IP Library Granted Patent US 7,297,480
Granted Patent B2
US 7,297,480 · App. 10/184,846 · Granted Nov 20, 2007

Method for detection of melanoma

Assignee: Dermtech International
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Quick Facts
Patent No.
US 7,297,480
App. No.
10/184,846
Granted
Nov 20, 2007
Kind
B2
Abstract

The present invention provides non-invasive methods for detecting, monitoring, staging, and diagnosing malignant melanoma in a skin sample of a subject. The methods include analyzing expression in skin sample of one or more melanoma skin markers. The melanoma skin markers include IL-1 RI, endothelin-2, ephrin-A5, IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (βA subunit), TNF RII, SPC4, and CNTF Rα. The skin sample can include nucleic acids, and can be a human skin sample from a lesion suspected of being melanoma.

Claims (27)

1. A non-invasive method for detecting early stage melanoma in a skin sample of a human subject, the method comprising:

(a) obtaining a skin sample by applying at least one application of an adhesive to the skin of a human subject and removing the adhesive from the skin to remove a skin sample comprising RNA; and

(b) detecting the level of lnterleukin-1 RI (IL-1 RI) RNA in the skin sample, wherein a decrease in the IL-1 RI RNA level, as compared to the RNA level in a control sample, is indicative of early stage melanoma, thereby detecting early stage melanoma in the skin sample.

2. The method of claim 1 , further comprising detecting the RNA levels of endothelin-2 and ephrin-A5, and wherein a wherein a decrease in the level of IL-1 RI RNA, and an increase in the level of endothelin-2 or ephrin-A5 RNA levels, as compared to the RNA levels in a control sample, is indicative of early stage melanoma.

3. The method of claim 1 , further comprising detecting RNA levels of one or more of markers selected from IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (βA subunit), TNF RII, SPC4, and CNTF Rα, wherein an increase in the RNA levels of the one or more markers, as compared to the RNA levels in a control sample, is indicative of melanoma.

4. The method of claim 1 , further comprising detecting RNA levels of the markers IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (βA subunit), TNF RII, SPC4, and CNTF Rα wherein an increase in the RNA levels of these markers, as compared to the RNA levels in a control sample, is indicative of melanoma.

5. The method of claim 1 , wherein the sample is obtained in a manner such that residual skin nucleic acid after removing the adhesive is not affected.

6. The method of claim 1 , wherein the skin sample is isolated by applying the adhesive to the skin between one and two times to obtain the skin sample.

7. The method of claim 1 , wherein the adhesive comprises an adhesive tape and the skin sample is isolated from a lesion suspected to be melanoma.

8. The method of claim 3 , further comprising analyzing expression of one or more of the markers.

9. The method of claim 3 , wherein the RNA comprises mRNA, and expression is analyzed by analyzing mRNA levels of one or more of the markers.

10. The method of claim 8 , wherein expression of the skin markers is analyzed by detecting polynucleotides encoding the markers.

11. The method of claim 3 , wherein the RNA levels of the markers are analyzed by applying the RNA to a microarray.

12. The method of claim 4 , wherein RNA levels of IL-1 RI IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (βA subunit), TNF RII, SPC4, and CNTF Rα are detected in the skin sample, wherein a decrease in the level of IL-1 RI RNA is indicative of early stage melanoma, and an increase in the RNA levels of IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (βA subunit), TNF RII, SPC4, and CNTF Rα, as compared to the RNA levels in a control sample, is indicative of late stage melanoma.

13. A non-invasive method for monitoring the presence of melanoma in a human subject, the method comprising:

(a) obtaining a first skin sample at a first time point by applying at least one application of an adhesive to the skin of a human subject and removing the adhesive from the skin to remove a skin sample comprising RNA;

(b) detecting RNA levels in the first skin sample of the marker lnterleukin-1 RI (IL-1 RI);

(c) obtaining a second skin sample at a second time point by applying at least one application of an adhesive to the skin of said human subject and removing the adhesive from the skin to remove a skin sample comprising RNA;

(d) detecting RNA levels in the second skin sample of the marker IL-1 RI; and

(e) comparing the RNA level of IL-1 RI at the first time point to the RNA level of IL-1 RI at the second time point to thereby monitor the presence of melanoma in the human subject, wherein a decrease in the level of IL-1 RI RNA, as compared to the RNA level in a control sample, is indicative of early stage melanoma.

14. The method of claim 13 , wherein the skin sample is obtained in a manner such that residual skin nucleic acid after removing the adhesive is not affected, thereby obtaining a skin sample for use in isolating or detecting RNA in a skin sample.

15. The method of claim 12 , further comprising detecting the RNA levels of endothelin-2 and ephrin-A5, and wherein a decrease in the level of IL-1 RI RNA and an increase in the RNA levels of endothelin-2 and ephrin-A5, as compared to the RNA levels in a control sample, is indicative of early stage melanoma.

16. The method of claim 12 , further comprising detecting the RNA levels of IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (βA subunit), TNF RII, SPC4, and CNTF Rα, and wherein an increase in the RNA levels of IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (βA subunit), TNF RII, SPC4, and CNTF Rα, as compared to the RNA levels in a control sample, is indicative of late stage melanoma.

17. A non-invasive method for staging melanoma in a skin sample of a human subject, the method comprising:

(a) obtaining a skin sample by applying an adhesive surface to the skin of a human subject and removing the adhesive surface from the skin such that a skin sample comprising RNA in an amount sufficient for subsequent detection adheres to the adhesive surface after its removal; and

(b) detecting the level of Interleukin-1 RI (IL-1 RI) RNA in the skin sample, wherein a decrease in the level of IL-1 RI RNA, as compared to the RNA level in a control sample, is indicative of early stage melanoma.

18. The method of claim 17 , wherein the sample is obtained in a manner such that residual skin nucleic acid after removing the adhesive is not affected, thereby obtaining a skin sample for use in isolating or detecting RNA in a skin sample.

Assignments (4)
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 →
SECURITY AGREEMENT Recorded Feb 20, 2004
From: DERMTECH INTERNATIONAL
To: BROWN FAMILY TRUST; BANDER FAMILY TRUST; FIRST REGIONAL BANK TTEE FBO; GAUGHAN FAMILY TRUST; MEANS FAMILY TRUST; JACQUELINE E. ZINN REVOCABLE TRUST; KRISTEN J. GRAVIN LIVING TRUST; VILLALOBOS, LUIS; ELLIOT FEUERSTEIN TRUSTEE FOR BRETT FEURSTEIN; PROSPERITAS INVESTMENT PARTNERS, LP; DONALD R. SWORTWOOD TRUST; WILLIAM G. CLAPP SEPARATE PROPERTY TRUST; DRAXLER FAMILY TRUST; TODD AND MARI GUTSCHON FAMILY TRUST; ZINN FAMILY TRUST-E; MEACHAM 1985 INSURANCE TRUST; GEORGE, MICHAEL W.; FEUERSTEIN, ELLIOT; ELLIOT FEUERSTEIN TRUSTEE FOR MICHAEL FEUERSTEIN; ANCHORAGE ANGELS LP; LETITIA H. SWORTHWOOD REVOCABLE TRUST
Reel/Frame 015001/0841 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 5, 2003
From: VOGT, THOMAS
To: DERMTECH INTERNATIONAL
Reel/Frame 014147/0413 →
Continuity (2)
Provisional Application 6030234800 · Jun 28, 2001
Related Publication 20030108896A1 · Jun 12, 2003