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FDA approves first device to detect skin cancer



YouTube video courtesy of DemaSensor, Inc.


CANCER DIGEST – Jan. 19, 2024 – One day soon, along with the usual stethoscope and reflex hammer and finger thumping you are used to with your annual checkup, your primary care doctor may also scan suspicious lesions on your skin with a handheld device and evaluate them for cancer with 96 percent accuracy.


The FDA on Jan. 17, 2024 approved the DermaSensor for clinical use for point of care testing for all types of skin cancer. The approval was based on half a dozen studies demonstrating the effectiveness of the device. The pivotal study involved 1,000 patients, led by the Mayo Clinic across 22 study centers to validate effectiveness. The results showed that the device had a sensitivity of 96 percent in detecting more than 200 skin cancers, while eliminating benign lesions 97 percent chance of the time.


“Equipping PCPs (primary care physicians), the most abundant clinicians in the country, to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine," Cody Simmons, co-founder and Chief Executive Officer of DermaSensor said in a press release. "While dozens of companies have attempted to address this problem in recent decades, we are honored to be the first device cleared by the FDA that provides PCPs with an automated tool for evaluation of suspicious lesions.”


In another clinical study involving 108 physicians, the DermaSensor device decreased the number of missed skin cancers by half from 18% to only 9%, increasing the physicians’ accuracy and confidence in referring lesions for further examination.


The handheld device is expected to improve skin cancer detection and help primary care physicians identify cancers sooner and increase efficiency of referrals to dematologists, allowing patients to confidently begin skin cancer therapy sooner when chances of success are higher.


The DermaSensoruses Elastic Scattering Spectroscopy (ESS) to test lesions for cancerous cells. The tip of the device reflects and records quick bursts of light off both the skin surface cells and cells below the skin surface. The light is analyzed by the built-in computer to provide information to help physicians assess the skin lesions (including melanomas, squamous cell carcinomas, and basal cell carcinomas) to help determine which lesions need further examination.


Elastic Scattering Spectroscopy (ESS), is a process that evaluates how photons scatter when reflected off different cellular structures. Malignant lesions have different cellular and sub-cellular structures than benign lesions, scattering light differently.


In its press release, the FDA cautioned that the device is not to be used as a sole diagnostic test. "The device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used to confirm a diagnosis of skin cancer."


Sources: DermaSensor, Inc. press release and Federal Drug Administration press release.



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