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FRIENDSWOOD, Texas - Castle Biosciences, Inc. (NASDAQ:CSTL), a diagnostics company known for its innovative tests that guide patient care, confirmed the efficacy of its DecisionDx-UM test for uveal melanoma (UM) through new data from an independent validation. The company, which maintains an impressive 82% gross profit margin and has demonstrated strong revenue growth of 38% in the last twelve months, continues to strengthen its position in the diagnostic testing market. The findings, which support the inclusion of PRAME gene expression information to refine metastatic risk prediction in UM patients, were presented at the recent ARVO 2025 Annual Meeting in Salt Lake City.
The study presented involved a real-world cohort of 1,297 UM patients and aimed to validate the results of the COOG2.1 study. The COOG2.1 study previously determined that the addition of PRAME status to the DecisionDx-UM test results could improve metastatic risk stratification. The validation study confirmed that the co-reporting of DecisionDx-UM class and PRAME status offers a more detailed risk assessment, which could enhance patient management and treatment decisions. According to InvestingPro analysis, Castle Biosciences maintains a strong financial health score and holds more cash than debt on its balance sheet, supporting its continued investment in diagnostic innovation.
DecisionDx-UM, Castle Biosciences’ 15-gene expression profile test, has been utilized in the majority of ocular oncology practices in the United States as a standard of care for newly diagnosed UM. It is the only prognostic test for UM validated in prospective, multi-center studies and is recognized by the American Joint Committee on Cancer and the National Comprehensive Cancer Network guidelines for its prognostic capabilities.
Castle Biosciences emphasizes its commitment to improving health outcomes by providing tests that offer precise information for personalized treatment planning. The company’s portfolio includes tests for various cancers and is actively developing new diagnostics for other diseases with high clinical need. For detailed insights into Castle Biosciences’ financial health and growth prospects, InvestingPro subscribers can access comprehensive analysis, including 12+ additional ProTips and the company’s detailed Research Report, part of the platform’s coverage of 1,400+ US stocks.
The information presented is based on a press release statement from Castle Biosciences.
In other recent news, Castle Biosciences reported a significant 21% year-over-year revenue increase in the first quarter of 2025, amounting to $88 million, surpassing forecasts. Despite this revenue growth, the company faced a net loss of $25.8 million and missed earnings per share expectations, which were reported at -$0.20 against a forecast of -$0.06. Following these results, Castle Biosciences raised its 2025 revenue guidance to a range of $287-$297 million, signaling optimism in its growth trajectory. The company also announced the acquisition of Previse, a gastrointestinal diagnostics company, to bolster its portfolio, although this acquisition is not expected to immediately impact revenue. KeyBanc maintained an Overweight rating on Castle Biosciences, citing the company’s robust first-quarter performance and strategic adjustments, while BTIG adjusted its price target for the company to $32 but maintained a Buy rating. Castle Biosciences’ strategic focus includes expanding its dermatology and gastrointestinal salesforces, despite challenges such as the discontinuation of its IDgenetix test and the loss of reimbursement for its SCC test. Analysts suggest that Castle Biosciences might regain reimbursement for its SCC test through reconsideration requests, reflecting a cautiously optimistic outlook.
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