This blinded, prospective, multi-center study was conducted at 22 primary care study sites across the United States (18 sites) and Australia (4 sites). Patients with lesions suggestive of skin cancer were clinically assessed by PCPs and then evaluated by the DermaSensor. Patients and PCPs were blinded to device output. All lesions enrolled were biopsied per physician assessments and standard of care. Each lesion’s diagnosis involved 2-5 dermatopathologists, dependent on pathology and discordance. Statistical analyses after study unblinding included standard diagnostic test parameters of the device for detecting skin cancer as well as the influence of lesion and patient factors on device performance.

During study enrollment, five lesions (0.3%) were excluded due to device data capture issues and five lesions (0.3%) due to lack of dermatopathology consensus. A total of 1,005 patients with 1,579 lesions suggestive of skin cancer were enrolled. Among the patients enrolled, 51.4% were female with a mean age of 59 years, and 72.5% of patients were Fitzpatrick Skin Type I-III.

The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer adjunctive diagnostic device with high sensitivity and NPV to help inform PCP decision-making about skin lesions suspicious for cancer that need further evaluation and those that may be monitored. Coupled with clinical exam findings, this device may aid PCPs to improve clinical decisions about suspicious skin lesions (i.e., to refer, or monitor), with this study suggesting device use could rule out 20.7% of suspicious lesions from needing further evaluation. With the device PPV reaching as high as 61%, the device can also help inform which lesions merit urgent evaluation by dermatologists.

In this clinical utility study, 108 PCPs evaluated 50 skin lesions (25 malignant, 25 benign), with and without ESS device output. For each case, high-resolution digital clinical images, the patient’s clinical information, including prior skin cancer history, risk factors, and physical examination results were provided. The PCPs completed a questionnaire about their diagnosis of the lesion, their recommended management decision, and their confidence level in their management decision for each case. Sensitivity and specificity of PCP diagnostic and management with and without the device output were calculated.

PCP participants included U.S. board-certified internal and family medicine physicians with an even distribution of years in practice (range:1-21+ years). PCPs were recruited from across the U.S., including urban and rural areas.

Management sensitivity increased significantly from 82.0% to 91.4% (p=0.003) with device output. Thus, PCPs’ false negative referrals decreased from 18.0% to 8.6%, a relative decrease in false negatives of 52%. Diagnostic sensitivity increased significantly from 71.1% to 81.7% with device output (p=0.008). Specificity was found to decrease non-significantly from 60.9% to 54.7% (p=0.190) for diagnosis and 44.2% to 32.4% (p=0.026) for referrals. Additionally, the effectiveness analyses observed an increase in PCPs’ overall diagnostic performance (i.e. AUC) and confidence level in their management decisions with the use of the handheld DermaSensor. This technology improves sensitivity and inherent validity of skin cancer diagnosis and management. The use of the ESS device in a primary care setting is further supported by a reduction in the subjectivity of the PCPs regarding their evaluations and the limited training required for its use, as well as the increased diagnostic and management performance.

Ten dermatology study centers, across the US and Australia, scanned lesions that they found concerning for melanoma. All dermatologists were blinded to the device results. Gold standard comparison for performance of the device and dermatologists was the biopsy result with multiple dermatopathologist review when consensus was not reached during the primary review process. High resolution digital images and the patient’s clinical information, including prior skin cancer history, risk factors and physical exam results, were recorded for each case. After clinical evaluation, dermatologists reported their diagnosis and confidence level, which provided the physician comparison data. The results evaluated were sensitivity, specificity, Negative Predictive Value for melanoma, melanoma + severely atypical nevi, and all high-risk lesions. Area Under the Curve (AUC) was also calculated and modeled and compared between the study dermatologists and the device performance.

A total of 311 patients with 440 biopsied lesions were evaluated by the study dermatologists, device and dermatopathology results.

The use of the handheld DermaSensor by physicians, in addition to clinical evaluation, may improve melanoma detection. The device was able to identify 96% of melanomas when compared to dermatopathology results.

While this study was conducted by melanoma specialists, given the device’s similar overall performance to these specialists and its simple, non-invasive use, there is potential for the device to be used to help rule in or out lesion referrals for primary care physicians.

Ten dermatology study centers, across the US and Australia, scanned lesions that they found concerning for melanoma. All dermatologists were blinded to the device results. Gold standard comparison for performance of the device and dermatologists was the biopsy result with multiple dermatopathologist review when consensus was not reached during the primary review process. High resolution digital images and the patient’s clinical information, including prior skin cancer history, risk factors and physical exam results, were recorded for each case. After clinical evaluation, dermatologists reported their diagnosis and confidence level, which provided the physician comparison data. The results evaluated were sensitivity, specificity, Negative Predictive Value for melanoma, melanoma + severely atypical nevi, and all high-risk lesions. Area Under the Curve (AUC) was also calculated and modeled and compared between the study dermatologists and the device performance.

A total of 311 patients with 440 biopsied lesions were evaluated by the study dermatologists, device and dermatopathology results.

The use of the handheld DermaSensor by physicians, in addition to clinical evaluation, may improve melanoma detection. The device was able to identify 96% of melanomas when compared to dermatopathology results.

While this study was conducted by melanoma specialists, given the device’s similar overall performance to these specialists and its simple, non-invasive use, there is potential for the device to be used to help rule in or out lesion referrals for primary care physicians.

This melanoma-focused reader study was a web-based, MRMC investigation using clinical information, digital images, and ESS device result data. PCPs were asked to perform 200 reads for 100 skin lesion cases, each presented without and then with ESS device output.

The study examined two aspects of PCP decisions concerning skin evaluation using the device: (1) the impact of the device result on the PCPs’ management decision on whether the lesion should be referred for further evaluation by a dermatologist, and (2) the device’s impact on the PCP’s diagnostic assessment of whether the lesion was malignant or benign.

A total of 118 PCP readers, none of whom participated in prior studies pertaining to the device, completed the study and were eligible for the effectiveness analysis.

The study met the primary endpoint; the area under the receiver operating characteristic (AUROC) of the PCPs aided with the device was 0.671 compared with the AUROC unaided by the device of 0.630, a significant increase (p=0.036).

The device significantly improved physicians’ accuracy in managing lesions suggestive of melanoma, as well as significant increases in sensitivity for all skin cancers and melanoma, while not significantly raising the rate of unnecessary referrals. Moreover, the physicians reported increased confidence in their assessments with the availability of the device result. As such, the device can improve PCP decision making and confidence when managing
lesions suggestive of melanoma.

By enhancing PCP management accuracy and confidence, this FDA-approved device has the potential to optimize resource utilization by minimizing unnecessary referrals and biopsies, saving healthcare dollars, and reducing patient morbidity and concern, while helping to prioritize access for patients with high-risk lesions. Given the rising rates of skin cancer in the US and limited access to dermatologic care, this device has the potential to make a significant impact in skin cancer detection in the primary care setting.

The authors prospectively evaluated 150 patients presenting with self-identified lesions of concern to 3 outpatient dermatology offices. Diagnostic accuracy of device readout (classifying lesions as either “Monitor,” alone, or “Investigate Further,” alongside a score of 1 to 10, indicating spectral similarity to malignant tissue) was compared to blinded dermatologist management decisions and histopathology.

The study included 150 lesions in 72 males and 78 females, with a mean age of 59.6 years.

Malignant lesions were identified in 14.7% of cases (22/150), with melanoma, BCC, and SCC accounting for 3, 9, and 10 cases, respectively.

This study suggests that the ESS device, as a complementary tool, may enhance triage and decision-making for patient-identified lesions to be employed by non-specialists in any clinical setting.

The ESS device identified 138 lesions as “Investigate Further” and 12 as “Monitor.” Sensitivity for detecting malignant lesions was 100%, negative predictive value (NPV) was 100%, specificity was 9.4%, and positive predictive value (PPV) was 15.9%. For lesions with a spectral score of 7 to 10, sensitivity was 86.4%, NPV 96.6%, with specificity increasing to 67.2% and PPV to 31.1%. Compared to dermatologists’ decisions, sensitivity was 95.5%, NPV 75%, specificity 10.7%, and PPV 45.7% (Table II)

• These results were similar to those found in the DERM-SUCCESS pivotal study for
  sensitivity and AUROC as well as lesion distribution across spectral scores.
• Applicability of the device in the PCP setting can be enhanced with development of clear management guidelines for specific lesion types.