The invention provides assays and methods for detecting and monitoring systemic inflammation Particularly, the invention in embodiments thereof relates to the use of urinary biomarkers for non-invasive determination of the level of inflammation.

Provided are a method for predicting a risk of deterioration of a pathogenic condition of a patient suffering a coronavirus disease (COVID-19), especially a severe patient suffering a COVID-19 and a kit thereof. The method of the present application may effectively predict the deterioration of the pathogenic condition of the patient suffering a COVID-19, thereby carrying out clinical intervention in advance, to improve prognosis of the patient suffering a COVID-19. The present application finds for the first time that the level of a heparin-binding protein (HBP) can be used as a significant indicator for early predicting relapse of the patient suffering a COVID-19, expression time of an HBP indicator is around 5 days earlier than that of a series of other clinical indicators, and thus the HBP indicator particularly has a clinical value.

Provided herein are methods and articles of manufacture for use with cell therapy for the treatment of diseases or conditions, e.g., cancer, including for predicting and treating a toxicity. In some embodiments, the toxicity is related to cytokine release syndrome (CRS). The methods generally involve assessing a change in a factor indicative of tumor burden prior to administration of a cell therapy in a subject that is associated with and/or correlate to a risk of developing toxicity. In some aspects, the methods can be used to determine if the subject is at risk or likely at risk for developing a toxicity following administration of the cell therapy. Also provided are methods for treating a subject having a disease or condition, in some cases involving administration of the cell therapy, based on assessment of risk of developing a toxicity following administration of the therapy. Also provided herein are reagents and kits for performing the methods.

Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response during intravenous PEGylated uricase therapy in gout patients is provided. Routine SUA monitoring can be used to identify patients receiving PEGylated uricase who may no longer benefit from treatment and who are at greater risk for infusion reactions.

The present invention is directed to methods for detecting a melanoma, methods for determining whether a melanoma is stable or progressive, methods for evaluating the extent of surgery resection in a subject having a melanoma, and methods for determining a response by a subject having a melanoma to a therapy.

Methods for treating coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, is described. The methods can be used to reduce the severity of outcomes related to COVID-19, such as hospitalization and ventilation. For example, treatment of a subject with a therapeutic agent that neutralizes interleukin 13 (IL-13) can result in reduced risk for mechanical ventilation in the subject. Also described are methods of predicting risk of mechanical ventilation in subjects with COVID-19.

Provided herein are methods and biomarkers useful for detecting and diagnosing osteoarthritis and predicting the progression of osteoarthritis in subjects. The diagnoses and predictions of prognosis may be used to develop treatment plans for subjects. Also included are methods of treating subjects and administering pharmaceuticals based on the diagnosis and prognosis predictions.

Methods and reagents for diagnosing, prognosing, and treating systemic lupus erythematosus (SLE) are disclosed, involving calculating an SLE risk score for a subject based on a level of each of an erythrocyte C4d (EC4d) marker, a B-cell C4d (BC4d) marker, anti-nuclear antibodies (ANA), and optional rule-out markers.

The invention relates to the use in vitro of a kit for diagnostics, more particularly therapy-accompanying diagnostics, relating to a transplant and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to an autoimmune disease and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to a tumor disease and/or for diagnostics, more particularly therapy-accompanying diagnostics, relating to a vaccination, wherein the kit has the following components: a blood collection container, a blood collection set or blood collection system including a blood collection container, a nutrient medium for blood, and at least one activator for activating blood cells, more particularly immune cells, and/or at least one inhibitor for inhibiting blood cells, more particularly immune cells, and/or at least one modulator for modulating blood cells, more particularly immune cells.

The invention further relates to the use in vitro of a method for diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations, to a messenger-substance-containing supernatant for use in vitro in diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations, and to a combination for use in diagnostics in transplants and/or autoimmune diseases and/or tumor diseases and/or vaccinations.

The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a measured urine concentration of one or more of TIMP2 and IGFBP7 in combination with one or more of a measured serum creatinine and a measured urine output, which results are correlated to the renal status of the subject, and can be used for diagnosis, prognosis, risk stratification, staging, monitoring, categorizing and determination of further diagnosis and treatment regimens in subjects suffering or at risk of suffering from an injury to renal function, reduced renal function, and/or acute renal failure.