Abstract: Provided herein are methods for classifying how a subject having a cancer will respond to immunotherapeutic (IT) therapy based on the subject's immunosignature or frameshift signature. Also provided herein are methods for classifying a subject having a cancer as having a good prognosis or a poor prognosis based on the subject's immunosignature or frameshift signature.

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 present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a measured urine concentration of one or more of TIMP2 and IGFBP7 in combination with one or more of a measured serum creatinine and a measured urine output, which results are correlated to the renal status of the subject, and can be used for diagnosis, prognosis, risk stratification, staging, monitoring, categorizing and determination of further diagnosis and treatment regimens in subjects suffering or at risk of suffering from an injury to renal function, reduced renal function, and/or acute renal failure.

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: Heritable pathogenic variants in the mismatch repair (MMR) pathway, also known as Lynch Syndrome (LS), can lead to the development of colon cancer and other cancers. Following mismatch, a complex of proteins consisting of MLH1, MSH2, MSH6 and PMS2 translocate into the nucleus to signal recruitment of repair mechanisms. Flow cytometry-based, functional variant assays (FVAs), were developed to determine whether variants in these MMR repair genes and/or other related genes would augment the nuclear translocation of MLH1 and MSH2 and downstream nuclear phosphorylation of ATM and ATR in response to DNA mismatches. Each assay distinguished pathogenic variants in MMR repair genes (MLH1, MSH2, PMS2 and MSH6) from benign controls. The combination of multiple assays provided robust separation between heterozygous pathogenic variant carriers and benign controls.

Abstract: The invention relates to methods and products associated with in vivo enzyme profiling. In particular, biomarker nanoparticles capable of quantitatively detecting enzymatic activity in vivo are described. These nanoparticles can be used to detect in vivo enzyme activity. The invention also relates to products, kits, and databases for use in the methods of the invention.

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 are 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: The invention generally relates to a microfluidic platforms or “chips” for testing and understanding cancer, and, more specifically, for understanding the factors that contribute to cancer invading tissues and causing metastases. Tumor cells are grown on microfluidic devices with other non-cancerous tissues under conditions that simulate tumor invasion. The interaction with immune cells can be tested to inhibit this activity by linking a cancer chip to a lymph chip.

Abstract: Provided herein are methods for classifying how a subject having a cancer will respond to immunotherapeutic (IT) therapy based on the subject's immunosignature or frameshift signature. Also provided herein are methods for classifying a subject having a cancer as having a good prognosis or a poor prognosis based on the subject's immunosignature or frameshift signature.

Abstract: A method of examining a possibility of a subject having pancreatic cancer, including measuring GPRC5C (G protein-coupled receptor family C group 5 member C) present in an exosome in a specimen collected from the subject.

Abstract: Herein is reported a method for determining the binding interaction with a multimeric antigen of an antibody of the human IgG1 subclass that has at least two binding sites specifically binding to the antigen comprising the steps of 1) determining the binding affinity of the antibody for the multimeric antigen, and 2) incubating a mixture comprising the antibody and a polypeptide that is derived from lysine-gingipain of Porphyromonas gingivalis under conditions and for a time sufficient to cleave the antibody into Fabs and Fc-region, and determining the binding affinity of the Fabs of the antibody for the multimeric, whereby the binding affinity of the antibody to the multimeric antigen to be affinity-driven if the binding affinity determined in both steps are comparable and to be avidity-driven if the binding affinity determined in both steps are different.

Abstract: This invention provides minimally invasive methods, reagents, diagnostic and prognostic markers useful for staging, prognosis and surveillance of colorectal cancers, and therapeutic intervention in individuals with colorectal cancers, or individuals who may be susceptible to developing colorectal cancers.

Abstract: Disclosed are compositions and methods to detect proteins associated with Head and Neck Cancer, generally, or more particularly, biomarkers of Head and Neck Squamous Cell Carcinoma (HNSCC). Such markers may be useful to allow individuals susceptible to HNSCC to manage their lifestyle and/or medical treatment to avoid further progression of disease.

Abstract: The present disclosure relates to the use of one or more biomarkers to evaluate the likelihood that a CDK4 inhibitor would produce an anti-cancer effect in a subject. Accordingly, in certain non-limiting embodiments, the present disclosure provides for methods, compositions and kits for a companion diagnostic for CDK4 inhibitors, and in particular, for the use of the colocalization of Enigma and CDH18 biomarkers to foci within the cancer for determining whether the cancer can be successfully treated by CDK4 inhibition.

Abstract: Quality control formulations that do not require human donor-derived blood components for use in testing the efficacy of viscoelastic analysis reagents, and methods for preparing these formulations, are described.

Abstract: Herein is reported a method for the determination of the binding affinity of a binder and its ligand comprising the step of determining based on the result of an immunoassay the fraction of free binder in a sample comprising binder, ligand and binder-ligand-complexes for at least two different binder:ligand ratios in the sample, and if the determined fraction of free binder is not comparable for all used binder:ligand ratios then the binder:ligand ratio in the sample is lowered and the sample is re-analyzed by the same immunoassay, and calculating based on the fraction of free binder in the previous step the binding affinity for the binder to its ligand.

Abstract: The present invention pertains to a diagnostic and therapeutic method for assessing whether a patient is susceptible to the treatment of an ester-prodrug. The methods of the invention include the analysis of carboxyelesterase 2 (CES2)-expression in tumor samples as a predictive value for the assessment of treatment success with an ester-prodrug of a chemotherapeutic agent. Alternatively, the invention provides methods involving the analysis of the urinary ratio of the prodrug and the active therapeutic as another predictive value for assessing treatment susceptibility.

Abstract: High levels of nuclear NMT1 are associated with longer relapse free survival in ER? positive breast cancer patients. Both low levels of cytosolic and nuclear NMT1 correlated to very poor clinical outcomes. NMT2 also plays an important function in breast cancer signalling, regulated through phosphorylation. For example, NMT2 phosphorylation status is a key element in the progression of ER+ breast cancer cells. Specifically, nuclear localization of NMT2 is associated with poor outcomes in breast cancer patients.

Abstract: The present disclosure relates to a method for diagnosing preeclampsia or a preeclampsia-related condition in a pregnant subject. The method is based on the measurement of the amount of the biomarker IGFBP-7 (Insulin-like Growth Factor Binding Protein 7) in a sample from the subject and on the comparison of the measured amount to a reference. Also disclosed are methods for assessing the severity of preeclampsia or a preeclampsia-related condition and methods for monitoring a preeclampsia or a preeclampsia-related condition in a pregnant subject. The present disclosure further relates to the use of the biomarker IGFBP-7 or of an agent that specifically binds to IGFBP-7 in a sample from a pregnant subject for diagnosing, for monitoring or for assessing the severity of preeclampsia or a preeclampsia-related condition. Finally, the present disclosure relates to a device or kit adapted to carry out the method of the present invention.

Abstract: The present disclosure relates to the technical field of rapid detection of molecules, and specifically relates to a method for rapid fluorescent immunoassay (FIA) and chemiluminescent immunoassay (CLIA) based on electrokinetic acceleration. The method includes the following steps sequentially: S1. sample acceleration: applying an actuating signal to a chip on which a target molecule is dripped to obtain a chip binding to the target molecule, where the chip includes an electrode sheet and coating molecules is immobilized on the electrode sheet; and S2. secondary antibody acceleration: adding a secondary antibody for binding to the target molecule dropwise on the chip binding to the target molecule, and applying an actuating signal to the chip to obtain a chip binding to the secondary antibody. The method can effectively improve a rate of FIA and CLIA, and can speed up a detection process and meet the need for rapid point-of-care testing (POCT).