Abstract: A method of producing protein products including alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins from plasma includes steps of: (1) adding a salt to the blood product to produce a first intermediate, wherein the salt comprises between 11-13 wt % of the first intermediate; (2) separating the first intermediate to produce a first supernatant and a first paste; (3) adding a salt to the first intermediate to produce a second intermediate, wherein the salt comprises between 21-23 wt % of the second intermediate; (4) separating the second intermediate to produce a second supernatant and a second paste; (5) separating a third intermediate from the second supernatant by affinity chromatography; and (6) separating the third intermediate by ion exchange chromatography to produce an eluate containing the protein product. Advantageously, the inventive methods are simple and produce alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins in high yields.

Abstract: Methods of analyzing a biological fluid to determine an expected therapeutic benefit of the fluid include determining amounts of components within the biological fluid. Comparisons of a first component of the biological fluid relative to another component of the biological are made to characterize a therapeutic effect of the biological fluid.

Abstract: A disposable system, in some embodiments, includes a multi-channel or multi-chamber test cartridge device configured to operate with a testing system for evaluation of hemostasis in a subject by in vitro evaluation of a test sample from the subject. The disposable system, in some embodiments, is configured to interrogate the test sample to evaluate clot stiffness, strength, or other mechanical properties of the test sample to assess the function of various physiological processes occur during coagulation and/or dissolution of the resulting clot.

Abstract: A portable drug testing device for handheldly collecting a sample from exhaled breath of a subject for further sensor based analysis. The portable drug testing device comprising a housing comprising at least one inlet and at least one outlet for the exhaled breath to exit through, and a sampling membrane arranged in the housing. a tubular element having a mouthpiece section for the subject to exhale into, and a selective trap section in fluid communication with the mouthpiece and the inlet of the housing having a non-straight gas flow path for letting aerosols pass through the tubular element. The sampling membrane is arranged to collect the aerosols from the exhaled breath. The portable drug testing device further comprises a volume measure unit for determining that a pre-defined volume of the exhaled breath has passed through the sampling membrane.

Abstract: A system for certifying a detection of a gaseous substance present in air exhaled by an individual. The system includes a sensor providing a measurement of the quantity of the gaseous substance, a portable terminal connected to the sensor and having a camera for taking an image of the individual. The terminal has a module for authenticating the individual and the sensor used for the exhaled air sample by analyzing the data of images using facial recognition and by analyzing a graphic marker for the sensor. The terminal produces an item of data representative of the quantity of gaseous substance measured in the sample and a piece of authenticated identification data of the individual who has exhaled the sample. The system can at the same time authenticate the identity of the individual, authenticate the sensor used, and associate the result of the value of the test with the individual.

Abstract: Embodiments of the invention relate to the quantitative measurement of halide ion concentration and pH using novel fluorescent polypeptides. One embodiment of the invention provides a polypeptide containing at least one amino acid sequence selected from a group consisting of: Sequence ID No. 3, Sequence ID No. 4, Sequence ID No. 5, and Sequence ID No. 6.

Abstract: The present invention provides Genome-Scale T Cell Activity Arrays (GS-TCAA), as well as methods of making these arrays and methods of using them to identify immune modulators.

Abstract: It is an object to provide a method for evaluating a medicinal substance targeting a G protein-coupled receptor (GPCR). Specifically, the present invention relates to a method for evaluating the activity of a GPCR comprising a step of bringing a target substance into contact with a cell expressing a GPCR on the cell membrane; and a step of determining the diffusive dynamics of the GPCR on the cell membrane.

Abstract: The disclosure provides for methods of compositions for making astrocytes from induced pluripotent stem cells as well as method of treating and diagnosing neurological disorders such as Rett syndrome.

Abstract: The present invention provides methods of identifying and distinguishing different types of nerve cells in ex vivo cell culture, the method comprising the steps of: a) culturing somato-sensory nerve cells ex vivo, b) loading the nerve cells with a calcium, sodium, or voltage-sensitive indicator or expressing a genetically encoded calcium, sodium, or voltage-sensitive indicator, c) pulsing the nerve cells with an electrical train of bipolar square waves at two different voltages and two different frequencies; wherein the first voltage is 10 V/cm or less (low voltage) and the second voltage is between 12 and 20 V/cm (high voltage); and wherein the first frequency is 5 Hz or less (low frequency) and the second frequency is between 15 and 20 Hz (high frequency), and d) detecting activation of the nerve cell by measuring the changes in the signal intensity of the indicator, wherein low voltage and low frequency activation indicates a first type of cell and activation detected only at high voltage indicates a secon

Abstract: Provided herein are compositions and methods for the assembly of a bioluminescent complex from two or more non-luminescent (e.g., substantially non-luminescent) peptide and/or polypeptide units. In particular, bioluminescent activity is conferred upon a non-luminescent polypeptide via structural complementation with another, complementary non-luminescent peptide.

Abstract: Provided herein are compositions and methods for determining the structure of individual targets using by determining long-range distances within such targets.

Abstract: A device and method for filtering blood is disclosed herein. The device can filter blood and attach analytes within the blood to magnetic particles. The analytes can then be strongly bound to an analyzing device by a magnetic force. The analytes can then be counted by the analyzing device and the result can be displayed.

Abstract: This application discloses a lateral flow assay method and device for quick collection and testing of chemical or biochemical samples by immunoassay or Immunochromatographic assays and use of the devices or methods for diagnosing diseases or conditions in a subject. The device includes a fluid sample collector and a test strip for collecting fluid samples and detecting biological analytes in it semi-quantitatively or quantitatively.

Abstract: The invention described herein provides methods for treating a disease or disorder associated with angiotensin receptor signaling in a patient exhibiting elevated levels of ATIR autoantibodies. The invention also provides methods of identifying a patient suffering from a disease or disorder associated with angiotensin receptor signaling that may benefit from treatment with an angiotensin receptor blocker. Patients with elevated levels of ATIR autoantibodies are identified as candidates that particularly benefit from treatment with an angiotensin receptor blocker.

Abstract: The present invention relates to a method for diagnosing a disease comprising the step detecting in a sample comprising antibodies from a patient and also antibody binding to RGS8, a method for diagnosing a disease comprising the step detecting in a sample from a patient the level or activity of RGS8, a polypeptide comprising RGS8 or a variant thereof, a use of set polypeptide for the diagnosis of a disease, an antibody binding to RGS8, a use of the antibody for the diagnosis of the disease, a method for isolating an autoantibody binding to RGS8, a pharmaceutical composition or medical device comprising the polypeptide according to the present invention, a kit for the diagnosis of a disease comprising the polypeptide or the medical device according to the present invention and a use of the polypeptide, the antibody or the antibody for the manufacture of a kit or medical device.

Abstract: Compositions and methods useful for treating a number of human disorders including, but not limited to, cancer, cardiovascular disease, obesity, and metabolic disorders are provided. For example, the disclosure features compositions and methods for modulating the hydroxylation of ACC2 by PHD3 in vitro or in vivo. Also provided are methods for monitoring and/or detecting the expression of PHD3 and/or levels of ACC2 hydroxylation, which are useful for, inter alia, determining whether a cancer cell is sensitive to glycolytic pathway inhibitors or inhibitors of fatty acid metabolism.

Abstract: The present invention relates to antigen recognizing constructs against a tumor associated antigen (TAA) derived from the target protein DDB1 and CUL4 associated factor 4-like 2 (DCAF4L2). The invention in particular provides novel T cell receptor (TCR) based molecules which are selective and specific for the TAA of the invention. The TCR of the invention, and TAA binding fragments derived therefrom, are of use for the diagnosis, treatment and prevention of TAA expressing cancerous diseases. Further provided are nucleic acids encoding the antigen recognizing constructs of the invention, vectors comprising these nucleic acids, recombinant cells expressing the antigen recognizing constructs and pharmaceutical compositions comprising the compounds of the invention.

Abstract: The present invention provides use of EB1 as a biomarker for predicting the response of a brain neoplasm to a compound of formula (I) wherein R represents phenyl or pyridinyl; wherein phenyl is optionally substituted by one or two substituents independently selected from lower alkyl, lower alkoxy, amino, acetylamino, halogen and nitro; and wherein pyridinyl is optionally substituted by amino or halogen; R1 represents hydrogen or cyano-lower alkyl; or a pharmaceutically acceptable derivative thereof, and wherein the prefix lower denotes a radical having up to and including a maximum of 4 carbon atoms; in particular wherein a higher level of EB1 in the sample from the subject relative to a standard value or set of standard values predicts sensitivity of the brain neoplasm to the compound of formula I or pharmaceutically acceptable derivative thereof. The invention also provides methods of treatment and kits for use according to the invention.

Abstract: Methods are provided for determining prognosis of multiple myeloma in a patient by measuring expression of BCMA in a sample. Also provided are methods for treating multiple myeloma by measuring expression of BCMA in a sample and administering an effective amount of an antigen binding protein that binds BCMA. Also provided are kits for measuring BCMA expression in a sample.

Abstract: A fluorescence probe with mitochondrial targeting and two-photon property, its preparation method and application in detecting and tracking endogenous H2S in samples or living cells. The fluorescent probe is prepared by a four-step preparation method and demonstrates a UV-vis absorption increment ?ab=395 nm and ˜43 fold higher fluorescence intensity in the presence of H2S. The probe further demonstrates stability, selectivity for H2S over competing agents and sensitivity as low as 20 nm. A method of detecting endogenous H2S rapidly in the absence of any external stimulators is provided. Samples are contacted with the probe and the changes in fluorescence are monitored to detect H2S levels. The disclosed probe is non-toxic and suitable as a biomarker and therapeutic molecule in cancer and other diseases.

Abstract: The invention pertains to diagnosis and treatment of ovarian cancer (OC), cervical cancer (CC), or colorectal cancer (CRC). One embodiment of the invention provides a method of identifying OC, CC, or CRC based on the level of RHAMM in the urine of a subject. Another embodiment of the invention provides a method of identifying OC based on the level of RHAMM in the urine and CA125 in the blood of a subject. The invention also pertains to monitoring the efficacy of a treatment of OC, CC, or CRC based on the level of RHAMM protein in the urine and/or the level of CA125 in the blood. Another embodiment of the invention provides devices and reagents to assay RHAMM in a urine sample and optionally, assay CA125 in a blood sample.

Abstract: Provided are methods of producing gene expression profiles of subjects having cancer. In certain aspects, the methods include contacting a sample obtained from breast tumor tissue (e.g., breast tumor tissue of a Luminal A molecular subtype) with reagents for determining the expression levels of ZIC2, RGS16, SLC2A1, DDR2, PTPLAD1, CMTM8, and TROAP. In some aspects, the methods include contacting a RNA sample obtained from breast tumor tissue (e.g., breast tumor tissue of a Basal molecular subtype) with reagents for determining the expression levels of CXCL13, CRYBB2, ITSN1, PLA1A, LAMC2, RGS5, WWC3, TTLL7, ANAPC1, TSSC1, CFH, HAUS4, RAMP3, MED28, TSC22D3, LSM14A, and ASIP. Kits that find use, e.g., in practicing the methods of the present disclosure, are also provided.

Abstract: The present invention relates to the use of a fibrinogen capture agent or a fibrinogen detection agent in an assay to detect a Ciz1 b-variant.

Abstract: In some aspects, the disclosure provides methods of modulating the level of proteasome inhibitor resistance of a cell, the methods comprising manipulating the level of expression or activity of a subunit of the 19S proteasome in the cell. In some aspects, cells in which the level of a 19S subunit is modulated, e.g., reduced, are provided. In some aspects, methods of identifying agents that reduce proteasome inhibitor resistance are provided. In some aspects, methods of classifying cancers according to predicted proteasome inhibitor resistance are provided. In some aspects, methods of killing or inhibiting proliferation of cancer cells, e.g., proteasome inhibitor resistant cancer cells, are provided. In some aspects, methods of treating cancer, e.g., proteasome inhibitor resistant cancer, are provided.

Abstract: Among the various aspects of the present disclosure is the provision of a method of detecting ceramides as prognostic indicators. An aspect of the present disclosure provides for a prognostic indicator for risk of developing a cardiovascular-related disease, disorder, or condition and mortality risk.

Abstract: Embodiments include obtaining a stroma liquid biopsy from a patient and detecting a pattern of dysregulation amongst the biomarkers in the stroma liquid biopsy that can be monitored to help screen, diagnose or treat the patient for cancer. The biomarkers in the stroma liquid biopsy are involved in interconnected pathways such as the coagulation pathway, acute-phase inflammation pathway, and complement pathway. Particular embodiments involve assaying for levels of biomarkers, such as neutrophil elastase, as well as subpopulations of other biomarkers, such as subpopulations of SERPIN proteins. The levels of biomarkers and/or the ratios of levels of biomarker subpopulations can be informative for predicting the cancer disease state in the patient, thereby enabling more personalized or tailored medical intervention for the patient.

Abstract: The present invention relates to novel antibodies and fragments that bind to a V-domain Ig Suppressor of T cell Activation (VISTA), and methods of detecting VISTA.

Abstract: Methods and materials involved in assessing samples (e.g., cancer cells) for the status of PINK1-Parkin pathway biomarkers, as well as materials and methods for identifying cancer patients likely to respond to a particular cancer treatment regimen.

Abstract: The present invention relates to a method of capturing, enriching, purifying, detecting or measuring a cell in a sample at a sub-nanogram level comprising providing a nanocomposition, contacting the sample with the nanocomposition to form a mixture solution and allowing the binding of the cell with the nanocomposition, applying a magnetic field to the mixture, and evaluating the presence of or absence of the cell. The nanocomposition is capable of capturing or enriching an analyte at a sub-nanogram level, and comprise a nanostructure operably linked to an analyte-capturing member.

Abstract: A method of quantifying the amount of glucose in a sample is provided herein that may further comprise an interferent such as mannitol. At least two measurements are obtained using measurement methods that differ in their sensitivity to the amount of interferent in the sample, thus enabling the results to be compared to determine whether any interferent is present in the sample.

Abstract: Provided are systems and methods to identify subjects at risk for preterm labor and/or preterm birth. The systems and methods utilize biomarkers. Also provided are systems and methods for decreasing the risk of preterm labor by administering a treatment following a positive risk identification.

Abstract: The invention relates to the use of a cell-free nucleosome as a biomarker in a sputum sample for the diagnosis or detection of cancer, adenoma, autoimmune disease or inflammatory disease. The invention also relates to methods of detecting said cell free nucleosomes in sputum samples, in particular in methods of diagnosis.

Abstract: Compositions that include isolated, functionally active, recombinantly produced class I HLA trimolecular complexes that include epitopes unique to breast cancer cells are disclosed.

Abstract: The invention provides biomarkers and methods for determining the risk of a subject for developing mild traumatic brain injuries (mTBI). In some aspects, the methods of the invention also determine the fitness of a subject for participating in an activity with increased chances of receiving a head impact. Some embodiments of the invention are directed to kits for determining the risk of a subject for developing mTBI or the fitness of a subject for participating in an activity with increased chances of receiving a head impact.

Abstract: The present disclosure provides immunoassay methods of detecting a cleaved high molecular weight kininogen (HMWK) with high sensitivity and specificity and isolated antibodies that specifically bind cleaved HMWK

Abstract: The present invention relates to a method for the accurate, rapid and sensitive detection of breast or ovarian cancers from body fluid samples of a mammalian subject and related assay, kits and peptides suitable for such a method.

Abstract: The present invention provides methods and systems to accurately detect and measure levels of endogenous antibodies, for examples endogenous IgA, to particular antigens in a biological sample from a companion animal, which is useful to diagnose inflammatory conditions, including bowel disease (IBD), gastrointestinal infections, and food sensitivities in companion animals, e.g., dogs or cats, and to distinguish among such gastrointestinal disorders. Such methods and systems identify whether a sample from the patient is associated with an inflammatory condition, infection, and/or food sensitivity condition, by using non-invasive means, thus conveniently providing information useful for guiding treatment decisions.

Abstract: Disclosed are antibodies and methods of using the antibodies to detect Transactive response DNA-binding protein 43. In particular, the present disclosure discloses antibodies that specifically bind to phosphorylated epitopes of TDP-43 and methods for using the antibodies to detect phosphorylated epitopes of TDP-43.

Abstract: The present invention relates to methods of determining if a subject has an increased risk of suffering from memory impairment. The methods comprise analyzing at least one plasma sample from the subject to determine a value of the subject's proteomic profile and comparing the value of the subject's proteomic profile with the value of a normal proteomic profile. A change in the value of the subject's proteomic profile, over normal values is indicative that the subject has an increased risk of suffering from memory impairment compared to a normal individual.

Abstract: Disclosed herein are methods that aid in the hyperacute diagnosis and evaluation of a human subject that has sustained or may have sustained an injury to the head, such as mild or moderate, severe, or moderate to severe traumatic brain injury (TBI), using an early biomarker, such as ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) glial fibrillary acidic protein (GFAP), or a combination thereof. Also disclosed here are methods that aid in the hyperacute determination of whether a human subject that has sustained an injury or may have sustained to the head would benefit from and thus receive a head computerized tomography (CT) scan based on the levels of UCH-L1.

Abstract: The present invention relates to methods of identifying pharmacophores and inhibitors against protein aggregation. The present invention also provides pharmacophores themselves and medical uses of agents in the treatment of Alzheimer's.

Abstract: The present invention provides an in vitro method for detecting the presence of neutralizing antibodies against recombinant human insulin (rHI) in human serum. It also provides a kit for an in vitro method of detection of the presence of recombinant human insulin (rHI) neutralizing antibodies.

Abstract: In one aspect, the inventive concepts disclosed herein are directed to a lateral flow assay comprising: one or more chromatographic substrates, a sample application site, a first capture site, and a second capture site. The first capture site comprising an anti-hCG capture antibody with broad affinity for a group of multiple hCG variants and the second capture site comprising an anti-hCG capture antibody that is specific to a first variant of hCG. Additional aspects of the invention disclose using the later flow assay to determine a ratio of the first variant of hCG to the group of multiple hCG variants.

Abstract: A method for the in vitro differential diagnosis of thyroid diseases is described comprising the step of determining by means of mass spectrometry in a biological sample the variation in intensity of at least one of the peaks (m/z) ±0.3% selected from the group consisting of 10129 Th, 9749 Th, 10092 Th, 7935 Th, 4620 Th, 4748 Th, 8565 Th, 7565 Th, 4518 Th, 7936 Th, 5044 Th, 6699 Th, 11310 Th, 12277 Th, 6805 Th, 6880 Th, 8566 Th, 8309 Th, 5564 Th, 9711 Th, 7263 Th, 10296 Th and 4353 Th and/or of at least one of the peaks (m/z) ±0.3% selected from the group consisting of 4987 Th, 7110 Th, 4804 Th, 9957 Th, 6719 Th, 4372 Th, 4196 Th, 4111 Th, 4282 Th, 5935 Th and 5519 Th.

Abstract: The present disclosure relates to methods for generating blood protein profiles in red blood cell-enriched blood samples. The disclosed methods represent a new and improved laboratory technique for producing a protein profile from blood, increasing protein detection.

Abstract: Artificial microvascular network (AMVN) devices are provided and related methods of making and methods of using such devices are provided. The present disclosure generally relates to an AMVN device comprising a substrate including a capillary network configured so as to simulate those actually encountered in the circulation of various humans and animal model systems. In certain aspects, the AMVN devices may be used, e.g., to investigate the effect of storing RBCs under aerobic and anaerobic conditions. However, the use of such AMVN devices is not so limited.

Abstract: The present invention provides platelet aggregation tests using synthetic, self-assembling type I human collagen, methods of measuring an individual's platelet anti-platelet medication sensitivity and residual platelet activity status when the individual is on a an anti-platelet medication and kits useful in the assays and methods.

Abstract: Disclosed is an analyzing method, for analyzing a blood specimen, which includes: mixing a blood specimen and a thrombin-containing reagent to coagulate the blood specimen, and obtaining a coagulation waveform; obtaining a value of a parameter concerning differentiation of the coagulation waveform, based on the coagulation waveform; and obtaining information concerning an amount of antigen of fibrinogen based on the obtained value of the parameter.

Abstract: The present invention pertains to the diagnosis of coronary artery disease. Specifically, the present invention pertains to the diagnosis of coronary artery disease using phosphatidylinositol (36:5) or lysophosphatidylinositol (20:5) as a molecular marker.