FRIENDSWOOD, Texas–()–Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced the publication of a multicenter, prospective study demonstrating that DecisionDx®-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma (UM). The study was published in the peer-reviewed journal Melanoma Management.

DecisionDx-UM is Castle’s 15-gene expression profiling (GEP) test developed to identify patients at low risk (Class 1) or high risk (Class 2) of metastasis, based on the unique biology of their primary tumor, and is current standard of care for uveal melanoma patients. 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.

The multicenter CLEAR II study (Clinical Application of DecisionDx-UM Gene Expression Assay Results II) was designed to prospectively evaluate patterns of physician referral and metastatic surveillance regimens for UM patients who were tested with DecisionDx-UM as part of their diagnostic work up, and to compare management plans between DecisionDx-UM low-risk (Class 1) and DecisionDx-UM high-risk (Class 2) patients.

“The results from the CLEAR II study demonstrate that the DecisionDx-UM test has a significant impact on treatment plan recommendations for patients with uveal melanoma,” said first author Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center at Houston, and Retina Consultants of Houston. “DecisionDx-UM stratifies patients, based on tumor biology, into high- and low-risk groups, and this study demonstrates that physicians developed appropriate, risk-aligned treatment plans based on this genomic information.”

Study Highlights:

  • 138 patients from nine centers were enrolled in the CLEAR II study.
  • 93 patients (67%) had a low-risk Class 1 test result; and 45 patients (33%) had a high-risk Class 2 test result. This ratio is consistent with clinical experience (in 2019, 68% of all test results were Class 1, and 32% were Class 2 test results).
  • Medical oncology referral was more common for high-risk Class 2 patients than for low-risk Class 1 patients (p<0.001).
  • Class 1 patients were less likely to have their metastatic surveillance managed by a medical oncologist compared to Class 2 patients (p<0.001).
  • Patients with a Class 1 result were significantly less likely to receive recommendations for frequent (three or four times a year) surveillance imaging and liver function testing compared to Class 2 patients (p<0.001).
  • These findings show that treatment plan recommendations are aligned with metastatic risk and are consistent with results from previously published studies documenting the impact of DecisionDx-UM on patient management.

About DecisionDx-UM

DecisionDx-UM is a 15-gene expression profiling (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is considered to be standard of care in the management of 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.MyUvealMelanoma.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx®-CMSeq; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq; www.MyUvealMelanoma.com), with products in development for other underserved cancers, the two most advanced of which are focused on patients with cutaneous squamous cell carcinoma, and patients who have a difficult-to-diagnose pigmented lesion. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

The information in this press release contains forward-looking statements and information 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 ability of DecisionDx-UM test results to optimize diagnostic treatment decisions. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “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, the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, 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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