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.

An object of the present invention is to provide a method for predicting a therapeutic effect of a drug that inhibits FKN-CX3CR1 interaction on rheumatoid arthritis in a rheumatoid arthritis subject, and novel and more effective therapeutic agent for rheumatoid arthritis exploiting the method. In order to predict a therapeutic effect of a drug that inhibits fractalkine (FKN)-CX3CR1 interaction in a rheumatoid arthritis subject, provided is a method comprising predicting the therapeutic effect of the drug in the subject on the basis of a measurement value of CD16+ monocytes in a biological sample obtained from the subject before the start of administration of the drug.

The invention relates to a method of characterizing an antibody, which method is suitable as a potency assay for batch release of a pharmaceutical composition comprising an antibody, specifically for use when applying for marketing authorization for said pharmaceutical composition. The assay provided is a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor.

The present disclosure provides methods of assaying for antibody-dependent cell-mediated phagocytosis (ADCP). In some embodiments, the methods include monomerizing and labeling a protein, contacting the protein with a protein-specific antibody to form an antibody-protein complex, contacting the antibody-protein complex with a phagocytic cell to permit phagocytosis, and assessing the amount of internalized fluorescence.

Herein is reported a method for selecting an antibody with a systematic clearance in cynomolgus monkeys of less than 8 mL/kg/day comprising the steps of measuring the retention time of the antibody on performing an FcRn affinity chromatography with a positive linear pH gradient and on a heparin affinity chromatography with a positive linear conductivity/salt gradient, and selecting an antibody that has a relative retention time on the FcRn affinity chromatography column is less than 1.78 times the retention time difference between peaks 2 and 3 the retention time of preparation of an oxidized anti-Her3 antibody of SEQ ID NO: 03 and 04, and a relative retention time on the heparin affinity chromatography column is less than 0.87 times the retention time of an anti-pTau antibody of SEQ ID NO: 01 and 02.

The present invention relates to a method for the diagnosis, prognosis, risk assessment, risk stratification, monitoring, therapy guidance and/or therapy control of a fungal infection, in particular invasive fungal infections (IFI) and/or the ruling in or ruling out of an fungal infection and/or the differential diagnosis of a fungal colonization vs. an invasive fungal infection in a subject, wherein in particular the subject has an increased risk of getting or having a fungal infection and/or the subject is in a critical disease state, particularly has an existing infection and/or a state of sepsis, particularly a septic shock. The method of the invention comprises determining the level of at least one marker selected from the group of ICAM1, AHSG, CPN1, FABP1, HRG, PIGR, RAP1A, THBS1, VCL, ET-1. Furthermore, the invention relates to a diagnostic assay and a kit for carrying out the method.

Provided are methods involving the assaying of a labeled cell suspension, e.g., to detect cancer-related cells, populations ON thereof and/or screen for metastatic cancer. Labeled cell suspensions may be assayed to detect whether a tumor infiltrating lymphocyte (TIL) population is present in a cellular suspension of a subject. Cancer-related cell populations of interest include, e.g., those expressing one or more markers, including where the markers are members of a marker panel. Markers assayed may vary depending on the context and may include protein markers, nucleic acid markers, cell cycle markers, DNA content markers, and the like. Useful markers include one or more immune checkpoint markers and/or one or more immune cell-type markers, including where the marker(s) assayed are part of one or more panels of markers. Also provided are methods of treating a subject for a neoplasia based on the outcome of an assay of a labeled cell suspension of sample from a subject. Kits for practicing the described methods are also provided.

Compositions and methods are provided for determining platelet reactivity where the levels of FcγRIIa on the surface of platelets is measured and if the levels of FcγRIIa are greater than a reference value, the platelets have enhanced reactivity.

Compositions and methods are provided for determining platelet reactivity where the levels of FcγRIIa on the surface of platelets is measured and if the levels of FcγRIIa are greater than a reference value, the platelets have enhanced reactivity.

The present disclosure is directed to identifying characteristics and biomarkers in patients that benefit from treatment with an anti-CD19 antibody.