Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a new independent meta-analysis in Cancers assessing the efficacy of its DecisionDx-Melanoma test in predicting melanoma patient outcomes. The article, titled “The Prognostic Value of the 31-Gene Expression Profile Test in Cutaneous Melanoma: A Systematic Review and Meta-Analysis,” concluded that DecisionDx-Melanoma consistently provides improved risk stratification over staging alone to inform personalized management strategies for patients with CM.¹

“We believe the clinical performance of our DecisionDx-Melanoma test is unmatched by other tests currently on the market, both in its ability to provide precise and clinically meaningful risk stratification as well as accurate predictions of sentinel lymph node positivity,” said Matthew Goldberg, M.D., board-certified dermatologist and dermatopathologist, and senior vice president, medical, of Castle Biosciences. “This independent publication adds to the robust body of evidence supporting DecisionDx-Melanoma and provides a compelling analysis highlighting the broad utility of the test to improve care for patients with melanoma.”

The authors evaluated peer-reviewed articles that analyzed DecisionDx-Melanoma risk class data alongside at least one survival-based metric with a minimum of three years of follow-up. Systematic reviews, meta-analyses and studies without at least three years of patient follow-up were excluded. Following these criteria and additional analyses using Oxford Center guidelines and the Quality in Prognosis Studies (QUIPS) tool, which assesses six domains of bias, a total of 13 studies were included in the meta-analysis.

Across all studies, the DecisionDx-Melanoma test consistently stratified patients into risk groups with significantly different outcomes. The five-year melanoma-specific survival rates were:

• 99.8% (95% CI: 98–100%) for patients with a Class 1A/lowest risk test result,
• 97.6% (95% CI: 92.4–99.3%) for patients with a Class 1B/2A/increased risk test result and
• 83.4% (95% CI: 66.5–92.7%) for patients with a Class 2B/highest risk test result.

Similar trends were observed for recurrence-free and distant metastasis-free survival, showing a significant separation of risk between patients with Class 1A and Class 2B test results.

As summarized by the authors, “the ability to more accurately stratify patients based on their risk of recurrence and metastasis has the potential to significantly improve personalized care strategies, optimizing the balance between treatment efficacy and quality of life for patients with CM.” The findings provide further support for use of the DecisionDx-Melanoma test alongside current staging systems to enhance risk stratification and inform personalized management strategies for melanoma patients.

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 Sept. 30, 2024, DecisionDx-Melanoma has been ordered approximately 183,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

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, 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, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

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 ability of the DecisionDx-Melanoma test to (i) significantly improve care for patients with CM; (ii) consistently provide improved risk stratification over staging alone to inform personalized management strategies for patients with CM; and (iii) provide accurate predictions of sentinel lymph node positivity. The words “believe,” “can,” “could,” “potential” 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 obtained in these studies, including with respect to the discussion of our tests 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 December 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

1. Durgham RA, Nassar SI, Gun R, et al. The Prognostic Value of the 31-Gene Expression Profile Test in Cutaneous Melanoma: A Systematic Review and Meta-Analysis. Cancers. 2024; 16(21):3714. https://doi.org/10.3390/cancers16213714

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