Study Finds Nurse Practitioners and Physician Assistants Would Alter Patient Care Decisions Based on DecisionDx®-Melanoma Test Results

In a survey of nurse practitioners and physician assistants (NPs/PAs), 82.4% of respondents who use DecisionDx-Melanoma in clinical practice stated that a high-risk test result in a thin melanoma tumor (≤1mm) would impact their patient treatment plan; similarly, 81.3% of test users would alter treatment plans based on a high-risk test result in Stage 1 tumors

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a study in the Journal of the Advanced Practitioner in Oncology (JADPRO) that assessed the viewpoints of NPs/PAs toward the clinical use of DecisionDx®-Melanoma in patients diagnosed with cutaneous melanoma. The study found that more than 90% of the NPs/PAs who completed a survey about DecisionDx-Melanoma believe that prognostic (i.e., risk-stratification) information about a patient’s melanoma is valuable and improves patient care. The study is available here.

“Historically, patients with thin or Stage 1 tumors would be considered to be at the lowest risk of metastasis or recurrence, based on traditional staging factors alone,” said Renata Block, MMS, PA-C, first study author and board-certified physician assistant at Advanced Dermatology & Aesthetic Medicine, LLC in Chicago. “As the study data affirmed, the personalized, clinically actionable results provided by DecisionDx-Melanoma can significantly impact the treatment plans of patients with melanoma, particularly in the 'low-risk' patient population when their test results indicate aggressive tumor biology that would place them at a higher risk of a poor outcome.”

Study methods and findings:

• NPs and PAs who attended one of three selected conferences in 2020 and 2021 were asked to complete an 18-question online survey about their viewpoints and clinical use of DecisionDx-Melanoma.
• Of the 369 NPs/PAs who completed the survey, 176 (47.7%) reported using the DecisionDx-Melanoma test in the prior 12 months.
• 90.5% of the respondents felt that comprehensive prognostic testing, such as with DecisionDx-Melanoma, improves patient care.
• The majority of DecisionDx-Melanoma test users stated that they used the test results to determine follow-up schedules and referrals (78.4%), inform treatment decisions (65.9%), as part of the decision to decision to recommend a patient receive or forego sentinel lymph node biopsy (SLNB) (61.9%) and inform surveillance imaging (50.0%).
• Additionally, almost all test users would recommend use of DecisionDx-Melanoma to a colleague (99.4%) or a friend or close relative who had been diagnosed with melanoma (97.7%); interestingly, most NPs/PAs who had not used DecisionDx-Melanoma would also recommend use of the test to a colleague (81.9%) or a friend or close relative with melanoma (62.7%).
• The value of both high-risk (Class 2B) and low-risk (Class 1A) DecisionDx-Melanoma test results were reported by all of the NPs/PAs who completed the survey (test users and non-users):
  • Most (62.1%) reported that a high-risk DecisionDx-Melanoma test result would alter their treatment plan for a patient with a thin tumor (≤1mm). Similarly, more than half of all respondents (58.8%) stated that a high-risk test result would alter their treatment plans for patients with a Stage 1 tumor.
  • When asked if there was value in a T1 patient receiving a low-risk result (i.e., test results confirming a low-risk tumor according to clinicopathologic staging), 74.5% indicated that patients would benefit from relief of uncertainty about their cancer, and 56.9% responded that providers would benefit from more confidence in their chosen treatment plan.

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 Sept. 30, 2023, DecisionDx-Melanoma has been ordered more than 146,000 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 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, DecisionDx-SCC, MyPath 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: (i) the ability of our DecisionDx-Melanoma test to alter patient care decisions and significantly impact, inform and/or alter patient treatment plans, including follow-up schedule and referrals, overall treatment decisions, SLNB recommendations and surveillance imaging; (ii) whether users would recommend use of DecisionDx-Melanoma to a colleague, friend or close relative; and (iii) whether DecisionDx-Melanoma test results would allow patients to benefit from relief of uncertainty about their cancer, and/or providers to benefit from more confidence in their chosen treatment plan. The words “can,” “would” 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 shown in this study, including with respect to the discussion of DecisionDx-Melanoma 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 quarter ended September 30, 2023, 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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