Abstract: The present invention relates to biomarkers, methods and assay kits for the identification, monitoring and treatment of breast cancer.

Abstract: An in vitro method and a kit for the quantification of antibodies anti-beta amyloid protein in a sample of cerebrospinal fluid comprising the following steps a) concentrating the quantity of said antibodies of said sample with magnetic micro beads coated with macromolecules capable of binding said antibodies b) analysing the concentrated sample obtained in step a) by immunoenzyme assay or by radioimmunoassay; c) analysing a sample comprising antibodies anti-beta amyloid protein having a known titre with the same assay used in step b) and elaborating the related calibration curve, wherein said antibody having a known titre is a murine antibody belonging to the IgG2a or IgG2b class or a human or humanized antibody belonging to the IgG2b or IgGi class.

Abstract: Products and methods for the research, diagnosis, risk assessment, course monitoring, treatment and prophylaxis of various metabolic disorders and their early forms, concomitant diseases and secondary diseases are provided. Metabolic diseases include, for example, metabolic syndrome, non-insulin-dependent diabetes, (type II diabetes), insulin resistance, obesity (adiposis), in addition to diseases that are associated with disorders of the fatty acid metabolism. Methods may include analysis of the concentration of the adipocytic form of the fatty acid binding protein (A-FABP, FABP 4, P2) in various bodily fluids.

Abstract: The invention relates to an in vitro analysis method for predicting resistance to azacitidine treatment in a patient, using the BCL2L10 protein contained in a sample of biological fluid taken from said patient, and also biological molecules which specifically bind the BCL2L10 protein. It is characterized in that a sample of biological fluid is recovered from a patient; the percentage of total cells in said biological fluid expressing the BCL2L10 protein is calculated; this calculated percentage is compared with a reference threshold value, this threshold value being between 20% and 60%; and resistance to azacitidine treatment is diagnosed in a patient who has a percentage of cells expressing the BCL2L10 protein in said biological fluid which is greater than said reference value.

Abstract: The present invention relates to methods and systems for detecting one or more analytes in a sample and/or for classifying a sample. In particular, the present invention relates to methods and systems which can be used to detect the analytes in real time and which rely on flowing through a microfluidic device one or more types of sensor molecule each comprising a domain that binds one or more analytes, a chemiluminescent donor domain and an acceptor domain, wherein the separation and relative orientation of the chemiluminescent donor domain and the acceptor domain, in the presence and/or the absence of analyte, is within +50% of the Forster distance.

Abstract: Methods for detecting, diagnosing and monitoring an epithelial cancer in a patient are described comprising measuring in a sample from the patient Ep-ICD polypeptides and Ep-ICD polynucleotides. Methods for prognosis of breast cancer comprising measurement of nuclear Ep-ICD polypeptides and optionally EpEx polypeptides are provided. The invention also provides kits and compositions for carrying out the methods of the invention. The invention also provides a unique scoring system using immunohistochemical analysis to arrive at an Ep-ICD Subcellular Localization Index (ESLI) score, which is used to arrive at a diagnosis of cancer in a patient, or, more particularly, to identify patients that are in need of aggressive clinical treatment.

Abstract: The present invention is based on the discovery that three proteins, Cystatin B, Chaperonin 10, and Profilin are present in the urine of patients with bladder cancer, a cancer of epithelial origin. Accordingly, the present invention is directed to methods for prognostic evaluation of cancers of epithelial origin and to methods for facilitating diagnosis of cancers of epithelial origin by monitoring the presence of these markers in biological samples. The invention is also directed to markers for therapeutic efficacy.

Abstract: An entity of a Th2 adjuvant activity in mother's milk has been revealed as coenzyme A by HPLC and mass spectrometry. The followings have been found out that: a risk of developing atopic dermatitis can be evaluated by targeting coenzyme A; and any one of a food and mother's milk with a reduced risk of developing atopic dermatitis can be prepared by removing or inactivating coenzyme A.

Abstract: The present invention contemplates use of encapsulated aqueous and non-aqueous reagents, solutions and solvents and their use in laboratory procedures. These encapsulated aqueous or non-aqueous reagents, solutions and solvents can be completely contained or encapsulated in microcapsules or nanocapsules that can be added to an aqueous or non-aqueous carrier solution or liquid required for medical and research laboratory testing of biological or non-biological specimens.

Abstract: Disclosed are composition and methods for treating development-related disorders. Also disclosed are diagnosis methods, prognosis methods, and drug screening methods.

Abstract: The present invention is based in part on a chemically defined method of generating neural stem cells (NSCs) and dopaminergic (DA) neurons from human pluripotent stem cells (hPSCs). The DA neurons of the invention can be derived from hPSCs and NSCs. The present invention also provides reagents and kits useful for the derivation of neural stem cells and dopaminergic neurons from human pluripotent stem cells.

Abstract: The present invention is directed to in vitro methods to predict the presence of inflammation, gene IRG1 or protein encoded by IRG1 in a subject by determining presence of itaconic acid in a biological sample isolated from the subject. The invention is also directed to methods to predict the ability of a subject to produce itaconic acid under inflammation by determining the presence IRG1 in a biological sample. The invention is also related to pharmaceutical composition to initiate production of itaconic acid in a subject for preventing or treating inflammation, or bacterial infection.

Abstract: The present invention provides for methods and compositions for treating cancer. A subject having cancer is administered an interferon and an inhibitor of mitogen-activated protein kinase (MAPK) signaling pathway. The combination of the interferon and the inhibitor of the MAPK pathway produces a synergistic effect on the cancer compared to the effect of the interferon or the inhibitor of the MAPK pathway alone. The activity of the interferon pathway, interferon expression levels and/or interferon locus copy number can be used as biomarkers for treatment of cancer by MAPK pathway inhibitors.

Abstract: A method for assessing risk of losing a transplanted organ by a patient having an episode of acute rejection of the transplanted organ is described. The method includes obtaining from the patient a cell sample from the transplanted organ or peripheral blood, determining a level of FOXP3 in the cell sample, and correlating the level with the risk of loss of the transplanted organ, wherein, compared to a control level, a significantly greater level of FOXP3 in the cell sample from the transplanted organ or a significantly lower level of FOXP3 in the cell sample from the peripheral blood correlates with a decreased risk of loss of the transplanted organ.

Abstract: The present invention relates to biomarkers for use in determining the sensitivity of patients to therapy with ?v?6 integrin inhibition or therapy with TGF-? pathway inhibitors. The biomarker profiles disclosed herein provide individualized gene and protein profiles which will aid in treating diseases and disorders which are amenable to treatment with therapies designed against ?v?6-integrin and/or TGF-? pathway inhibitors.

Abstract: The present invention relates to new marker sequences for rheumatoid arthritis and the diagnostic use thereof together with a method for screening of potential active substances for rheumatoid arthritis by means of these marker sequences. Furthermore, the invention relates to a diagnostic device containing such marker sequences for rheumatoid arthritis, in particular a protein biochip and the use thereof.

Abstract: Disclosed is a panel of biomarkers associated with angiogenesis, and the use of such biomarkers (genes, proteins, homologues and analogs thereof) to regulate angiogenesis. Methods for identifying compounds useful for regulating angiogenesis and conditions related thereto are disclosed.

Abstract: The invention relates to methods of diagnosis or prognosis of a tissue or organ fibrosis (e.g., skin fibrosis, hypertrophic scar or a keloid) in a reparative or reactive process comprising the step of determining the levels of expression of genes encoding different molecular markers in a sample of a tissue or organ from a mammalian, wherein different genes markers are studied.

Abstract: The subject relates to a cross-neutralizing antibody comprising at least one polyspecific binding site that binds to alpha-toxin (Hla) and at least one of the bi-component toxins of Staphylococcus aureus, its medical and diagnostic use, method of producing the antibody, including an isolated nucleotide sequence, plasmids and host cells as used in the production of the antibody; and further an isolated conformational epitope recognized by a specific cross-neutralizing antibody.

Abstract: A polypeptide binding to Annexin A1, an antagonist against Annexin A1 including the polypeptide, an anti-Annexin A1 antibody including the polypeptide or an antigen-binding fragment thereof, and methods of preventing, treating and/or diagnosing a disease, including administering the antagonist and/or the antibody or an antigen-binding fragment thereof to a subject.

Abstract: The present invention relates to methods and kits for the prediction of risk for heart failure using post-translation modified forms of cardiac troponin T as a biomarker.

Abstract: Antigen binding proteins, such as antibodies, which bind to human MAGE-A3, polynucleotides encoding such antigen binding proteins, and uses and manufacture thereof.

Abstract: The present invention relates to mammalian antibodies, designated 12B1 and antigen-binding portions thereof that specifically bind to insulin-like growth factor I receptor (IGF-IR), preferably human IGF-IR. Also included are chimeric, bispecific, derivatized, single chain antibodies derived from the antibodies disclosed herein. Nucleic acid molecules encoding the mammalian antibodies as well as methods of use thereof are also disclosed. Also included are pharmaceutical compositions comprising these antibodies and methods of using the antibodies and compositions thereof for treatment and diagnosis of pathological hyperproliferative oncogenic disorders associated with expression of IGf-1R.

Abstract: The present invention provides a liquid sampling, storage, transfer and delivery device comprising housing containing a porous nib. The porous nib in the device contacts the sample, collects the sample, stores the sample, transports the sample inside its porous matrix and releases the sample from the porous matrix upon demand.

Abstract: The non-invasive methods described herein generally relates to methods of detecting bladder cancer or bladder cancer recurrence. The methods involve identifying a cutoff level for a protein biomarker parameter to provide a predetermined sensitivity for an assay, in which the measured biomarker parameter values below a defined cutoff level is indicative of the absence of cancer and measured biomarker parameter values above a defined cutoff level are indicative of the presence of cancer. The method can also involve establishing a cutoff level for two or more nucleic acid markers in which the nucleic acid markers increase the specificity of the assay without decreasing the sensitivity of the assay, and in which the cutoff level is indicative of the absence of cancer.

Abstract: The present invention relates to a method for the prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD the method comprising the steps of: i) providing a sample of a bodily fluid from said patient, ii) determining in said sample the level of at least one biomarker, selected from the group consisting of pro-adrenomedullin (proADM), pronatriuretic peptide, pro-Vasopressin (proAVP) and Procalcitonin (PCT) or fragments thereof of at least 12 amino acids in length, iii) determining one, two or three of the BODE-index parameters body-mass index (BMI, parameter B), degree of airflow obstruction (FEV1, parameter O), dyspnea (parameter D) and exercise capacity (parameter E), iv) correlating said level of said at least one biomarker determined in step ii), in combination with said one, two or three BODE-index parameters determined in step iii) to the prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD.

Abstract: The present invention relates to conjugates of 5-fluorouracil, 5-fluorouracil immunogens, antibodies that bind 5-FU and/or 5-FU conjugated to another molecule, and assays for detecting, quantitating, and monitoring amounts of 5-fluorouracil in a sample such as in blood plasma.

Abstract: The present invention relates to new therapeutic and diagnostic uses of soluable neuregulin-1 isoforms and polypeptides, particularly neurological disorders.

Abstract: The present invention is directed to methods for predicting a pregnant woman's risk of carrying a fetus with Down syndrome (Trisomy 21) or Trisomy 18. The methods are based on measuring one or more metabolites obtained from a pregnant woman's bodily fluid, such as blood or urine, and found to be predictive of Trisomy 21 or Trisomy 18.

Abstract: The present invention aims to diagnose rheumatoid arthritis more accurately and rapidly, and relates to a method and a kit for diagnosing rheumatoid arthritis, based on the detection of citrullinated autoantigens in a test sample.

Abstract: Mechanisms for complications of renal failure and processes for treating the same are disclosed. They include contacting a biological fluid (e.g. blood) with a filter body, the filter body having immobilized thereon either a CD36 receptor or a CD36 receptor fragment or a SCARB1 receptor or a SCARB1 receptor fragment, the blood having a reduced quantity of oxidatively modified proteins after contacting the filter body. They also include administering an antagonist drug to a patient that blocks the binding activity of the RAGE receptor or the CD36 receptor or the SCARB1 receptor. Diagnostic methods are also provided.

Abstract: The invention relates to generation and use of cellular and humoral responses for the prevention and treatment of P. gingivalis related conditions and diseases.

Abstract: A luminescence detecting apparatus and method for analyzing luminescent samples is disclosed. Luminescent samples are placed in a plurality of sample wells in a tray, and the tray is placed in a visible-light impervious chamber containing a charge coupled device camera. The samples may be injected in the wells, and the samples may be injected with buffers and reagents, by an injector. In the chamber, light from the luminescent samples pass through a collimator, a Fresnel field lens, a filter, and a camera lens, whereupon a focused image is created by the optics on the charge-coupled device (CCD) camera. The use of a Fresnel field lens, in combination with a collimator and filter, reduces crosstalk between samples below the level attainable by the prior art. Preferred embodiments of the luminescence detecting apparatus and method disclosed include central processing control of all operations, multiple wavelength filter wheel, and robot handling of samples and reagents.

Abstract: The invention provides compositions and methods for diagnosing a patient as having a myeloproliferative disease by identifying mutations in the MPL gene or gene products.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control signal readout patterns, and the methods for detecting an analyte using the lateral flow devices.

Abstract: One aspect of the present disclosure relates to a calorimeter for detecting the presence of a target analyte in a fluid sample. The calorimeter can include a substrate, a hermetically-sealed, thermally decoupled central reaction zone associated with the substrate, at least one droplet transport region, and detection electronics. The at least one droplet transport region can be associated with the substrate and configured to merge a reagent droplet with a sample droplet including the fluid sample to form a reaction droplet in the central reaction zone. The detection electronics can be in electrical and/or thermal communication with the central reaction zone and associated with the substrate. The calorimeter can be configured to detect a heat of reaction produced by a reaction event between the target analyte and a capture reagent upon formation of the reaction droplet.

Abstract: The present invention provides compositions and methods of use in the treatment/prevention of chlamydial infection and/or diseases and disorders associated with chlamydial infection in a subject.

Abstract: The invention relates to antibodies against S100A4, methods for the preparation of these antibodies, pharmaceutical compositions comprising these antibodies, and therapeutic and diagnostic uses thereof.

Abstract: The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

Abstract: The invention relates to novel cyclic compounds (cyclic peptides), linkers useful as beta-turn promoters in cyclic peptides, and methods for treatment of malignant cells in vitro or in vivo using one or more linear and cyclic peptides. The peptides can act as integrin interaction inhibitors and may be used in the treatment of cancers as monotherapies or in combination with other anti-cancer agents, such as proteasome inhibitors, inhibitors of autophagy, alkylating agents, MEK inhibitors, FAK/PYK2 inhibitors, and EGFR inhibitors. The invention further concerns a method of predicting the binding of a cyclic or linear HYD1 peptide to a cancer cell by assessing overexpression of biomarkers such as CD44, VLA-4 integrin, basigin, CD138 (syndecan 1), NCAM, ICAM1, ICAM3, and CD59.

Abstract: Herein is reported a method for the detection of free antigen of a multispecific antibody in a sample, whereby the antigen to be detected can be specifically bound by a first binding site of the multispecific antibody, comprising the step of incubating a sample comprising free antigen and multispecific antibody with an anti-idiotypic antibody that specifically binds to a second binding site of the multispecific antibody, which is different from the first binding site, and thereby depleting the multispecific antibody from the sample.

Abstract: Immune-stimulatory compositions and methods of manufacture are described with an unexpectedly greater immunostimulatory effect on the immune system than the individual components alone. The compositions include a combination of arabinogalactan protein (AGP) compounds, particularly those derived from honey or with similar activity to honey derived AGP's along with apisimin proteins, peptides or functional fragments thereof, particularly those isolated from royal jelly or apisimin produced via recombinant methods.

Abstract: The invention provides a method of diagnosis and/or prognosis of lung cancer, the method comprising the steps of: (a) determining the level of a C4 activation fragment in a test sample, and (b) comparing the level of the test sample with the level of a C4 activation fragment detected in a control sample, wherein if the level of C4 activation fragment is higher than the level in a reference control, it is indicative that the subject suffers lung cancer or has a bad prognosis. The present invention further provides methods for determining the risk of suffering from lung cancer as well as for deciding whether to initiate a medical regimen and to determine the efficacy of said medical regimen, based on the determination of a C4 activation fragment. C4 activation fragment, used as marker, confers high sensitivity and specificity to the methods object of the invention.

Abstract: Systems, methods, and devices for detecting infections in a clinical sample are provided. Small-volume clinical samples obtained at a point-of-service (POS) location and may be tested at the POS location for multiple markers for multiple diseases, including upper and lower respiratory diseases. Samples may be tested for cytokines, or for inflammation indicators. Dilution of samples, or levels of detection, may be determined by the condition or past history of a subject. Test results may be obtained within a short amount of time after sample placement in a testing device, or within a short amount of time after being obtained from the subject. A prescription for treatment of a detected disorder may be provided, and may be filled, at the POS location. A bill may be automatically generated for the testing, or for the prescription, may be automatically sent to an insurance provider, and payment may be automatically obtained.

Abstract: This disclosure relates to methods and kits for diagnosing osteoarthritis and for determining the progression of osteoarthritis in a subject.

Abstract: Methods, devices, systems, and kits useful for the collection and analysis of samples obtained by swabs are disclosed. Swab containers configured for receiving a swab containing a sample; cartridges for holding one or more of: a swab container, a swab, assay units, pipette tips, vessels, transport units, and implements; systems (which may include a sample processing device); kits; and methods for their use are disclosed. A swab container may include an entry port; an assay chamber having an assay port; a conduit comprising an interior channel connecting the entry port; and an interior channel providing fluidic communication between the entry port and assay chamber. An interior channel may be configured to squeeze a portion of a swab placed in or through the conduit. A cartridge may include a cartridge frame configured to receive one or more of swab containers, assay units, transport units, pipette tips, vessels or implements.

Abstract: The present disclosure provides methods and compositions useful for preventing gastrointestinal and/or colorectal cancer in animals, including humans, having pre-cancerous adenomatous polyps. The present disclosure provides compositions comprising anti-PG antibodies suitable for use in the methods of the disclosure. The present disclosure also provides methods and compositions useful for monitoring the efficacy of anti-PG treatment in subjects with pre-cancerous polyps.

Abstract: Methods and compositions for treating Gaucher disease are described.

Abstract: Antibodies and antigen-binding fragments of antibodies that bind to human fractional C-Reactive Protein (fracCRP), kits containing these antibodies and antibody fragments, and assays using these antibodies and antibody fragments.

Abstract: Composition and methods for characterizing cancer cells by determining a marker of PKM2 activity. For example, methods are provided for predicting a patient response to a NF-?B, PKC?, PKM2, MEK/ERK, Pin1 or Src inhibitor therapy. Methods for treating patients with such therapies are likewise provided. Phosphorylation selective ?-catenin, MLC2, histone H3, Bub3, and PKM2-binding antibodies are also provided.