samples of said patients.

Abstract: Fully human monoclonal Abs includes (i) an antigen-binding variable region that exhibits very high binding affinity for IL-1? and (ii) a constant region that is effective at both activating the complement system though C1q binding and binding to several different Fc receptors.

Abstract: Compositions and methods for the detection, prevention, or treatment of anthrax or other infectious diseases. In one aspect, the present invention provides methods for immunizing humans or animals against Bacillus anthracis or other capsulated pathogens. The methods include administering a capsular polypeptide of a pathogen of interest and a CD40 agonist to a human or animal. The capsular polypeptide or the CD40 agonist is administered in such an amount or frequency that an immunoprotective response can be elicited in the human or animal against the pathogen of interest. In another aspect, the present invention provides methods of using passive immunization with anti-capsular polypeptide antibodies to prevent or treat infections caused by Bacillus anthracis or other pathogens. In yet another aspect, the present invention provides methods useful for diagnosis of anthrax by detection of capsular polypeptide in serum or other biological samples.