Methods for diagnosing and monitoring diseases or conditions using disease modified biomolecules and measurement of a functional immune response
AssigneeViracor-IBT Laboratories, Inc.
InventorsJianrong Lou, Brad L. Stewart, Nathaniel Rill
Life of this patent
Estimating the term…
Abstract
Methods and assays for disease prognosis, detection and treatment monitoring are provided. The assays and methods measure functional immune responses to disease modified biomolecules (DMBs) that are characteristic of a disease of interest. Exemplary diseases of interest include rheumatoid arthritis (RA), for which citruUinated peptides or proteins (CPs), are characteristic DMBs.
Claims17
A method of determining whether or not a subject has or is at risk of developing a disease or condition of interest, comprising the steps of
- obtaining at least one disease modified biomolecule (DMB) that is identified as being present in biological samples from one or more subjects in a pool of subjects with the disease of interest, wherein the DMB does not appear or the DMB level is significantly lower in biological samples from one or more control subjects who do not have the disease or condition of interest;
- obtaining a biological sample from a subject that has or may have the disease or condition of interest;
- exposing the biological sample or cells from the biological sample to the DMB;
- detecting at least one functional immunological response in the biological sample;
- and, if at least one functional immunological response is detected, then
- concluding that the subject has or is at risk of developing the disease or condition of interest.
A method of monitoring the efficacy of treatment of a disease or condition of interest in a patient in need thereof, comprising the steps of
- i) obtaining at least one disease modified biomolecule (DMB) that is identified as being present in biological samples from one or more subjects in a pool of subjects with the disease of interest, wherein the DMB does not appear or the DMB level is significantly lower in biological samples from one or more control subjects who do not have the disease or condition of interest;
- ii) obtaining a biological sample from a subject that has and is receiving treatment for the disease or condition of interest;
- iii) exposing the biological sample or cells from the biological sample to the DMB;
- iv) detecting and/or quantifying at least one functional immunological response in the biological sample;
- and, based on results obtained in said detecting and/or quantifying step
- v) determining whether or not said treatment is efficacious.
A composition comprising
- a citrullinated peptide or protein comprising one or both of
- i) a citrullinated amino acid sequence VYAT[Cit]SSAV[Cit]L[Cit]SSVP (SEQ ID NO:
- 1) or a functional variant thereof, and
- ii) a citrullinated amino acid sequence GGVYAT[Cit]SSAV[Cit]L[Cit]SSVP (SEQ ID NO:
- 11) or a functional variant thereof;
- and
- a physiologically acceptable carrier.
Dependencies are inferred from the claim text.