DermaSensor’s FDA clearance is supported by 10 clinical studies enrolling over 1,300 subjects and more than 2,000 pathology-verified lesions across more than 30 study sites. The pivotal DERMSUCCESS study was an international, multicenter, prospective, blinded trial conducted at 22 sites with 30 primary care physicians, enrolling 1,005 patients with 1,579 lesions. The device demonstrated 95.5% sensitivity for all common skin cancers (melanoma, BCC, SCC) in patients 40 and above. Standalone melanoma sensitivity was 90.2% with a negative predictive value of 98.1%. Three multi-reader, multi-case (MRMC) studies involving over 280 primary care physicians consistently demonstrated that DermaSensor significantly improves physician performance. In the pivotal reader study, PCP sensitivity increased from 82.0% to 91.4% with device use (p=0.0027), cutting false negative referrals in half. The DERM-ASSESS III study, conducted at ten high-volume skin cancer dermatology practices, demonstrated melanoma sensitivity of 95.5%. No adverse events were reported in any of the clinical trials.

In the pivotal DERM-SUCCESS study, DermaSensor demonstrated 96.3% sensitivity for detecting all common skin cancers (melanoma, BCC, SCC) in patients 40 and above. For melanoma specifically, sensitivity was 90.2%. For device specificity, the DERM-SUCCESS study demonstrated the device correctly classified 20.7% of the benign lesions that the physicians deemed suspicious and biopsied per their standard of care. In the supplemental study DERM-ASSESS III, conducted with ten dermatology study centers, the device sensitivity was 95.5% for benign lesions the dermatologists biopsied due to suspicion for melanoma. The negative predictive value (NPV) of the device in DERM-SUCCESS was 96.6% and the positive predictive value (PPV) for Investigate Further results ranged from 6.4% for a score of 1 to 61.3% for a score of 10. This score and ten-fold difference in cancer likelihood helps physicians understand the level of malignancy risk of the given lesion and helps inform patient management, for example whether to urgently refer a patient to dermatology. The
device’s sensitivity significantly exceeded primary care physicians’ unaided sensitivity of 83.0% on the same lesions, and when PCPs used the device as an adjunct, their sensitivity improved from 82.0% to 91.4%, cutting false negative referrals in half from 18.0% to 8.6%. For full details, please review the Instructions For Use.

No. DermaSensor is explicitly designed to assist non-dermatologist physicians in making referral decisions. It does not replace dermatologists, biopsies, or clinical judgment. DermaSensor should be used in conjunction with the totality of clinically relevant information from your clinical assessment, including visual analysis of the lesion. DermaSensor should be used to help you decide whether to refer a patient to dermatology, not to diagnose or rule out skin cancer. Once referred, the dermatologist makes the final diagnostic and treatment decisions. The device cannot replace biopsy for definitive diagnosis, cannot be used as a standalone diagnostic, and cannot confirm a diagnosis of skin cancer. It serves as an objective data point to inform your referral decision-making process. Please review all indications, warnings, and precautions in the Instructions For Use.