There was no significant difference in decision regret levels among those receiving a low- (Class 1A), intermediate- (Class 1B) or high-risk (Class 2) DecisionDx-UM test result

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a study completed in collaboration with the Melanoma Research Foundation (MRF) in which most patients diagnosed with uveal melanoma (UM) indicated their desire for prognostic testing at diagnosis, reported finding value in their test result and experienced lower decision regret, regardless of whether their test result indicated that their UM tumor was at a high or low risk of metastasis. The study, titled “Uveal melanoma patient attitudes towards prognostic testing using gene expression profiling,” was published in Melanoma Management and can be viewed on Castle's website.

“We were excited to embark on this collaboration with Castle Biosciences, a leader in prognostic testing for uveal melanoma, as few studies have explored patients’ perspectives towards prognostic testing and the value patients can gain by having personalized prognostic information,” said Kyleigh LiPira, M.B.A., chief executive officer of the MRF. “The more information patients can have in advance of making treatment decisions is critical to having successful outcomes. This data further reinforces the need for patients to understand their options so they can be active participants in their care.”

The study aimed to assess patient experiences with DecisionDx®-UM testing and other prognostic methods through an online questionnaire that was distributed by the MRF’s CURE OM initiative. CURE OM (the Community United for Research and Education of Ocular Melanoma) is the MRF’s initiative to increase awareness, education and research funding for ocular melanoma, while improving the lives of people affected by this disease. The questionnaire captured anonymized information regarding patients’ experiences with prognostic testing following a diagnosis of UM; 177 patients completed the survey.

Highlights from the study include the following:

• 90% of respondents reported wanting prognostic information at the time of diagnosis.
• 99% of respondents who had prognostic testing performed with DecisionDx-UM and shared their test results (80 out of 81 respondents) reported gaining value from their test result.
• Patients reported gaining value from their prognostic test results, including:
  • More personalized treatment options
  • Increased knowledge and understanding of their disease
  • Relief from uncertainty about the future
  • Information relevant to life planning
• Patients who received a low-risk (Class 1A) DecisionDx-UM result were 10 times more likely than those who received a high-risk (Class 2) result to report gaining a “sense of relief from uncertainty about the future.” (X²=11, df=1, p=0.0009). Conversely, a majority of patients who received a high-risk (Class 2) result reported that their test result provided them “increased knowledge and understanding” about their disease (X²=17.48, df=3, p=0.0006).
• There was no significant difference in decision regret levels among those receiving a low- (Class 1A), intermediate- (Class 1B) or high-risk (Class 2) DecisionDx-UM test result (Kruskal-Wallis rank sum test, X²=4.1, p=0.13).
• Patients who chose to have some kind of prognostic testing experienced less decision regret than patients who opted out of testing, reinforcing the overall value that prognostic testing can bring to a patient’s care, regardless of whether they receive a low- or high-risk result.

About DecisionDx®-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma. DecisionDx-UM is the standard of care in the management of newly diagnosed uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type. It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found at www.CastleTestInfo.com.

About The Melanoma Research Foundation

The Melanoma Research Foundation (MRF) is the largest independent organization devoted to melanoma. Committed to the support of medical research in finding effective treatments and eventually a cure for melanoma, the MRF also educates patients and physicians about prevention, diagnosis and the treatment of melanoma. The MRF is an active advocate for the melanoma community, helping to raise awareness of this disease and the need for a cure. The MRF’s website is the premier source for melanoma information seekers.

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 value patients can gain by having personalized prognostic information; that having more information in advance of making treatment decisions is critical to having successful outcomes; our expectation that patients will continue to value and appreciate the information provided by tests like DecisionDx-UM, regardless of their overall prognosis; and the overall value that prognostic testing can bring to a patient’s care, regardless of whether they receive a low- or high-risk result. The words “can,” “expect,” “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: the effects of macroeconomic events and conditions, including inflation, the COVID-19 pandemic and geopolitical events, among others, on our business and our efforts to address its impact on our business; subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in this study, including with respect to the discussion of DecisionDx-UM 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 September 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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