Castle Biosciences surpasses 100,000 orders for its flagship risk-stratification test designed to help guide risk-appropriate treatment decisions for patients diagnosed with cutaneous melanoma

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a significant milestone for the Company’s DecisionDx®-Melanoma gene expression profile test, surpassing 100,000 tests ordered. From the launch of DecisionDx-Melanoma through June 30, 2022, the test has been ordered more than 105,000 times by more than 10,200 providers for patients diagnosed with cutaneous melanoma.

“Since I founded the Company, a cornerstone of our strategy has been a keen focus on improved patient care and for DecisionDx-Melanoma, transforming the management of cutaneous melanoma,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “Today, we celebrate reaching this milestone of more than 100,000 clinical orders, which has allowed us the opportunity to make a significant impact in the lives of patients diagnosed with cutaneous melanoma. As we look to tomorrow, we believe that DecisionDx-Melanoma will continue to help clinicians and their patients make improved treatment decisions.”

DecisionDx-Melanoma is designed to inform two clinical treatment questions in the management of cutaneous melanoma:

1. a patient’s individual risk of sentinel lymph node (SLN) positivity and
2. a patient’s personal risk of recurrence and/or metastasis.

Integrating a patient’s tumor biology and their clinicopathologic features, DecisionDx-Melanoma provides comprehensive and actionable results to guide risk-aligned patient care.

DecisionDx-Melanoma’s clinical utility is supported by more than 35 peer-reviewed publications, including two meta-analyses, which the Company believes represents the largest body of data for a cutaneous melanoma prognostic test. The test has been independently validated and studied in more than 9,000 patient samples, including an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma cases. In a recent study in collaboration with the NCI, patients diagnosed with cutaneous melanoma and tested with DecisionDx-Melanoma had a 27% improvement in melanoma-specific survival compared to untested patients, suggesting that DecisionDx-Melanoma test results can aid in providing more risk-aligned treatment plans for improved patient outcomes.¹

About DecisionDx®-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 9,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration resulted in a study to evaluate melanoma-specific survival and overall survival, where patients tested with DecisionDx-Melanoma had better survival rates than untested patients. This data shows that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. DecisionDx-Melanoma has been validated in four archival risk-of-recurrence studies of more than 900 patients and six prospective risk-of-recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.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, 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 predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, myPath Melanoma, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix 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 potential of DecisionDx-Melanoma test results to continue to help clinicians and their patients make improved treatment decisions and help guide patient care by aiding in providing more risk-aligned treatment plans for improved patient outcomes and survival. The words “can,” “believe,” “will” 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 discussed in this press release; actual application of our DecisionDx®-Melanoma test may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended March 31, 2022, 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.

¹Press Release: Expanded SEER Registries Dataset Shows Improved Survival for DecisionDx®-Melanoma Tested Patients Compared to Untested Patients

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