US2020383665A1PendingUtilityA1

Non-invasive skin collection system

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Assignee: DERMTECH INCPriority: May 1, 2015Filed: Aug 25, 2020Published: Dec 10, 2020
Est. expiryMay 1, 2035(~8.8 yrs left)· nominal 20-yr term from priority
A61B 10/00A61B 2017/00761A61B 2017/00774A61B 10/0096A61B 2050/3015A61B 2050/0065A61B 2010/0225A61B 10/02A61B 50/30A61B 2017/00951
66
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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
What is claimed is: 
     
         1 . A method for non-invasive collection and analysis of a skin sample using an adhesive skin sample collection kit, the method comprising:
 receiving the adhesive skin sample collection kit, wherein the adhesive skin sample collection kit comprises a skin sample adhered to an adhesive matrix; and   quantifying the expression levels of one or more target genes in a portion of the skin sample, wherein the portion of the skin sample comprises less than about 6 milligrams of cellular material.   
     
     
         2 . The method of  claim 1 , where the portion of the skin sample comprises less than about 500 micrograms of cellular material. 
     
     
         3 . The method of  claim 1 , where the adhesive matrix comprises a plurality of adhesive tapes. 
     
     
         4 . The method of  claim 3 , where the skin sample comprises 1 picogram to 500 micrograms of cellular material per adhesive tape. 
     
     
         5 . The method of  claim 1 , wherein the sample collection kit comprises a tri-fold skin sample collector. 
     
     
         6 . The method of  claim 5 , wherein the tri-fold skin sample collector comprises an area for labeling patient information, wherein the patent information comprises identification of a disease state, likelihood of treatment success for a given disease state, identification of progression of a disease state, or identification of a disease stage. 
     
     
         7 . The method of  claim 1 , wherein the adhesive skin sample collection kit comprises a lab requisition form, and wherein the lab requisition form is labeled with a unique barcode assigned to a patient sample. 
     
     
         8 . A method for non-invasive collection and analysis of a skin sample using an adhesive skin sample collection kit, the method comprising:
 receiving the adhesive skin sample collection kit comprising a sample of skin adhered to an adhesive matrix,   extracting nucleic acids from at least a portion of the sample of skin adhered to the adhesive matrix, wherein the nucleic acids are present in an amount of less than about 500 micrograms; and   quantifying the expression levels of one or more target genes in the portion of the sample.   
     
     
         9 . The method of  claim 8 , wherein the nucleic acids are present in an amount of less than about 15 micrograms. 
     
     
         10 . The method of  claim 8 , wherein the nucleic acids are present in an amount of about 1 picogram to about 500 micrograms. 
     
     
         11 . The method of  claim 8 , wherein the method further comprises amplifying the nucleic acids. 
     
     
         12 . The method of  claim 8 , wherein the portion of the skin sample to be extracted is demarcated. 
     
     
         13 . The method of  claim 8 , wherein quantifying comprises use of a pigmented lesion assay. 
     
     
         14 . A method for non-invasive collection and analysis of a skin sample using an adhesive skin sample collection kit, the method comprising:
 receiving the adhesive skin sample collection kit comprising one or more adhesive tapes, wherein each tape comprises at least one collection area having an adhesive layer configured to collect about 1 picogram to about 15 micrograms of cellular material per square millimeter of the adhesive layer, when applied to and subsequently peeled from skin of a subject, and quantifying the expression levels of one or more target genes in the cellular material.   
     
     
         15 . The method of  claim 14 , wherein the longest dimension of the at least one collection area is about 5 millimeters to about 100 millimeters. 
     
     
         16 . The method of  claim 14 , wherein the area of the at least one collection area is about 20 square millimeters to about 8000 square millimeters. 
     
     
         17 . The method of  claim 14 , wherein the at least one collection area has a circular or elliptical shape. 
     
     
         18 . The method of  claim 14 , wherein the adhesive layer comprises an adhesive matrix comprising a synthetic rubber compound. 
     
     
         19 . The method of  claim 14 , wherein the adhesive skin sample collection kit comprises 1 to about 8 tapes. 
     
     
         20 . The method of  claim 14 , wherein the at least one collection area is configured to collect about 1 picogram to about 1 gram of cellular material.

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