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AssigneeT Cell Diagnostics, Inc.
InventorsPatrick C. Kung, Stephen H. Ip, Michael C. Brown, Linda A. MacKeen
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The present invention is directed to the measurement of soluble T cell growth factor receptors, soluble T cell differentiation antigens, or related soluble molecules or fragments thereof, and the use of such measurements in the diagnosis, staging, and therapy of diseases and disorders. Specific embodiments involve the diagnosis and monitoring of therapy using absolute values of such soluble molecules. Further embodiments involve detecting a change in the levels of such soluble molecules, in the diagnosis and therapy of diseases and disorders. In specific embodiments, measurements of interleukin-2 receptor levels can be made to detect lung cancer, or to stage squamous cell lung carcinoma. In other embodiments, detection of increases in both soluble IL2R and creatinine in the body fluid of a transplant patient can be used to differentially diagnose renal allograft rejection from infection. The invention is also directed to methods for measurement of soluble CD4 antigens, which measurements can be used, in a specific embodiment, to diagnose a state of immune activation, to diagnose rheumatoid arthritis, to monitor therapeutic efficacy (e.g. of AIDS treatments), or to stage adult T cell leukemia in a patient. In another aspect, the invention relates to the detection, staging, and monitoring of therapy of diseases and disorders by measuring a plurality of soluble T cell markers.
A method for detecting or measuring the amount in a sample of a soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen comprising:
A kit for measuring the level of a cell free soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen comprising in one or more vials:
A method for diagnosing a state of immune activation in a subject comprising detecting or measuring an increase, relative to a baseline level, in the amount in a sample from the subject of a spontaneously released, soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen.
A method for determining the phenotype of a T cell comprising first incubating the cell in a cell culture fluid, and subsequently detecting or measuring the amount, in a sample of the cell culture fluid, of a spontaneously released, soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen, the presence of said spontaneously released, soluble molecule being indicative of the phenotype of the cell.
A method for staging adult T cell leukemia in a patient comprising measuring the amount of a spontaneously released, soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen in a sample obtained from the patient, in which increases in amounts relative to healthy individuals or to the patient at an earlier time indicates more advanced stages of disease.
A method for diagnosing rheumatoid arthritis in a patient comprising detecting or measuring an increase in the amount, relative to healthy individuals or to the patient at an earlier time, of a spontaneously released, soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen in synovial fluid obtained from the patient.
A method for diagnosing rheumatoid arthritis in a patient comprising detecting an increase in the amount in synovial fluid of the patient relative to the amount in serum of the patient of a spontaneously released, soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen.
A method for monitoring the treatment of a patient with a viral infection comprising measuring the level in a body fluid of the patient after treatment of a spontaneously released, soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen.
A kit for detecting, monitoring the treatment of, or staging a disease or disorder in a patient comprising in one or more vials:
A composition suitable for use in the detection or measurement of a spontaneously released soluble molecule carrying antigenic determinants of the CD4 T cell surface antigen comprising:
Dependencies are inferred from the claim text.