Page 39 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

method may be a helpful diagnostic tool when used in conjunction with ABCDE guidelines.
DermTech International (www.dermtech.com) developed and patented the commercialized form
of this technology. DermTech’s Epidermal Genetic Information Retrieval (EGIR TM ) utilizes a
custom adhesive film to collect surface skin samples. EGIR TM is reported to be quick and
painless and can be applied to virtually any skin surface. To help increase diagnostic accuracy,
EGIR TM allows for re-testing of lesions. In a 2011 study by Wachsman, reporting on the testing
with an independent dataset, this classifier discerned in situ and invasive melanomas from naevi
with 100-percent sensitivity and 88-percent specificity, with an area under the curve for the
receiver operating characteristic of 0·955. 133
A recent search on the ClinicalTrials.gov Web site (accessed November 3, 2010) identified
one non-randomized study, sponsored by DermTech International, assessing tape stripping for
diagnosis of early stage melanoma. This study has been terminated (withdrawn per sponsor and
investigator), and results have not been posted (see Appendix C, Table C2). No information was
found on the FDA clearance status for the devices of this type on the FDA CDRH database.

Thermography
Dermatologic use of thermography involves measuring and mapping surface skin
temperature through direct contact (via application of liquid crystal plates to a part of the body)
or at a distance (utilizing a highly-sensitive medical infrared camera and sophisticated computer
interface). A single narrative review 134 published in 1995 from the San Gallicano Dermatological
Institute for Research and Care in Italy assessed thermography and its potential application in
clinical and experimental dermatology. Among the topics reviewed was the clinical use of
thermography as a diagnostic tool for cutaneous melanoma. The review reports that due to high
percentages of false-negative results from studies in the 1980s, 135,136 the use of thermography as
a stand-alone diagnostic tool for melanoma has diminished. However, thermography used in
conjunction with thermostimulation (application of thermal stress on the skin to be examined)
has allowed for better differentiation of melanoma from other types of pigmented lesions. A
recent search of the ClinicalTrials.gov Web site (accessed 11-3-2010) identified one trial
studying the application of infrared thermography to find skin lesions in patients with Kaposi’s
sarcoma—a topic outside the scope of this technical brief. No information was found on the FDA
clearance status for the devices of this type on the FDA CDRH database.

Multispectral Imaging and Fully Automated Computer-Based Analysis
A fully automated device that has been reported in the literature is a device that captures
multispectral images of a pigmented lesion in 10 bands, from blue to near infrared (MelaFind ,
MELA Sciences Inc, Irvington, New York). It uses automated image analysis and statistical
pattern recognition to help identify lesions that should be considered for biopsy. This multi-
spectral imaging system shows quantitative and more objective results compared with
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conventional dermoscopic analysis, which is qualitative and potentially subjective. Diagnostic
performance in a prospective, multicenter study of patients with at least one pigmented lesion
scheduled for biopsy was recently reported. 137 This device is currently undergoing an FDA
Premarket Approval review for use by dermatologists.

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