The techniques for evaluating lesions suspicious for melanoma are primarily subjective visual assessments. DermTech’s Nevome offers the first non-invasive biopsy platform for aiding the detection of melanoma by analyzing gene expression and known melanoma gene mutations.
WHAT IS NEVOME?
Nevome is the first test to identify high-risk pigmented lesions by analyzing known genomic risk factors for melanoma. This revolutionary new test uses tissue samples collected non-invasively with an adhesive patch biopsy, rather than a surgical scalpel. The test includes both RNA gene expression and DNA mutation analysis to provide a more complete picture of lesions at high risk for melanoma.
DNA MUTATION ANALYSIS
The analysis of DNA risk factors includes partial exon sequencing of the BRAF, NRAS, and TERT genes. Mutations of these genes are found in primary cutaneous and metastatic melanoma. Cancer transformation, as in melanoma, is associated with mutations in specific genes known as driver mutations. Driver mutations in nevi can be viewed as risk factors for melanoma and may help identify the cancer at its earliest stages. BRAF, NRAS, and TERT promoter genes are associated with lesions that have the potential to metastasize. Double mutations in these genes are associated with borderline lesions, melanoma in-situ lesions and invasive melanoma lesions. Nevome includes these mutations to identify high risk lesions.
Nevome’s non-invasive approach may be ideal for patients that are not good candidates for surgical biopsy such as patients with multiple lesions or lesions in cosmetically sensitive areas. This includes patients that have wound healing difficulties, are on blood thinners or are unable to provide adequate care for their wounds. Many patients simply do not want to be cut when another option is available to them.
With a sensitivity of 91%, specificity of 69% and a negative predictive value of 99%, DermTech’s Nevome is helping to facilitate the early detection of melanoma skin cancer.
At DermTech, We Love Making a Difference in Patient Care
“Recently, I had a young female patient with a mildly suspicious lesion on the back of her neck. Given the age of the patient, I am not sure I would have done an invasive biopsy on this lesion. Since I have the non-invasive PLA test in my office, I chose to do that first. The test came back positive for both LINC and PRAME and substantiated the need for a surgical biopsy. The histopathology showed a 1.1mm SS MM. You all may have saved her! The lesion didn’t look that bad, so I may have just photographed it and regularly monitored it. Having the PLA gave me an additional option to obtain objective information to guide my clinical treatment decision.
Wanting further information, I requested DermTech’s Nevome DNA reflex test be performed. The Nevome test detected DNA hot spot driver mutations TERT promoter and BRAF. The additional information provided by Nevome guided my follow-up protocol with this patient to bring her in for more frequent skin checks as well as to perform skin checks on her family members.”
Dr. Brook Brouha, MD, Ph.D.
Board Certified Dermatologist and Dermatopathologist
2018 AAD Abstract
Cancer Genome Atlas Network. Genomic Classification of Cutaneous Melanoma. Cell. 2015 Jun 18;161(7):1681-96. doi: 10.1016/j.cell.2015.05.044. PubMed PMID: 26091043
Shain AH, Yeh I, Kovalyshyn I, Sriharan A, Talevich E, Gagnon A, Dummer R, North J, Pincus L, Ruben B, Rickaby W, D’Arrigo C, Robson A, Bastian BC. The Genetic Evolution of Melanoma from Precursor Lesions. N Engl J Med. 2015 Nov 12;373(20):1926-36. doi: 10.1056/NEJMoa1502583. PubMed PMID: 26559571.
Haqq C, Nosrati M, Sudilovsky D, Crothers J, Khodabakhsh D, Pulliam BL, Federman S, Miller JR 3rd, Allen RE, Singer MI, Leong SP, Ljung BM, Sagebiel RW, Kashani-Sabet M. The gene expression signatures of melanoma progression. Proc Natl Acad Sci U S A. 2005 Apr 26;102(17):6092-7. Epub 2005 Apr 15. PubMed PMID: 15833814
- No. 6,720,145 – “Method of detection of biological factors in epidermis”
- No. 6,949,338 – “Methods and kits for obtaining and analyzing skin samples for the detection of nucleic acids”
- No. 7,183,057 – “Tape stripping methods for analysis of skin disease and pathological skin state”
- No. 7,297,480 – “Method for detection of melanoma”
- Patent Pending No. 62562250. 2017. “Non-invasive skin-based detection methods”
*The test has not been validated for samples collected from mucosal surfaces, the palms of hands, the soles of feet, sites that have been pre-viously biopsied, areas where non-vellus hair cannot be sufficiently trimmed (e.g. scalp), bleeding or ulcerated lesions, pediatric patients, and patients with a Fitzpatrick skin type IV or higher. As with all tests, results should be interpreted by the physician in conjunction with clinical find-ings and patient risk assessment. The test is not intended for screening or for use on non-pigmented lesions, nor should it be used to confirm a clinical diagnosis of melanoma.