Research published in Melanoma Management finds 99% of uveal melanoma patients tested with DecisionDx®-UM benefit from the results

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the release of a study done in collaboration with the Melanoma Research Foundation (MRF) in which most patients diagnosed with uveal melanoma (UM) indicated their desire to undergo prognostic testing at the time of diagnosis, said they found value in their outcome and felt lower decision regret whether or not their test result indicated that their UM tumor was at a high level. or at low risk of metastasis. The study, titled “Attitudes of patients with uveal melanoma toward prognostic testing using gene expression profiling,” was published in Management of melanoma and can be viewed on the Castle 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 patient perspectives on prognostic testing and the value that patients can win by having personalized prognostic information,” said Kyleigh LiPira, MBA, Managing Director of MRF. “The more information patients can have before making treatment decisions is critical to achieving good outcomes. These data further reinforce the need for patients to understand their options so they can actively participate in their care.

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

Highlights of the study include the following:

  • 90% of respondents said they want prognostic information at the time of diagnosis.
  • 99% of respondents who took prognosis tests with DecisionDx-UM and shared their test results (80 out of 81 respondents) said they benefited from their test result.
  • Patients reported gaining value from their prognostic test results, including:
    • More custom processing options
    • Better knowledge and understanding of their disease
    • Relief from uncertainty about the future
    • Relevant information for life planning

  • Patients who received a low-risk (Grade 1A) DecisionDx-UM result were 10 times more likely than those who received a high-risk (Grade 2) result to report having a “sense of relief from uncertainty about in the future “. (X2=11, df=1, p=0.0009). Conversely, the majority of patients who received a high-risk (grade 2) result said that their test result provided them with “greater knowledge and understanding” of their disease (X2=17.48, df=3, p=0.0006).
  • There was no significant difference in levels of decision regret among those who received a DecisionDx-UM test result of low (class 1A), intermediate (class 1B), or high risk (class 2) (test of sum of Kruskal-Wallis ranks, X2=4.1, p=0.13).
  • Patients who chose to undergo some sort of prognostic test experienced less decision regret than patients who chose not to participate in the test, which reinforces the overall value that prognostic testing can bring to a patient’s care. , 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 recommended to be collected as part of clinical care. Additionally, 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 monitoring treatment regimens based on a result of class 1A, 1B and 2. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective multicenter studies, and has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutation status, AJCC stage and cell type. It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the United States receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and the disease can be found at www.CastleTestInfo.com.

About the Melanoma Research Foundation

The Melanoma Research Foundation (MRF) is the largest independent organization dedicated to melanoma. Committed to supporting medical research to find effective treatments and eventually a cure for melanoma, the MRF also educates patients and physicians about the prevention, diagnosis and treatment of melanoma. The MRF is an active advocate for the melanoma community, helping to raise awareness of this disease and the need for treatment. The MRF website is the main source of information on melanoma.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company that improves health through innovative tests that guide patient care. The Company aims to transform disease management by putting people first: patients, clinicians, employees and investors.

Castle’s current portfolio includes tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health issues. Additionally, the Company has active research and development programs for testing in other diseases of high clinical need, including its test in development to predict systemic therapeutic response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeqDecisionDx-SCC, Melanoma MyPath, DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeqTissueCypher and IDgenetix are registered 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 “sphere of security” created by these sections. These forward-looking statements include, but are not limited to, statements regarding: the value that patients can gain by having personalized prognostic information; that having more information before making treatment decisions is essential for good 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, whether they receive a low- or high-risk result. The words “may”, “expect”, “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such 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 we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those contained in the forward-looking statements, including, without limitation: the effects of macroeconomic events and conditions, including inflation , the COVID-19 pandemic and events, among others, on our business and our efforts to address their impact on our business; the results and conclusions of subsequent studies or trials may contradict the results and conclusions of earlier studies or trials or may not support the results obtained in this study, including with respect to the discussion of DecisionDx -UM in this press release; the actual application of our tests may not provide the above benefits to patients; and the risks set forth under “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. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update any forward-looking statements except as required by law.