In the two clinical trials, dubbed DERM-ASSESS 3 and DERM-SUCCESS, the device showed a 94% sensitivity in classifying 338 high-risk lesions and a 23% specificity in classifying 1,681 low-risk lesions
DermaSensor Base and Device. (Credit: Business Wire/ DermaSensor Inc.)
US-based health technology company DermaSensor has unveiled positive results for its non-invasive device that detects skin cancer, from a pooled analysis of two clinical studies.
The two clinical trials, dubbed DERM-ASSESS 3 and DERM-SUCCESS, assessed the performance of the device that deploys non-invasive, optical spectroscopy technology.
In the studies, the device showed 94% of sensitivity in classifying 338 high-risk lesions and 23% of specificity in classifying 1,681 low-risk lesions, from samples suspected of skin cancer.
DermaSensor said that the device met its primary endpoint in the DERM-SUCCESS study, with superior sensitivity compared to primary care physicians (PCPs) for all skin cancers.
DermaSensor scientific advisory board Dr Jane Grant-Kels said: “DermaSensor’s technology will help primary care physicians detect cancerous skin lesions and refer those patients appropriately to a dermatologist.
“Prompt referral from a PCP to a dermatologist can help minimise patient mortality, morbidity and result in the saving of health care dollars.”
DermaSensor said that its objective, non-invasive device supports PCPs with the rapid, point-of-care assessment of lesions suggestive of skin cancer during an exam.
The device has been granted the US FDA Breakthrough Device designation and is currently being reviewed by the US regulatory agency.
In the two studies, more than 2,000 suspicious lesions were biopsied by 32 study centres, with no device-related safety issues reported.
The DERM-ASSESS 3 study was conducted at 10 dermatology centres and found 96% device sensitivity for detecting melanoma in the dermatology setting.
It has also accurately classified 32.5% of benign lesions that were biopsied by the study dermatologists for suspicion of melanoma.
In addition, the DERM-SUCCESS study, conducted at 22 primary care study canters, showed 96% device sensitivity for all skin cancers in the primary care setting.
The study showed 21% device specificity for precisely classifying benign lesions biopsied by the physicians, with a 97% device positive predictive value (PPV) and 17% negative predictive value (NPV).
DermaSensor CEO Cody Simmons said: “It is an honour to have been selected to present data at the AAD from our two major clinical validation studies, which are two of our four studies serving as principal support for our FDA submission.
“Having spent a decade miniaturising and conducting studies with our spectroscopy technology, we hope to soon equip PCPs in the US with our handheld, wireless device in order to improve their detection and referral of skin cancer, which is more common than all other cancers combined.”