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 EIS functionality is intended for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma. Nevisense is designed to be used to obtain additional information prior to decision about most appropriate action for the patient. Nevisense should not be used to confirm a clinical diagnosis of melanoma.

Nevisense EIS functionality is only for use by medical professional 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 decision about most appropriate action.

Nevisense View functionality is intended for documentation and not for diagnostic purposes.

The system is also intended to use for research purposes in general measurement of electrical impedance of the skin. The research measurements could be made with non invasive as well with micro invasive (spike) electrodes.

 

Clinical 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 38% 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.

Easy procedure

The Nevisense procedure 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.