Scientific Evidence

DecisionDx Squamous Cell Carcinoma

The decision is in the data

DecisionDx-SCC is the only test proven to accurately identify the risk of metastasis in SCC patients with one or more risk factors.

 

Clinical validation 

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. (Ibrahim et al, 2021).

Class 2A and Class2B are independent predictors in multivariate analysis with risk factors. This means that DecisionDx-SCC provides unique information that is complementary to risk assessment for SCC. While deep invasion and poor differentiation were statistically significant in the multivariate analysis, DecisionDx-SCC is the strongest independent predictor of metastasis.

Demonstrated clinical utility 

3,000+

clinicians have ordered DecisionDx-SCC to help inform prognosis and subsequent management decisions

97%

of clinicians would change patient management given DecisionDx-SCC results with 2 risk factors. (Goldberg et al, 2022)

Helping to guide SCC management

DecisionDx-SCC adds valuable information independent of clinical factors or staging criteria, and provides unique, complementary information for SCC management.

 

Case study depicts how a patient with two high-risk factors may be re-estimated to be a higher-risk stage when their overall metastasis risk accounts for the biological risk results from a DecisionDx SCC test. In this case, because the patient can be re-estimated at a higher-risk stage where recommended management is more intensive, they receive more risk-appropriate care.

  • The DecisionDx-SCC test can complement our clinical way of assessing risk for patients, allowing us to make better decisions in the management of their care.”

    Jason Newman, MD, FACS | Chief: Hollings Cancer Network, Director: Head and Neck Cancer, Medical University of South Carolina

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