IP Library Granted Patent US 9,057,109
Granted Patent B2
US 9,057,109 · App. 14/199,900 · Granted Jun 16, 2015

Diagnosis of melanoma and solar lentigo by nucleic acid analysis

Inventor: Sherman H. Chang (San Diego, CA)
Assignee: DERMTECH INTERNATIONAL
C12Q1/6886C12Q1/68C12Q2600/112C12Q2600/158C12Q2600/178
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Quick Facts
Patent No.
US 9,057,109
App. No.
14/199,900
Granted
Jun 16, 2015
Kind
B2
Abstract

The present invention provides methods for diagnosing melanoma and/or solar lentigo in a subject by analyzing nucleic acid molecules obtained from the subject. The present invention also provides methods for distinguishing melanoma from solar lentigo and/or dysplastic nevi and/or normal pigmented skin. The methods include analyzing expression or mutations in epidermal samples, of one or more skin markers. The methods can include the use of a microarray to analyze gene or protein profiles from a sample.

Claims (24)

1. A method of detecting melanoma in a human subject comprising:

(a) obtaining a sample of a skin lesion suspected of comprising melanoma from a human subject, wherein the skin lesion sample comprises or is suspected of comprising a nucleic acid molecule expressed from C6orf218;

(b) detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample, whereby the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample in an amount that is greater than the presence of C6orf218 in a non-melanoma sample is indicative of melanoma in the skin lesion sample, wherein detecting the presence of a nucleic acid molecule expressed from C6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218; and

(c) characterizing the skin lesion as having melanoma or not having melanoma.

2. The method of claim 1 , wherein the nucleic acid molecule is RNA.

3. The method of claim 1 , further comprising amplifying the nucleic acid molecule.

4. The method of claim 1 , wherein the nucleic acid molecule or an amplification product thereof, is quantified using quantitative real-time PCR.

5. The method of claim 1 , further comprising amplifying the nucleic acid molecule and quantifying the amplification product using quantitative real-time PCR.

6. The method of claim 1 , wherein the skin lesion sample is obtained by applying an adhesive tape to a target area of skin in a manner sufficient to isolate the skin lesion sample adhering to the adhesive tape.

7. The method of claim 1 , wherein the skin lesion sample is obtained from a biopsy taken at the site of the skin lesion.

8. The method of claim 6 , wherein the tape comprises a rubber adhesive on a polyurethane film.

9. The method of claim 6 , wherein about one to ten adhesive tapes or one to ten applications of a tape are applied and removed from the skin.

10. The method of claim 6 , wherein about one to eight adhesive tapes or one to eight applications of a tape are applied and removed from the skin.

11. The method of claim 6 , wherein about one to five adhesive tapes or one to five applications of a tape are applied and removed from the skin.

12. The method of claim 6 , wherein the method further comprises taking a biopsy of the target area of the skin.

13. The method of claim 1 , wherein the detecting is performed in situ.

14. The method of claim 1 , further comprising determining a treatment regimen.

15. A method for diagnosing melanoma in a subject, comprising:

(a) obtaining a sample of a skin lesion suspected of comprising melanoma from a subject, wherein the skin lesion sample comprises or is suspected of comprising a nucleic acid molecule expressed from C6orf218;

(b) detecting the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample, wherein detecting the presence of a nucleic acid molecule expressed from C6orf218 is by application of a detectably labeled probe that hybridizes to a nucleic acid molecule expressed from C6orf218; and

(c) comparing the presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample to the presence of C6orf218 in a non-melanoma sample, whereby the increased presence of a nucleic acid molecule expressed from C6orf218 in the skin lesion sample as compared to the non-melanoma sample is indicative of melanoma, thereby diagnosing the skin lesion as having melanoma.

16. The method of claim 15 , further comprising determining a treatment regimen.

17. The method of claim 15 , wherein the presence of a nucleic acid molecule expressed from C6orf218 in the non-melanoma skin sample is contained with a database.

18. The method of claim 15 , wherein the analyzing step is carried out using a computer.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 23, 2024
From: DERMTECH, INC.; DERMTECH OPERATIONS, INC.
To: DERM – JES HOLDINGS, LLC
Reel/Frame 069231/0065 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 23, 2024
From: DERM – JES HOLDINGS LLC
To: DERMTECH, LLC
Reel/Frame 069231/0216 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2014
From: CHANG, SHERMAN H.
To: DERMTECH INTERNATIONAL
Reel/Frame 032824/0491 →
Continuity (6)
Continuation 14172784 · Feb 4, 2014
Continuation 12991685
Provisional Application 61058149 · Jun 2, 2008
Provisional Application 61053988 · May 16, 2008
Provisional Application 61127731 · May 14, 2008
Related Publication 20140256584A1 · Sep 11, 2014