The U.S Food and Drug Administration (FDA) has cleared DermaSensor for skin cancer detection in primary care, the Company reports.
Wireless and handheld, DermaSensor’s AI-powered spectroscopy technology non-invasively evaluates cellular and subcellular characteristics of a lesion, providing an immediate and objective result using an FDA-cleared algorithm.
The FDA pivotal study of more than 1,000 patients, showed that the device had a sensitivity of 96% across all 224 skin cancers. A negative result had a 97% chance of being benign for all skin cancers. In a companion clinical utility study with 108 physicians, the DermaSensor device was found to decrease the number of missed skin cancers by half (from 18% to only 9%), increasing the physicians’ accuracy and confidence in assessing cancerous lesions.
In an exclusive interview with The DermDigest, Cody Simmons, Co-founder and Chief Executive Officer of DermaSensor, shared his plans for the rollout and discussed the impact that this device will have on patients, primary care physicians, and dermatologists.
TDD: How do you see DermaSensor used in practice now that it has the FDA’s coveted nod?
Cody Simmons: “Our evidence shows that the device improved primary care prevention and detection of skin cancer and confidence in skin lesion evaluation, and physicians report that they are excited to increase the number of skincare exams that they can perform.”
TDD: Why is it so important to put this device in the hands of internists?
Cody Simmons: “Access to dermatologists is limited already so upscaling primary care physician capabilities to diagnose skin cancer can help save lives. They do receive some training on the evaluation of skin lesions along with training on thousands of other diseases that they are responsible for diagnosing and treating.”
TDD: How will DermaSensor change this treatment paradigm?
Cody Simmons: “Typically, a patient may point to a lesion of concern during a visit with their internist, and the doctor will then assess the lesion for skin cancer risk. DermaSensor changes this paradigm by encouraging a proactive – not a reactive –approach.”
TDD: How will this strategy benefit dermatologists?
Cody Simmons: “DermaSensor is expected to improve primary care and dermatology collaboration, enabling better-prioritized referrals in addition to the referral of more patients with skin cancer. “
TDD: What is the plan for the rollout of DermaSensor?
Cody Simmons: “The focus of the soft launch is Florida and Pennsylvania with wider distribution planned for the second half of 2024. The company is pursuing reimbursement avenues that are typically used for devices like DermaSensor.”
