Enabling Access to Prognostic Gene Expression Profile (GEP) Testing for Invasive Melanoma by Leveraging RNA-based Testing in the Diagnostic Workflow
Main Article Content
Keywords
GEP, gene expression profile, prognostic testing, melanoma, ambiguous lesions
Abstract
Background: 31-GEP prognostic testing is an important tool for patients diagnosed with invasive melanoma and stratifies patients into groups at low, intermediate, or high risk of recurrence, metastasis, or death. The pathway to a melanoma diagnosis is not always straightforward and often dermatopathologists utilize molecular testing to assist in the accurate classification of ambiguous lesions, which utilize varied tissue amounts. Separately, the 23-GEP test is an objective molecular ancillary diagnostic test which uses RNA extracted from 9 unstained slides. Both diagnostic (23-GEP) and prognostic (31-GEP) tests are offered from the same laboratory and can utilize the same RNA. Here, 23-GEP clinical order trends are described March through July 2023.
Methods: 23-GEP orders from March through July 2023 were analyzed.
Results: 23-GEP tissue was primarily obtained from shave biopsies (88.6%, where biopsy type was specified). 57.5% of samples were female and median patient age was 49.5 years old. The test result distribution was 61.8% benign, 20.3% malignant, 13.7% intermediate, and 4.2% technical fail. Median turnaround time (TAT) (calculated as receipt of tissue until report date and inclusive of weekends and holidays) of 23-GEP was 4 days (interquartile range = 2, 5). If a 23-GEP-tested clinical order subsequently receives an invasive melanoma diagnosis, 31-GEP can be utilized efficiently without additional tissue and RNA extraction time.
Conclusions: Overall, when the 23-GEP ancillary test is utilized to achieve a confident diagnosis in an otherwise ambiguous neoplasm, rapid access to 31-GEP prognostication without the need for additional tissue can be achieved.
References
2. Busam KJ et. al. JAMA Dermatol. Published online November 8, 2023. doi:10.1001/jamadermatol.2023.4324.
3. Elmore JG et al. BMJ 2017. 357 (1) j2813.
4. Fung et al. J Cutan Pathol 2022. 49 (3) 231-245.
5. Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Cutaneous V.2.2023. National Comprehensive Cancer Network, Inc. 2023.
6. Swetter SM et al. J Am Acad Dermatol. 2019;80(1):208-250.
7. Skin Cancer Prevention Working Group (SCPWG). The use of molecular testing to diagnose ambiguous melanocytic lesions. Published online April 30, 2022.
8. Clarke LE et al. J Cutan Pathol 2015. 42 (4) 244–52.
9. Clarke LE et al. Cancer 2017. 123 (4) 617–28.
10. Ko JS et al. Cancer Epidem Biomar Prev. 2017. 26 (7) 1107–13.
11. Ko JS et al. Human Pathology. 2019. 86 213–21.
12. Clarke LE et al. Personalized Medicine. 17 (5) 361–71.
13. Whitman ED et al. JCO Precision Oncology. 2021;(5):1466-1479.
14. Hsueh EC et al. JCO Precision Oncology. 2021;5(5):589-601.
15. Podlipnik S et al. Cancers. 2022;14(4):1060.
16. Jarell A et al. Future Oncol. 2021;17(36):5023-5031.
17. Bailey CN et al. JCO Precis Oncol. 2023;7:e2300044.
18. Dillon LD et al. Curr Med Res Opin. 2022;38(8):1267-1274.
19. Yamamoto M et al. Curr Med Res Opin. 2023;39(3):417-423.
20. Dhillon S et al. Arch Dermatol Res. 2023;315(8):2295-2302
21. Warf MB et al. Biomark Med. 2015;9(5):407-416.
22. Cook RW et al. Diagn Pathol. 2018;13(1):13. 2020.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution 4.0 International License.
Creative Commons Attribution (CC BY): lets others distribute and copy the article, to create extracts, abstracts, and other revised versions, adaptations or derivative works of or from an article (such as a translation), to include in a collective work (such as an anthology), to text or data mine the article, even for commercial purposes, as long as they credit the author(s), do not represent the author as endorsing their adaptation of the article, and do not modify the article in such a way as to damage the author's honor or reputation.
Authors retain copyright in their work and license the publisher to publish the content. The publisher is the National Society for Cutaneous Medicine, with production and publishing support provided by OJS, Open Journal Systems,see https://pkp.sfu.
Prior to January 2022, authors transferred copyright to the National Society for Cutaneous Medicine. However, all articles are freely available to anyone in the world. There are no subscription fees, page charges, or article processing charges.