DermaSensor today announced the publication of two pivotal studies validating its device for skin cancer detection in primary care.
In collaboration with faculty from Mayo Clinic, Yale University, the University of North Carolina School of Medicine, and SUNY Downstate Health Sciences University, the Miami-based company shared data highlighting the performance of the novel elastic scattering spectroscopy (ESS) device.
DermaSensor develops a handheld device that uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound. DermaSensor says physicians can use its AI-powered spectroscopy technology to non-invasively evaluate lesions. They can look at cellular and subcellular characteristics of a lesion in question for skin cancer. The wireless device then provides an immediate, objective result using an FDA-cleared algorithm.
In January, the FDA cleared the DermaSensor real-time, non-invasive, AI-powered skin cancer evaluation system.
“These two FDA pivotal studies – the main clinical studies of the six submitted to FDA – highlight the strong performance and benefits of our device, which were instrumental in DermaSensor becoming the first FDA-authorized tool in the US that provides anyone with any kind of objective risk assessment for melanoma, BCC and SCC,” said Cody Simmons, co-founder and CEO of DermaSensor. “Since receiving FDA de novo clearance of this FDA breakthrough device last year, there are already hundreds of diverse doctors using our devices, and we are working to quickly scale device adoption so that our device can benefit many of the millions of patients that are diagnosed with skin cancer each year.”
A look at the DermaSensor studies
One study assessed the device’s standalone performance. The other evaluated how device use impacted primary care physicians (PCPs) in skin cancer detection and management.
In a multicenter validation study led by Mayo Clinic, investigators evaluated 1,579 lesions in 1,005 patients across 22 primary care sites. Dermatopathologic analysis confirmed 224 skin cancers, including melanomas, basal cell carcinomas, and squamous cell carcinomas
DermaSensor said its ESS device delivered a skin cancer detection rate, or sensitivity, of 96% in the study. This compared favorably to the 90% target based on dermatologists’ sensitivity in the literature. The FDA also has the same minimum required sensitivity for melanoma.
For negative device results, the likelihood that a lesion was benign (i.e. negative predictive value (NPV)) was 97%. For positive results, the likelihood a lesion was cancerous (i.e. positive predictive value (PPV)) ranged from 6% for the lowest score of 1 to 61% for the highest score of 10.
The companion clinical utility study with 108 physicians found that use of the ESS device significantly enhanced physicians’ ability ot identify and correctly refer skin cancers. It also showed improvements in their overall skin lesion management accuracy.
PCPs correctly referred 91.4% of malignant lesions when aided by the device. That compared to just 82% without it, marking a 50% reduction in missed cancer referrals (from 18% to 8.6%).
