WHAT IS NEVOME?
At DermTech, we believe in cutting the uncertainty, not the patient. Nevome is the first test to identify high-risk pigmented lesions by analyzing known mutation risk factors for melanoma. This revolutionary new test uses tissue samples collected non-invasively with an adhesive patch. When combined the Pigmented Lesion Assay (PLA) gene expressed analysis, the additional RNA gene expression and DNA mutation analysis can provide a more complete picture of lesions or moles at high risk for melanoma. Nevome analyzes mutations in BRAF, NRAS and TERT promoter genes, while the PLA analyzes the gene expression of LINC and PRAME.
DNA MUTATION ANALYSIS
The analysis of DNA risk factors includes partial exon sequencing for hotspot mutations of the BRAF, NRAS, and TERT genes. Mutations of these genes are found in early stage (MIS / Stage 1) 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 lesions at risk for cancer at the earliest stages. Double mutation lesions are also associated with histologic criteria of progression including mitotic counts and ulceration. Nevome includes these mutations to identify high risk lesions.
THE DNA ADVANTAGE
The combined RNA/DNA test has a sensitivity of 97% and a negative predictive value of >99%. DermTech’s Nevome is helping to facilitate the early detection of melanoma skin cancer.
WHEN SHOULD I TEST?
Nevome can currently be ordered if the PLA test is positive. Nevome and the PLA are intended for use on pigmented skin lesions, clinically suspicious for melanoma. These lesions may meet one or more ABCDE criteria. Nevome uses include:
- Lesions positive for LINC or PRAME.
- Lesions being followed for change.
- Lesions in cosmetically sensitive areas.
- Lesions on patients with potential contraindications to surgical biopsy including patients that are anti- coagulated, those at risk for infection, and those at risk for poor wound healing or elevated abnormal scarring.
DermTech provides physicians with a non-invasive option for the biopsy of clinically atypical pigmented lesions (or moles) using an adhesive patch rather than a scalpel. DermTech provides highly accurate, objective information to the physician to improve patient care and comfort through advanced molecular pathology gene expression and mutation testing.
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
Ferris L, et al. Clinical Abstract 2018 IID.
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.