Informing risk assessment, improving management decisions for patients with SCC
Accurately identifies the risk of metastasis in high-risk squamous cell carcinoma patients and predicts which patients are most likely to benefit from adjuvant radiation therapy (ART)
DecisionDx-SCC is a validated 40-GEP test that is designed to identify the risk of nodal or distant metastasis in squamous cell carcinoma patients (SCC) with one or more NCCN high or very-high-risk risk factors, based on the biological profile of 40 genes within their tumor tissue. In addition to being the strongest independent predictor of SCC metastasis, DecisionDx-SCC also identifies which patients are most likely to benefit from ART. Test results deliver precision patient classification, complementing commonly used traditional risk factors and improving risk assessment in SCC to inform key clinical management decisions:
- Adjuvant radiation therapy (ART)
- Nodal evaluation; imaging and sentinel lymph node biopsy (SLNB)
- Frequency of follow-up and surveillance
Why DecisionDx-SCC?
Meets an increasing unmet clinical need
Managing SCC in patients diagnosed with one or more risk factors is a significant clinical issue as deaths from SCC are now estimated to exceed those from melanoma. Because treatment and management plans are guided by risk for metastasis, prognostic accuracy has direct implications on patient management. And traditional clinicopathological risk factors alone are often not specific enough to determine risk-appropriate SCC treatment and management.
1. SEER Data Release 2019
2. Mansouri B et al. JAMA Dermatology 2017
Provides more precise and individualized risk prediction of metastasis
Knowing the risk of metastasis helps inform the best management and treatment strategy for patients. The utility of traditional clinicopathologic risk factors is limited by their low positive predictive value, and these traditional risk factors alone are often not specific enough to determine a risk appropriate SCC treatment pathway. Incorporating DecisionDx-SCC test results with traditional risk factors provides enhanced accuracy, helping clinicians tailor risk predictions and personalize treatment or management plans based on each patient's unique tumor profile.
DecisionDx-SCC addresses two critical clinical questions:
Who is eligible for the DecisionDx-SCC test?
DecisionDx-SCC intended use reflects NCCN high and very-high-risk factors.
Patients are eligible for the DecisionDx-SCC test if they have recently been diagnosed with squamous cell carcinoma and have one or more of the risk factors listed below.
Risk factors |
Tumor size ≥2 cm anywhere on the body |
Tumor location on the head, neck, hands, genitals, feet or pretibial surface (areas H or M) |
Immunosuppression |
Rapidly growing tumor |
Tumor with poorly defined borders |
Tumor at site of prior radiation therapy or chronic inflammation |
Neurologic symptoms in region of tumor |
Perineural involvement: (1) Large (≥0.1 mm) or named nerve involvement; (2) Small (<0.1 mm in caliber) |
Poorly differentiated tumor histology |
Depth: (1) Invasion beyond subcutaneous fat; (2) Invasion beyond ≥2mm; (3) Clark level ≥ IV |
Aggressive histologic subtypea |
Lymphovascular invasion |
Desmoplastic SCC |
aAcantholytic (adenoid), adenosquamous (showing mucin production), or carcinosarcomtaous (metaplastic) subtypes (others will be considered on a case-by-case basis)