TechReview: Exploring the DermaSensor™

Until recently, the approach of identifying skin cancers was commonly a visual self-exam or a clinical exam conducted by a health care provider and/or a dermatologist.  A skin biopsy is the only way to definitively diagnose skin cancer- where a small sample of the suspicious skin is removed and sent to a lab for examination (under a microscope) in search of cancer cells.

HEALTHTECH REPORTER is proud to introduce another non-invasive advancement in skin cancer diagnostics. DermaSensor™ is an AI powered, FDA-cleared innovation designed to help physicians detect skin cancer at the point of care. According to a recent DEMO DAY @ Bard Diagnostics in NYC, clinical educators provided a comprehensive tour of what appears to be a ground-breaking innovation for primary care physicians "offering actionable results to aid in skin cancer detection by assessing cellular and sub-cellular features that cannot be seen visually or dermoscopically". 

DermaSensor™ was designed as a portable and fast-access noninvasive point-of-care assessment tool for primary care physicians to offer additional information about a lesion to aid in their consideration of a referral decision. (DermaSensor™ does not definitively determine whether or not cancer is present, specify what type of cancer may be present, or make any decision for the user.)

By examining the difference in light scattering, DermaSensor™ determines if the skin lesion suggests to “Investigate Further” or “Monitor” - as an immediate output. Elastic Scattering Spectroscopy (ESS) has been validated in 30+ publications on clinical studies. Many studies have shown ESS to provide information that is comparable to histopathologic assessment in the analysis of cellular microscopic structure.*

 

(Image 1-Right) The solid red line is malignant melanocytic lesions. The solid blue line is benign melanocytic lesions and the dotted lines are for malignant non-melanocytic and benign non-melanocytic lesions. And the separation here is the varying spectral signatures for these different categories, and it uses dozens of these wavelengths to discern malignant from benign tissue. for example, it does not use ~600 microns in the center where the lines overlap. That's the reflectance of hemoglobin.

According to Dr. Kiran Chatha (medical science liaison), DermaSensor™ uses the science of Elastic Scattering  Spectroscopy layered with a machine learning algorithm. ESS shines visual light from approximately 350 to 850 nanometers of light onto a given lesion. Based on the reflectance of the intensity of the photons of light, it's able to create a chart which is then compared to spectral signatures which are validated for different tissue types. DermaSensor’s™ tip reflects and records pulses of light off the lesion’s cellular and sub-cellular content. The built-in computer analyzes the light to provide information to help physicians assess skin lesions (including melanomas, squamous cell carcinomas, and basal cell carcinomas) to aid in a referral decision.

DEMO DAY: 

DERMASENSOR PERFORMANCE TEST By Dr. Robert L. Bard

When our scheduler locked down an official device demo of the DermaSensor™, my skin imaging team and I were excited to explore the future of skin cancer detection and how AI truly plays a role in intelligent scanning.  This is the first that we have experienced that inspired the level of confidence to provide immediate objective cancer risk information to PCPs. We originally learned about this technology from Dr. Alina Bridges, Dermatopathologist @ Northwell Health and research collaborator for the DermaSensor™ team. She presented her involvement in an upcoming (FDNY) firefighter skin cancer screening promoted by the American Academy of Dermatology. She also mentioned the technology was being considered for the program. Though the AAD did not learn of this technology in time to evaluate it for this program, she piqued our interest in this device and the science of Elastic Scattering Spectroscopy (EES) as one that may raise the bar for skin cancer detection. 

We stacked the day with patients with chronic skin disorders from basal cell carcinoma, squamous cell carcinoma, and melanoma.  We also brought in patients who recently underwent mohs surgeries to remove malignant lesions.  One by one, the device was surprisingly 'spot on' with its challenge to determine the skin pathologies of each volunteer. We found this performance test to fully quantify each lesion.

My research group conducted their own homework on the technology and found their R&D efforts to rank highly in accuracy and efficacy. With their reported sensitivity rating of 96% and a negative predictive value of 97%, the science of a non-invasive, portable, AI-powered data scanning aligns with our entire med-tech movement trends. 

As a skin cancer radiologist, I have always been passionate about validating pathologies based on a comparative (side by side) view from above the skin and underneath. I relied on the latest quantitative imaging solutions (3D Doppler Ultrasound, Reflectance Confocal Microscopy etc). This DermaSensor™ satisfies both the current status of the malignancy, but its database guides the physician as far as what the malignancy could mean and recommends next steps.

Beneath this simple-looking device holds a vast amount of data to identify a skin anomaly and its malignancy.  I'm told that it is a common question to ask whether this competes with dermatologists, but I immediately see how this actually elevates the reliance between the PCP and the skin specialist. My colleagues in the dermatology society would certainly welcome the benefits that it provides in 1) resulting in more skin cancers detected and referred from primary care, and 2) the objective risk output helps PCPs prioritize referral of high-risk lesions with a PPV of 40% for 8-10 scores (i.e. a NNR of 2.5).

Overall, we found the technology to be quite intelligent and expect the patient care market to embrace this device. It is priced well and is backed by a significant amount of proven research. Their team of dermatology and primary care medical advisors and research collaborators are certainly well recognized in the industry, winning significant votes of confidence within the medical community.

DERMASENSOR MAKES MEDICAL NEWS

The first medical news headline about DermaSensor™  began in May of 2021 where the developers of DermaSensor™  were awarded Breakthrough Device Designation by the FDA-  acknowledging that the DermaSensor™ device is a supportive tool to primary care providers by addressing life-threatening disease and is expected to offer improved effectiveness compared to currently available products. “DermaSensor’s ability to analyze cellular-level features, which is invisible to the human eye even when aided by a dermatoscope, and to accomplish this in seconds, is already empowering clinicians at the important moment of patient assessment and medical decision making", said Cody Simmons, co-founder and Chief Executive Officer of DermaSensor. 

In January 2024, DermaSensor™ received official FDA clearance of its First-In-Class Device and is shaping the future of its market by winning deserved recognition and innovation awards for its continued advancement in cancer diagnostics. An article in Nature agrees, as it describes the FDA’s authorization of this device as “a pivotal moment in digital health innovation” and “establishes a new regulatory precedent for FDA authorization of medical devices incorporating AI and ML technologies within dermatology.”

SPECIAL THANKS:  We wish to express our deep appreciation for the generosity of Mr. Cody Simmons (CEO), Dr. Kiran Chatha, Ms. Ruth Stachura and Dr. Alina Bridges- with whose kind efforts this report could not have been made possible. Healthtech Reporter and Dr. Bard are in no way compensated nor otherwise conflicted with DermaSensor, Inc.

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