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Informing risk assessment, improving management decisions
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
Why DecisionDx-SCC?
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1
TRADITIONAL RISK FACTORS MISS BIOLOGICAL RISK
The DecisionDx-SCC test provides strong, consistent information, and is an independent risk stratification tool for SCC patients with one or more risk factors. The DecisionDx-SCC test is prognostic and predictive, and provides individualized information about the estimated risk of metastasis of SCC.
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DECISIONDX-SCC INFORMS RISK-APPROPRIATE PATIENT MANAGEMENT
Results deliver precision patient classification to identify patients with high biological risk who would otherwise be deemed low risk using traditional risk stratification methods.
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3
WHY GENOMIC TESTING, AND NOT GENETIC TESTING?
Genetic tests help people understand their risk of getting cancer. Genomic tests personalize cancer treatment for those patients diagnosed with the disease.
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.
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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