Abstract: A method of prognosing and predicting breast cancer recurrence stratifies early stage ER+/PR+ and Her2? breast cancer patients with invasive ductal/lobular carcinoma of the breast into low risk or high risk for breast cancer recurrence by employing an IHC based assay which assesses or measures expression of a combination of 5 biomarkers and by employing a histopathological analysis which assesses 3 clinical prognostic parameters.

Abstract: The present invention relates to methods for predicting a risk of a subject for Type 1 diabetes (T1D) on the basis of expression levels of protein markers in a sample obtained from the subject. The present invention also relates to in vitro kits for use in said methods.

Abstract: The present invention is related to novel methods for identifying a population of subjects that are at risk for developing of atopic allergic diseases, and to the prevention of these allergic diseases.

Abstract: A method for detecting a cardiac failure patient is provided. The method comprises (1) measuring a value of CKAP4 in a blood sample collected from a subject; (2) comparing the measured value of CKAP4 with a predetermined standard value; and (3) determining the subject as being a cardiac failure patient when the measured value of CKAP4 in the blood sample of the subject is lower than the predetermined standard value.

Abstract: The present invention relates to a method for discrimination of p16.sup.INK4a overexpressing metaplasias from neoplastic or preneoplastic p16.sup.INK4a overexpressing lesions by determination of the level of high risk HPV encoded gene-products such as e.g. HPV E2 and/or HPV E7 molecules in biological samples in the course of cytological testing procedures. The method thus enables for reduction of false positive results in the p16.sup.INK4a based detection of anogenital lesions in cytological testing procedures.

Abstract: Methods and compositions disclosed herein generally relate to methods of identifying, validating, and measuring clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction, particularly as those responses relate to septic shock in pediatric patients. In particular, the invention relates to identifying one or more biomarkers associated with septic shock in pediatric patients, obtaining a sample from a pediatric patient having at least one indication of septic shock, then quantifying from the sample an amount of one or more of said biomarkers, wherein the level of said biomarker correlates with a predicted outcome.

Abstract: Provided are compositions and methods for preparing a cell suitable for producing a bispecific antibody. A plurality of eukaryotic cells are incubated with an agent under conditions to allow the cells to arrest at G1/S phase. The agent is then removed from the cells and the cells are transfected with a first vector comprising a sequence encoding a first monovalent antigen-binding unit having specificity to a first antigen and a second vector comprising a sequence encoding a second monovalent antigen-binding unit having specificity to a second antigen. A cell is identified from the plurality of cells that expresses both the first and the second antigen-binding units.

Abstract: Antibodies that bind to AXL protein and variants thereof are described herein. AXL exhibits a distinct and limited expression pattern in normal adult tissue(s), and is aberrantly expressed in the cancers listed in Table I. Consequently, the MAbs of the invention provide a diagnostic composition for the treatment and management of cancer.

Abstract: Antibodies that bind to AXL protein and variants thereof are described herein. AXL exhibits a distinct and limited expression pattern in normal adult tissue(s), and is aberrantly expressed in the cancers listed in Table I. Consequently, the MAbs of the invention provide a diagnostic composition for the treatment and management of cancer.

Abstract: The present invention relates to pancreatic cancers and the use of biomarkers in biological samples for the diagnosis of such conditions, in particular pancreatic ductal adenocarcinoma. The biomarker panel comprises LYVE1, REG1 and TFF1. Methods of treatment arc also provided, as well as kits useful in the diagnosis and treatment of pancreatic ductal adenocarcinoma. The present invention is particularly useful in detecting early-stage PDAC.

Abstract: A microscope slide staining system has a chamber, a plurality of slide support elements, a plurality of spreading devices positionable in association with microscope slides supported on the slide support elements so the spreading devices define a gap between the spreading device and the microscope slide and so the spreading device and the microscope slide are movable relative to one another to spread at least one reagent on the microscope slide independent of the other spreading devices and microscope slides.

Abstract: Methods of predicting or detecting sensitivity to therapeutic effects of anti-PD-1 therapy in a patient suffering from melanoma, as well as for selecting somatic mutanomes and transcriptomes of melanoma biopsies. A tumor sample obtained from the patient is assayed for a measure of anti-PD-1 therapy sensitivity via, for example, whole transcriptome sequencing, antibody based protein quantifications, mass spectrometry based protein quantification, targeted mRNA sequencing, real-time RT-PCR, Sanger sequencing, targeted sequencing and/or whole exome/genome sequencing. Samples are selected that exhibit a higher first enrichment similarity score and/or a lower second enrichment similarity score, and/or at least one measure of sensitivity. A patient whose sample was selected herein as a candidate for anti-PD-1 therapy is thereby identified. The method of the invention can further comprise treating the patient with anti-PD-1 therapy, optionally in conjunction with combinatorial therapy.

Abstract: The present invention relates to methods of determining cancer cell sensitivity to treatment by using antibodies that specifically bind to and detect the presence of a Bcl-2 heterodimer protein, or a caspase and an inhibitor of caspase-IAP heterodimer protein in the cell. The methods provide a predictive tool to identify patients likely to respond to drugs that perturb heterodimer binding and induce apoptosis in a cancer cell. The invention also provides a method of predicting therapeutic efficacy in a cancer patient.

Abstract: Described herein are compositions and methods for the detection of inner ear disorders such as balance disorders and hearing disorders resulting from acoustic injury, exposure to ototoxins, head trauma or viral illness. Specifically, otolin-1 and prestin have been verified as inner-ear specific biomarkers suitable for the detection of inner ear disorders.

Abstract: A kit for in vitro or ex vivo measurement of sCD127 expression in a biological sample, the kit including: specific tools or reagents allowing measurement of sCD127 expression in said biological sample; and a positive standard sample which is a sample calibrated to contain an amount of sCD127 which corresponds to the mean amount measured in a pool of samples from patients who are known to have developed a nosocomial infection, and/or a negative standard sample which is a sample calibrated to contain the amount of sCD127 which corresponds to the mean amount measured in a pool of samples from patients who are known not to have developed a nosocomial infection.

Abstract: The present invention provides a facile method for separation (fractionation) of HA in a sample over a broad M range, including low M HA, by ion exchange (IEX) chromatography. The present invention also provides an assay method for quantifying in a sample the presence of low M HA in total HA isolated from a biological source. The method involves HA fractionation according to M by use of IEX separation, followed by HA-specific assay of HA size range fractions.

Abstract: A method for diagnosing and/or stratifying the risk of infections or chronic diseases of the respiratory tract and lungs, particularly lower respiratory tract infections and chronic obstructive pulmonary disease, in which method provasopressin (proAVP) or fragments or partial peptides thereof, especially copeptin or neurophysin II, is/are determined. Suitable biomarker combinations for in-vitro diagnosis are also included.

Abstract: The present invention provides methods for predicting post-operative recurrence of Crohn's disease (CD) in a subject. With the present invention it is possible to predict whether a patient undergoing surgical treatment of CD is at risk of developing histological, radiographic, endoscopic, and/or clinical recurrence of the disease.

Abstract: Described herein are methods and compositions for the diagnosis, prognosis, selection of treatment and treatment of cancer, and particularly, of lung cancer such as non-small cell lung cancer. Embodiments of the present invention involve the detection of LKB1 levels and sensitivity to endoplasmic reticulum (ER) stress. Treatment can be made through the administration of ER stress activators.

Abstract: This invention relates to bioassay method wherein the presence of a specific soluble antibody in a sample of a bodily fluid, plasma or serum, of an animal, including human, is qualitatively and/or quantitatively determined. The method employs, a first group labelled with an energy donor and a second group labelled with an energy acceptor; the first group, or second group, comprising an antigen of the soluble antibody and the second group, or first group, respectively, comprising a Fab binding moiety capable of binding to a Fab region of antibodies of said animal. The donor and the acceptor form an energy transfer pair capable of energy transfer. The invention further comprises a kit for the bioassay method.