# US 11,111,537 B2 · Methods of detecting autoimmune or immune-related diseases or conditions

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- Number: US 11,111,537 B2
- Document ID: US11111537B2
- Status: Granted
- Kind: B2
- Application number: 15/014,476
- Filed: 2016-02-03
- Published: 2016-06-02
- Granted: 2021-09-07
- Earliest claimed: 2010-07-23
- Assignees: President and Fellows of Harvard College
- Applicants: President and Fellows of Harvard College
- Inventors: Amin I. Kassis
- Web page: https://patentgrep.com/patent/US11111537B2

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 1/02: involving viable microorganisms
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/136: Screening for pharmacological compounds
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q 2600/158: Expression markers
- C12Q 2600/16: Primer sets for multiplex assays
- C12Q 2600/178: miRNA, siRNA or ncRNA
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- G01N 2500/10: involving cells
- G01N 2800/24: Immunology or allergic disorders
- G01N 2800/50: Determining the risk of developing a disease
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

This invention provides methods of using phagocytic cells alone or in combination with non-phagocytic cells in the diagnosis, prognosis, or monitoring of autoimmune or immune-related diseases or conditions. The invention also provides methods of using phagocytic cells alone or in combination with non-phagocytic cells to identify markers of autoimmune or immune-related diseases or conditions.

## Claims

### Claim 1

An assay for detecting a marker of an autoimmune or immune-related disease or condition in a human subject, wherein the autoimmune or immune-related disease or condition is multiple sclerosis or inflammatory bowel disease, the assay comprising:
a) obtaining a macrophage having a DNA content of more than 2n (>2n macrophage cell) from the blood of the human subject, wherein the >2n macrophage has been separated from phagocytic cells having a DNA content of 2n (=2n phagocytic cells), and detecting a first gene expression profile of the marker of an autoimmune or immune-related disease or condition; and
b) obtaining a non-phagocytic cell from the blood of the human subject and detecting a second gene expression profile of the marker of an autoimmune or immune-related disease or condition in the obtained non-phagocytic cell.

### Claim 2 (depends on 1)

The assay of claim 1, further comprising lysing the >2n macrophage and the non-phagocytic cell before performing the detecting.

### Claim 3 (depends on 1)

The assay of claim 1, further comprising extracting cellular contents from the >2n macrophage and the non-phagocytic cell before performing the detecting.

### Claim 4 (depends on 3)

The assay of claim 3, wherein the cellular contents of the >2n macrophage comprises viable diseased cells, dead diseased cells, apoptotic diseased cells, circulating tumor cells, infectious agents, fetal cells, trophoblasts, or fragments thereof.

### Claim 5 (depends on 1)

The assay of claim 1, wherein the >2n macrophage and the non-phagocytic cell are obtained from a bodily fluid sample, tissues, or cells of the subject.