A method to assess the disease status, determine the mean/average control of the disease and monitor the compliance to treatment over a period of time of a respiratory disease, comprising of predicting the degree of airway inflammation and disease activity by measuring the inflammatory markers, evaluating the mucosal integrity/damage by measuring the moisture levels of the exhaled air, evaluating the breathing function and obstruction by measuring the FEV1 value, and evaluating the symptom control by determining the COPD Score.

Described are methods and uses employing metabolomic data to diagnose an asthma disease state or a Chronic Obstructive Pulmonary Disease (COPD) state. Further described are methods of uses of employing metabolomic data to distinguish between asthma and COPD. In particular, urinary metabolomic profiles are employed to enable differential diagnosis of asthma and COPD.

The present invention relates to systems and methods for identifying a biomarker from associative and knowledge based systems and processes. Particularly, aspects of the present invention are directed to a computer implemented method that includes data mining one or more public sources of biomedical text, scientific abstract, or bioinformatic data using queries to identify database terms associated with one or more predetermined terms, scoring association(s) between each of the identified database terms and the one or more predetermined terms, determining a subset b based on the score of the association(s), developing an interaction network model comprising the database terms in subset b, interactions, and additional database terms using a combination of algorithms in a predetermined order, and identifying candidate biomarkers from the interaction network model based on a ranking of the database terms in subset b and the additional database terms in the interaction network model.

The presently disclosed subject matter is directed to an assay that detects and quantitatively determines the activity of a lytic peptide that exhibits antimicrobial activity, such as LL-37. Particularly, the assay comprises inducing and/or transfecting bacteria to produce high levels of an enzyme, such as -galactosidase. The bacteria are then preserved by lyophilization. After a desired amount of time, the bacteria are hydrated with a target sample from a subject suspected of having a specific disease or disorder characterized by an increase in levels of lytic peptide. In the presence of lytic peptide, the enzyme is released from the interior of the bacteria, which can then be detected by alteration of the enzyme substrate. In the absence of lytic peptide, the enzyme remains within the bacteria and no detection of the enzyme occurs.

The present invention features, inter alia, methods of treating patients having a mast cell-mediated inflammatory disease, methods of determining whether patients having a mast cell-mediated inflammatory disease are likely to respond to a therapy (e.g., a therapy comprising an agent selected from the group consisting of a tryptase antagonist, an Fc epsilon receptor (FcR) antagonist, an IgE.sup.+ B cell depleting antibody, a mast cell or basophil depleting antibody, a protease activated receptor 2 (PAR2) antagonist, an IgE antagonist, and a combination thereof), methods of selecting a therapy for a patient having a mast cell-mediated inflammatory disease, methods for assessing a response of a patient having mast cell-mediated inflammatory disease, and methods for monitoring the response of a patient having a mast cell-mediated inflammatory disease.

Methods and compositions are provided for diagnosing or detecting a condition, e.g., lung disease in a mammalian subject by use of a micro-RNA expression level or an expression level profile of multiple miRNA in the peripheral blood mononuclear cells (PBMC) of the subject which is characteristic of COPD or NSCLC. Detection of changes in expression in specific miRNA biomarkers from that of a reference sample or miRNA expression profile are correlated with non-small cell lung cancer (NSCLC) and/or COPD and permit differentiation among healthy subjects, subjects with COPD and subjects with adenocarcinoma or squamous cell carcinoma.

In some aspects, the invention provides methods of treating a subject in need of treatment for a chronic complement-mediated disorder. In some aspects, the invention provides methods of treating a subject in need of treatment for a Th17-associated disorder. In some aspects, the invention provides methods of treating a subject in need of treatment for a chronic respiratory system disorder. In some aspects, the invention provides methods of administering a complement inhibitor to a subject. In some embodiments, a method of treating a subject comprises administering multiple doses of a complement inhibitor to the subject according to a dosing schedule that leverages the prolonged effect of complement inhibition in chronic respiratory disorders. In some embodiments, a subject has chronic obstructive pulmonary disease. In some embodiments, a subject has asthma.

The invention relates to a method for detecting and measuring the presence of mono-nucleosomes and oligo-nucleosomes and nucleosomes that contain particular histone variants and the use of such measurements for the detection and diagnosis of disease. The invention also relates to a method of identifying histone variant biomarkers for the detection and diagnosis of disease and to biomarkers identified by said method.

A system for predicting the onset of a physiological condition of a subject combines an in-vitro subject model having input parameters relating to actual or predicted external stimuli to which the subject is or may be exposed and an in-silico model. The in-vitro model outputs subject-specific parameters which are not being monitored, or cannot be monitored, in-vivo. The in-silico subject model uses subject-specific parameters to predict the response of the subject to the actual or predicted external stimuli and thereby predict an onset of a physiological condition of the subject.

Embodiments of the disclosure can include biomarkers for systems, methods, and devices for detecting and identifying certain substances, such as chemicals, volatile organic compounds (VOCs), volatile gases (VGs), ketones, cannabis, controlled substances, pharmaceuticals, or anesthetics, in the exhaled breath of a subject or person in real-time; and further diagnosing, treating, and addressing one or more associated health conditions or diseases, including a virus, such as COVID-19, tuberculosis (TB), lung cancer, or chronic obstructive lung disease (COPD).