A clinical registry case study from Montgomery Medical, Inc.

This page reports real-world DermaSensor results from Montgomery Medical, a two-physician primary care practice in Pennsylvania. Over 12 months of device use, the practice recorded 8.5 times more pathology-confirmed skin cancer diagnoses, a 10.1 times improvement in diagnostic yield, and 33% fewer monthly dermatology referrals.*

Drs. Marcy Goisse and Betty Thomas compared 12 months of practice data before DermaSensor was introduced with the subsequent 12 months of device use.

*Results reflect a single-practice clinical registry and should not be interpreted as outcomes that will occur in every practice.

What Happened When a Primary Care Practice Adopted DermaSensor?

The Montgomery Medical registry compared two 12-month periods: one before DermaSensor was implemented and one after the device became part of the practice’s approach to suspicious skin lesions.

During the pre-device period, 71 lesions underwent further evaluation and 2 were confirmed as malignant, giving a diagnostic yield of 2.8%. During the device-use period, 60 lesions underwent further evaluation and 17 were confirmed as malignant, increasing diagnostic yield to 28.3%. That meant 8.5 times more skin cancers were diagnosed even though fewer lesions were further evaluated. The diagnoses were confirmed by pathology following further investigation of the lesions.

How Much Did Skin Cancer Diagnostic Yield Improve With DermaSensor?

In the Montgomery Medical registry, skin cancer diagnostic yield increased from 2.8% to 28.3%, a 10.1 times improvement. Diagnostic yield measures how often a lesion sent for further investigation is ultimately confirmed as cancer.

For a primary care practice, the finding is notable because the increase in confirmed cancers did not come from sending more lesions for further investigation. Fewer lesions were further evaluated during the device-use period, while substantially more cancers were identified.

Did Dermatology Referrals Increase or Decrease With DermaSensor?

In the Montgomery Medical registry, average dermatology referrals decreased 33%, from 1.5 per month before DermaSensor implementation to 1.0 per month during device use. At the same time, the number of diagnosed skin cancers increased from 2 to 17.

The registry authors concluded that the additional cancers identified reflected changes in lesion management and skin-examination frequency rather than an increase in dermatology referrals.

These are findings from Montgomery Medical and should be viewed as real-world practice experience, rather than as evidence that every practice using DermaSensor will experience the same change in referral volume.

How Did a Primary Care Practice Use the DermaSensor Device?

Montgomery Medical evaluated 125 lesions with DermaSensor during the 12-month device-use period. The patient population was predominantly older and fair-skinned, with a mean age of 63. Ninety percent of patients were aged 40 or older, consistent with the device’s cleared indication.

DermaSensor returned an “Investigate Further” result for 92% of lesions and a “Monitor” result for 8%.

No lesion receiving a “Monitor” result was subsequently found to be malignant in this registry. Among lesions with available pathology results, confirmed cancers included squamous cell carcinoma and basal cell carcinoma.

Did Higher DermaSensor Spectral Scores Correspond to Higher Cancer Risk?

Yes. In the Montgomery Medical registry, the malignancy rate increased as DermaSensor spectral scores increased. An “Investigate Further” result from DermaSensor is accompanied by a score from 1 to 10 reflecting the degree of spectral similarity to malignant lesions in studies.¹

The Montgomery Medical registry found a clear increase in malignancy rate as scores increased: 0% malignant for scores 1-3, 14% for scores 4-7, and 56% for scores 8-10.

Clinician management also changed as scores increased: further investigation was pursued in 14% of low-score lesions, 61% of moderate-score lesions, and 68% of high-score lesions. The registry authors reported that these patterns suggest the score informed clinical management rather than overriding physician judgment.

How Do the Montgomery Medical Results Compare With DermaSensor’s Published Clinical Evidence?

The Montgomery Medical registry findings are directionally consistent with DermaSensor’s published clinical evidence, and they are practice experience rather than trial evidence.

In the DERM-SUCCESS pivotal validation study, which enrolled 1,579 lesions across 22 primary care sites, device sensitivity was 96.3% in patients aged 40 years and older, the FDA-indicated population, and 95.5% across all ages.¹ In the companion multi-reader multi-case utility study, primary care physicians’ management sensitivity increased from 82.0% without the device to 91.4% with it, and their false negative rate decreased by more than half, from 18.0% to 8.6%.³

A single-practice registry does not reproduce the design of a blinded, multi-center clinical trial, and its findings are best read as real-world experience alongside the published studies rather than in place of them.

Where Does DermaSensor Fit in Evaluating Suspicious Skin Lesions?

DermaSensor is designed to provide objective information alongside the physician’s existing clinical assessment.

The handheld device is applied directly to the suspicious lesion and takes five recordings immediately at the point of care, each of which takes a non-invasive sample of lesion tissue. The algorithm analyzes the spectral data and returns one of two results: “Monitor” or “Investigate Further.” An “Investigate Further” result is accompanied by a spectral score from 1 to 10. There is no tissue removal, no incision, and no specimen collection.

The device does not replace visual assessment or physician judgment. Its output is intended to be considered with the totality of clinically relevant information when deciding how a suspicious lesion should be managed.²

For practices considering adoption, the device requires no procedure-room setup and no up-front capital expense, and there are no training seminars or courses needed, just minutes of reading the device Instructions for Use.

Learn more about How DermaSensor Works.

About the Montgomery Medical Clinical Registry

The clinical registry was participated in by Montgomery Medical, Inc. in Smithfield and Brownsville, Pennsylvania, by Marcy Goisse, MD, and Betty Thomas, MD. The analysis compared skin-lesion data and practice metrics from the 12 months before DermaSensor implementation with the subsequent 12 months of device use.

Funding for the registry was provided by DermaSensor Inc. The report analyzed retrospective medical-record data as well as prospective medical-record data following IRB review of the clinical registry.

This registry provides a view of how DermaSensor was used in one primary care practice in routine clinical care. It should be considered alongside DermaSensor’s broader prospective clinical evidence rather than as a substitute for multi-center validation data.

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Indications for Use

The DermaSensor device is indicated for evaluating skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above, to assist in the decision to refer the patient to a dermatologist. The DermaSensor device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm clinical diagnosis of skin cancer.²