Publications
Validation of a Handheld Elastic Scattering Spectroscopic Device in the Evaluation of Lesions Suggestive of Melanoma
Hartman, R. Tepedino, K., Fung, MA., McNiff, JM., Grant-Kels, J. Clinical, Presentation at the American Academy of Dermatologists Annual Meeting, Mar 24-28th, 2022-
Safety and Effectiveness of Elastic Scattering Spectroscopy and Machine Learning in the Evaluation of Skin Lesions for Cancer
Benvenuto-Andrade, C., Manolakos, D., Cognetta, A.B. (2020) -
Clinical Utility of a Handheld Elastic Scattering Spectroscopy Tool and Machine Learning on the Diagnosis and Management of Skin Cancer by Primary Care Physicians
Tepedino, K., Tablada, A. M., Barnes, E., Silva, T. -
Use of Elastic-Scattering Spectroscopy and Machine Learning when Assessing Skin Lesions Suggestive of Skin Cancer
Salmon, P., Bonning, M. -
Optical Spectroscopy as a Method for Skin Cancer Risk Assessment
Rodriguez-Diaz, E., Manolakos, D., Christman, H., Bonning, M., Geisse, J. K., A'Amar, O. M., Leffell, D. J., Bigio, I. J. (2019) -
Elastic Scattering Spectroscopy in Assessing Skin Lesions: An "In Vivo" Study
Upile, T., Jerjes, W., Radhi, H., Mahil, J., Rao, A., Hopper, C. (2011) -
A new tool to inform intra-operative decision making in skin cancer treatment: The non-invasive assessment of basal cell carcinoma of the skin using elastic scattering spectroscopy
Upile, T., Jerjes, W., Johal, O., Lew-Gor, S., Mahil, J., Sudhoff, H. H. (2012) -
Elastic scattering spectroscopy in the diagnosis of pigmented lesions: comparison with clinical and histopathological diagnosis
Scarisbrick, J. J., Pickard, C. D. O., Lee, A. C., Briggs, G. M., Johnson, K., Bown, S. G., Novelli, M., Keshtgar, M. R. S., Bigio, I. J., Yu, R. (2003) -
Comparison between ultraviolet-visible and near-infrared elastic scattering spectroscopy of chemically induced melanomas in an animal model
A'amar, O. M., Ley, R. D., Bigio, I. J., (2004) -
Spectroscopic Sensing of Cancer and Cancer Therapy: Current Status of Translational Research
Bigio, I. J., Bown, S. G. (2004) -
Real-time pathology to guide breast surgery: seeing alone is not believing
Bigio, I. J., (2012) -
The Color of Cancer: Margin Guidance for Oral Cancer Resection Using Elastic Scattering Spectroscopy
Grillone, G. A., Wang, Z., Krisciunas, G. P., Tsai, A. C., Kannabiran, V. R., Pistey, R. W., Zhao, Q., Rodriguez-Diaz, E., A'Amar, O. M., Bigio, I. J., (2017) -
Preoperative Discrimination of Benign From Malignant Disease in Thyroid Nodules With Indeterminate Cytology Using Elastic Light-Scattering Spectroscopy
Rosen, J. E., Suh, H., Giordano, N. J., A'Amar, O. M., Rodriguez-Diaz, E., Bigio, I. J., Lee, S. L. (2014) -
Endoscopic Histological Assessment of Colonic Polyps by Using Elastic Scattering Spectroscopy
Rodriguez-Diaz, E., Huang, Q., Cerda, S. R., O'Brien, M. J., Bigio, I. J., Singh S. K. (2014) -
Skin Cancer: Precancers
Bruner, P., Bashline, B.(2019)
Indications for Use
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The DermaSensor™ device is indicated for use as an objective tool to assist qualified healthcare professionals in evaluating skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma. The DermaSensor device is intended to assist the user in deciding whether skin lesions require further clinical care and is not intended to be used for direct diagnosis of skin cancer. DermaSensor is only for use by qualified healthcare professionals appropriately trained in the assessment of skin lesions for cancer.
CLAIMS #1 - “faster [and easier] route to reliable information”
SUBSTANTIATION: “Faster” when compared to other technologies that require extensive training, skin preparation and/or image interpretation. "ESS requires no skin preparation and is easy to administer, requiring minimal practitioner training. [It] generates a simple dichotomous output in a non-invasive way." (Rodriguez-Diaz et al (Photochemistry and Photobiology, 2019) https://onlinelibrary.wiley.com/doi/abs/10.1111/php.13140).
SUBSTANTIATION: “reliable information” – Published data on DermaSensor’s ESS and Machine Learning technology shows sensitivity >90% across all skin cancers combined (Rodriguez-Diaz et al (Photochemistry and Photobiology, 2019) https://onlinelibrary.wiley.com/doi/abs/10.1111/php.13140).
CLAIMS #2 - “Smarter clinical choices”
SUBSTANTIATION: DermaSensor’s ESS and Machine Learning technology sensitivity in published data surpasses the sensitivity of naked eye examination for skin cancers, while decreasing the morbidity associated with skin cancers . In a published 2018 meta-analysis physician naked eye sensitivity was greater than 90% in only six of 28 in‐person‐based evaluations and physician experience may influence accuracy. (“Diagnosing skin cancer.” Posted December 6, 2018. https://onlinelibrary.wiley.com/doi/abs/10.1111/php.13140).
CLAIMS #3 - “DermaSensor may help you to avoid benign excisions with poor reimbursement rates and unnecessary morbidity”
SUBSTANTIATION: If the DermaSensor device is used with lesions suggestive of skin cancer that the healthcare professional intended to excise and the true negative device results lead to the healthcare professional deciding to not excise certain benign lesions, that could decrease benign excisions. Published data on DermaSensor’s ESS and Machine Learning technology shows specificity >30% across all benign lesion pathologies (Rodriguez-Diaz et al (Photochemistry and Photobiology, 2019) https://onlinelibrary.wiley.com/doi/abs/10.1111/php.13140).
CLAIM #4 - “DermaSensor is the new, quicker route to better outcomes”
CLAIM #5 - “Enabling early detection using non-invasive spectroscopy”
CLAIM #6 - “DermaSensor may help you detect more of your patients' skin cancer”
SUBSTANTIATION: “Quicker” when compared to other technologies that require extensive training, skin preparation and/or image interpretation. "ESS requires no skin preparation and is easy to administer, requiring minimal practitioner training. [It] generates a simple dichotomous output in a non-invasive way." (Rodriguez-Diaz et al (Photochemistry and Photobiology, 2019) https://onlinelibrary.wiley.com/doi/abs/10.1111/php.13140).
SUBSTANTIATION: “...route to better outcomes”, "Enabling early detection" and “DermaSensor may help you detect more of your patients’ skin cancer”– Published data on DermaSensor’s ESS and Machine Learning technology shows sensitivity >90% across all skin cancers combined (Rodriguez-Diaz et al (Photochemistry and Photobiology, 2019). Published data on naked eye examination is variable; in a published 2018 meta-analysis, physician naked-eye sensitivity was greater than 90% in only six of 28 in‐person‐based studies and physician experience may influence accuracy. (“Diagnosing skin cancer.” Posted December 6, 2018. https://www.cochranelibrary.com/collections/doi/SC000033/full ). Therefore, DermaSensor’s technology provides a "route to better outcomes", "enables early detection" and/or “may help you detect more of your patients’ skin cancer” by potentially improving detection of skin cancer. Earlier stages of skin cancer diagnoses have better prognoses. “Skin cancers require early diagnosis and management for optimal outcomes.” https://www.aafp.org/cme/subscriptions/fp-essentials/editions/481-ed.html (Perez LL, Bashline B, Bruner P. Skin Cancer. FP Essent. 2019;481:1-44.)
Risks
False-positive and false-negative results may lead to unnecessary care or to a malignant skin lesion not being optimally managed, respectively. However, it is important to note that biopsy is used to confirm pathology and that elastic scattering spectroscopy is to be used as an adjunctive tool to visual inspection and history-taking. The DermaSensor device is not a screening tool—lesions that clearly warrant a biopsy should be biopsied per normal clinical practice. Clearly benign lesions do not require the use of the DermaSensor device.80-0006.3 v2