Safety and Effectiveness Results Across Multiple Clinical Studies:

  • DERM-ASSESS II Prospective Skin Cancer Validation Study1
  • DERM-ASSESS II Prospective Clinical Utility Study2
  • DERM-ASSESS III Prospective Melanoma Validation Study3
  • DERM-SUCCESS Prospective Skin Cancer Validation Study4
  • PATIENT-SELECT Prospective Specificity Validation Study4

DermaSensor and Dermatologist Sensitivity for Melanoma and Highly Atypical Nevi3

Overall study performance summary:

All clinical validation studies reported no adverse events, and studies showed DermaSensor sensitivity superior to GPs and similar to Dermatologists.1,2,3,4

DermaSensor and GP Sensitivity for Skin Cancer4

High-performance that could benefit GPs:

DermaSensor sensitivity across all skin cancers was 96%, 98% for non-melanoma skin cancer and 88% for melanoma, compared to the GPs’ sensitivity of 83%, 85% and 73%, respectively.

  • There were no adverse events among over 2,000 enrolled lesions from DERM-ASSESS II, DERM-ASSESS III, and DERM-SUCCESS.1,3,4
  • In DERM-ASSESS II, there was no statistical difference between the sensitivity of DermaSensor (97%) and dermatologists’ (96%) across skin cancer types.1
  • In a blinded, prospective study with 10 dermatology study centers in the U.S. and Australia, DermaSensor was found to have melanoma sensitivity comparable to the dermatologists’ in diagnosing melanoma (DermaSensor: 96%; Investigators: 91%).3
  • Across 1,500+ lesions in a blinded, prospective study with 22 GP study sites in the U.S. and Australia, DermaSensor’s sensitivity results for melanoma, SCC and BCC were 88%, 98%, and 98%, respectively.4
  • Specificity of the device ranged from 27-67% for benign nevi, 19-70% for SKs, and 7-57% for AKs.1,3,4
  • An Independent Investigator-Initiated Study conducted in NZ found a 98% sensitivity of the device across all skin cancers.5
  • DermaSensor's specificity was 61% for lesions of concern to patients, 36-37% for unbiopsied lesions of concern for non-specialist HCPs, and 21-33% for physician biopsied lesions.1,4
  • As reported in Nature in 2019, "... most skin lesions are diagnosed by primary care doctors, and problems with inaccuracy have been underscored; if AI can be reliably shown to simulate experienced dermatologists, that would represent a significant advance."6
  • In a randomized, prospective study of DermaSensor utility with 57 GPs, these physicians made over 5,000 assessments of skin lesions. DermaSensor increased physicians’ cancer detection sensitivity from 81% to 94%, and this improvement was statistically significant (p = .0009).2 There was no statistically significant change in the GP’s specificity, or false positive rate, for benign lesions (p = .3558).2
88-97%
DermaSensor’s spectroscopy technology showed a 88-97% sensitivity for melanoma (including highly atypical nevi) in three multi-year, multi-site prospective studies.1,3,4
94%
Skin cancer detection results improved from 81% to 94% with use of the DermaSensor device.2

DERM-SUCCESS Summary Table4

DERM-SUCCESS DeviceGP Assessment
All skin cancers96%83%
Melanoma and Highly Atypical Nevi88%73%
SCC98%84%
BCC98%88%

*Note: Biopsy results with dermatopathologist review were used as gold standard for all three of these studies.

DERM-ASSESS II Summary Table2,7,8

DERM-ASSESS IIDeviceDermatologist
All skin cancers97%96%
Melanoma100%*90%
SCC97%96%
BCC97%100%

*Note: There were only 20 melanomas included in the sample and the study was not powered for melanoma detection.

DERM-ASSESS III Summary Table3

DERM-ASSESS IIIDeviceDermatologist
All skin cancers90%69%
Melanoma96%91%
Melanoma and Highly Atypical Nevi91%72%

DermaSensor Number Needed to Biopsy, NPV/PPV Performance Across Spectral Score Ranges 1-10

DermaSensor Number Needed To Biopsy & PPV

Lesion Type and StudyDevice NNBPPV
GPs for All Skin Cancers6.7417%4
Specialists for Melanoma6.3316%3
Specialists for Melanoma and Highly Atypical Nevi3.8327%3

Device NPV and PPV for Melanoma and Skin Cancers with Real World Estimates

Performance MetricMelanoma3All Skin Cancers4
NPV98%97%
Real World Estimate98%98%
PPV16%17%
Real World Estimate15%12%

*Note: Real World Estimates based on biopsy prevelance of 10% for melanoma by skin specialists and 10% for all skin cancers by non-skin specialists.

Spectral Score Groupings4

Spectral Scores GroupingsPPV (NNB)Frequency of ‘Investigate Further’ Lesions
1-57% (14)64%
6-1033% (3)36%
1-47% (14)56%
5-722% (4.5)25%
8-1040% (2.5)19%

Note: Number neeeded to Biopsy (NNB) assumes all positive device results were biopsied by the HCP. It is calculated by dividing 100 by the PPV.

1Benvenuto-Andrade C, Manolakos D, Cognetta AB. Safety and Effectiveness of Elastic Scattering Spectroscopy and Machine Learning in the Evaluation of Skin Lesions. Poster Presentation, World Congress of Teledermatology, Nov 2020.

2Tepedino K, Tablada A, Barnes E, Da Silva, T. Clinical Utility of a Handheld Elastic Scattering Spectroscopy Tool and Machine Learning on the Diagnosis and Management of Skin Cancer by Primary Care Physicians. Poster Presentation, SDPA Fall Conference, Nov 4-7, 2021.

3DA III- Hartman, R. Tepedino, K., Fung, MA., McNiff, JM., Grant-Kels, J. Clinical Validation of a Handheld Elastic Scattering Spectroscopic Device in the Evaluation of Lesions Suggestive of Melanoma, Presentation at the American Academy of Dermatologists Annual Meeting, Mar 24-28th, 2022.

4Data on file, DermaSensor, Inc.

5Salmon P and Bonning M. Use of Elastic-scattering Spectroscopy and Machine Learning When Assessing Skin Lesions Suggestive of Skin Cancer, Poster Presentation, SDPA Fall Conference, Nov 4-7, 2021.

6Topol E. High-performance medicine: the convergence of human and artificial intelligence. Nature Medicine. 2019;25:44-66.

7For lesions biopsied in DERM- ASSESS II, dermatologist performance (i.e. dermatologist sensitivity and specificity) is based on the study dermatologists’ in-person binary assessment of biopsied lesions as being malignant or benign, prior to receiving pathology results.

8For unbiopsied lesions the dermatologists’ clinical determination of the lesion as benign was used as the reference standard; however, for the dermatologists’ clinical assessment there was no reference standard since no biopsies were performed and accordingly no specificity is reported for their evaluations.

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