Benefits of Using DermaSensor™
Major Findings from Clinical Studies
96% device sensitivity for detecting all skin cancers1
PCPs' overall skin cancer sensitivity was found to increase by 6-9%; their relative decrease in false negative referrals (I.e. missed skin cancers) decreased by 30-52%2,3
PCPs' melanoma sensitivity was found to increase by 7-9%; their relative decrease in false negative referrals (i.e. missed skin cancers) decreased by 21-30% 2*
PCPs' confidence significantly increased in managing suspicious lesions 2,3
Device correctly classified 21-33% of benign lesions that physicians biopsied 1,4
With increasing positive predictive value for malignancy, higher the device scores can be used to objectively, systematically prioritize patient referrals 1,3
Major Product Firsts
First FDA-cleared skin cancer device developed for PCPs
First FDA-cleared FDA Breakthrough device for skin cancer
First FDA-cleared automated device indicated for all three common skin cancers (Melanoma, BCC and SCC)
Only FDA-cleared skin cancer device available that provides any risk assessment using any type of imaging or optical technology
References
- Merry SP, Chatha K, Croghan I, Nguyen VL, McCormick B, Leffel D. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial. J Clin Aesthet Dermatol 2023 April: 16(4 Suppl): s16.
- Data on file
- Seiverling EV, Agresta T, Cyr P, Caines L, Nguyen VL, Chatha K, Siegel DM. Clinical Utility of an Elastic Scattering Spectroscopy Device in Assisting Primary Care Physician’s Detection of Skin Cancers. J Clin Aesthet Dermatol 2023 April: 16(4 Suppl): s16-17.
- Hartman RI, Trepanowski N, Chang MS, Tepedino K, Gianacas C, McNiff JM, Fung M, Braghiroli NF, Grant-Kels JM, Multicenter Prospective Blinded Melanoma Detection Study with a Handheld Elastic Scattering Spectroscopy Device, JAAD International (2023),
doi: https://doi.org/10.1016/j.jdin.2023.10.011. - J. Boyer, J. R. Mourant, and I. J. Bigio, "Theoretical and Experimental Investigations of Elastic Scattering Spectroscopy as a Potential Diagnostic for Tissue Pathologies," in Advances in Optical Imaging and Photon Migration, (Optica Publishing Group, 1994), paper OPTTM.265.
*Melanoma false negative results are only reported from the two studies powered for analysis by individual skin cancer types, DERMSUCCESS pigmented reader study and DERM-ASSESS III reader study