An in-vitro method for the prediction, prognosis and/or diagnosis of an inflammatory response associated with a condition or disease such as schizophrenia in a subject, the method comprising determining in a sample of a subject the level of 25-hydroxy vitamin D3, preferably in combination with the level of least one biomarker wherein the at least one biomarker is selected from innate chemokine (IL-8) and matrix metalloproteinase (MMP-9); and comparing the levels of said 25-hydroxy vitamin D3 and at least one biomarker to a control level of 25-hydroxy vitamin D3 and the at least one biomarker respectively in order to determine a positive or negative prediction, prognosis and/or diagnosis of said inflammatory response indicating an associated condition or disease, such as schizophrenia.

Methods and compositions disclosed herein generally relate to methods of identifying, validating, and measuring clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction, particularly as those responses relate to sepsis and/or necrotizing enterocolitis in pediatric patients. In particular, the invention relates to identifying two or more biomarkers associated with septic shock in pediatric patients, obtaining a sample from a pediatric patient having at least one indication of sepsis and/or necrotizing enterocolitis, then quantifying from the sample an amount of two or more of said biomarkers, wherein the level of said biomarker correlates with a predicted outcome.

The present invention relates to the quantification of various biomarkers, including MMP9 (Inflammatory marker), LOX (Lysyl oxidase), IL6 (Interleukin-6), TNFα (tumor necrosis factor alpha), VEGF (Vascular Endothelial Growth Factor) ICAM-1 (Intercellular Adhesion Molecule-1) in aqueous humor, vitreous humor, tear and serum of patients with ocular diseases. The invention further describes the role of biomarkers in the pathogenesis, progression of ocular diseases. Hence, the level of biomarkers serves as a diagnostic and/or prognostic marker in ocular diseases. The invention further relates to the use of multiple biomarkers that can be simultaneously used for testing various corneal and retinal diseases.

A method of electronically diagnosing a cause of an inflamed and/or painful joint of a patient using a joint specific biological material, the method including: receiving, data regarding tests performed on the joint specific biological material; determining if osteoarthritis (OA) is the cause of the inflamed and/or painful joint based upon one or more of the tests, wherein the diagnosing is based upon a level of cartilage oligomeric matrix protein (COMP) and a ratio of COMP to interleukin-8 (IL-8) in the joint specific biological material; if the one or more of the tests indicate OA is not the cause of the inflamed joint, determining if inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis is the cause of the inflamed joint based upon a further plurality of the tests; and generating a sample results report with result data including diagnosis for use by a clinician.

Provided herein are methods for reducing risk of severe symptoms and outcomes associated with Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection by measuring levels of interleukin 6 (IL-6), IL-8, IL-22, and serum ferritin in a subject. Also provided are methods for treating a subject exposed to or at elevated risk of expose to SARS-CoV-2 based on levels of IL-6, IL-8, IL-22, and ferritin in the serum of the subject.

The present disclosure provides, in part, a method of treating an autoimmune disease in a subject by reducing the number of pDCs through administration of a human interleukin-3 (IL-3)-diphtheria toxin conjugate (DT-IL3). The disclosure also generally relates to methods of monitoring the effectiveness of therapy in subjects receiving DT-IL3 for treating an autoimmune disease, and methods of determining continuing treatment of subjects receiving DT-IL3 for treating an autoimmune disease. The disclosure also provides pharmaceutical compositions of DT-IL3 for use in such methods.

Methods are disclosed for enhancing growth of a human acute myeloid leukemia (AML) sample, a human myelodysplastic syndrome (MDS) sample, a human IL-8 dependent tumor sample, human preleukemia cells, and a human preleukemia clone or subclone ex vivo or in a xenograft animal model comprising adding human interleukin-8 (hIL-8) or a hIL-8 agonist to the sample or administering hIL-8 or a hIL-8 agonist to the animal model or expressing a gene encoding hIL-8 or a hIL-8 agonist in the animal model. The invention also provides a transgenic animal that expresses a gene encoding human interleukin-8 (hIL-8) or a hIL-8 agonist, which can be used to test the effectiveness of treatments for AML, MDS and IL-8 dependent tumors.

Biomarker panels for the prediction of patient response to immunotherapy, and methods of use thereof.

Provided herein are methods for the clinical treatment of tumors (e.g., advanced solid tumors) in patients having certain levels of serum IL-8 using an anti-IL-8 antibody in combination with an anti-PD-1 antibody.

Provided herein are methods for reducing risk of severe symptoms and outcomes associated with Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection by measuring levels of interleukin 6 (IL-6), IL-8, IL-22, and serum ferritin in a subject. Also provided are methods for treating a subject exposed to or at elevated risk of expose to SARS-CoV-2 based on levels of IL-6, IL-8, IL-22, and ferritin in the serum of the subject.