The present invention relates to methods for detecting whether a subject suffers from an autoimmune disease, such as, for example, antiphospholipid syndrome (APS), by detecting antiphospholipid antibodies (aPL) in a sample using a novel target, the lysobisphosphatidic acid (LBPA) bound to the endothelial protein C receptor (EPCR) or an LBPA-binding fragment thereof. Furthermore, the present invention relates to methods for identifying an inhibitor of endothelial protein C receptor (EPCR) function in autoimmune disease, preferably without a side effect on EPCR regulatory function in coagulation, and a method for producing a pharmaceutical composition comprising the steps of identifying a potential inhibitor, and suitably formulating said potential inhibitor into a pharmaceutical composition. Moreover, the present invention relates to said inhibitor as identified or said pharmaceutical composition for use in the prevention and/or treatment of an autoimmune disease, such as, for example, an antiphospholipid syndrome, in a subject. Furthermore, the present invention relates to a method for treating and/or preventing an autoimmune disease, such as, for example, antiphospholipid syndrome, in a subject.

Provided are humanized antibodies that selectively bind to and inhibit activated protein C without binding to or inhibiting unactivated protein C. Methods of treatment employing these antibodies are described herein.

Provided are methods and devices for evaluating coagulation, including the identification of a coagulation impairment such as a factor deficiency or the presence of a factor inhibitor. In various embodiments, the methods and devices measure coagulation of a sample in response to the addition of one or more coagulation factors, added at various concentrations to portions of the sample. Such coagulation measurements can be evaluated to accurately profile coagulation impairments of the sample. In additional various embodiments, point-of-care or bedside testing with a convenient, microfluidic device can be used by minimally trained personnel.

The present invention relates generally to genetically modified non-human animals. The present invention relates to a genetically modified non-human animal, in which at least one copy of the endogenous nucleotide sequence encoding Protein C in the genome of said non-human animal has been replaced by a nucleotide sequence encoding human Protein C, encoding a functional fragment of human Protein C or encoding a functional variant of human Protein C. The invention also relates to vectors, cells and methods for the production of such non-human animals. The invention also relates to methods of testing agents for their ability to alter to the level and/or functional activity of human protein C and thus provides methods of testing agents for their potential therapeutic efficacy.

Compositions and methods for regulating the blood coagulation pathway are disclosed. More particularly, the present disclosure relates to thrombin-thrombomodulin fusion proteins, vectors, host cells and methods for preparing the thrombin-thrombomodulin fusion proteins. The present disclosure further relates to methods for measuring protein C in plasma and kits for measuring protein C in plasma.

Provided is a genetically modified non-human animal, in which at least one copy of the endogenous nucleotide sequence encoding Protein C in the genome of said the non-human animal has been replaced by a nucleotide sequence encoding human Protein C or a functional fragment or variant thereof. Also provided are vectors, cells, and methods for the production of such non-human animals. Further provided are methods of testing agents for their ability to alter to the level and/or functional activity of human protein C, for example, to test their potential therapeutic efficacy.

Biomarkers for predicting weight loss The present invention provides a method for predicting the degree of weight loss attainable by applying one or more dietary interventions to a subject, said method comprising; determining the level of one or more biomarkers in one or more samples obtained from the subject, wherein the one or more biomarkers include vitamin K-dependent protein C.

Compositions and methods for regulating the blood coagulation pathway are disclosed. More particularly, the present disclosure relates to thrombin-thrombomodulin fusion proteins, vectors, host cells and methods for preparing the thrombin-thrombomodulin fusion proteins. The present disclosure further relates to methods for measuring protein C in plasma and kits for measuring protein C in plasma.

The present invention relates to a method for measuring the levels of Protein C (PROC), preferably Activated Protein C (APC), in a subject in need thereof, the method comprising a step of performing an enzymatic digestion of one or more biological samples isolated from the subject, and a step of measuring the levels of the peptide of SEQ ID NO 1 (LGEYDLR) and/or SEQ ID NO 2 (TFVL-NFIK), wherein the levels of SEQ ID NO 1 and/or SEQ ID NO 2 correspond to the levels of PROC, preferably APC, present in said one or more biological samples. Methods for classifying subjects and prognosticating the response to treatments are also included.

Provided are humanized antibodies that selectively bind to and inhibit activated protein C without binding to or inhibiting unactivated protein C. Methods of treatment employing these antibodies are described herein.