New data demonstrate the potential impact of DecisionDx®-SCC test results to guide risk-aligned patient management plans and increase confidence in disease management decisions

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, is presenting data highlighting its portfolio of skin cancer gene expression profile (GEP) tests at the 2022 American Society for Dermatologic Surgery (ASDS) Annual Meeting, being held Oct. 6-10 in Aurora, Colorado, including new data highlighting impactful changes in risk-aligned patient management strategies after clinicians received DecisionDx®-SCC test results.

DecisionDx-SCC is Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients diagnosed with cutaneous squamous cell carcinoma (SCC) who have one or more high-risk factors. The test stratifies patients into one of three classes based on their biologic risk of metastasis: Class 1 (low risk), Class 2A (moderate risk) or Class 2B (high risk).

“Incorporating DecisionDx-SCC test results into existing risk-assessment frameworks can give clinicians confidence that they are making informed and risk-appropriate decisions regarding the overall treatment intensity of their high-risk SCC patients,” said study investigator Sarah T. Arron, M.D., Ph.D., board-certified dermatologist and Mohs surgeon with Peninsula Dermatology in Burlingame, California. “In the study, 42% of Mohs surgeons reported greater confidence in their patient management decisions when using the personalized, risk-stratification information provided by DecisionDx-SCC test results.”

The study data is available in a pre-recorded oral presentation given by Dr. Arron and titled “How Mohs surgeons utilize prognostic testing for high-risk cutaneous squamous cell carcinoma (SCC): a clinical impact study.”

Study highlights:

• A clinical impact survey was distributed to current American College of Mohs Surgery (ACMS) members; a total of 39 members provided responses to a variety of questions, including their familiarity with DecisionDx-SCC and their approach to a number of treatment modalities for a high-risk SCC patient, pre- and post-DecisionDx-SCC test results.
• 97% of respondents were at least somewhat familiar with or had used the DecisionDx-SCC test.
• Several National Comprehensive Cancer Network (NCCN) high- or very-high risk factors, such as perineural involvement, lymphatic or vascular involvement, poor differentiation and more, that the clinicians believed were the most influential in the development of metastasis were also considered reasons to use DecisionDx-SCC.
• Additionally, the survey highlighted a risk-appropriate trend where respondents’ overall approach to patient management intensity increased as the DecisionDx-SCC test results indicated an increased risk of metastasis and decreased when test results indicated a lower risk.
• 42% of Mohs surgeons reported increased confidence in management decisions when DecisionDx-SCC test results were provided.
• Overall, the study demonstrates how DecisionDx-SCC test results can assist Mohs surgeons in making risk-aligned management plans and increase confidence in their treatment decisions.
• Additionally, the study suggests that DecisionDx-SCC can focus treatment options in the most risk-appropriate manner, allowing for an optimization of healthcare resources and improved patient outcomes.

The following pre-recorded oral presentations highlighting Castle’s other GEP tests for skin cancer are also available during the ASDS annual meeting:

DecisionDx®-Melanoma

• “Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: a Surveillance, Epidemiology, and End Results (SEER) collaboration” will be presented by Sarah J. Kurley, Ph.D., director of evidence development at Castle Biosciences.
• “The 31-gene expression profile test stratifies the risk of recurrence in patients with T1 cutaneous melanoma” will be presented by Abel Jarell, M.D., board-certified dermatologist and dermatopathologist with Northeast Dermatology Associates, P.C., in Portsmouth, New Hampshire.

DecisionDx®-SCC

• “Integration of the 40-gene expression profile (40-GEP) for management and treatment of high-risk cutaneous squamous cell carcinoma (cSCC)” will be presented by Gaurav Singh, M.D., M.P.H., F.A.A.D., board-certified dermatologist and Mohs surgeon.

Diagnostic GEP Tests, MyPath® Melanoma and DiffDx®-Melanoma

• “A clinical impact study of dermatologists’ use of MyPath Melanoma and DiffDx-Melanoma: diagnostic gene expression profile tests guide surgical excision and enhance management plan confidence” will be presented by Aaron S. Farberg, M.D., F.A.A.D., board-certified dermatologist and Mohs surgeon with Derm Texas and Baylor Scott & White Health System in Dallas, Texas.

About DecisionDx®-Melanoma

DecisionDx-Melanoma is a risk stratification gene expression profile test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) 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 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma.

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), 2A (moderate) or 2B (high) 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 MyPath® Melanoma and DiffDx®-Melanoma

MyPath Melanoma and DiffDx-Melanoma are Castle’s two gene expression profile tests designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

More information about Castle’s tests 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, 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-SCC test results to (i) guide risk-aligned patient management plans, (ii) give clinicians confidence that they are making risk-appropriate decisions regarding the overall treatment intensity of their high-risk SCC patients and (iii) focus treatment options in the most risk-appropriate manner and allow for an optimization of healthcare resources and improved patient outcomes. The words “can,” “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 suite of skin cancer 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 Quarterly Report on Form 10-Q for the three months ended June 30, 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.

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