Castle Biosciences announced that the COOG2 study, the largest prospective, multicenter trial of uveal melanoma to date, found that its DecisionDx‑UM gene‑expression profiling test combined with PRAME expression data predicts metastatic risk more accurately than next‑generation sequencing (NGS) mutation analysis. The study enrolled 1,140 primary tumors, including 131 small, early‑stage lesions, and was published in Nature Communications after enrolling patients from April 2017 to April 2020.
The clinical data show that the DecisionDx‑UM + PRAME combination achieved higher metastatic‑free survival and overall survival predictive accuracy than NGS alone. By providing a more precise risk stratification, the test can help ophthalmic oncologists tailor surveillance intensity and treatment plans, potentially leading to earlier intervention for high‑risk patients.
From a business perspective, the study’s validation strengthens Castle’s clinical value proposition and supports the company’s push for expanded payer coverage. The company’s DecisionDx‑UM test is already the standard of care in the U.S. and is covered by Medicare, and the new evidence is expected to accelerate adoption by ophthalmic oncologists and broaden reimbursement opportunities.
Castle’s Q3 2025 financial results provide context for the clinical announcement. Revenue rose to $83 million, a beat over the $71.03 million consensus estimate, driven by strong demand for core diagnostics such as DecisionDx‑Melanoma and TissueCypher. However, the company posted a net loss of $0.5 million versus a net income of $2.3 million in Q3 2024, and gross margin fell from 79.2% to 74.7% as operating expenses and cost of goods sold increased. CEO Derek Maetzold said the results reflected “continued demand for our core diagnostics and the momentum from our new product launches,” and highlighted the launch of AdvanceAD‑Tx.
Management raised full‑year 2025 revenue guidance to $327–$335 million, up from the prior $320–$330 million range, signaling confidence in sustained demand. Analyst coverage has been positive, with BTIG raising its price target to $50 from $38 and maintaining a “Buy” rating, reflecting the company’s strong execution and the clinical validation of its flagship tests.
The COOG2 findings, combined with the company’s robust financial performance and upward guidance, position Castle to capture a larger share of the uveal melanoma diagnostic market. The study’s evidence base is expected to accelerate payer coverage expansion, increase test adoption, and reinforce Castle’s leadership in ocular oncology diagnostics.
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