Castle Biosciences Stock Price, News & Analysis

Castle Biosciences (Nasdaq: CSTL) has published a new study showing their DecisionDx-Melanoma test surpasses both AJCC staging and CP-GEP in identifying low-risk melanoma patients. The test achieved a 2.8% sentinel lymph node positivity rate, significantly below the NCCN guidelines' 5% threshold for avoiding sentinel lymph node biopsy (SLNB) surgery.

The study, published in Cancer Diagnosis & Prognosis, analyzed T1-T2 melanoma tumors across multiple validation studies. While patients classified as low risk by CP-GEP showed a 6.2% SLN positivity rate, DecisionDx-Melanoma demonstrated superior performance at 2.8%. This improvement is particularly significant as over 90% of T1-T2 tumor patients who undergo SLNB receive negative results.

The findings support using DecisionDx-Melanoma to guide SLNB decisions, especially for patients with thin tumors where surgical complications may outweigh benefits. The test provides personalized risk assessment for sentinel lymph node positivity and recurrence, enabling more informed melanoma management decisions.

Castle Biosciences (Nasdaq: CSTL) has announced reaching a significant milestone of over 200,000 DecisionDx-Melanoma clinical test orders. The DecisionDx-Melanoma is a 31-gene expression profile test designed for patients with stage I-III cutaneous melanoma.

The test provides personalized risk assessment by analyzing tumor biology and clinicopathologic features to predict recurrence risk, metastasis potential, and sentinel lymph node positivity. Its clinical value is validated by more than 50 peer-reviewed publications and studies involving over 10,000 patient samples, demonstrating association with improved patient survival.

Castle Biosciences (CSTL) presented new research data at the AACR Annual Meeting 2025 focusing on their DecisionDx tests for melanoma patients. The study of DecisionDx-Melanoma (n=1,661) showed that patients with Class 2B results had significantly higher distant metastasis rates compared to Class 1A across multiple sites: CNS (7.4% vs 0.9%), lung (7.4% vs 1.2%), liver (4.5% vs 0.6%), and bone (3.0% vs 0.8%).

Additionally, research on DecisionDx-UM for uveal melanoma revealed that among 79 patients, 72% were classified as low risk (Class 1) and 28% as high risk for metastasis. The study identified significant protein differences in aqueous humor samples between risk classes (N=386, p<0.0001), potentially enabling earlier detection and intervention for uveal melanocytic tumors.

Castle Biosciences (CSTL) has scheduled the release of its first quarter 2025 financial results for Monday, May 5, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern time to discuss the results.

The live webcast will be accessible through the company's investor relations website and a dedicated event link. Participants can join via phone by dialing 1 833 470 1428 from the United States using access code 040892. International dial-in numbers are available. A Q&A session will follow management's presentation, and a webcast replay will be provided after the call.

Castle Biosciences (CSTL) is strengthening its commitment to esophageal cancer awareness through partnerships with key organizations during Esophageal Cancer Awareness Month in April 2025. The company is collaborating with the Esophageal Cancer Action Network (ECAN), the American Foregut Society (AFS), and The Gut Doctor Podcast.

With esophageal cancer's five-year survival rate at only 20%, early detection is crucial. The company's TissueCypher® test helps identify which Barrett's esophagus patients among the 1.5 million U.S. cases are at risk of progressing to cancer, affecting approximately 0.5% of cases.

Key initiatives include:

• ECAN partnership featuring digital media campaigns and awareness kits
• Special episode on AFS's All Fore Guts! podcast about screening importance
• Collaboration with The Gut Doctor Podcast discussing risk factors and treatment

Castle Biosciences (Nasdaq: CSTL) has secured the Top Workplaces USA Award for the fourth consecutive year, ranking 30th among 358 U.S. companies with 500-999 employees. The recognition, awarded by Energage and USA Today, is based on employee feedback through a third-party engagement survey.

Key highlights from the survey include:

• 95% participation rate (above 56% benchmark)
• 85% employee engagement score (exceeding 74% industry average)
• Assessment based on 15 culture drivers indicating high performance

The company, which specializes in innovative health tests for patient care, was selected from over 42,000 invited organizations. The achievement underscores Castle's commitment to maintaining a people-first culture and fostering an environment that promotes innovation and employee empowerment.

Castle Biosciences (CSTL) has published significant results from their DECIDE study regarding their DecisionDx-Melanoma test in melanoma patients. The study demonstrates the test's ability to accurately identify patients with less than 5% risk of sentinel lymph node (SLN) positivity who can safely avoid sentinel lymph node biopsy (SLNB) surgery.

Key findings show that DecisionDx-Melanoma influenced 85% of SLNB decisions. In patients with low-risk test results (Class 1A), none who underwent SLNB had positive nodes (0/35 patients). Notably, all patients with Class 1A results remained recurrence-free after two years of median follow-up, regardless of whether they underwent SLNB.

The study validates the test's alignment with National Comprehensive Cancer Network guidelines, which recommend avoiding SLNB when SLN positivity risk is below 5%. This helps reduce unnecessary surgical procedures, complications, and associated costs while focusing surgical interventions on higher-risk patients.

Castle Biosciences (CSTL) will present new data at the 11th World Congress of Melanoma and 21st EADO Congress in Athens, Greece (April 3-5, 2025), highlighting the clinical value of their DecisionDx-Melanoma test.

Two key studies will be presented: The first demonstrates the test's ability to stratify survival rates in stage IIB-IIC cutaneous melanoma patients, while the second shows its capability to identify early-stage patients at higher risk of central nervous system metastasis.

Key findings include:

• The test effectively stratified melanoma-specific and overall survival in stage IIB-IIC patients
• Patients with Class 2B (high risk) results showed significantly higher death risk
• DecisionDx-Melanoma was the only significant predictor of CNS metastasis in multivariable analyses

Dr. Brent Moody of Heritage Medical Associates emphasized that the test provides valuable biological insights complementing traditional staging, potentially improving melanoma outcomes through personalized care.

Castle Biosciences (CSTL) will present new validation data for its skin cancer tests at the NCCN 2025 Annual Conference. The company's DecisionDx-SCC test, earning a top-five abstract recognition, demonstrated enhanced risk stratification in a large cohort of 1,412 high-risk squamous cell carcinoma patients.

The study showed that combining DecisionDx-SCC with BWH staging significantly improved metastatic risk prediction within NCCN risk groups. Class 1 results indicated a nearly two-fold decrease in metastatic risk, while Class 2B showed more than a five-fold increase in risk for lower-stage NCCN High-Risk patients.

Additionally, new data for DecisionDx-Melanoma, tested in 6,892 patients with early-stage cutaneous melanoma, demonstrated the test's ability to predict mortality risk beyond traditional AJCC8 staging criteria. The study validated the test's effectiveness in identifying high-risk patients who might benefit from enhanced surveillance.