The invention relates to methods of diagnosing, prognosing, or monitoring or staging the progression of non-alcoholic fatty liver disease (NAFLD) using biomarkers. The invention also relates to a method of scoring to determine the severity of NAFLD, and a method of treating NAFLD.

The invention provides a method for screening for and detection of solid organ graft rejection in a subject that comprises assaying a patient sample of plasma, serum or blood from the subject for a protein marker identified herein. An elevated or reduced amount of marker present in the patient sample compared to a control sample is indicative of rejection, and identifies subjects in need of biopsy or modified treatment. The method can be used to screen for patients in danger of transplant rejection without having to undergo more costly, risky and invasive biopsy procedures.

The present invention provides biological markers associated with gastric cancer. In particular, the present invention provides a method of diagnosing gastric cancer (GC) in a subject, the method including: measuring an expression level of one or more proteins in the subject, wherein the one or more proteins are selected from the group consisting of vitamin D binding protein (VDBP), clusterin, insulin like growth factor binding protein complex acid labile subunit (IGFALS), and afamin; comparing the expression level of the or each protein in the subject to a reference expression level for the or each protein; and diagnosing GC in the subject on the basis of the comparison. On the basis of the identification of biological markers associated with gastric cancer, the present invention also provides a method of determining if a subject is susceptible to developing gastric cancer, a method of assessing progression of gastric cancer in a subject, a method for screening a candidate therapeutic agent useful for treating gastric cancer in a subject, and a kit for diagnosing gastric cancer in a subject.

A2M polypeptide compositions containing a non-natural bait region are disclosed. Methods of producing wild-type and variant A2M polypeptides and polynucleotides containing a non-natural bait region are also disclosed. The bait regions of the variant A2M polypeptides demonstrate enhanced protease inhibitory characteristics compared to wild-type A2M. Variant A2M polypeptides that demonstrate longer half-lives upon administration to an organism compared to wild-type A2M are disclosed. The A2M compositions are useful in treating a number of diseases and conditions including inflammation, chronic wounds, and diseases with a pathology associated with proteases.

The present invention provides biological markers associated with gastric cancer. In particular, the present invention provides a method of diagnosing gastric cancer (GC) in a subject, the method including: measuring an expression level of one or more proteins in the subject, wherein the one or more proteins are selected from the group consisting of vitamin D binding protein (VDBP), clusterin, insulin like growth factor binding protein complex acid labile subunit (IGFALS), and afamin; comparing the expression level of the or each protein in the subject to a reference expression level for the or each protein; and diagnosing GC in the subject on the basis of the comparison. On the basis of the identification of biological markers associated with gastric cancer, the present invention also provides a method of determining if a subject is susceptible to developing gastric cancer, a method of assessing progression of gastric cancer in a subject, a method for screening a candidate therapeutic agent useful for treating gastric cancer in a subject, and a kit for diagnosing gastric cancer in a subject.

According to one embodiment, a detection device includes a sensor element and a probe molecule. The probe molecule is immobilized at the sensor element. The probe molecule associates with a receptor exposed at a surface of a detection target. The sensor element detects cleavage of the receptor having associated with the probe molecule.

The present invention relates to a universal calibration method of use for assaying inhibitors of the same enzyme, for example for assaying inhibitors of an enzyme of blood coagulation. The invention also relates to the use of this universal calibration in a method for assaying a reversible or irreversible inhibitor of the enzyme in a biological sample. The invention also relates to the use of the universal calibration in a method for screening inhibitors of the enzyme.

Described herein are methods for evaluating the risk of preterm birth in pregnant subjects. The methods involve detecting and quantifying one or more biomarkers associated with preterm birth in a biological sample from the subject. Also described herein are isolated biomarkers and kits useful in predicting the risk of preterm birth.

There is provide a method for determining whether a subject has developed or is suspected to have developed prostate cancer is provided, the method including: comparing a prostate-specific antigen (PSA) level in serum with a first threshold value; comparing an ?1-antitrypsin (AAT) level in urine with a second threshold value; and determining whether a subject in which the PSA level in serum is the first threshold value or more and the AAT level in urine is the second threshold value or more has developed or is suspected to have developed prostate cancer.

Aspects of the disclosure relate to improved assay systems for measuring certain markers (e.g., kallikrein proteins) and determining their presence and/or level in a sample. Further, aspects of the disclosure related to improved methods are provided for determining the probability of an event associated with prostate cancer in a subject.