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TEST:
DecisionDx®-SCC

Type:
Laboratory Developed Test
Related tests:
Evidence

News

3ms
New Evidence Published Supporting Use of DecisionDx®-SCC Test in Guiding and Improving Treatment Pathway Decisions in NCCN High-Risk Cutaneous Squamous Cell Carcinoma (Castle Biosciences Press Release)
"Castle Biosciences, Inc...today announced the publication of two new studies related to its DecisionDx-SCC test, adding to its validated uses for patients with high-risk cutaneous squamous cell carcinoma (SCC).1,2 DecisionDx-SCC is a gene expression profile test (40-GEP) designed to use a patient’s tumor biology to predict individual risk of metastasis as well as response to adjuvant radiation therapy (ART).:"
Clinical data
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DecisionDx®-SCC
8ms
Castle Biosciences’ DecisionDx®-SCC Data Earns Top Five Abstract at NCCN 2025, Shows Significantly Enhanced Risk Stratification Beyond Current Staging Within NCCN Risk Groups (Castle Biosciences Press Release)
"Castle Biosciences...will share new data on its risk-stratification tests for patients with skin cancers, DecisionDx-SCC and DecisionDx-Melanoma, via two poster presentations at the NCCN 2025 Annual Conference, being held March 28-30 in Orlando, Florida."
Clinical data
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DecisionDx® DiffDx-Melanoma • DecisionDx®-SCC
11ms
Castle’s Poster on DecisionDx®-SCC Selected as a “Late Breakers” Top Five Finalist for the Akamai Award, Recognizing the Best Posters at Maui Derm Hawaii 2025 (Castle Biosciences Press Release)
"Castle Biosciences, Inc...will share data supporting its dermatologic portfolio of tests for skin cancer, DecisionDx-SCC, DecisionDx®-Melanoma and MyPath® Melanoma, through poster presentations at the annual Maui Derm Hawaii meeting, being held Jan. 20-24, 2025, in Maui, Hawaii."
Clinical data
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DecisionDx®-SCC
12ms
The Role of Gene Expression Profiling in the Management of Cutaneous Squamous Cell Cancer: A Review. (PubMed, Cancers (Basel))
Finally, we discuss the implications for future cSCC management and highlight areas for further research. As molecular profiling techniques continue to evolve, GEP represents a promising approach to optimizing care for cSCC patients, aligning with the growing emphasis on personalized medicine in oncology.
Review • Journal
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DecisionDx®-SCC
12ms
Primary Cutaneous Rhabdoid Squamous Cell Carcinoma: A Case Report and Review of Molecular Features. (PubMed, Cureus)
We discuss potential molecular events underlying this transformation. This case highlights the importance of recognizing this rare variant and its implications for patient management and prognosis.
Journal • Review
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TP53 (Tumor protein P53) • VIM (Vimentin) • KRT5 (Keratin 5)
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VIM expression
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DecisionDx®-SCC
1year
New Data at ASTRO 2024 Shows Castle Biosciences’ DecisionDx-SCC Test Provides More Precise Risk Stratification Than BWH Staging Alone to Guide Intensified Treatment for Immune Suppressed Patients with High-Risk Cutaneous Squamous Cell Carcinoma (Businesswire)
P=NA | N=954 | "The data will be shared in an oral presentation at the American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting....Patients with T1 tumors had similar metastasis-free survival (MFS) rates regardless of immune status yet were further stratified by their DecisionDx-SCC test result (3-year MFS: Class 1 test result: 96.9% vs. Class 2A/2B test result: 88.6%, p<0.001). Immune suppressed patients with T2a tumors had significantly worse MFS than immune competent patients with T2a tumors (71.4% vs. 91.2%, p<0.001). DecisionDx-SCC further stratified immune suppressed patients with T2a tumors into those with more favorable (Class 1 test result; 3-yr MFS of 83%) and less favorable survival (Class 2A/2B test result; 3-yr MFS of 57%)."
Clinical data
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DecisionDx®-SCC
1year
40-Gene expression profile test predicting metastatic risk in localized, high-risk cutaneous squamous cell carcinoma for peer review. (PubMed, SAGE Open Med Case Rep)
The patient successfully underwent Mohs surgery, and pathology was notable for positive perineural invasion of large caliber nerves. This case highlights the potential of the 40-gene expression profile as an independent predictor in assessing metastatic risk compared to traditional staging methods.
Journal • Review • Gene Expression Profile • Metastases
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DecisionDx®-SCC
1year
Study Confirms the Ability of Castle Biosciences’ DecisionDx-SCC Test to Predict Likelihood of Benefit from Adjuvant Radiation Therapy in Patients with High-Risk Cutaneous Squamous Cell Carcinoma (Businesswire)
P=NA | N=399 | "Castle Biosciences, Inc...today announced the publication of a new study in Future Oncology further substantiating use of its DecisionDx-SCC test in guiding patient selection and decision-making related to the use of ART in patients with high-risk SCC based on the ability of the test to identify patients likely to benefit from treatment...'In this study, we were successful in validating, in an independent SCC patient cohort, that DecisionDx-SCC can objectively inform these challenging decisions by identifying patients for whom ART would be beneficial, as well as those who may be best served by avoiding it. In the study, a novel, independent cohort of patients with high-risk SCC tumors (399 patients; 423 tumors) from two academic centers were tested using DecisionDx-SCC and analyzed for five-year metastasis-free survival and projected time to metastasis."
Clinical data
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DecisionDx®-SCC
over1year
Predicting adjuvant radiation therapy benefit in cutaneous squamous cell carcinoma with the 40-gene expression profile. (PubMed, Future Oncol)
Aim: To independently confirm that the 40-gene expression profile (40-GEP) test can identify patients with high-risk cutaneous squamous cell carcinoma who are more or less likely to benefit from adjuvant radiation therapy (ART).Materials & Primary cutaneous squamous cell carcinoma tumors from two academic centers received retrospective 40-GEP testing and were analyzed for 5-year metastasis-free survival and projected time to event. Random sampling of matched patient pairs (n = 52 ART-treated; 371 no ART) showed a median 50% decrease in 5-year progression rate for ART-treated patients (vs no ART) with 40-GEP Class 2B. Class 2A was associated with a modest ART benefit, but not Class 1. The 40-GEP identified patients most likely to benefit from ART (Class 2B) and those that can consider deferring treatment (Class 1).
Journal • Gene Expression Profile
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DecisionDx®-SCC
over1year
Utility of the 40 gene expression profile (40-GEP) test in refining risk of metastasis in high-risk cutaneous squamous cell carcinoma (HR-cSCC) patients stratified through a clinicopathological prognostic nomogram. (EADV 2024)
The nomogram classified 9 out of 10 tumors that metastasized as lower risk. However, the 40-GEP classified 70% of tumors missed by the nomogram as high-risk Class 2. These data demonstrate that 40-GEP improves risk stratification of NCCN high or very high-risk patients who were categorized as low-risk by this nomogram.
Clinical • Gene expression profiling • Gene Expression Profile
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DecisionDx®-SCC