DermaSensor Presents Pooled Analysis Results from the (DERM-ASSESS III) & (DERM-SUCCESS) Clinical Studies of Skin Cancer Detection Device
Shots:
- The 2 clinical studies (DERM-ASSESS III) & (DERM-SUCCESS) evaluating the performance of the non-invasive devices in detecting skin cancer
- In (DERM-ASSESS III) & (DERM-SUCCESS) trials, the device showed 96% device sensitivity for detecting melanoma & all skin cancers in the dermatology & primary care setting, 32.5% & 21% correctly classifying benign lesions that were biopsied. In (DERM-SUCCESS) trials, device NPV was 97% & the PPV was 17%, i.e., one in six lesions with a positive device result was cancerous
- Additionally, no device-related safety issues were reported while there was a higher risk for melanoma with a positive device result from (DERM-ASSESS III) trial. The device received the BTD from the US FDA & is currently under review by the agency
Ref: Businesswire | Image: DermaSensor
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