Immune Profiling Technology for Assessing Immune Status in Cancer (Case 2073)

Principal Investigators:


Karl Kelsey, MD, Professor

Department of Public Health-Epidemiology

Brown University

Providence, RI


John Wiencke, PhD, Professor

University of California, San Francisco

San Francisco, CA


Brief Description:


Immune profiling to rapidly and accurately indicate presence or absence of disease and stage has been fraught with challenges and shortcomings. It is often laborious, expensive, not easily scalable or standardized, time-consuming, requires large blood sample volumes with extensive, specific and stringent processing protocols, and has inherent histological limitations.


Quantifying the principal immune cells with accuracy/precision and without laborious processing and handling, is desirable but has not been achieved due to the absence of biomarkers. Therefore, an approach is needed that allows for simultaneous quantification of the origin of individual cell types in mixtures, using an array of biomarkers, especially in studies of human disease and exposure.


The invention is an immunodiagnostic method using DNA methylation arrays as surrogate measures for cell or cell population identity, to determine changes in immune cell distribution (cell numbers and ratios). Measurement is based on the differential DNA methylation of genes that are differentially expressed. The method includes the mathematical treatment of DNA methylation data to control bias.


Diverse biological media (blood, urine, tumor, biopsy, CNS fluid) can be analyzed without the need for viable, stable cells, cell sorting, or the use of any antibodies or protein markers.


This invention can be incorporated in diagnostic laboratory procedures, a diagnostic kit or platform for human or animal use in the prognosis or diagnosis cancer, inflammatory, autoimmune or infectious diseases, among many other pathogenic states or disorders that affect an immune or cellular response.




US patent application 14/089,398 is pending

US patent application 15/271,909 is pending

Corresponding foreign applications are pending

Patent Information:
For Information, Contact:
Margaret Shabashevich,
Manager of Operations
Office of Industry Engagement & Commercial Venturing
Brown University
Karl Kelsey
William Accomando
E. Andrés Houseman
John Wiencke
Carmen Marsit
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