Castle Biosciences announced that it will present new data on its DecisionDx‑Melanoma i31‑SLNB test at the Society of Surgical Oncology (SSO) 2026 Annual Meeting in Phoenix, scheduled for March 5‑7. The presentation will be delivered as ePoster EP49, titled “The integrated 31‑gene expression profile test identifies patients with T1b–T2a cutaneous melanoma who can safely avoid sentinel lymph node biopsy.”
The i31‑SLNB algorithm combines a 31‑gene expression score with clinicopathologic factors—Breslow thickness, ulceration, mitotic rate and age—to generate a personalized likelihood of sentinel lymph node positivity. The new data extend prior findings that the test can guide sentinel lymph node biopsy decisions and align with National Comprehensive Cancer Network (NCCN) guidelines, which now incorporate gene‑expression profiling for risk‑aligned management of T1b–T2a melanoma patients. The presentation underscores Castle’s strategy to strengthen its dermatology portfolio and may enhance adoption and reimbursement prospects for the test.
Castle’s Q4 2025 results provide context for the company’s current trajectory. Revenue rose to $87.0 million, a 1% increase over Q4 2024, while the company reported a net loss of $2.3 million versus a net income of $9.6 million in the prior year. Full‑year 2025 revenue reached $344.2 million, up 4% from 2024, but the company posted a net loss of $24.2 million compared with a $18.2 million net income in 2024. Core revenue drivers—DecisionDx‑Melanoma and TissueCypher—grew 42% and 37% year‑over‑year, respectively. Adjusted EBITDA fell to $11.5 million in Q4 2025 from $21.3 million in Q4 2024, and full‑year 2025 Adjusted EBITDA was $44.0 million versus $75.0 million in 2024. Gross margin for 2025 was 69% (adjusted 80%) compared with 79% (adjusted 82%) in 2024. The company has guided 2026 revenue to $340 million–$350 million.
CEO Derek Maetzold emphasized the company’s disciplined execution and the strength of its innovative test portfolio: “We closed out an outstanding year with a strong fourth quarter, reflecting the strength of our innovative test portfolio, disciplined execution and the dedication of the entire Castle team who continue to deliver meaningful impact for patients and clinicians every day.” VP of Research and Development Rebecca Critchley‑Thorne added, “The data being presented at SSO 2026 further extend this growing body of evidence supporting the use of DecisionDx‑Melanoma to guide risk‑aligned management decisions consistent with National Comprehensive Cancer Network® guideline risk thresholds, including whether to forgo, consider or pursue SLNB.”
The presentation of the new data is expected to reinforce the clinical utility of DecisionDx‑Melanoma, potentially accelerating its adoption by surgeons and expanding reimbursement opportunities. By providing a more precise risk assessment for sentinel lymph node biopsy, the test could reduce unnecessary procedures for low‑risk patients while ensuring high‑risk patients receive appropriate surgical intervention. This aligns with Castle’s broader goal of expanding its dermatology portfolio and strengthening its position in the competitive molecular diagnostics market.
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