Castle Biosciences to Highlight Clinical Value of Its Skin Cancer Tests at the 2023 American Academy of Dermatology (AAD) Annual Meeting

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that new data supporting its portfolio of skin cancer gene expression profile (GEP) tests will be showcased in one late-breaking oral presentation and three ePosters at the 2023 American Academy of Dermatology (AAD) Annual Meeting, being held March 17-21 in New Orleans.

“At Castle, we believe our tests help clinicians make more informed decisions in the care of patients with skin cancers,” said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. “As such, we focus strongly on continued evidence development to demonstrate where our tests can add value to clinical decision-making to improve outcomes for patients. In collaboration with leading physicians across the U.S., we are proud to present new data at this year’s AAD meeting highlighting the utility of our dermatologic tests as part of our commitment to advancing patient care.”

Following are details for the four abstracts that were accepted at AAD. Abstract content for the ePosters will be available in the online viewing portal beginning the first day of the meeting and on-site using the computers at the Poster Exhibit Presentation Center. They will also be published online via the JAAD supplement in Fall 2023.

DecisionDx®-SCC

Late-breaking oral presentation title: The 40-gene expression profile (40-GEP) continues to demonstrate independent metastatic risk stratification and improved accuracy in risk assessment in a novel cohort of cutaneous squamous cell carcinoma (cSCC) patients with one or more risk factors

Presenter and Lead Author: Ashley Wysong, M.D., M.S., Department of Dermatology, University of Nebraska Medical Center

Date: March 18, 2023

Time: 3:40-3:50 p.m. Central time

Location: New Orleans Ernest N. Morial Convention Center, Theater B

ePoster title: Clinicians’ use of the 40-gene expression profile (40-GEP) test for high-risk cutaneous squamous cell carcinoma (SCC) patients is consistent with intended use parameters

Lead Author: Gaurav Singh, M.D., Milwaukee

Abstract Number: 44006

DecisionDx®-Melanoma

ePoster title: The 31-gene expression profile test for cutaneous melanoma identifies patients with stage IB-IIA disease who have recurrence risk similar to that of stage IIB-IIC disease

Lead Author: Abel Jarell, M.D., Northeast Dermatology Associates, P.C., Portsmouth, New Hampshire

Abstract Number: 43858

MyPath® Melanoma

ePoster title: Diagnostic discordance among histopathological reviewers for difficult-to-diagnose melanocytic lesions

Lead Author: Matthew Goldberg, M.D., Castle Biosciences and Icahn School of Medicine at Mount Sinai, New York

Abstract Number: 42072

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 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 (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 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2022, DecisionDx-Melanoma has been ordered 120,287 times for patients diagnosed with cutaneous melanoma.

About MyPath® Melanoma

MyPath Melanoma is Castle’s gene expression profile test 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 is 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 our tests to help clinicians make more informed decisions in the care of patients with skin cancers and add value to clinical decision-making to improve outcomes for patients. The words “believe,” “can” 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, 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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