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When in doubt - Nevisense

Visual examination, with or without dermoscopy, is normally sufficient when identifying most types of lesions. However, when it comes to atypical lesions, a clinical diagnosis based on only a visual examination may pose a challenge, leading to unnecessary excisions or - even worse - missed melanomas. In such cases Nevisense provides additional and unique information from an objective analysis - a new way to increase accuracy in melanoma detection.

THE NEVISENSE PRODUCT

A breakthrough in non-invasive detection of melanoma

Nevisense is the world’s first objective diagnostic support tool for non-visual detection of malignant melanoma. By gathering and analyzing precise electrical measurements in the epidermis and dermis, it provides reliable information unavailable through any other method. Through one simple procedure, it allows you to objectively evaluate suspicious lesions prior to excision.

The diagnostic challenge

Most dermatologists feel confident with today’s methods of visual examination. Literature shows, however, that the accuracy of clinical diagnosis of cutaneous melanoma with or without dermoscopy is far from 100%.

The consequences of this uncertainty are two-fold. On the one hand, life-threatening melanoma may be missed. On the other, as a safety precaution, benign lesions are unnecessarily excised.

With Nevisense, this is addressed by complementing the examination process with reliable, objective information that leads to more confident and accurate diagnoses.

The Nevisense solution

With Nevisense, SciBase has developed an innovative method for improving accuracy in the detection of malignant melanoma. Utilizing Electrical Impedance Spectroscopy (EIS), applied as a harmless electrical signal to the skin, Nevisense is able to provide a reliable, objective analysis of suspicious lesions which complements the physician’s regular clinical evaluations.

The Nevisense method is both safe and painless. By providing valuable diagnostic information that is unavailable through other methods, it allows physicians to make more informed decisions in difficult or borderline cases. Nevisense, used as a diagnostic support tool, makes it possible to increase diagnostic accuracy, leading to both early detection of malignant melanoma and a reduction in unnecessary biopsies.

Intended use

Nevisense is intended for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma. Nevisense is designed to be used when a physician chooses to obtain additional information when considering excision. Nevisense should not be used to confirm a clinical diagnosis of melanoma.

Nevisense is only for use by physicians trained in the clinical diagnosis of skin cancer. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to excise.

Indication for use

Nevisense is indicated only for use on primary skin lesions with a diameter between 2 mm and 20 mm; lesions that are accessible by the Nevisense probe; lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions); lesions that do not contain a scar or fibrosis consistent with previous trauma; lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions , lesions not in hair-covered areas, lesions which do not contain foreign matter; and, lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).

THE EIS METHOD

Unique technology

SciBase Electronic Impedance Spectroscopy (EIS), a patented technology developed over 20 years at Karolinska Institutet Stockholm, is applied to the skin as harmless electrical signals. EIS is sensitive to changes in cellular structure, cellular orientation, cell sizes and cell types – all of which are similar to those on which a histopathologist would base his or her diagnosis. This new methodology enhances information extraction from multi-depth spectra using an innovative non-invasive electrode system that facilitates precise data collection and analysis.

How it works

Skin tissues have different electrical properties under different medical conditions. Based on this, it is possible to identify a condition, such as malignant melanoma, using Nevisense’s unique EIS method.

EIS is a measure of the overall resistance within the tissue at alternating currents of various frequencies. It is measured by applying an unnoticeable alternating potential between the bars on the tip of the probe. In order to cover the lesion in both width and depth, the measurement is performed in 10 permutations covering both shallow measurements between neighboring electrode bars as well as deeper measurements between more distant electrode bars.

EIS reflects different cellular properties in different frequency regions. In general, EIS measurements at low frequencies are affected by the extracellular environment, whereas both the intra- and extracellular environments affect measurements at higher frequencies. The frequencies used by Nevisense (1 kHz – 2.5 MHz) relate to clinically relevant properties, such as composition of intra- and extracellular environments, cell shape and size, and cell membrane composition, all of which are similar to those used by histopathologists to diagnose skin cancer.

Within seconds, an advanced algorithm is used to classify the lesion based on measurement data from both the lesion and the reference measurement. This classifier, developed in several iterations with data from multiple clinical studies, has proven to increase accuracy in melanoma detection in the pivotal study – the world’s largest clinical study of its kind.

HOW IT’S USED

Increased diagnostic accuracy in the detection of malignant melanoma.

Nevisense is a safe and painless diagnostic support tool designed to complement a dermatologist’s regular visual examination. In difficult or borderline cases, it allows you to objectively analyze precise information collected from suspicious lesions prior to making a decision whether to excise.

Nevisense makes it possible to increase accuracy in melanoma detection, leading to earlier detection and fewer unnecessary excisions.

The Nevisense procedure is fast, simple and effective:

  1. Moisten skin

    Before performing a measurement, moisten the skin with physiological saline solution.

  2. Reference measurement

    Perform a reference measurement on healthy skin close to the lesion. The measurement takes only 8 seconds to perform.

  3. Lesion measurement

    Repeat the measurement procedure on the lesion to be examined.

  4. Evaluate results

    The results of your measurements will be analyzed and displayed on the Nevisense screen within seconds. The Nevisense classifier provides an EIS score output reflecting the degree of atypia identified by the method. You can then combine the results of your visual inspection with the added, objective information provided by Nevisense to reach a more informed clinical decision.

FEATURES & BENEFITS

Easy. Accurate. Objective.

Through a series of comprehensive clinical studies, Nevisense has proven to deliver accurate, objective diagnostic information unavailable through any other method or device. The result is more informed clinical decisions, potentially leading to fewer missed melanomas and a reduction in unnecessary excisions.

Unique complementary information

Nevisense provides physicians with a unique EIS analysis of suspicious lesions, providing additional information in uncertain cases. For cutaneous lesions with unclear clinical or historical signs of melanoma, it allows physicians to obtain further information, complementary to visual examination, prior to a decision to excise.

Diagnostic accuracy

Nevisense has a proven diagnostic accuracy in the detection of malignant melanoma in three consecutive studies with more than 4,000 lesions. In the pivotal study with a total inclusion of more than 2,400 lesions, the Nevisense system achieved a sensitivity of 97% in the target population. It also has a proven specificity of 34% on lesions with clinical suspicion of malignant melanoma, representing the potential reduction of unnecessary biopsies.

Objective analysis

Visual inspection, whether through dermoscopy or with the naked eye, is inherently subjective. Nevisense enables physicians to complement their expertise with an objective analysis of cellular characteristics, thereby leading to more informed conclusions in difficult or borderline cases.

Fast and easy procedure

The Nevisense procedure takes just minutes to perform and fits easily within physicians’ normal patient flow. Compared with pathology which can take time to provide results, Nevisense provides immediate diagnostic information to the physician at point-of-care.

NEVISENSE VIEW

Nevisense View is designed to support clinicians in the diagnostic process by providing full documentation of lesions, combining EIS with clinical and dermoscopic images in one solution.

With its user-friendly interface it is easily integrated in the clinical workflow. Images are wirelessly transferred from the camera, to be viewed and documented together with the EIS-score. A split view functionality allows you to follow and compare lesions over time in a simple format.
A comprehensive case report can also be made available in PDF format.


  • Wireless transfer of photo and dermoscopy images from camera to Nevisense.
  • Split view function to compare and follow up on lesions.
  • Case report with EIS, images and patient information in PDF for full documentation.

DOWNLOAD MATERIALS

Nevisense at a glance

Download the brochure to learn more about the Nevisense method: the technology, clinical evidence and how it can benefit you and your patients.

Nevisense_Brochure

Nevisense at a glance - German version

Download the brochure to learn more about the Nevisense method: the technology, clinical evidence and how it can benefit you and your patients.

Nevisense_Brochure_DE

British Journal of Dermatology Publication

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