US2020289099A1PendingUtilityA1

Non-invasive skin collection system

65
Assignee: DERMTECH INCPriority: May 1, 2015Filed: May 28, 2020Published: Sep 17, 2020
Est. expiryMay 1, 2035(~8.8 yrs left)· nominal 20-yr term from priority
A61B 2010/0225A61B 10/02A61B 10/0096A61B 2017/00774A61B 2017/00951A61B 10/00A61B 50/30A61B 2017/00761A61B 2050/0065A61B 2050/3015
65
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Claims

Abstract

The subject matter described herein provides non-invasive tape stripping methods for the collection of a skin sample. The tape stripping method includes applying and removing at least one adhesive tape, provided that a skin sample is adhered to the adhesive tape after removal. The at least one adhesive tape is supplied in an adhesive skin sample collection kit. The adhesive skin sample collection kit further comprises a sample collector and instructions for use sheet.

Claims

exact text as granted — not AI-modified
1 - 37 . (canceled) 
     
     
         38 . A method for non-invasive collection and analysis of a skin sample, the method comprising:
 providing an adhesive skin sample collection kit comprising at least one adhesive tape, wherein the adhesive tape comprises a collection area comprising an adhesive matrix on a first surface of the collection area and a handling region;   subsequently receiving the adhesive skin sample collection kit comprising a skin sample adhered to the adhesive matrix, wherein the collection area comprises a demarcation indicative of a region to be processed; and   quantifying expression levels of one or more target genes in the skin sample.   
     
     
         39 . The method of  claim 38 , wherein the demarcation is representative of an outline of a skin lesion. 
     
     
         40 . The method of  claim 38 , wherein the demarcation comprises marker on a second surface of the collection area. 
     
     
         41 . The method of  claim 38 , wherein the handling region comprises a tab for avoiding unnecessary contact with the matrix material of the first collection area when handling the adhesive tape. 
     
     
         42 . The method of  claim 38 , wherein the handling region extends from the periphery of the collection area. 
     
     
         43 . The method of  claim 38 , wherein the collection area comprises a transparent material. 
     
     
         44 . The method of  claim 38 , wherein the adhesive skin sample collection kit comprises a plurality of adhesive tapes. 
     
     
         45 . The method of  claim 38 , wherein the adhesive skin sample collection kit indicates an identity of a patient from which the skin sample is collected. 
     
     
         46 . The method of  claim 45 , wherein the identity is indicated by a barcode. 
     
     
         47 . The method of  claim 45 , wherein the identity is indicated by printed patient information. 
     
     
         48 . The method of  claim 38 , wherein the skin sample comprises from about 1 picogram to about 1 gram of cellular material. 
     
     
         49 . The method of  claim 38 , wherein the skin sample comprises from about 100 picograms to about 500 micrograms of cellular material. 
     
     
         50 . The method of  claim 38 , wherein the skin sample comprises from about 750 picograms to about 1 microgram of cellular material. 
     
     
         51 . The method of  claim 38 , wherein the skin sample comprises from about 1 nanogram to about 500 nanograms of cellular material. 
     
     
         52 . The method of  claim 48 , wherein the cellular material comprises RNA or DNA. 
     
     
         53 . The method of  claim 38 , further comprising deriving information related to a disease comprising an inflammatory dermatosis, a bullous disease, an infection, or a cancer, wherein the deriving is based on the quantified expression levels of the one or more target genes. 
     
     
         54 . The method of  claim 53 , further comprising electronically transmitting the information related to the disease from a diagnostic lab. 
     
     
         55 . The method of  claim 53 , wherein the information related to the disease comprises an identification of a disease state, a likelihood of treatment success for a disease state, an identification of progression of a disease state, or an identification of a disease stage. 
     
     
         56 . A system for non-invasive collection and analysis of a skin sample, the system comprising:
 an adhesive skin sample collection kit comprising at least one adhesive tape, wherein the at least one adhesive tape comprises a handling region and a collection area comprising an adhesive matrix on a first surface of the collection area, wherein the collection area comprises a demarcation indicative of a region to be processed, and wherein the adhesive matrix is configured to adhere to an effective amount of a skin sample for quantifying expression levels of one or more target genes in the skin sample.   
     
     
         57 . The system of  claim 56 , wherein the demarcation is representative of an outline of a skin lesion. 
     
     
         58 . The system of  claim 56 , wherein the demarcation comprises marker on a second surface of the collection area. 
     
     
         59 . The system of  claim 56 , wherein adhesive skin sample collection kit indicates the identity of a patient from which the skin sample is collected. 
     
     
         60 . The system of  claim 56 , wherein the effective amount of the skin sample comprises from 1 picogram to about 1 gram of cellular material.

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