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According to the Skin Cancer Foundation, one in five persons in the U.S. develops skin cancer before turning 70. For many cancer types, including melanoma, delayed diagnosis is a major challenge. With a localized stage diagnosis of early melanoma, there is a 98 percent 5-year relative survival rate, yet when this deadliest of skin cancers advances to the distant stage, the survival rate drops down to 23 percent. Early detection is imperative to gaining the upper hand in treating melanoma.
Dermatologists still rely on decades-old visual assessments and histopathology as the standard methods to diagnose earlystage melanoma. Diagnosing pigmented lesions suspicions of melanoma using these methods of subjective visual pattern recognition can be challenging even for experts due to inherent limitations. This is why California-based DermTech is bringing a revolution to the diagnosis of skin cancer with precise, scalpel-free, and scar-free melanoma detection. DermTech’s proprietary, pigmented lesion assay (PLA) helps to accurately detect genomic changes of melanoma in its earliest stages.
“We offer a first-of-its-kind, non-invasive, geneexpression test for early detection of melanoma,” says John Dobak, the president and CEO of DermTech. Gene expression changes are detectable long before morphological changes in a mole occur that can be visually ascertained. This genomic atypia, including mutational and gene expression changes, may precede the morphologic change indicative of melanoma. Using genomic analysis, DermTech can detect the malignant changes indicative of early melanoma. DermTech’s diagnostic platform technology exemplifies sophistication in simplicity.
Turning the Tables in Early-stage Melanoma Detection
DermTech’s PLA is an objective test that can be used on pigmented lesions clinically suspicious for melanoma that meet one or more ABCDE criteria to provide accurate and actionable information. With its gene expression technology, the company improves the negative predictive value (NPV) to more than 99 percent, (which means there is less than a 1 percent chance that the DermTech PLA misses melanoma), sensitivity to 91 percent, and specificity to 69 percent while reducing biopsies by over 90%. The DermTech PLAs uses nonadhesive patches that sample the entire mole or lesion in question while preserving the mole for additional diagnostic procedures or monitoring as needed.
The process exemplifies ease of use. The clinician only needs to firmly position adhesive patches on a skin lesion, mark the lesion outline with a permanent marker, and peel the patches with the skin sample before returning the sample to DermTech’s high complexity molecular pathology laboratory. Upon receiving the sample, DermTech’s laboratory carries out genomic analyses to accurately distinguish between benign and malignant lesions. The RNA is extracted from the skin cells, and the expression level of specific genes associated with melanoma is assessed using RT-PCR where two genes—LINC and PRAME—are analyzed to deliver results.
Patients benefit from the convenience of non-invasive, pain-free procedures that reduce unnecessary biopsies and provide customized objective care that inevitably improves patient satisfaction and outcomes. Integrating DermTech’s genomic technology into the current diagnostic pathway can reduce the number of surgical biopsies performed per melanoma found by tenfold—from 25 to about 2.5.
Broadening the Scope of the DermTech PLA
We offer a first-of-its-kind, non-invasive, gene-expression test for early detection of melanoma
“We have developed several unique processes that allow us to extract enough information to run genomic tests that can give a good diagnostic result to clinicians and patients,” mentions Dobak. DermTech has also led the development and use of noninvasive tests for inflammatory skin diseases identifying pathways that are causing them as well as evaluating potential treatment options. The company is collaborating with several large pharma companies in developing targeted drugs for inflammatory diseases.
DermTech’s patches can sample normal or lesional skin, providing a non-invasive platform to improve the overall assessment of inflammatory diseases. Pharma partners can stratify and select patients based on initial skin gene expression profiles, identify biomarkers of specific diseases and disease subsets, and track and predict drug responses. DermTech’s validated platform technology is being used to support drug discovery and development programs focused on cancers and inflammatory diseases in Phase 1-3 clinical trials.
As a revolutionary precision genomic company with a dedicated team of industry experts and strong IP, DermTech has carved a unique niche in the dermatology space. The capability to quickly adapt to changes gives the company a competitive edge in the market. For example, aligning with the emerging need for telehealth services due to the COVID-19 outbreak, DermTech has made its PLA part of the telemedicine solution allowing dermatologists the option to supervise their patient’s sample collection remotely. Further, DermTech is among the first companies to conduct early research on mutation analysis of TERT promoter genes for early melanoma detection and it is doing so noninvasively. “We are planning to add TERT promoter to our PLA test, which helps us improve test performance and accuracy,” says Dobak. The addition of TERT to the PLA, themed PLAplus, increases the sensitivity to detect melanoma to 97%.
As a visionary entrepreneur, Dobak is always looking to conquer new and untouched areas in dermatology by leveraging the potential of DermTech’s gene expression assays. The innovation gene lab at DermTech is now working on incorporating the early detection of Basal cell carcinoma, Squamous cell carcinoma, and cutaneous lymphoma into its portfolio. “We have brought a paradigm shift in the dermatology space. As an agile startup, we are constantly engaged in bringing more radical changes in the way dermatology is practiced, making melanoma detection more objective, accurate, non-invasive, and costeffective,” concludes Dobak.
Company
DermTech
Management
John Dobak, MD President & CEO, DermTech
Description
Global leader in molecular dermatology, developing proprietary, non-invasive, adhesive patch to diagnose melanoma skin cancer in the early stage
DermTech News
DermTech Announces Positive Topline Results From a Study Evaluating the DermTech Melanoma Test (DMT) Across All Skin Types
- Negative predictive value (NPV) higher than 99% regardless of skin type
SAN DIEGO - DermTech, Inc. (NASDAQ: DMTK) (DermTech or the Company), a leader in precision dermatology enabled by a non-invasive skin genomics technology, today reported positive topline results from a study evaluating the foundational gene expression assay component of the DermTech Melanoma Test (DMT) across all skin types in the real-world clinical setting. The peer-reviewed study entitled, “Non-invasive gene expression analysis rules out melanoma with high negative predictive value regardless of skin phototype” was presented at the Winter Clinical Dermatology Conference (January 12-17, 2024).
Utilizing follow-up data and biopsy findings sourced from an extensive registry database, which also formed the foundation for the recently concluded Trust 2 Study, this investigation examined the performance of the DMT in patients with Fitzpatrick skin phototypes I-III (n=4,152) in comparison to its performance in patients with skin phototypes IV-VI (n=130). Consistent with previous DMT studies, lesions on acral skin (palms, soles, and nail beds) were excluded due to the thicker skin on acral sites potentially affecting the non-invasive sample collection method of the test.
For both skin phototype groups (I-III and IV-VI), the negative predictive value (NPV) exceeded 99%, and the 95% confidence interval for the difference in NPV between the groups indicated that there was no statistically significant distinction between the skin phototype groups. Further analysis, specifically focusing on subjects with re-examination of DMT-negative lesions at least 6 months after testing, validated the results observed in the complete cohort. These findings affirm that the performance of the DMT remains consistent across Fitzpatrick skin types.
“This study demonstrated that regardless of a patient’s skin type, the DMT can help clinicians rule out melanoma non-invasively, with an NPV of over 99%,” said Loren Clarke, M.D., chief medical officer, DermTech. “A high NPV means a suspicious pigmented lesion that tests negative is unlikely to be a melanoma. The DMT provides genomic information that can help guide biopsy decisions for suspicious pigmented lesions across all skin types.”
“This study shows that the DMT can help clinicians improve outcomes for cutaneous melanomas in patients of all skin types,” commented Neal Bhatia, M.D., director of Therapeutics Clinical Research and a co-author of the study. “This is significant progress toward making this test available for patients with Fitzpatrick skin types IV-VI, which is important because ruling out melanoma in individuals with these skin types can be particularly challenging.”