Nevisense

Nevisense is a novel non-visual tool, designed to provide additional information to dermatologists to detect cutaneous melanoma during skin examinations. It works by utilizing Electrical Impedance Spectroscopy (EIS), applied as an electrical signal to the skin. Using this technology, Nevisense is able to provide additional objective analysis of suspicious lesions, complementing the physician’s routine clinical and dermoscopy evaluation. In studies evaluating Nevisense, the skin is moistened for 30 seconds prior to taking measurements. The applied voltage and resulting current is limited to 150 mV and 75 μA, respectively, and is not sensed by the patient. Measurements take approximately 8 seconds, and the system computes both a numerical score (0–10) and a dichotomous output (EIS negative/positive) at a fixed cut-off. To demonstrate the sensitivity and specificity end points of this novel tool, the fixed cut off was set at 4 to yield a dichotomous output.

Nevisense is designed for use on primary skin lesions on intact skin (i.e. non-ulcerated or non-bleeding lesions) with a diameter between 2 mm and 20 mm. It may not be accurate in lesions containing a scar or fibrosis, or in lesions with previous trauma. Lesions with surrounding inflammation such as those located in areas of psoriasis, eczema, acute sunburn, or similar skin conditions may not be accurately evaluated by this technology. Other limitations include: lesions in hair-covered areas like the scalp, lesions which contain foreign matter, and lesions on special anatomic sites (i.e. acral skin, genitalia, eyes, concha of the ear, under nails and mucosal areas).

Approvals:

  • Nevisense is commercially available in Belgium, Great Britain, Germany, Australia and Nordic markets.
  • Nevisense is now commercially available in Belgium, Great Britain, Germany, Australia and Nordic markets.
  • Rest of Europe launches planned throughout 2015, per company website.
  • Nevisense is not currently approved by FDA for use in the USA.

Data:

A multicenter, prospective, blinded clinical study funded by SciBase was conducted at five American and 17 European investigational sites, and published in 2014 in the British Journal of Dermatology. All eligible skin lesions in the study were examined with the EIS-based Nevisense system, photographed, and followed by excisional biopsy and histopathological evaluation. A total of 1943 lesions were analyzed, including 265 melanomas – 112 in situ and 153 invasive melanomas with a median Breslow depth of 0.57 mm. Additionally, 48 basal cell carcinomas (BCCs) and seven squamous cell carcinomas (SCCs) were examined.

The sensitivity of Nevisense to detect melanoma was 96.6% (256 of 265 melanomas) [95% CI at 93.7-98.4%] and specificity was 34.4%, [95% CI at 32.0-36.9%]1. Nevisense missed 9 melanomas, 7 of which were melanomas in situ and 2 were pT1a. The positive and negative predictive values of Nevisense were 21.1% and 98.2%, respectively1. The observed sensitivity for nonmelanoma skin cancer was 100% (55 of 48 BCCs and seven SCCs) [95% CI at 93.5-100.0%]1. The overall specificity for benign lesions (mild-moderate dysplastic nevi, benign melanocytic nevi, seborrheic keratoses and lichenoid keratoses) was 34.4% [95% CI at 32.0%-36.9%].

In the same study, the specificity of a dermatologist’s examination via the ABCD dermoscopy algorithm with a cutoff of <5.45 was 94%. With the seven point checklist, the specificity was 94.2% for 1701 examined lesions, theoretically making dermoscopy examination with Nevisense’s additional input a highly sensitive and specific tool to evaluate pigmented lesions1.

Industry Affiliations:

NeviSense is developed by a medical device company called SciBase AB, based in Stockholm, Sweden.

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