The sub-analysis came from the company’s DERM-SUCCESS study, which previously demonstrated positive results. It focused on the company’s handheld elastic scattering spectroscopy (ESS) device performance across Fitzpatrick skin types. This skin tone scale classifies skin coloring and response to ultraviolet radiation.
Miami, Florida-based DermaSensor’s handheld device uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.
In the study, DermaSensor’s ESS device demonstrated high sensitivity — 96% — in detecting all skin cancer types. The company said it compared its device performance to histopathologic examination, the gold standard. It demonstrated similar sensitivity and specificity across Fitzpatrick skin type subgroups as well.
“Our mission at DermaSensor has always been to provide access to tools to aid in skin cancer evaluations”, said Cody Simmons, DermaSensor CEO. “The results from the DERM-SUCCESS study suggest that our ESS technology performs comparably regardless of skin type, which could improve providers’ ability to assess lesions on all patients and thus increase equitable access to effective skin cancer exams.”
More details from the DermaSensor sub-analysis
The sub-analysis divided patients into two groups based on Fitzpatrick skin types (FST) — FST I-III and FST IV-VI. These fall in line with previous studies defining skin color, DermaSensor said.
Of the 1,005 patients enrolled, 729 (72%) belonged to the FST I-III group. The remaining 276 (28%) belonged to the FST IV-VI group. The device detected 48 skin cancers in subjects in the latter group.
Importantly, DermaSensor said, the study observed minimal variation in device sensitivity, specificity and Area under the Receiver Operating Characteristic Curve (AUROC) when comparing patients in the two subgroups to each other and the overall study results.
Device sensitivity came in at 96% and 92% for the FST I-III and IV-VI groups, respectively. AUROC results proved similar, too, at 0.779 for FST I-III and 0.764 for FST IV-VI.
“The findings of this sub-analysis are highly encouraging as they suggest that DermaSensor’s ESS device performance is not significantly impacted by underlying melanin content and can be a valuable tool in detecting skin cancer across different skin types, including patients with skin of color,” said Dr. David J. Leffell, professor of dermatology, plastic surgery and otolaryngology and chief of the Dermatologic Surgery Program at the Yale School of Medicine.
Leffell also serves on the Scientific Advisory Board of DermaSensor.