Abstract: Provided herein are methods of assessing the efficacy of a treatment regimen in a subject by measuring the concentration of one or more biomarkers associated with plasma kallikrein prior to the first dose of a polypeptide that binds plasma kallikrein. A treatment regimen is considered effective if the concentration of one or more biomarkers decreases after administration of the polypeptide.

Abstract: Fucosylated ?1-acid glycoprotein (fAGP) was found to be useful for the diagnosis of pancreatic cancer and malignant intraductal papillary mucinous neoplasm (IPMC), resulting in the finding of a new biomarker for pancreatic cancer or malignant intraductal papillary mucinous neoplasm (IPMC), in particular, a new biomarker useful for rapid diagnosis of malignant intraductal papillary mucinous neoplasm (IPMC) that increases the accuracy of malignant intraductal papillary mucinous neoplasm (IPMC) and aids conventional imaging diagnosis by making a suitable preoperative diagnosis of a benign neoplasm or a malignant neoplasm in intraductal papillary mucinous neoplasm (IPMN).

Abstract: Provided are a method for assaying a specific IgM antibody and a total antibody for the 2019 novel coronavirus (2019-nCOV), a method for determining whether subjects are infected with 2019-nCOV, and a virus antigen and a kit for carrying out the above-mentioned detection.

Abstract: The present disclosure provides kits for detecting Mycobacterium avium subspecies paratuberculosis (MAP) infection and biomarkers correlated with MAP-associated diseases or disorders. The present disclosure also provides methods of diagnosing a subject with a MAP-associated autoimmune disease or disorder and/or determining the treatment course of a subject diagnosed with a MAP-associated autoimmune disease or disorder.

Abstract: Methods, reagents, kits and systems for analyzing different proteoforms of proteins of interest are provided. The provided methods, systems, etc. provide detection, characterization and quantitation of proteoforms for different biologically relevant proteins for monitoring and characterizing biological processes.

Abstract: Disclosed herein are methods and kits to assess an absorbed dose of ionizing radiation and/or the severity of tissue injury from radiation in a patient. Also disclosed are algorithms used to calculate an absorbed dose of radiation based on biomarker measurements of a plurality of biomarkers that are altered relative to a normal control in the event of radiation exposure.

Abstract: The present application discloses diagnostic methods and kits for detecting disease activity in a subject having an inflammatory bowel disease, such as Crohn's disease. Methods of treating endoscopically active gastrointestinal disease, as well as methods of determining effectiveness of a treatment for endoscopically active gastrointestinal disease in a subject, are also disclosed.

Abstract: Immunoassays to detect the presence of Bcl-2 family heterodimeric complexes are described. The immunoassays are designed to detect one or more of BIM-Bcl-2, BIM-Bcl-xL, BIM-Mcl-1 and BAX BAK heterodimers. The assays can be used, for example, to select a BH3 mimetic, or other drug targeting the apoptosis pathway, that is effective for treating a specific cancer, or to select a subject who is likely to respond to a particular BH3 mimetic.

Abstract: In vitro method for predicting mortality risk in patients suffering from shock. The present invention refers to the medical field. Particularly, it refers to an in vitro method for predicting mortality risk among patients suffering from shock, which comprises determining in a biological sample obtained from the patient the concentration level of specific proteins.

Abstract: Methods for the detection, monitoring, and treatment of cardiac fibrosis, progression of cardiac fibrosis, or heart failure in a subject comprising: (a) contacting a sample obtained from the subject with a binding agent that binds a region of cartilage intermediate layer protein 1 (CILP) that spans the cleavage site of the CILP precursor or a nucleotide encoding same. The cardiac fibrosis may be associated with one or more of: ischemia, congenital defect, familial fibrosis, infiltrative fibrosis, idiopathic fibrosis, amyloidosis, hemosiderosis, valvular disease, and other idiopathic cardiomyopathies.

Abstract: Described is a method and device for detecting an analyte in a sample, comprising bringing a sample comprising a target analyte into contact with magnetisable particles, the particles being coated with binding molecules complementary to the target analyte, resulting in bound and unbound binder complexes, positioning the magnetisable particles, comprising both bound and unbound binder complexes, in proximity to a magnetic field sensor, changing the magnetic field sufficient to release at least a portion of the magnetisable particles, comprising both bound and unbound binder complexes, from their proximity to the magnetic field sensor, and measuring changes in a magnetic signal detected from the net movement, being either translational or rotational movement, of the magnetisable particles relative to the magnetic sensor.

Abstract: The present invention in general relates to the field of antibody profiling in spondyloarthritis. In particular, the inventors found that antibody levels against selected peptides are raised in spondylarthritis patients, and herein provide a diagnostic method and kit comprising such peptides for use in the diagnosis of spondyloarthritis.

Abstract: Provided is a method for assisting in grasping the status of platelet activation, by developing a biomarker that more accurately reflects platelet activation in vivo, said method being usable in testing for thrombotic hemostatic diseases. The method for assisting in grasping the status of platelet activation comprises (1) measuring the concentration of soluble CLEC-2 and a platelet count in a sample obtained from a subject, and (2) calculating a value of [soluble CLEC-2 concentration]/[platelet count] by dividing the soluble CLEC-2 concentration by the platelet count. If desired, the method may further comprise (3) comparing the value with a value of [soluble CLEC-2 concentration]/[platelet count] obtained by using samples from healthy persons.

Abstract: In various embodiments methods of distinguishing Crohn's disease from ulcerative colitis are provided. In certain embodiments the methods comprise determining, or causing to be determined, the level of IgG antibodies that bind a malondialdehyde-acetaldehyde adduct (MAA adduct) in a biological sample from a mammal, where an elevated level of said antibodies as compared to the average level found in a mammal with Crohn's disease is an indicator that the mammal has ulcerative colitis rather than Crohn's disease.

Abstract: Described herein is a method of diagnosing Lyme disease in a subject. The method includes determining a glycosylation profile of a protein whose glycosylation profile is associated with Lyme disease in a subject, and comparing the glycosylation profile of the protein with a predetermined glycosylation profile of the protein indicating free of Lyme disease or a predetermined glycosylation profile of the protein indicating Lyme disease. Further described herein is a method of treating and/or ameliorating Lyme disease in a subject. The method includes diagnosing Lyme disease in a subject and, if the subject is diagnosed to have Lyme disease, administering to the subject an effective amount of compound effective for treating Lyme disease. Further described herein is a method of evaluating a treatment for Lyme disease. The method includes comparing a glycosylation profile of the patient with glycosylation profiles associated with successful/unsuccessful treatments.

Abstract: Methods and kits for detecting antibodies (e.g., anti-drug antibodies). Such methods and kits permit the detection of, for example, anti-drug antibodies in human body fluids, such as blood, plasma and serum.

Abstract: The present disclosure provides a whole blood, protein-based diagnostic test for presence and evaluation of aneurysm status. Further, the present disclosure relates to methods of treating aneurysms.

Abstract: Methods are provided for detection of a target cell type within a cell population, and compositions are provided comprising cells and an indicator that indicates the number of cells of the target cell type in the cell population. Examples are provided in which these methods are used to detect human embryonic stem cells within a differentiated cell population with exquisite sensitivity. Differentiated cells produced from embryonic stem cells can be characterized by these methods before transplantation into a recipient, thereby providing further assurance of safety.

Abstract: Disclosed herein are high performance biomarkers and panel for small cell lung cancer (SCLC) early detection useful for identifying, diagnosing and treating SCLC patients at an early stage. The method of detecting and diagnosing small cell lung cancer (SCLC) includes contacting a sample from a subject suspected of being at-risk of acquiring or having SCLC with at least two SCLC-specific autoantibody molecules and detecting binding of four different protein types—SCLC autoantibody-antigen complexes, SCLC uncomplexed autoantibodies, SCLC associated proteins and SCLC glycoproteins—in the sample, thereby detecting SCLC in the subject.

Abstract: Management of the health status of an animal colony using a plurality of blood collection cards and the analysis of dried blood from members of the colony that has been collected on the cards. Members of the colony may be removed from the colony as a result of the analysis.