DecisionDx®-SCC

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DecisionDx-SCC Overview

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), moderate (Class 2A) or high (Class 2B) biological risk of metastasis. DecisionDx-SCC complements factors commonly used for risk assessment in SCC. The incorporation of the test with traditional risk factors provides additional risk prediction to better inform choices about treatment and follow-up care.

DecisionDx-SCC Clinical Evidence

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.

Univariate Analysis Reproduced Traditional Risk Factors

Clinical Benefits of Using DecisionDx-SCC

DecisionDx-SCC provides higher positive predictive value than previously possible, >50% (Class 2B) compared to >30% for staging (i.e. BWH T2b/T3). DecisionDx-SCC adds valuable information independent of clinical factors or staging criteria: this means the test is providing unique, complementary information for SCC management.

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Class 2A and 2B Are Independent Predictors of Metastasis

DecisionDx-SCC results can inform management decisions within established guidelines.

Treatment Plans May Include

Low Intensity

Low Intensity

  • Surgery, if feasible
  • Clinical nodal exam

Moderate Intensity

Moderate Intensity

  • Surgery, if feasible
  • Consider nodal imaging
  • Consider oncology referral

High Intensity

High Intensity

  • Surgery, if feasible
  • Nodal imaging
  • Consultation: radiation oncology
  • Consultation: medical oncology

Follow-Up Plans May Include

Low Intensity

Low Intensity

  • Clinical follow-up: 1-2x per year
  • Clinical nodal exam

Moderate Intensity

Moderate Intensity

  • Clinical follow-up: 2-4x per year for 3 years
  • Baseline and annual nodal US/CT for 2 years

High Intensity

High Intensity

  • Clinical follow-up: ≥4x per year for 3 years
  • Baseline and 2x per year nodal US/CT for 2 years
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Order DecisionDx®-SCC

For Information

Call: 866-788-9007

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What Is the Testing Process?

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DecisionDx®-SCC Test?

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