DermaSensor™ is a fast, handheld, point-and-click device developed by DermaSensor, a health technology company based in the US, to allow general practitioners (GPs) to swiftly assess any suspicious skin lesions in patients for skin cancer.
Skin cancer is the most prevalent form of cancer in the US and melanoma is projected to become the second most common cancer in the country by 2040.
DermaSensor has been designed as a spectroscopy-based objective tool to help clinicians evaluate suspected lesions for some of the most common forms of skin cancer, including basal cell carcinoma, squamous cell carcinoma and melanoma, in a timely and efficient manner.
The device received CE marking in Europe and is registered and commercially available for sale in Australia and New Zealand. It received breakthrough device designation from the US Food and Drug Administration (FDA) in May 2021 and is currently awaiting approval in the US.
DermaSensor presented data from two clinical studies (DERM-ASSESS III and DERM-SUCCESS) at the American Academy of Dermatology’s (AAD) 2023 annual meeting in March 2023. The studies are the first pivotal clinical trials conducted successfully for any skin cancer evaluation device for primary care physicians (PCPs).
Device design and specifications
The DermaSensor device comprises a wireless, standalone handheld unit and base with a power socket, complemented by software, an operating manual and recyclable packaging.
Weighing 1.9kg, the device is installed with a standard 110V-250V/50-60Hz general power outlet (GPO). The battery lasts for a whole day in practice.
The handheld unit uses artificial intelligence (AI) and spectroscopy to rapidly assess skin lesions for potential cancer. The desktop base supports wireless charging, eliminating the need for any wall-mounted installation or hardware. Its small footprint and ergonomic design allow it to be set up quickly on a desk.
The device’s secure wireless connectivity enables easy data transfer between the device and the companion software.
Details of the DermaSensor cancer detection device
The DermaSensor device ensures early detection of skin cancer using AI-powered, ultra-miniaturised non-invasive elastic scattering spectroscopy (ESS) technology, a form of optical spectroscopy. The device works in a similar way to sonar but uses pulses of light instead of sound to capture information on a cellular and sub-cellular level from a non-invasive tissue sample.
The tip of the handheld unit is non-invasively pressed on the lesion of concern and emits light pulses of more than 40 distinct wavelengths. The device receives and analyses data from the cellular and sub-cellular structures of a lesion, using ESS technology.
The unit captures five quick recordings through the scans, which are then analysed by a proprietary machine learning system, delivering an instant high-risk or low-risk result.
The entire process takes under 30 seconds for a lesion. The precise optics in the tip can detect pathological abnormalities on skin lesions as small as 2.5mm in diameter. The user-friendly on-screen interface guides users through the assessment step-by-step.
Clinical study demonstrating the DermaSensor’s potential
A randomised prospective clinical trial was conducted with 57 primary care physicians in the US to evaluate the DermaSensor device’s potential. The physicians assessed more than 5,000 lesions in patients.
The study results showed that DermaSensor’s output improved the physicians’ ability to diagnose skin cancer by 13% compared to the analysis with no device output.
The usage of DermaSensor enhances physicians’ skin cancer detection sensitivity from 81% to 94% with no significant loss in specificity.
DERM-ASSESS III and DERM-SUCCESS clinical studies details
DermaSensor, in collaboration with medical institutions including the Mayo Clinic and the University of Connecticut School of Medicine, evaluated the performance of the device in detecting skin cancer in the DERM-ASSESS III and DERM-SUCCESS clinical studies.
More than 2,000 suspicious lesions were biopsied in 32 study centres across the two studies. The device accurately classified 338 high-risk lesions with 94% sensitivity and 1,681 low-risk lesions with a specificity of 23% during biopsy.
The device met its primary endpoint in the DERM-SUCCESS trial, showing that the sensitivity of DermaSensor’s non-invasive, optical technology was superior to that of PCPs for all common skin cancers.
The DERM-ASSESS III study, carried out across ten dermatology centres, found 96% device sensitivity for detecting melanoma in the dermatology setting, and precisely classified 32.5% of benign lesions for suspicion of melanoma.
The DERM-SUCCESS study, conducted in 22 primary care study centres, showed 96% device sensitivity for all skin cancers. The device specificity was 21% for correctly classifying benign lesions biopsied by the physicians.
The device’s negative predictive value (NPV) was 97% and the positive predictive value (PPV) was 17%, which meant one in six lesions with a positive device result were cancerous.
Benefits of the DermaSensor device
The device features a user-friendly interface, allowing healthcare providers to navigate easily and interpret the results.
The device makes real-time spectroscopic measurements and may detect 93% of skin cancers, while sparing up to 37% of unnecessary morbidity from benign excisions. It is easy to operate and offers a painless patient experience.
The software provides clear and concise information, guiding clinicians in making informed decisions and providing appropriate recommendations to patients. Its advanced algorithms can analyse data with precision, reducing the chances of misdiagnosis and unnecessary biopsies.
Unlike traditional skin cancer detection methods that often involve invasive procedures or uncomfortable biopsies, the DermaSensor device is non-invasive and painless.
The device enables clinicians to make more confident clinical decisions, improves the standard skin examination process and enhances the reimbursement level.
It maximises income by offering a value-based skin health service with out-of-pocket payments for patients.
Its compact and portable design makes it highly accessible for medical professionals in various settings to use in dermatology clinics, primary care practices and remote areas. It extends the reach of skin cancer detection and potentially benefits under-served populations.