DecisionDx®-Melanoma Can Identify Melanoma Patients with Low Risk of Sentinel Lymph Node Positivity Who May Safely Forego Biopsy Surgery, New Independent Study Affirms
Using the DecisionDx-Melanoma test to guide sentinel lymph node biopsy (SLNB) surgery decisions could have significantly reduced the number of unnecessary SLNBs by 33% for patients with T1-T2 melanoma tumors
“While SLNB is a common procedure used to determine possible tumor metastasis, our current criteria for biopsy may be overestimating a person’s risk of having a positive node, meaning we are probably performing more surgeries than necessary,” said lead author
“Our DecisionDx-Melanoma test has significant clinical utility in helping to rule-out and rule-in SLNB procedures, as this study showed,” added
The DecisionDx-Melanoma test integrates a patient’s tumor biology with their personal clinicopathologic factors to help answer the likelihood of SLN positivity and risk of recurrence in patients with melanoma. Current National Comprehensive Cancer Network (NCCN) guidelines suggest foregoing SLNB when the likelihood of finding a positive SLN is less than 5%, to consider SLNB when between 5-10% and to offer the surgery when the likelihood is above 10%. This study evaluated the performance of DecisionDx-Melanoma in predicting the risk of SLN positivity in 156 melanoma patients with known SLN outcomes at the
In the study, none of the patients (0/30) considered low-risk by the DecisionDx-Melanoma test (less than 5% predicted risk of SLN positivity) had a positive SLN, compared to a 31.9% SLN positivity rate (30/94, p<0.001) in patients predicted to have greater than 10% risk by the test. Of the 91 patients in the study who had
The results of this study demonstrate that DecisionDx-Melanoma can allow for more precise and personalized management of melanoma patients, improving patient selection for the SLNB surgical procedure and reducing unnecessary procedures and their associated healthcare costs. Moreover, the data provide evidence that DecisionDx-Melanoma can identify patients with a low risk of SLN positivity who may safely forego SLNB, as well as those with a higher risk who may want to consider the surgery.
About DecisionDx®-Melanoma
DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node positivity and a patient's personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through
About
Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. 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. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the continued ability of the DecisionDx-Melanoma test to precisely predict SLN positivity risk, guide risk-aligned SLNB decisions and allow certain patients to safely forego SLNB. The words “can,” “may” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results shown in this study, including with respect to the discussion of DecisionDx-Melanoma in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended
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