# US 8,465,923 B2 · Markers for diagnosis of pulmonary inflammation and methods related thereto

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- Number: US 8,465,923 B2
- Document ID: US8465923B2
- Status: Granted
- Kind: B2
- Application number: 13/328,886
- Filed: 2011-12-16
- Published: 2012-06-14
- Granted: 2013-06-18
- Earliest claimed: 2008-03-10
- Assignees: National Jewish Health
- Applicants: Milene Saavedra; Jerry Nick
- Inventors: Milene Saavedra; Jerry Nick
- Web page: https://patentgrep.com/patent/US8465923B2

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/136: Screening for pharmacological compounds
- C12Q 2600/158: Expression markers
- 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

## Abstract

The present invention is related to the novel discovery of a number of genes that were identified as systemic markers of pulmonary inflammation. This discovery allows for development of a novel tool for reliable, rapid and efficient assessment of therapeutic responses and enables design of novel therapies targeted against diseases associated with pulmonary inflammation. In one embodiment, the present invention allows quantification of therapeutic response in patients who have a disease associated with pulmonary inflammation. In preferred embodiments, the genes are CD64, ADAM9, CD36, IL32, HPSE, PLXND1, HCA 112, CSPG2, TLR2, and CD163.

## Claims

### Claim 1

A method to assess response to antibiotic treatment of acute pulmonary exacerbation in a human subject having cystic fibrosis comprising:
a) detecting the level of mRNA expression of CD64, IL32, PLXND1, HCA112, TLR2, and CD163 genes in a blood sample taken from the subject before an antibiotic treatment is administered to the subject;
b) detecting the level of mRNA expression of CD64, IL32, PLXND1, HCA112, TLR2, and CD163 genes in a blood sample taken from the subject after an antibiotic treatment has been administered to the subject;
c) comparing the level of the mRNA expression of the genes from step (a) in the sample taken from the subject before administering the treatment to the mRNA level of the expression of the genes from step (b) in the sample taken from the subject after administering the treatment; and
d) predicting that the subject will respond to the antibiotic treatment if there is a difference in the mRNA expression levels of CD64, PLXND1, HCA112, TLR2, CD163 and IL32 genes from step (a) compared to the mRNA expression levels of the same genes from step (b).

### Claim 2 (depends on 1)

The method of claim 1, further comprising the step of measuring FEV1 in the subject before and after administering the treatment.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sample comprises one or more cells selected from the group consisting of: leukocytes, lymphocytes, monocytes, basophils, and eosinophils.