Back to results
US 12,360,103 B2Granted
Blood biomarker for eosinophilic gastrointestinal disorders
AssigneeChildren's Hospital Medical Center
InventorsMarc E. Rothenberg, Ting Wen, Yrina Rochman
Life of this patent
Estimating the term…
Abstract
The disclosure provides a simple and rapid blood-based bioassay useful in the diagnosis, treatment and monitoring of eosinophilic gastrointestinal disorders, and related compositions and methods.
Claims18
A method for treating eosinophilic gastrointestinal disorder (EGID) in a human subject in need thereof, the method comprising
- detecting thymic stromal lymphopoietin (TSLP) responsive cells in a sample of whole blood obtained from the subject by
- contacting cells in vitro with TSLP without stimulation of the cells with anti-CD3 or anti-CD28 antibodies, wherein the cells are selected from PBMC, CD4+ T cells, or memory CD4+ T cells, and
- detecting one or more analytes in the cells or secreted by the cells, the one or more analytes selected from phosphorylated signal transducer and activator of transcription 5 (pSTAT5), interleukin-5 (IL-5), and interleukin-13 (IL-13),
- wherein the detection of the one or more of the analytes indicates TSLP responsive cells in the blood of the human subject,
- determining whether an amount of the one or more analytes is above or below a predetermined diagnostic threshold, wherein an amount above the threshold indicates an EGID status of active disease for the subject and an amount below the threshold indicates that an EGID status of managed, and
- administering an EGID therapy to the subject having an EGID status of active disease, wherein the EGID therapy is selected from proton pump inhibitor therapy, dietary therapy, anti-cytokine therapy, anti-ALOX15 therapy, anti-TSLP therapy, anti-eosinophil therapy, glucocorticoid therapy, and esophageal dilation;
- or
- re-administering current therapy to the subject having an EGID status of managed.
5 more elements
An assay for detecting a thymic stromal lymphopoietin (TSLP) responsive population of cells in human blood, wherein the method is performed within 1-6 hours, the method comprising
- contacting cells in vitro with TSLP, wherein the cells are previously isolated from a sample of whole blood obtained from a human subject in need of treatment for an eosinophilic gastrointestinal disorder (EGID), and
- detecting phosphorylated signal transducer and activator of transcription 5 (pSTAT5) in the cells by a method comprising one or more of flow cytometry, immunoassay, and a chromatographic technique,
- wherein the presence of pSTAT5 indicates a TSLP responsive population of cells in the blood of the human subject,
- wherein the cells are selected from PBMC, CD4+ T cells, or memory CD4+ T cells, and
- wherein the method does not include stimulation of the cells with anti-CD3 or anti-CD28 antibodies.
2 more elements
Dependencies are inferred from the claim text.