scc metastasis, cutaneous squamous cell carcinoma, scc test

Informing Risk Assessment, Improving Management decisions

DecisionDx Squamous Cell Carcinoma

Accurately identifies the risk of metastasis in SCC patients with one or more risk factors

DecisionDx-SCC is a validated 40-GEP test that is designed to identify the risk of nodal or distant metastasis in squamous cell carcinoma (SCC) patients with one or more risk factors, based on the biological profile of 40 genes within their tumor tissue. It is the strongest independent predictor of SCC metastasis. DecisionDx-SCC 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

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. When the DecisionDx-SCC test is incorporated with traditional risk factors, it provides improved accuracy, thus enabling clinicians to personalize additional risk prediction and invaluable information you can use to personalize a treatment or management plan specifically for each patient's individual tumor profile.

Biological risk stratification adds prognostic value

DecisionDx-SCC is a genomic test that was developed to predict metastatic risk for SCC patients with one or more risk factors. The test classifies patients as low (Class 1), higher (Class 2A) or highest (Class 2B) biological risk of metastasis.

 

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. 

There are twice as many annual SCC death in the U.S. as melanoma. 1/3 of SCC patients are under-staged as low risk.

1. SEER Data Release 2019
2. Mansouri B et al. JAMA Dermatology 2017

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), agenosquamous (showing mucin production), or carcinosarcomtaous (metaplastic) subtypes (others will be considered on a case-by-case basis)

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