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Scientific evidence

DecisionDx Squamous Cell Carcinoma

Explore the clinical studies and scientific evidence validating DecisionDx-SCC

DecisionDx-SCC is the only test proven to accurately identify the risk of metastasis in SCC patients with one or more risk factors.

 

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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).

Class 2A and Class2B are independent predictors in multivariate analysis with risk factors. This means that DecisionDx-SCC provides unique information that is complementary to risk assessment for SCC. While deep invasion and poor differentiation were statistically significant in the multivariate analysis, DecisionDx-SCC is the strongest independent predictor of metastasis.

Demonstrated clinical utility 

5,500+

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.

 

Case study depicts how a patient with two high-risk factors may be re-estimated to be a higher-risk stage when their overall metastasis risk accounts for the biological risk results from a DecisionDx SCC test. In this case, because the patient can be re-estimated at a higher-risk stage where recommended management is more intensive, they receive more risk-appropriate care.

Que, et al. JAAD. 2018.

  • The DecisionDx-SCC test can complement our clinical way of assessing risk for patients, allowing us to make better decisions in the management of their care.”

    Jason Newman, MD, FACS | Chief: Hollings Cancer Network, Director: Head and Neck Cancer, Medical University of South Carolina

Scientific references

  1. Wysong, A., Somani, A., Ibrahim, S.F. 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 (cSCC) Patients. Dermatol Ther. (Heidelb) 14, 593–612 (2024). https://doi.org/10.1007/s13555-024-01111-5

  2. 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  
  3. 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  
  4. 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 

  1. 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  

  1. Ruiz, E. S., Brito, K., Karn, E. E., Vidimos, A. T., Campbell, S. R., Wang, D. M., … Koyfman, S. A. (2024). Predicting adjuvant radiation therapy benefit in cutaneous squamous cell carcinoma with the 40-gene expression profile. Future Oncology, 1–10. https://doi.org/10.1080/14796694.2024.2390820
  2. 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  
  3. Sarah T Arron MD PhD, Javier Canueto MD PhD, Jennifer Siegel PhD, Alison Fitzgerald PhD , Anesh Prasai PhD , Shlomo A Koyfman MD , Sue S Yom MD PhD , Association of a 40-Gene Expression Profile With Risk of Metastatic Disease Progression of Cutaneous Squamous Cell Carcinoma (cSCC) and Specification of Benefit of Adjuvant Radiation Therapy, International Journal of Radiation Oncology, Biology, Physics (2024). doi: https://doi.org/10.1016/j.ijrobp.2024.05.022

  4. Somani AK, Ibrahim SF, Tassavor M, Yoo J, Farberg AS. Use of the 40-gene Expression Profile (40-GEP) Test in Medicare-eligible Patients Diagnosed with Cutaneous Squamous Cell Carcinoma (cSCC) to Guide Adjuvant Radiation Therapy (ART) Decisions Leads to a Significant Reduction in Healthcare Costs. J Clin Aesthet Dermatol. 2024 Jan;17(1):41-44. PMID: 38298751; PMCID: PMC10826833.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826833/

  5. Moody, B.R., Farberg, A.S., Somani, AK. et al. Inconsistent Associations Between Risk Factor Profiles and Adjuvant Radiation Therapy (ART) Treatment in Patients with Cutaneous Squamous Cell Carcinoma and Utility of the 40-Gene Expression Profile to Refine ART Guidance. Dermatol Ther (Heidelb) 14, 861–873 (2024). https://doi.org/10.1007/s13555-024-01125-z

  6. Singh G, Tolkachjov SN, Farberg AS, et al. Clinical, Cosmetic and Investig Dermatol. 2023. 16: 925-35. doi: 10.2147/CCID.S403330 

  7. Slater, K., Ryder, E., Gomez-Meade, C. 40-Gene Expression Profile Representative of Metastatic Risk of Squamous Cell Carcinoma in a Mohs Surgical Patient. Cureus. 2023. DOI: 10.7759/cureus.46853

    https://www.cureus.com/articles/169887-40-gene-expression-profile-representative-of-metastatic-risk-of-squamous-cell-carcinoma-in-a-mohs-surgical-patient#!/

  8. 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  
  9. 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  
  10. 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  
  11. 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 
  12. 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 
  13. 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 

  1. Gopal, R., Marquardt, M., Singh, G. et al. Integrating 40-GEP Testing to Improve Clinical Recommendations for Adjuvant Radiation for Cutaneous Squamous Cell Carcinoma: Multidisciplinary Consensus Guidelines. J Clin Aesthet Dermatol. 2024;17(3 Suppl 2):S3–S8. https://jcadonline.com/integrating-40-gep-testing-to-improve-clinical-recommendations-for-adjuvant-radiation-for-cutaneous-squamous-cell-carcinoma-multidisciplinary-consensus-guidelines/

  2. 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. 2023. 22(6), 588–593. https://doi.org/10.36849/JDD.7432  
  3. 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 

  1. 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
  2. National Comprehensive Cancer Network Squamous Cell Skin Cancer, NCCN Guidelines v1.2024.​
  3. Singh G, Tolkachjov SN, Farberg AS, et al. Clinical, Cosmetic and Investig Dermatol. 2023. 16: 925-35. doi: 10.2147/CCID.S403330
  4. 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.  
  5. 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  
  6. 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
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