Scientific evidence

The 40-gene expression profile (40-GEP) test enhances risk-aligned guidance for surveillance imaging in high-risk cutaneous squamous cell carcinoma (cSCC)

Oct 2024

Author: Ruiz E, et al.

Publication: Presented at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting

Predicting adjuvant radiation therapy benefit in cutaneous squamous cell carcinoma with the 40-gene expression profile

Sep 2024

The 40-GEP identified patients most likely to benefit from ART (Class 2B) and those that can consider deferring treatment (Class 1).

Author: Ruiz E, et al.

Publication: Future Oncology

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

Jul 2024

DecisionDx-SCC identifies patients at the highest risk of nodal/distant metastasis who may derive the greatest benefit from ART, as well as patients who may have clinical indications for ART but are at low risk of metastasis. Compared with current guidelines, 40-GEP could provide greater specificity concerning the benefit of ART in individual patients.

Author: Arron S, et al.

Publication: International Journal of Radiation Oncology, Biology, Physics

Addition of the 40-gene expression profile (40-GEP) test improves prognostic accuracy and risk stratification for high-risk cutaneous squamous cell carcinoma (HR-cSCC) of the head and neck treated with Mohs micrographic surgery (MMS)

May 2024

Assess the ability of the 40-GEP test to significantly improve metastatic risk prediction of NCCN, AJCC8, and BWH staging systems when included.

 

Author: Ibrahim S, et al.

Publication: Poster, presented at the American College of Mohs Surgery 2024

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

Mar 2024

ART guidance is not determined by the presence of specific clinicopathologic factors, with treated and untreated patients sharing the same risk factor profiles. cSCC risk determination based on NCCN recommendations for clinical factor assessment results in inconsistent use of ART. Including tumor biology-based prognostic information from the 40-GEP refines risk and identifies patients who are most appropriate and likely to benefit from ART, and those that can consider deferring ART

Author: Moody B, et al.

Publication: Dermatology and Therapy

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

Mar 2024

The 40-GEP test demonstrates accurate, independent, clinically actionable stratification of metastatic risk and improves predictive accuracy when integrated into risk classification systems. The improved accuracy of risk assessment when including tumor biology via the 40-GEP test ensures more risk-aligned, personalized patient management decisions.

Author: Wysong A, et. al.

Publication: Dermatology and Therapy

Integrating 40-GEP testing to improve clinical recommendations for adjuvant radiation for cutaneous squamous cell carcinoma: multidisciplinary consensus guidelines

Feb 2024

Combining clinicopathologic staging with the 40-GEP test allows for more accurate prognostic staging of cSCC tumors; this, in turn, improves precision in multidisciplinary treatment recommendations, including the use of ART. The utility of 40-GEP testing has been demonstrated in low-, higher-, and highest-stage cSCC tumors. Additionally, 40-GEP testing has shown greater specificity than current clinicopathologic guidelines in identifying patients at highest risk of nodal or distant metastasis who would most likely benefit from ART, as well as lower risk patients who would benefit less from such therapy. Appropriate use of 40-GEP testing involves a shared decision-making model between the multidisciplinary team and the patient with cSCC, taking into consideration many factors, such as the patient’s risk of metastasis, tumor and nontumor characteristics, and individual preferences. 

Author: Gopal R, et al.

Publication: Journal of Clinical Aesthetic Dermatology

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

Jan 2024

Utilizing the 40-GEP test results to guide ART decision-making would result in material savings to Medicare.

Author: Somani A, et al.

Publication: Journal of Clinical and Aesthetic Dermatology

Incorporating a prognostic gene expression profile test into the mangement of cutaneous squamous cell carcinoma: An expert consensus panel report

Dec 2023

The 40-GEP test provides accurate and independent prognostic information beyond standard staging systems that only incorporate pathologic data. In this consensus paper, 8 dermatologists with significant expertise in diagnosing and managing cSCC concluded that incorporation of GEP testing into national guidelines can help further stratify patients based on risk of metastasis, and thus may improve morbidity and mortality.

Author: Zakria D, et al.

Publication: Journal of Drugs in Dermatology

40-gene expression profile representative of metastatic risk of squamous cell carcinoma in a Mohs surgical patient

Oct 2023

In this case, a more accurate assessment of the state of disease was attained through 40-GEP testing. Traditional staging methods, including AJCC8 and BWH, overestimated our patient’s risk profile. More research needs to be completed surrounding gene testing and metastatic risk. Our goal with this case is to contribute to the growing body of literature surrounding the use of gene expression profile testing in cutaneous cancer.

 

Author: Slater K, et al.

Publication: Cureus

Incorporation of the 40-gene expression profile (40-GEP) test to improve treatment decisions in high-risk cutaneous squamous cell carcinoma (cSCC) patients: case series and algorithm

May 2023

Cutaneous squamous cell carcinoma (cSCC) has become a significant public health issue due to its rapidly rising incidence and an estimated 1.8 million newly diagnosed cases annually. As with other cancers, treatment decisions for patients with cSCC are based primarily on a patient’s risk for poor outcomes. 

Author: Singh G, et al.

Publication: Clinical, Cosmetic and Investigational Dermatology

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)

Nov 2022

The incidence and mortality rates of cutaneous squamous cell carcinoma (cSCC) in the Medicare population are rapidly increasing. The current national guidelines are broad and the available staging systems for stratification are inadequate to accurately guide patient management. 

Author: Saleeby E, et al.

Publication: Skin