The invention relates to proteins for use as markers for the efficacy of sublingual immunotherapy. In particular, the proteins may be used to predict the responsiveness of a patient to immunotherapy. The invention may find use in selecting patients as suitable candidates for immunotherapy.

The present disclosure provides methods and compositions that find use in facilitating a diagnosis of inflammatory liver disease in a subject. The methods and compositions generally involve detection of eotaxin-3 (E3) levels, either alone or with levels of eotaxin-1 (E1), and optionally, with levels of CCL22 and, further optionally, with levels of IL15. These levels can be used to facilitate a diagnosis of a liver disease of at least one of autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC), and/or to facilitate a differential diagnosis between AIH, PBC, and PSC. The methods and compositions of the present disclosure also find use in facilitating treatment decisions for a subject.

Provided herein are methods for predicting the clinical sensitivity of an inflammatory disease (e.g., ankylosing spondylitis) and a subject's response to treatment with apremilast using the level of a biomarker (e.g., MCP1). Also provided herein are methods for treating an inflammatory disease.

The present invention relates to the identification of chemokine biomarkers predictive of future acute coronary syndromes including unstable angina pectoris (UAP). The present invention also identifies particular chemokines as potential therapeutic targets for intervention in cardiovascular diseases.

The present invention relates to methods of determining the clinical significance of an HPV infection in a subject and associated methods, systems and kits. The method involves detection of biomarkers associated with clinically significant HPV infections and associated dysplasia.

The present disclosure provides methods and compositions that find use in facilitating a diagnosis of inflammatory liver disease in a subject. The methods and compositions generally involve detection of eotaxin-3 (E3) levels, either alone or with levels of eotaxin-1 (E1), and optionally, with levels of CCL22 and, further optionally, with levels of IL15. These levels can be used to facilitate a diagnosis of a liver disease of at least one of autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC), and/or to facilitate a differential diagnosis between AIH, PBC, and PSC. The methods and compositions of the present disclosure also find use in facilitating treatment decisions for a subject.

Methods and kits are provided for determining whether an individual is responsive to an anti-CD47 agent and for determining whether an individual is maintaining responsiveness to an anti-CD47 agent by assaying biological samples for the level of at least one biomarker in a biological sample.

The present invention includes methods, systems, and kits, for identifying and modifying the treatment of a systemic lupus erythematosus (SLE) patient prior to the presence of autoantibodies, comprising: (a) obtaining a dataset representing protein expression level values for cytokines and molecules; (b) assessing the dataset for protein expression levels of at least one innate serum mediator; (c) assessing the dataset for protein expression levels of at least one adaptive serum mediator; and (d) determining the likelihood that the patient will develop SLE prior to the onset of autoantibodies when compared to a control.

The invention provides a method of defining the likelihood of a subject having bladder cancer, comprising the steps of: (A) assessing the subject's likelihood of having bladder cancer by: i. identifying at least one sub-population group appropriate to the subject; ii. determining the level of one or more biomarkers selected according to the sub-population group in a sample obtained from the subject; iii. inputting each of the biomarker values into an algorithm to produce an output value; and iv. correlating the output value with the likelihood of the subject having bladder cancer, wherein the sub-population group is selected according to smoking habits, gender, presence/absence of stone disease, history of benign prostate enlargement (BPE) or prescription of anti-hypertensive, anti-platelet and/or anti-ulcer medication, and (B) determining the subject's stratified risk level of serious disease by: v. determining the level of one or more biomarkers specific for one or more risk classifiers defined using Random Forest Classifiers (RFC), logistic regression or another appropriate systems biology or statistical approach in a sample obtained from the subject, vi. inputting each of the biomarker values into an algorithm or algorithms to produce an output value; and vii. correlating the output value with a stratified risk level of underlying serious disease, wherein the likelihood of having bladder cancer is combined with the stratified risk level of having serious disease, wherein the risk of having bladder cancer and/or serious disease is categorized as: high-risk bladder cancer requiring immediate cystoscopy; low-risk bladder cancer requiring urgent cystoscopy; high-risk control requiring close evaluation and further investigation; or low-risk control requiring primary care monitoring.

Disclosed are methods for conducting diagnostic tests for the detection of the inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis. Also described are methods for monitoring a patient by administering tests of the present invention. Also described are methods for monitoring patient's treatment by administering tests of the present invention. Also described are methods for evaluating the effectiveness of a drug or a drug candidate by administering tests of the present invention to samples from patients, animal models, and cell cultures treated with a drug or a drug candidate. Also disclosed are methods for determining the usefulness of analytes, e.g. cytokines, for acting as diagnostic and monitoring markers for inflammatory bowel disease in the various methods of the invention.