DecisionDx^®-SCC Overview

DecisionDx-SCC is now commercially available. DecisionDx-SCC is clinically validated as a significant predictor of metastasis and the strongest predictor of risk compared to traditional clinical and pathological factors. DecisionDx-SCC complements traditional prognostic risk assessment factors, enabling more informed choices about treatment and follow-up care.

Traditional Approaches May Have Limitations

Prior to the introduction of DecisionDx-SCC, risk assessment in SCC relied upon traditional clinical and pathologic prognostic factors. Approximately 20% of SCC patients have one or more clinical or pathological risk factors and suffer the majority of SCC mortality. However, these factors alone are often not specific enough to determine risk-appropriate treatment and further management. Managing SCC is a significant clinical issue, as deaths from SCC are now estimated to exceed those from melanoma.

We saw an opportunity to improve care by adding personalized genomic information to address this situation.  We believed that understanding the biological behavior of a patient’s tumor using the latest molecular diagnostic techniques would enable improvement in risk assessment and subsequent treatment and follow-up planning.

Designed To Identify Risk of Nodal or Distant Metastasis

DecisionDx-SCC, our gene expression profile (GEP) test was designed to identify the risk of metastasis in SCC patients with one or more risk factors, based on the biologic profile of 40 genes within their tumor tissue.  There are now 4 peer-reviewed publications and additional studies involving over 1,100 patients and healthcare providers, to support clinician adoption and payor adoption.

DecisionDx-SCC results may inform a large number of decisions in the treatment pathways for SCC patients with one or more risk factors. Three key areas are anticipated

1. Deciding the intensity of nodal evaluation at time of diagnosis and primary treatment
2. Adjuvant therapy referrals and decisions
3. Deciding the frequency and intensity of follow-up and surveillance.

DecisionDx-SCC is performed on formalin-fixed, paraffin embedded (FFPE) primary tumor tissue from either a biopsy or excision.