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CMCC 1609

Method to quantify high affinity lgE receptor alpha chain to monitor allergic diseases

Inventors: Wayne Lencer, Edda Fiebiger

Invention Types: Diagnostic/Prognostic

Research Areas: Allergy/Respiratory/Pulmonary Disease, Gastrointestinal/Nutrition, Inflammation

Keywords: Assay, Biomarker, Large Molecule, Receptor/Ligand

For More Information Contact:  Herrera Gutierrez, Aida


Invention Description:

The soluble form of the Fc-Epsilon-Receptor-1 (sFc-Epsilon-R1) could be an early biomarker of allergic reaction. sFc-Epsilon-R1 is secreted into the blood only after IgE-Antigen mediated receptor activation. Detection of this marker in blood a non-invasive approach to diagnosis of allergic disease.

The group has screened a cohort of 103 patients with normal and elevated IgE levels. using a semi-quantitative assay, those with normal IgE levels were shown to have higher levels of sFc-Epsilon-R1 than those with elevated IgE. In the elevated IgE group(=allerigcs) the sFc-Epsilon-R1 correlated with serum IgE levels. A fully quantitative assay using are recombinant standard protein is in development.


Diagnosing, monitoring and treating IgE-mediated disorders: Since sF-Epsilon-RI is released only upon IgE-antigen-mediated receptor cross-linking, it is a novel biomarker for allergic activation such as: allergy, allergic asthma, atopic dermatitis, hypersensitivity, eczema, urticaria, eosinophilic esophagitis, eosinophilic gastroenteritis, and hyper-IgE syndrome as well as other IgE-mediated allergic indications.

Competitive Advantages:

Currently, there are several major techniques used in the diagnosis of allergic disease, including skin tests, assays of IgE serum levels, and histamine release tests. Skin tests are the primary diagnostic tool in allergy since their introduction in 1865, but these tests are plagued by both false positive and false negative results. When assessing children or adults for the presence of allergic (atopic) disease by serum IgE, a raised level of IgE aids the diagnosis, although a normal total IgE level does not exclude an allergic condition or tendency. Thus because there is not absolute correlate with allergy, the current diagnostics can often be unhelpful.

Because the sFc-Epsilon-R1 is found in blood, diagnosis and treatment monitoring for conditions such as eosinophilic esophagitis (annual incidence similar to that of Crohn disease, about 12.9 in 100,000 people), may be done by a simple blood test rather than invasive upper GI biopsy.

Business Opportunity:

Exclusive License and Collaboration to create diagnostic kit

Key Publications: Dehlink E, et al. A soluble form of the high affinity IgE receptor, Fc-epsilon-RI, circulates in human serum. PLoS One. 2011 Apr 22;6(4):e19098.

MoƱino-Romero S, et al. The soluble isoform of human Fc-epsilon-RI is an endogenous inhibitor of IgE-mediated mast cell responses. Allergy. 2018 Jul 21. [Epub ahead of print]

IPStatus: Pat. Pend.