FDA Approves EIS System Nevisense 3.0 for the Early Detection of Melanoma

The FDA has granted approval to an electrical impedance spectroscopy system (EIS), Nevisense 3.0, the third-generation of the SciBase Nevisense system, for the early detection of melanoma, SciBase announced in a press release.¹

Nevisense uses an AI-based point-of-care system for a non-invasive procedure to evaluate irregular moles and is the only FDA-approved system available in the United States for the detection of melanoma. Nevisense 3.0 is a more efficient, streamlined version of Nevisense, which had previously received approval from the FDA.

A European version of Nevisense 3.0 was released at the end of 2018, which has significantly improved the adoption and utilization of the test. To date, it has been used clinically for over 30,000 patients.

The first Nevisense product assisted physicians in the detection of malignant melanoma, the most dangerous form of skin cancer. The product is also used as a tool to assess the skin barrier and inflammation after further development.

As an EIS tool, Nevisense uses varying electrical properties of human tissue to categorize the cellular structures to detect malignancies and abnormalities.

The accuracy and safety of Nevisense as a detector of cutaneous melanoma was previously evaluated. The results from the multicenter, prospective, blinded study of Nevisense, which was conducted across 5 institutions in the United States and 17 in Europe, were published in the Birtish Journal of Dermatology. Overall, 1,943 skin lesions were eligible and evaluable for the primary efficacy end point, including 265 lesions of melanoma, 112 of which were in situ, and 153 were invasive melanomas.²

The study had 2 co-primary end points, a 1-sided exact 95% confidence bound of sensitivity in the detection of cutaneous melanoma and nonrandom result at the given sensitivity. Safety was also measured by the occurrence and incidence of all adverse events (AEs) reported during the study.

Nevisense demonstrated a sensitivity rate of 96.6% in 256 of the 265 melanomas (1-sided 95% CI, 94.2%). The specificity rate observed was 34.4% (2-sides 95% CI, 32.0-36.9). Positive predictive values were 21.1%, and negative predictive values were 98.2% with Nevisense.

Overall, the sensitivity for nonmelanoma skin cancer was 100% (2-sided 95% CI, 93.5-100.0).

Thirty-six AEs were observed in 28 patients (1.5%), and only 3 AEs were determined to be related to Nevisense. Of those related to the device, all AEs were of mild severity, and no serious AEs occurred in the study.

In November 2019, SciBase announced that Mount Sinai ordered multiple Nevisense systems for their new melanoma center, making them the first health system in the United States to utilize Nevisense in clinical practice. Mount Sinai is the largest health system in the greater New York region and is composed of 8 hospitals and a leading medical school, as well as a vast network of ambulatory practices.³

The adoption of next-generation solutions at Mount Sinai further supports their commitment to improving patient care and outcomes with the appropriate tools and resources.

“The inclusion of EIS technology will allow us to provide patients with important risk information. This will help differentiate the Mount Sinai melanoma center while also providing our patients with best in class care", said Jonathan Ungar, MD, assistant professor of dermatology and medical education at Mount Sinai, in a statement.

_References

1. _{SciBase Receives FDA Approval for Nevisense 3.0 [news release]. Stockholm, Sweden: SciBase; May 1, 2020. https://prn.to/3bVlxUq. Accessed May 1, 2020.}
2. _{Malvehy J, Hauschild A, Curiel-Lewandrowski C, et al. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety [Published Online May 19, 2014]. British Journal of Dermatology. 2014; 171(5):1099-1107. doi: 10.1111/bjd.13121.}
3. _{SciBase Announces Order of Nevisense from Mount Sinai Hospital’s New Melanoma Clinic [news release]. Stockholm, Sweden: SciBase; November 12, 2019. https://prn.to/2ygPqQp. Accessed May 1, 2020.}