SciBase has reported positive results from the pivotal SIMPS study of its non-invasive point-of-care Nevisense device, designed for the detection of malignant melanoma.
The patented device, which includes an electrode on a hand-held probe, utilises electrical impedance spectroscopy (EIS) to detect and monitor skin tissue alterations.
Conducted under an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA), 22 clinics across Europe and the US participated, which included 2,400 skin lesions from 1,900 patients and 260 melanomas in the blind, prospective study.
Nevisense achieved an overall sensitivity of 98% (lower confidence bound 95.5%) with 100% sensitivity on all stages of invasive melanomas as well as a specificity of 33% (upper confidence bound 35.7%, lower confidence bound 30.4%).
The results meet and exceed target study endpoints, according to IDE-approval by the FDA.
Anders Lundqvist, SciBase CEO, said Nevisense’s outcome on sensitivity will allow for increased accuracy in diagnosis and save lives by early detection.
"Dermatologists will now have access to a support tool providing them with additional valuable and objective information not previously available," Lundqvist added.
"Pathologists may also benefit from the objective Nevisense output, as the study results confirm that even pathology is far from 100% accurate.
"Last, but not least, a specificity higher than that of the physicians paves the way for a dramatic reduction of performed biopsies and substantial healthcare savings."
The study data will provide the basis for the regulatory process for approval in the US as well as for market launch in Europe and Australia, all of which are planned for Q1 2013, according to the company.
Image: Non-invasive point-of-care Nevisense device detects and monitors skin tissue alterations. Photo courtesy of: SciBase AB.