Swedish SciBase AB has announced the British Journal of Dermatology publication of a multi-centre international study for its point-of-care device Nevisense.
According to SciBase the study shows that Nevisense provides an accurate and important new tool for the detection of malignant melanoma. Nevisense is a non-visual melanoma detection system, using Electrical Impedance Spectroscopy (EIS) to objectively analyze lesions with suspicion of melanoma.
The multi-centre, prospective and blinded study was conducted at 5 US and 17 European investigational sites. A total of 1,951 subjects with 2,416 lesions were enrolled into the study; 1,943 lesions including 265 malignant melanomas were eligible and evaluable for the primary efficacy endpoint. SciBase reports that Nevisense achieved a sensitivity of 97% with a specificity of 34% and the observed sensitivity for non-melanoma skin cancer was 100%.
“We are extremely excited about the results of this groundbreaking study. Detection of melanoma poses a challenge, especially in its earlier and most treatable stages. The study reflected this by evaluating the standalone performance of dermoscopy and histopathology, which showed sensitivities of 71% and 85% respectively. This confirms that Nevisense can detect melanomas potentially misdiagnosed using todays visual methods. The overall study results strongly indicate that Nevisense will improve the clinicians ability to detect melanoma in its earlier stages and thereby potentially save lives,” said Simon Grant, CEO SciBase, in a press release.
SciBase is a Swedish medtech company, founded 1998 and headquartered in Stockholm. The company is focused on skin cancer detection technology.