Recommendations by Expert Consensus Panel Relating to Risk-Stratification Tests and Tools for Use in Cutaneous Melanoma Have Been Adopted as an Official Policy Recommendation of the National Society for Cutaneous Medicine

• Report states that DecisionDx®-Melanoma offers more utility than other existing GEP assays or nomograms, supported by extensive evidence-driven data for the test in current literature
• Report includes 10 additional usage guidelines and consensus supporting statements for incorporating GEP testing, including DecisionDx-Melanoma, into clinical practice to improve care for patients with cutaneous melanoma

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a consensus panel report from the National Society for Cutaneous Medicine recommending use of gene expression profile (GEP) testing in the clinical assessment and management of cutaneous melanoma (CM). The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management. Additionally, the consensus report endorses Castle’s DecisionDx®-Melanoma GEP risk stratification test as offering more utility than other existing CM GEP assays or nomograms, supported by extensive, evidence-driven data in current literature.

“DecisionDx-Melanoma test results provide valuable information beyond current staging guidelines to help clinicians and patients make more informed, risk-aligned management decisions,” said Matthew Goldberg, M.D., F.A.A.D., board-certified dermatologist and dermatopathologist, and medical director of Castle Biosciences. “We are pleased that the consensus report supported the overall value and use of our test to help improve CM patient management.”

The report was compiled by a panel of six key opinion leaders in dermatology with specialized expertise in managing CM. The panel reviewed 32 studies published between 2019 through 2022 assessing the use of GEP testing in CM prognosis. Twenty-two of the studies reviewed assessed the utility of DecisionDx-Melanoma, Castle’s 31-GEP risk stratification test designed to inform two clinical questions in the management of CM: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. Based on a review of the studies, the panel developed six usage guidelines and five consensus supporting statements providing a framework for clinicians to integrate GEP testing into their CM patient management. Each of the recommendations was given a strength “A,” “B,” or “C” according to Strength of Recommendation Taxonomy (SORT) criteria. The panel report, published in SKIN: Journal of Cutaneous Medicine and available here, has been adopted as an official policy recommendation by the National Society for Cutaneous Medicine.¹

Four of the 11 key usage guidelines and consensus supporting statements were given a strength of “A,” the strongest recommendation by the panel. They include the following:

Usage guidelines:

• “Integrating GEP results can improve prognostic assessment for patients with T1a tumors at least 0.3mm in depth, T1b+ tumors or any tumor in which there is significant uncertainty about adequacy of microstaging (e.g., positive deep margin)” (SORT Level=A)
• “GEP testing can identify a high-risk subset for recurrence, distant metastasis or death of traditionally assessed low-risk patients (e.g., SLN negative or T1a/b)” (SORT Level=A)
• “GEP testing provides clinically useful information that augments risk-aligned management decisions to both rule-in or rule-out the need for SLNBx and subsequent management plans” (SORT Level=A)

Consensus supporting statement:

• “Current literature supports that the 31-GEP test [i.e., DecisionDx-Melanoma], with its more extensive evidence-driven data, offers more utility than other existing GEP assays or nomograms” (SORT Level=A)

A complete list of usage guidelines and consensus supporting statements for incorporating GEP testing into CM patient management can be found in the full consensus panel report.

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. 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, 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 (i) DecisionDx-Melanoma to improve patient care and patient management, and overall disease outcomes, for patients with cutaneous melanoma, and (ii) GEP testing to improve prognostic assessment for patients with certain tumors and identify a high-risk subset for recurrence, distant metastasis, or death of traditionally assessed low-risk patients. 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 recommendations and guidelines presented in this report, 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 twelve months 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.

1. The authors of the report include the following physicians; bolded names indicate that the physician is also a member of the board of the National Society for Cutaneous Medicine: Danny Zakria, M.D., MBA, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York; Nicholas Brownstone, M.D., Department of Dermatology, Temple University Health, Philadelphia; Brian Berman, M.D., Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine, Miami; Roger Ceilley, M.D., Department of Dermatology, The University of Iowa, Iowa City, Iowa; Gary Goldenberg, M.D., Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York; Mark Lebwohl, M.D., Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York; Graham Litchman, D.O., Department of Dermatology, St. John’s Episcopal Hospital, Far Rockaway, New York; Daniel Siegel, M.D., Department of Dermatology, SUNY Downstate, Brooklyn, New York

View source version on businesswire.com: https://www.businesswire.com/news/home/20230308005086/en/