The present invention is related to novel methods for categorizing and treating a population of subjects that are at risk for increased pulmonary exacerbation and disease progression.

The present invention provides a method for treating a subject having a clinical condition associated with increased level of L1 expression. The method generally includes determining the expression level of L1 in a subject and administering a TGF-1 inhibitor to a subject having an increased level of L1 expression. The clinical conditions that can be treated using the method of the invention include, but are not limited to, cancer, chronic obstructive pulmonary disease (COPD), atherosclerosis and pulmonary vascular disease as well as other fibrotic and inflammatory diseases.

A method for diagnosing and/or stratifying the risk of infections or chronic diseases of the respiratory tract and lungs, particularly lower respiratory tract infections and chronic obstructive pulmonary disease, in which method provasopressin (proAVP) or fragments or partial peptides thereof, especially copeptin or neurophysin II, is/are determined. Suitable biomarker combinations for in-vitro diagnosis are also included.

Asthma is a common, under-diagnosed disease affecting all ages. Mild to moderate asthma is particularly difficult to diagnose given currently available tools. A nasal biomarker of asthma is of high interest given the accessibility of the nose and shared airway biology between the upper and lower respiratory tract. A machine learning pipeline identified an asthma gene panel of 275 unique nasally-expressed genes interpreted via different classification models. This asthma gene panel can be utilized to reliably diagnose asthma in patients, including mild to moderate asthma, in a non-invasive manner and to distinguish asthma from other respiratory disorders, allowing appropriate treatment of the patient's asthma.

The present invention is directed to the use of (1) mucin concentration in sputum; (2) individual airway mucins MUC5AC and MUC5B ratio (MUC5AC/MUC5B) in sputum; and (3) combination of both measurements (Kesimer MUCQuant index) that can be used as an objective biomarker for differential diagnosis of smoking status and chronic bronchitis (CB), disease severity of CB (mild, moderate, and severe), exacerbation status, monitoring progression of CB, and guiding of therapies for CB. In addition, the ratio of amount of IgGFc-binding protein (FCGBP) and the amount of bactericidal/permeability-increasing fold-containing family member A1 (BPIFA1 (or SPLUNC1)) present in a sputum sample from a subject may be used in combination with the Kesimer MUCQuant index (Kesimer MUCQuant Plus index) for differential diagnosis of smoking status and CB, disease severity of CB, exacerbation status, p monitoring progression of CB, and guiding of therapies for CB.

A device for detecting a biomarker for inflammation in a respiratory system includes a sample collection and/or holding area to receive an exhaled breath condensate (EBC) sample obtained from a respiratory system; an electrode system coupled to the sample collection area, the electrode system including reduced graphene oxide (rGO); and circuitry coupled to the electrode system. The circuitry is configured to apply a voltage to the EBC sample in the sample collection area via the electrode system and to measure a current via the electrode system in response to the voltage applied, in order to determine a concentration of nitrite in the EBC sample based on the current measured. The concentration of nitrite is a biomarker for inflammation in the respiratory system.

Implementations are related to providing image selection suggestions. In some implementations, a method includes receiving first user input indicative of selection of one or more first images in an image library and determining one or more first image characteristics of the one or more first images. The method further includes identifying one or more second images in the image library. Each image of the one or more second images is associated with at least one second image characteristic that matches at least one of the one or more first image characteristics. The method further includes causing a user interface to be displayed. The user interface includes the one or more second images and enables selection of the one or more second images by a user.

The present invention relates to methods of diagnosing an inflammatory disorder in a patient, as well as methods of monitoring the progression of an inflammatory disorder and/or methods of monitoring a treatment protocol of a therapeutic agent or regimen. The invention also relates to assay methods used in connection with the diagnostic methods described herein.

Provided herein are methods for assessing a disease score of a subject suffering from or suspected to be suffering from chronic obstructive pulmonary disease (COPD) or associated disease mechanisms, wherein the disease score represents COPD activity. The disease score can be used to stratify the subject into a specific risk category and can further inform patient management decisions. The methods can involve determining a biomarker signature including four or more biomarkers associated with COPD or COPD mechanisms. The methods can further include supplementing the biomarker combinations with calculation or classification trees based on one or more additional clinical parameters or biomarkers. In some cases, the methods include timing of collection of patient samples with respect to acute event or treatment course.

The present invention provides diagnostic and therapeutic methods and compositions for treating a patient suffering from an interleukin-1 receptor-associated kinase 4 (IRAK4)-mediated disorder or condition, such as an immune disorder (e.g., systemic lupus erythematosus (SLE)) or an inflammatory disorder (e.g., asthma). The invention provides diagnostic methods of monitoring the response of a patient having an IRAK4-mediated disorder or condition to treatment including an IRAK4 pathway inhibitor, methods of identifying a patient having an IRAK4-mediated disorder or condition who may benefit from treatment including an IRAK4 pathway inhibitor, and methods of selecting a therapy for a patient having an IRAK4-mediated disorder or condition based on the expression level of one or more IRAK4 biomarkers (e.g., one or more genes set forth in Table 1). Related therapeutic methods and compositions (e.g., diagnostic kits) are also provided.