A Highly Sensitive ELISA for Detection of Serum Levels of Soluble IL-15 Receptor Alpha
Posted Jun 22 2010 5:00pm
Description of Invention: The invention is an ELISA based assay that can be used in the clinical setting to detect the presence of soluble human IL-15 receptor (IL-15R) in the serum or plasma.
Interleukin-15 (IL-15), a cytokine has potential as an immunotherapeutic agent for cancer treatment because it is a critical factor for the proliferation and activation of natural killer (NK) and CD8+ T-cells.
In addition to studies directed toward augmenting IL-15 action to increase patient immune responses to their tumor, IL-15R alpha play a pathogenic role in leukemia and autoimmune disorders. IL-15 and IL-15R alpha are coexpressed in association with a number of autoimmune disorders including rheumatoid arthritis, psoriasis, inflammatory bowel disease, multiple sclerosis, chronic liver disease, and refractory celiac syndrome including that disease associated with the development of enteropathy associated CD8 T-cell lymphoma. An assay for the released serum form of IL-15R alpha is required to evaluate these IL-15R alpha inducing agents.
Applications:
The assay has the potential of being a commercial assay for clinical use to detect soluble human IL-15R alpha (sIL-15R alpha) in serum or plasma.
The assay will help in predicting the efficacy of IL-15-based therapies since high levels of IL-15R are thought to be necessary to optimize the therapeutic effects of IL-15.
The assay can be used to identify patients who can be good candidates for IL-15 therapy.
The assay may also help clinicians identify patients susceptible to diseases associated with disorders of IL-15R expression.
Advantages:
The assay is in the industry accepted ELISA format.
This non-radioactive ELISA assay has a sensitivity of 1pg/ml that is significantly more sensitive than the current industry detection level of 20 pg/ml.
Development Status: Developed at the proof-of concept level and laboratory setting. Clinical validation of the assay is currently being planned.
Waldmann TA. The biology of interleukin-2 and interleukin-15: implications for cancer therapy and vaccine design. Nat Rev Immunol. 2006 Aug;6(8):595-601. [ PubMed: 16868550 ]
Licensing Status: Available for licensing.
Collaborative Research Opportunity: The Center for Cancer Research, Metabolism Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information. Click here to view the NCI collaborative opportunity announcement.
Portfolios: Devices/Instrumentation Devices/Instrumentation - Diagnostics Cancer Cancer - Diagnostics Cancer - Research Materials
For Additional Information Please Contact: Sabarni Chatterjee Ph.D. NIH Office of Technology Transfer 6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States Email: chatterjeesa@mail.nih.gov Phone: 301-435-5587 Fax: 301-402-0220
Description of Invention:
The invention is an ELISA based assay that can be used in the clinical setting to detect the presence of soluble human IL-15 receptor (IL-15R) in the serum or plasma.
Interleukin-15 (IL-15), a cytokine has potential as an immunotherapeutic agent for cancer treatment because it is a critical factor for the proliferation and activation of natural killer (NK) and CD8+ T-cells.
In addition to studies directed toward augmenting IL-15 action to increase patient immune responses to their tumor, IL-15R alpha play a pathogenic role in leukemia and autoimmune disorders. IL-15 and IL-15R alpha are coexpressed in association with a number of autoimmune disorders including rheumatoid arthritis, psoriasis, inflammatory bowel disease, multiple sclerosis, chronic liver disease, and refractory celiac syndrome including that disease associated with the development of enteropathy associated CD8 T-cell lymphoma. An assay for the released serum form of IL-15R alpha is required to evaluate these IL-15R alpha inducing agents.
Applications:
Advantages:
Development Status:
Developed at the proof-of concept level and laboratory setting. Clinical validation of the assay is currently being planned.
Inventors:
Jing Chen (NCI)
Thomas A Waldmann (NCI)
Patent Status:
HHS, Reference No. E-079-2009/0
US, Application No. 61/241,265 filed 10 Sep 2009
US, Application No. 61/242,595 filed 15 Sep 2009
Relevant Publication:
Licensing Status:
Available for licensing.
Collaborative Research Opportunity:
The Center for Cancer Research, Metabolism Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information. Click here to view the NCI collaborative opportunity announcement.
Portfolios:
Devices/Instrumentation
Devices/Instrumentation - Diagnostics
Cancer
Cancer - Diagnostics
Cancer - Research Materials
For Additional Information Please Contact:
Sabarni Chatterjee Ph.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Email: chatterjeesa@mail.nih.gov
Phone: 301-435-5587
Fax: 301-402-0220
Ref No: 2122
Updated: 06/2010