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New Data Presented at the 42nd Annual Fall Clinical Dermatology Conference®


Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: A Surveillance, Epidemiology, and End Results (SEER) Program Collaboration


In collaboration with the National Cancer Institute and Surveillance, Epidemiology, and End Results (SEER) program (covering 34% of the U.S. population during the study period) this study sought to:

  • Validate the performance of the 31-GEP for risk stratification in an unselected, prospectively tested cohort.
  • Compare survival outcomes between patients tested with the 31-GEP versus patients not tested with the 31- GEP

Key Results:

  • In a large, unselected prospectively tested cohort of patients with stage I-III CM, the 31-GEP stratified patient mortality risk (both melanoma specific survival [MSS] as well as overall survival [OS]). Consistent with the risk-stratification, the 31-GEP Class result was shown to be a significant and independent predictor for both MSs and OS. This study outcome is consistent with the risk-stratification performance of the 31-GEP, and i31-GEP, as shown in prior prospective as well as retrospective studies.
  • Most important, patients who received 31-GEP test results as part of their clinical care, in addition to traditional clinicopathologic factors, demonstrated improved survival compared to matched patients who only had traditional clinicopathologic factors, that is they only difference is that these latter patients did not receive 31-GEP test results as part of their clinical care and thus did not have this additional information available to determine their treatment and follow-up plan. Of clinical significance is the 3-year MSS Hazard Ratio of 0.73 (0.54-0.97; P=0.028). This Hazard Ratio indicates that patients who received 31-GEP test results as part of their clinical care demonstrated a 27% improvement in MSS at 3-years.
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A prospective clinical utility study demonstrates that physicians use the 40-gene expression profile (40-GEP) to guide clinical management decisions for Medicare-eligible patients with cutaneous squamous cell carcinoma (cSCC)


Management decisions for cSCC patients are determined by the clinician’s evaluation of the risk of disease progression. Contributing to the challenge for implementing risk-appropriate patient management are the limitations of staging systems and treatment guidelines in predicting poor outcomes. A prognostic 40 gene expression profile test (40-GEP) has been validated to accurately stratify risk for metastasis in patients with one or more high risk factors.


The objective of this ongoing prospective study is to capture the impact of 40-GEP testing on clinician recommendations and actions for patients for clinical management of their cSCC undergoing testing as part of their clinical care.


Key Results:

  • In this ongoing, prospective Clinical Utility and Health Outcomes Study (UTILISE), this analysis of Medicare-eligible patients showed that for more than 80% of patients under study, clinicians reported that the 40-GEP had a positive impact toward managing their high-risk SCC patient (i.e., increased confidence in treatment plan, risk-aligned changes, and patient more on board).
  • The 40-GEP impacts physicians’ assessment of risk for their patients with cSCC, which, in line with guidelines, is driving risk-aligned changes in treatment plans.
  • The clinical actionability rates of the 40-GEP for cSCC are comparable to commonly used GEP tests for cancer patients, such as those GEP tests for breast, prostate, and lung cancer.

How Mohs surgeons utilize prognostic testing for high-risk cutaneous squamous cell carcinoma (SCC): a clinical impact study


As Mohs surgeons are a clinical specialty likely to see high-risk SCC patients frequently, a clinical impact study was performed to determine how patient management decisions are impacted by their use of the 40-GEP test.


Key Results:

  • 97% of Mohs surgeons in this study are familiar with or use the 40-GEP test for high-risk SCC patients.
  • Study results determined that clinicopathologic risk factors most likely to cause metastasis are also ones that would prompt usage of the personalized molecular information provided by the 40-GEP.
  • 40-GEP results guide Mohs surgeons to make risk-aligned management plans and increase their confidence in these decisions.
  • Overall, the 40-GEP can focus treatment options in the most risk appropriate manner, allowing for an optimization of healthcare resources and improved patient outcomes.

Performance and clinical decision-making using the prognostic 40-gene expression profile (40-GEP) test in 1,018 patients with high-risk cutaneous squamous cell carcinoma (SCC)


SCC is a common skin cancer with overall favorable prognosis. However, due to its high incidence, mortality exceeds that of melanoma. Broad guidelines, along with lack of standardized and accurate risk assessment methods complicates treatment planning for SCC patients.


This study reports on 40-GEP performance metrics in risk stratification of >1,000 patients and highlight its impact on guiding risk-aligned decisions for patients with SCC.


Key Results:

  • In two independent high-risk SCC cohorts, the 40-GEP consistently demonstrates significant metastatic risk stratification.
  • When cohorts are combined, the 40-GEP continues significant performance in identifying metastatic risk, as shown with patients receiving Class 2A and Class 2B results incurring a 4- and 11-fold increase in metastasis, respectively, when compared to those with Class 1 results.
  • The impact of the 40-GEP on management decisions modeled across this large cohort represents a substantial improvement in risk-aligned clinical decision-making.

A clinical impact study of dermatologists’ use of the 23- or 35-gene expression profile tests to guide surgical excision and enhance management plan confidence


The 23-gene expression profile (GEP) and 35-GEP tests are clinically available, objective ancillary diagnostic tools that facilitate diagnosis of melanocytic lesions with ambiguous histopathology. The tests use proprietary algorithms to produce results of: suggestive of benign neoplasm; intermediate (cannot rule out malignancy); or suggestive of malignant neoplasm with high accuracy.


Communication between the diagnosing dermatopathologist/pathologist and the treating clinician is key to establishing appropriate patient management. There are circumstances when a dermatologist may find additional diagnostic information helpful in determining excision and follow-up actions.


Key Results:

  • GEP results can aid dermatologists in decision making to achieve appropriate management plans.
  • Management changes, including surgical excisions and follow-up frequency, were aligned with GEP results for these uncertain clinical scenarios.
  • Scenario-specific details demonstrate that a personalized approach can be achieved with GEP.
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