Scientific Evidence
The decision is in the data
DecisionDx-SCC is the only test proven to accurately identify the risk of metastasis in SCC patients with one or more risk factors.
Clinical validation
DecisionDx-SCC is validated to predict metastatic risk for individual SCC patients with one or more risk factors. Independent validation was established in a prospectively designed, multi-center (33 centers) study with archival tissue, in 420 patients, with known 3-year outcomes.
The study population was representative of a high-risk SCC population. Multivariate analysis shows DecisionDx-SCC provides the strongest independent prognostic information in SCC patients with one or more high-risk factors. (Ibrahim et al, 2021).
Demonstrated clinical utility
3,000+
clinicians have ordered DecisionDx-SCC to help inform prognosis and subsequent management decisions
97%
of clinicians would change patient management given DecisionDx-SCC results with 2 risk factors. (Goldberg et al, 2022)
Helping to guide SCC management
DecisionDx-SCC adds valuable information independent of clinical factors or staging criteria, and provides unique, complementary information for SCC management.
Que, et al. JAAD. 2018.
Scientific references
- Wysong A, Newman J, Covington K, et al. Validation of a 40-gene expression profile test to predict metastatic risk in localized high-risk cutaneous squamous cell carcinoma. Journal of the American Academy of Dermatology: JAAD. 2021. 84(2), 361–369. https://doi.org/10.1016/j.jaad.2020.04.088
- Ibrahim, S. F., Kasprzak, J. M., Hall, M. A., et al. Enhanced metastatic risk assessment in cutaneous squamous cell carcinoma with the 40-gene expression profile test. Future oncology. 2021. 18(7), 833–847. DOI: 10.2217/fon-2021-1277
- Arron, S. T., Wysong, A., Hall, M. A., et al. Gene expression profiling for metastatic risk in head and neck cutaneous squamous cell carcinoma. Laryngoscope investigative otolaryngology. 2022. 7(1), 135–144. DOI: 10.1002/lio2.724
- Borman, S., Wilkinson, J., Meldi-Sholl, L., et al. Analytical validity of DecisionDx-SCC, a gene expression profile test to identify risk of metastasis in cutaneous squamous cell carcinoma (SCC) patients. Diagnostic pathology. 2022. 17(1), 32. Doi: 10.1186/s13000-022-01211-w
- Teplitz R, Prado G, Litchman G, et al. Impact of Gene Expression Profile Testing on the Management of Squamous Cell Carcinoma by Dermatologists. Journal of drugs in dermatology : JDD. 18(10), 980–984. Link to article
- Farberg A, Hall M, Douglas L, et al. Integrating gene expression profiling into NCCN high-risk cutaneous squamous cell carcinoma management recommendations: impact on patient management. Current Medical Research and Opinion. 2020. 36:8, 1301-1307, DOI: 10.1080/03007995.2020.1763284
- Litchman G, Fitzgerald A, Kurley SJ, et al. Impact of a prognostic 40-gene expression profiling test on clinical management decisions for high-risk cutaneous squamous cell carcinoma. Current Medical Research and Opinion. 2020. 36:8, 1295-1300, DOI: 10.1080/03007995.2020.1763283
- Au, J.H., Hooper, P.B., Fitzgerald, A.L. et al. Clinical Utility of the 40-Gene Expression Profile (40-GEP) Test for Improved Patient Management Decisions and Disease-Related Outcomes when Combined with Current Clinicopathological Risk Factors for Cutaneous Squamous Cell Carcinoma (cSCC): Case Series. Dermatol Ther. (Heidelb) 12, 591–597 (2022). https://doi.org/10.1007/s13555-021-00665-y
- Farberg, A.S., Fitzgerald, A.L., Ibrahim, S.F. et al. Current Methods and Caveats to Risk Factor Assessment in Cutaneous Squamous Cell Carcinoma (cSCC): A Narrative Review. Dermatol Ther. (Heidelb) 12, 267–284 (2022). https://doi.org/10.1007/s13555-021-00673-y
- Hooper P, Farberg A, Fitzgerald A, et al. Cancer Investigation. 2022. VOL. 40, NO. 10, 911-922. https://doi.org/10.1080/07357907.2022.2116454
- Saleeby, E., Bielinski, K., Fitzgerald, A, et al. A Prospective, Multi-Center Clinical Utility Study Demonstrates That the 40-Gene Expression Profile (40-GEP) Test Impacts Clinical Management for Medicare-Eligible Patients with High-Risk Cutaneous Squamous Cell Carcinoma (cSCC). SKIN The Journal of Cutaneous Medicine. 2022. 6(6), 482–496. Doi: https://doi.org/10.25251/skin.6.6.5
- Singh G, Tolkachjov SN, Farberg AS, et al. Clinical, Cosmetic and Investig Dermatol. 2023. 16: 925-35. doi: 10.2147/CCID.S403330
- Arron, S., Cañueto, J., Siegel, J., Fitzgerald, A., et al. Association of a 40-Gene Expression Profile (40-GEP) with Risk of Metastatic Disease Progression of Cutaneous Squamous Cell Carcinoma (cSCC) and Benefit of Adjuvant Radiation Therapy (ART). SKIN The Journal of Cutaneous Medicine. 2024. 8(1), s335. https://doi.org/10.25251/skin.8.supp.335
- Arron, S. T., Blalock, T. W., Guenther, J. M., et al. Clinical Considerations for Integrating Gene Expression Profiling into Cutaneous Squamous Cell Carcinoma Management. Journal of drugs in dermatology : JDD. 2021. 20(6), 5s–s11. https://doi.org/10.36849/JDD.2021.6068
- Zakria, D., Brownstone, N., Armstrong, A. W., et al. Integrating Precision Medicine into Medical Dermatology Clinical Practice: An Expert Consensus Panel. Journal of drugs in dermatology : JDD. 2024. 22(6), 588–593. https://doi.org/10.36849/JDD.7432
- Wysong A, Somani A, Ibrahim S, et al. Integrating the 40-Gene Expression Profile (40-GEP) Test Improves Metastatic Risk-Stratification Within Clinically Relevant Subgroups of High-Risk Cutaneous Squamous Cell Carcinoma. Dermatology & Therapy. 2024. https://doi.org/10.1007/s13555-024-01111-5
- Ibrahim, S. F., Kasprzak, J. M., Hall, M. A., et al. Enhanced metastatic risk assessment in cutaneous squamous cell carcinoma with the 40-gene expression profile test. Future oncology. 2021. 18(7), 833–847. DOI: 10.2217/fon-2021-1277.
- Wysong A, Newman J, Covington K, et al. Validation of a 40-gene expression profile test to predict metastatic risk in localized high-risk cutaneous squamous cell carcinoma. Journal of the American Academy of Dermatology: JAAD. 2021. 84(2), 361–369. https://doi.org/10.1016/j.jaad.2020.04.088
- National Comprehensive Cancer Network Squamous Cell Skin Cancer, NCCN Guidelines v1.2024.
- Alam M, Armstrong A, Baum C, et al. Guidelines of care for the management of cutaneous squamous cell carcinoma. Journal of the American Academy of Dermatology: JAAD. 2018. 78 (3):560-578. doi: 10.1016/j.jaad.2017.10.007
- Singh G, Tolkachjov SN, Farberg AS, et al. Clinical, Cosmetic and Investig Dermatol. 2023. 16: 925-35. doi: 10.2147/CCID.S403330