FRIENDSWOOD, Texas — Castle Biosciences, Inc., a company improving health through innovative tests that guide patient care, today announced the publication of a new study in The Journal of Clinical and Aesthetic Dermatology (JCAD) which found that using its DecisionDx-SCC test to guide ART decisions for patients with SCC could result in substantial Medicare healthcare savings of up to approximately $972 million annually.
“The implications of this study are significant, as evidenced by the opportunity to save our overburdened healthcare system hundreds of millions of dollars through use of the DecisionDx-SCC test to guide more risk-appropriate utilization of ART in patients with SCC,” said Ally‐Khan Somani, M.D., Ph.D., lead author, director of Mohs micrographic, reconstructive surgery & cutaneous oncology at SkinMD LLC, and adjunct clinical assistant professor, Department of Dermatology & Otolaryngology-Head and Neck Surgery at Indiana University School of Medicine. “Above and beyond the considerable cost savings is the potential to truly improve SCC patient care by using the test’s results to provide added confidence in decisions to forgo radiation therapy when a patient’s risk of metastasis is low.”
ART has been shown to improve outcomes for patients with SCC who have a high risk of disease progression. As such, high-risk patients are eligible for ART under relevant society guidelines, such as those provided by the American Academy of Dermatology (AAD), the American Society for Radiation Oncology (ASTRO) and the National Comprehensive Cancer Network (NCCN; 2024, v1). NCCN lists three levels of clinicopathologic risk factors (low, high and very high) and recommends consideration of ART for tumors that are classified as high or very high risk. While ART can benefit some patients, selecting patients based upon clinicopathologic factors alone can lead to overtreatment of certain patients who may not experience disease progression. Multiple published studies have shown that DecisionDx-SCC is a significant risk stratification factor for regional and distant metastasis and improves the identification of high-risk patients when used in combination with clinicopathologic factors or staging systems.
Published studies have also demonstrated that clinicians use DecisionDx-SCC test results to guide personalized patient management decisions, such as frequency of follow-up care, surveillance imaging, sentinel lymph node biopsy (SLNB) and the use of ART. Two recent studies support the test’s utility in guiding more informed decisions regarding the use of ART. The first demonstrated DecisionDx-SCC’s ability to risk-stratify a cohort of ART-eligible patients. The second demonstrated that DecisionDx-SCC was able to identify patients who benefitted most from ART, along with those who are less likely to show a significant benefit of ART in controlling metastatic disease progression.
The cost savings article published in JCAD reports the significant, direct healthcare savings that could be realized in the management of SCC patients who use DecisionDx-SCC to guide decisions about ART. In the study, normalized medical claims data identified 22,917 Medicare-eligible SCC patients in the United States who received ART in the 12 months ending June 2022. The weighted average direct cost for ART across four of the most common radiation treatment modalities was found to be $60,693 per patient, or $1.4 billion for all such Medicare-eligible SCC patients annually. Results from the study indicate that using the DecisionDx-SCC test to guide decisions about ART could result in net Medicare healthcare savings of up to approximately $972 million annually. This outcome is based on the distribution of DecisionDx-SCC test results reported in previous studies, with cost reductions attributed to avoiding ART in patients with a DecisionDx-SCC low-risk, Class 1 test result and low rates of disease progression.
About DecisionDx®-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.
Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions.
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