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Reader study presentation v1
- 1. © 2014 DermTech International - All Rights Reserved.
Pigmented Lesion Assay
Introduction for 13-04 Study Participants
- 2. © 2014 DermTech International - All Rights Reserved.
Overview
Thank you for participating in DermTech’s Reader Study 13-
04. In Round A, you were asked to evaluate pigmented
lesions suspicious of melanoma based on patient
information and patient images only. In Round B, you will in
addition to patient information and images also have
access to DermTech’s non-invasive gene expression
Pigmented Lesion Assay (PLA) to help guide your decisions.
The PLA can help transform dermatologic diagnosis from a
visual, subjective process, to one that is objective,
biologically based, and highly accurate. The next slides will
familiarize you with the PLA’s non-invasive sample
collection and performance.
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- 3. © 2014 DermTech International - All Rights Reserved.
Adhesive Patch - Non Invasive Biopsy
Adhesive Patch
Sample Collection
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Biological material of pigmented lesions is collected
non-invasively via adhesive patches.
Collected samples are shipped to DermTech by
standard courier at ambient temperature.
- 4. © 2014 DermTech International - All Rights Reserved.
Transformation of Dermatologic Diagnosis
Current Diagnosis
Pattern recognition
Subjective
Prone to error
Non-melanoma Melanoma
Future Diagnosis
Gene expression/
Tumor Biology
Objective
Highly accurate
Non-melanoma Melanoma
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Non-invasively harvested samples processed in DermTech’s
CLIA laboratory via optimized qPCR – based 2-gene PLA
meet the desired characteristics outlined above.
- 5. © 2014 DermTech International - All Rights Reserved.
PLA Non-Melanoma / Melanoma Differentiation
p<<0.0001
Non-Melanoma Melanoma in situ Invasive Melanoma
0.2
0.4
0.6
0.8
1.0
5
p<0.0001
- 6. © 2014 DermTech International - All Rights Reserved.
Contribution of Gene Targets to the PLA
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Gene 1 : Elevated in Nevi relative to Melanoma
Gene 2: Reduced in Nevi relative to Melanoma
- 7. © 2014 DermTech International - All Rights Reserved.
PLA Performance
Dermatologist
Visual
Assessment
Diagnostic Aids
(e.g. Mela, SciBase)
DermTech
PLA
Pathology
(Current Standard)
Mechanism Pattern
Recognition
Pattern
Recognition
Tumor
Biology
Pattern
Recognition
Platform Tech No No Yes N/A
Complete solution No No Yes Yes
Physician Payment Yes No Yes Yes
Better Performance
NPV 80% 95-97% >99% >99%
Biopsy Ratio 12.5:1 10:1 3:1 N/A
Sensitivity 70% 90-97% 93% ≥90%
Specificity 5-10% 10-20% 90% ≥90%
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