Diagnostic Support Tool Improves Melanoma Detection

A new point-of-care (POC) device helps detect malignant melanoma by gathering and analyzing precise electrical measurements in the skin.

The SciBase (Sundbyberg, Sweden) Nevisense device uses electrical impedance spectroscopy (EIS) to extract multi-depth spectra that reflect changes in cellular structure, cellular orientation, and cell sizes. Non-invasive electrodes apply an discreet alternating potential between the bars on the tip of the probe; in order to completely cover the lesion, the measurements are performed in 10 permutations covering both shallow measurements between neighboring electrode bars, as well as deeper measurements between more distant electrode bars.

The EIS measurements at low frequencies are affected by the extracellular environment, whereas both the intra- and extracellular environments affect measurements at higher frequencies. Within seconds, an advanced algorithm classifies the lesion based on measurement data. The results are analyzed and displayed on the Nevisense screen as an EIS score output reflecting the degree of atypia identified. The result is combined with a visual inspection by a medical professional trained in the clinical diagnosis of skin cancer, and is intended for documentation and not for diagnostic purposes.

In studies to evaluate the differences between practicing dermatologists, physician's assistants, nurses and residents, all clinicians evaluated lesions using visual evaluation only, and then added the Nevisense information. In over 25,000 evaluations, the number of missed melanomas fell from 7% to less than one percent. Overall sensitivity increased on average by 14%, and specificity by 10.2%. In all, clinicians identified 1,343 more melanomas with Nevisense compared to visual evaluation alone.

“Clinicians face difficult decisions every day when they evaluate moles, so it was very positive to see that Nevisense could so significantly improve their accuracy. Nevisense was able to help clinicians of all levels of experience, and especially those who were most in need of support,” said Simon Grant, CEO of SciBase. “This is further proof of the potential for Nevisense to improve the standard of care of melanoma detection in the United States and will provide timely support to our ongoing reimbursement process.”

Melanoma, an aggressive form of skin cancer, is most often considered fatal once the cells (cutaneous, mucosal, or ocular) convert to metastatic melanoma (also known as stage IV melanoma) and spread through the lymph nodes to distant sites in the body and/or to the body's organs such as the liver, lungs, bones, and brain. Once it becomes metastatic it is usually not amenable to surgical treatment.

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