# US 6,720,145 B2 · Method for detection of biological factors in epidermis

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- Number: US 6,720,145 B2
- Document ID: US6720145B2
- Status: Granted
- Kind: B2
- Application number: 09/967,658
- Filed: 2001-09-28
- Published: 2002-08-15
- Granted: 2004-04-13
- Earliest claimed: 1998-08-18
- Assignees: DermTech International
- Inventors: Lawrence A. Rheins; Vera B. Morhenn
- Web page: https://patentgrep.com/patent/US6720145B2

## CPC

- C12Q 1/6806: Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence)
- A61K 49/0006: {Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity}
- C12Q 1/6883: for diseases caused by alterations of genetic material
- 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
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Disclosed is a method for removing polynucleotide from the skin. This polynucleotide can be used to detect dermatitis and distinguish an irritant reaction from an allergic reaction by characterizing the polynucleotide according to the polypeptide which it encodes. Additionally, provided are methods for non-invasive isolation of samples from the skin as well as kits for use in the methods provided herein.

## Claims

### Claim 1

A method of distinguishing an irritant contact dermatitis (ICD) from an allergic contact dermatitis (ACD) in human subject, comprising determining the quantity of IL-4 and IL-8 mRNA in skin cells from below the stratum corneum at 48 and 72 hours following contact with an agent, wherein an increase in the level of IL-4 relative to a control sample is indicative of ACD and wherein an increase in the level of IL-8 mRNA relative to a control sample is indicative of ICD.

### Claim 2 (depends on 1)

The method of claim 1, wherein the stratum corneum is removed before determining the quantity of IL-4 and IL-8, using procedures selected from the group consisting of:
a) abrading the stratum corneum; and
b) contacting the stratum corneum with an adhesive surface.

### Claim 3 (depends on 1)

The method of claim 1, wherein the quantity of IL-4 and IL-8 mRNA is determined in a polynucleotide sample collected from a surface exposed after removal of the stratum corneum using a procedure selected from the group consisting of:
a) scraping the surface exposed with a rigid surface; and
b) contacting the surface exposed with an adhesive surface.

### Claim 4 (depends on 3)

The method of claim 3, wherein the adhesive surface comprises adhesive tape.