Methods for diagnosing inflammatory and/or cardiovascular diseases by assaying for Fibroblast Activation Protein (FAP) expression in a body fluid is provided as well as therapeutic means based thereon.

The present invention provides methods for identifying biomarker proteins that exhibit differential expression in subjects with a first lung condition versus healthy subjects or subjects with a second lung condition. The present invention also provides compositions comprising these biomarker proteins and methods of using these biomarker proteins or panels thereof to diagnose, classify, and monitor various lung conditions. The methods and compositions provided herein may be used to diagnose or classify a subject as having lung cancer or a non-cancerous condition, and to distinguish between different types of cancer (e.g., malignant versus benign, SCLC versus NSCLC).

The present application discloses methods of making anti-hepsin antibodies, anti-hepsin antibodies, methods of screening the activity of anti-hepsin antibodies, pharmaceutical compositions of anti-hepsin antibodies, kits containing anti-hepsin antibodies, and methods of using anti-hepsin antibodies to diagnose a cancer.

Methods for detection, diagnosis, prognosis, theragnosis, and targeted therapy of a PRSS21-overexpressing condition (e.g., cancer), in particular, PRSS21-overexpressing acute myeloid leukemia of the AMKL subtype.

The present invention relates generally to the field of disorders of complement activation. More specifically, the present invention provides methods and compositions useful for identifying patients having a complement-mediated disease that could benefit from treatment with complement inhibitors. As described herein, the present invention utilizes patient sera and flow cytometry in the companion diagnostic assay. More specifically, the present invention comprises evaluating complement activity via cell surface deposition of C5b-9 and, in further embodiments, complement-dependent cell killing (the modified Ham assay) using patient sera.

Subject matter of the present invention is a method for (a) diagnosing or predicting the risk of life-threatening deterioration or an adverse event or (b) diagnosing or prognosing the severity or (c) predicting or monitoring the success of a therapy or intervention or (d) therapy guidance or therapy stratification or (e) patient management in a patient infected with a coronavirus, the method comprising: determining the level of dipeptidyl peptidase 3 (DPP3) in a sample of bodily fluid of said patient, comparing said level of determined DPP3 to a pre-determined threshold, and correlating said level of determined DPP3 with the risk of life-threatening deterioration or an adverse event, or correlating said level of determined DPP3 with the severity, or correlating said level of determined DPP3 with the success of a therapy or intervention, or correlating said level of DPP3 with a certain therapy or intervention, or correlating said level of DPP3 with the management of said patient.

Subject matter of the present invention is an inhibitor of the activity of DPP3 for use in therapy or intervention in a patient infected with a coronavirus.

The invention is in the field of therapy of gut inflammatory diseases such as Inflammatory Bowel Diseases (IBD) or Irritable Bowel Syndrome (IBS) including Gluten hypersensitivity. The inventors showed that ELA2A secreted by epithelial cells in the extracellular space is over-expressed in IBD conditions degrading tight junction proteins and controlling cytokines expression. Overexpression of ELA2A conferred a pro-inflammatory phenotype both in cell expression systems and in vivo in animal model of IBD. The inventors also showed that ELA2 over-expressing intestinal epithelial cells increase the release of CXCL8 protein compared to control cells. The increased CXCL-8 protein release observed in cells overexpressing ELA2A is inhibited by ELAFIN addition to the culture, in a dose-dependent manner. In particular, the invention relates to inhibitors of Elastase ELA2A, for use in the treatment of Inflammatory Bowel Diseases, such as Crohn's Disease, Ulcerative Colitis, Celiac disease, and Pouchitis.

Aspects of the disclosure relate to improved methods and systems for active surveillance of subject having non-aggressive prostate cancer.

An object of the present invention is to provide a method for measuring tryptase activity in a blood sample accurately and rapidly by a convenient operation in order to accurately evaluate the state of a disease whose state involves mast cells. The present invention enables tryptase activity in a blood sample to be directly measured without the pretreatment, such as purification or concentration, of the blood sample, using a substrate for measuring tryptase activity, comprising a tripeptide C-terminally linked through a peptide bond to a dye label, selected from the following formulas (1) to (3): (1) Lys-Ala-Arg-X, (2) Ala-Ala-Arg-X, and (3) Abu-Ala-Arg-X (wherein X represents a dye label whose fluorescence characteristics or color development characteristics change upon the cleavage of the peptide bond with Arg, and Abu represents 2-aminobutyric acid).

The invention provides methods of assessing unbound PCSK9 or effective PCSK9 activity in a subject based on the novel insights of the inventors that high levels of PCSK9 are bound to HDL in vivo and that this HDL can activate PCSK9 function. Specifically depleting HDL from a sample from a subject allows improved assessment of the level of unbound PCSK9. The invention provides such analytical methods, plus also associated methods of treatment and related kits.