Presented at American Society for Dermatologic Surgery (ASDS) 2021 Annual Meeting
FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to inform disease management decisions and improve patient outcomes, today announced oral presentations on its DecisionDx® gene expression profile (GEP) tests for skin cancer at the American Society for Dermatologic Surgery (ASDS) 2021 Annual Meeting, held Nov. 19-21, 2021.
“We are excited to share data further reinforcing the clinical utility of our GEP tests with leading experts and health care professionals,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We believe our DecisionDx tests complement dermatology clinicians’ arsenal of tools and help ensure the best possible outcomes for their patients. The clinically actionable information that our tests provide can help clinicians make informed and personalized treatment decisions for each patient based on their unique biology.”
DecisionDx®-Melanoma:
DecisionDx-Melanoma is Castle’s risk-stratification GEP test that is designed to predict 5-year risk of metastasis, as well as metastasis to the sentinel lymph node (SLN), independent of traditional staging factors. The test’s Integrated Test Result (ITR) includes the traditional class designation of lowest risk (Class 1A), increased risk (Class 1B/2A) or highest risk (Class 2B), as well as a more precise risk prediction for both SLN positivity and risk of recurrence, distant metastasis and melanoma survival in patients with stage I, II or III melanoma through the i31- GEP algorithms (i31-SLNB and i31-Risk of Recurrence (ROR)). The i31-SLNB and i31-ROR are distinct, independently validated algorithms that integrate clinicopathologic features with the DecisionDx-Melanoma score.
Nicholas Taylor, M.D., Ph.D. presented data on DecisionDx-Melanoma through an oral presentation titled “Integrated clinicopathologic data and gene expression profile predict sentinel lymph node positivity and recurrence-free and distant metastasis-free survival in cutaneous melanoma.”
Study background and findings:
- The study's objective was to understand how integrating gene expression profiling with clinical and pathologic features can improve personalized medicine.
- DecisionDx-Melanoma’s continuous score was integrated with clinical and pathologic factors using the proprietary i31-SLNB and i31-ROR algorithms to predict the likelihood of SLN positivity, recurrence-free survival (RFS) and distant metastasis-free survival (DMFS).
- The study results showed that patients with a negative SLN but a high-risk DecisionDx-Melanoma result for RFS had outcomes similar to patients with a positive SLN. In contrast, patients with a positive SLN but a low-risk DecisionDx-Melanoma result had outcomes similar to patients with a negative SLN.
- Overall, the study demonstrated that integrating the DecisionDx-Melanoma continuous risk score with a patient’s clinicopathologic factors can identify patients at the highest and lowest risk for recurrence or metastasis, thereby informing individualized management plans for patients with melanoma.
DecisionDx®-SCC:
DecisionDx-SCC is Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) having one or more risk factors.
An oral presentation on DecisionDx-SCC titled “Incorporation of a prognostic 40-gene expression profile (40-GEP) test into risk assessment of cutaneous squamous cell carcinoma (SCC) in a Mohs micrographic surgery (MMS) treated population” was presented by Sarah T. Arron, M.D., Ph.D.
Study background and findings:
- Mohs micrographic surgery (MMS) is the current standard of care for SCC and is an effective technique for treating high-risk SCCs.
- The objective of the study was to evaluate the potential of DecisionDx-SCC to stratify metastatic risk within a high-risk SCC population treated by MMS, representing patients with the highest likelihood for complete tumor resection.
- The study analyzed 328 patients with National Comprehensive Cancer Network (NCCN) high-risk tumors who were treated with MMS with confirmed clean margins.
- Patients receiving a DecisionDx-SCC Class 2B result had a high metastasis rate of 58.8%, suggesting that this set of patients may benefit from additional adjuvant treatment after MMS.
- Univariate and multivariate Cox regression analysis showed that DecisionDx-SCC provides independent prognostication for metastasis (hazard ratio of 15.12 and a p value of