Castle Biosciences, Inc.

ACG 2026 Data Show TissueCypher® Identifies Elevated Risk of Progression Beyond Pathology Findings in Barrett's Esophagus

Castle Biosciences announced three studies of its TissueCypher Barrett's Esophagus test being presented at the ACG 2026 Annual Scientific Meeting in Nashville. A multi-center cohort study found TissueCypher results changed management recommendations for 96% of patients, including extending surveillance intervals and prompting endoscopic eradication therapy in patients whose biopsies showed no dysplasia. Two case reports showed the test flagged high five-year progression risk (62% and 47%) in patients presumed low-risk on histology, leading to earlier intervention and detection of previously missed high-grade dysplasia. The data support TissueCypher's adoption case beyond pathology alone, a modest positive for the commercial narrative though not a near-term financial catalyst.

•20d ago

Late-Breaking EADV 2026 Data Support Use of DecisionDx®-Melanoma in SLNB Decision-Making and Risk-Aligned Post Surgical Management

Castle Biosciences will present late-breaking data on DecisionDx-Melanoma at the EADV 2026 Congress, from the largest prospective multicenter GEP study in cutaneous melanoma to date (2,799 patients across 29 U.S. centers). Low-risk i31-SLNB results showed observed SLN positivity of 4.4%, consistent with the test's <5% prediction, and 565 SLNB-eligible low-risk patients who skipped the procedure had five-year recurrence-free survival of 99.6%. A separate analysis of 687 transected melanomas showed the test stratified five-year RFS from 93.2% (Class 1A) to 64.1% (Class 2B), supporting risk-aligned surveillance when staging is uncertain. The data strengthen the clinical evidence base supporting broader ordering of DecisionDx-Melanoma, Castle's flagship dermatologic test.

•1mo ago

New Study Shows That TissueCypher® Changed Management at an Expert Surgery Center in 90% of Patients With Non-Dysplastic Barrett's Esophagus

Castle Biosciences announced publication of a study showing TissueCypher changed clinician management recommendations in 90% of non-dysplastic Barrett's esophagus patients at Keck Medicine of USC. In the 30-patient case series, all intermediate- or high-risk patients had management escalated, while management was de-escalated for 84% of low-risk patients; results changed management or increased physician confidence in 97% of cases. The findings, published in Foregut and presented at the American College of Surgeons Clinical Congress, add clinical-utility evidence supporting broader adoption of TissueCypher, though the small single-center cohort limits the weight of the signal.

•1mo ago

New Study Highlights Clinical Need for Molecular Guidance in Atopic Dermatitis Treatment Selection, Reinforcing the Value of AdvanceAD-Tx™

Castle Biosciences announced publication of a new study in Dermatology and Therapy highlighting unmet need in atopic dermatitis treatment, finding 55% of patients on targeted systemic therapies modified treatment due to lack of efficacy. Patient interest in molecular testing was strong — 83% overall and 94% among those open to a new systemic therapy — supporting demand for Castle's AdvanceAD-Tx test, which classifies patients into JAK Inhibitor Responder or Th2 Molecular Profiles. The small survey (43 participants) complements an earlier JAAD validation study showing JAK Responder Profile patients were 5.5 times more likely to achieve EASI-90 on a JAK inhibitor.

•1mo ago

New Decision Modeling Study Demonstrates TissueCypher® Significantly Improves Risk-Aligned Management for Patients with Barrett's Esophagus

Castle Biosciences announced publication of a decision modeling study in the Annals of Gastroenterology showing its TissueCypher Barrett's Esophagus test significantly improves risk-aligned management across non-dysplastic, indefinite, and low-grade dysplasia BE patients. Across 699 pooled patients, adding TissueCypher to clinical decision-making raised appropriate management from 59.8% to 75.3%, and in non-dysplastic BE patients who later progressed to high-grade dysplasia or cancer, appropriate escalation nearly doubled from 30.4% to 56.9%. Among all non-progressors, the model projected a 41.7% reduction in overtreatment. The findings strengthen the clinical-utility and payer case for TissueCypher, but they derive from a simulated decision-tree model rather than prospective outcomes data, making the commercial read-through incremental rather than binary.

•1mo ago

JAAD Publication Shows Improved Performance of DecisionDx®-SCC

Castle Biosciences announced publication of a multicenter validation study in the Journal of the American Academy of Dermatology (JAAD) supporting the integrated DecisionDx-SCC test result (i40-GEP) for high-risk cutaneous squamous cell carcinoma, based on an independent cohort of 572 patients. The Class 1A low-risk result, covering 44.6% of the cohort, showed a 97.3% negative predictive value supporting de-escalation of care, while the Class 2B highest-risk group (12.9% of patients) had a three-year metastasis-free survival of 66.2% versus 97.3% for Class 1A and was 10.7 times more likely to develop metastasis. Class 2B patients treated with adjuvant radiation therapy showed an approximately 50% lower median metastatic progression rate at five years than those who did not receive ART, sharpening the test's ability to identify which patients benefit from radiation. The publication strengthens the evidence base behind Castle's commercialized diagnostic — now supported by 20 peer-reviewed papers — and is an incremental positive for clinical adoption, though no financial impact was quantified.

•1mo ago

SciBase receives additional order from Castle Biosciences, advancing the collaboration

SciBase has received an additional order from Castle Biosciences valued at approximately $0.6 million to accelerate an ongoing clinical study and prepare for a second study. The order includes the portable Nevisense Go pen device and electrodes, with deliveries expected to begin in Q4 2026. CEO Pia Renaudin highlighted rapid patient recruitment in the first joint study and expressed excitement about expanding access to effective therapies for patients with skin barrier dysfunctions.

•1mo ago

Castle Biosciences Reports Second Quarter 2026 Results

Castle Biosciences delivered Q2 2026 revenue of $103.5 million, up from $86.2 million in the prior year, driven by a 32% increase in core test reports for DecisionDx-Melanoma and TissueCypher. Management raised full-year 2026 revenue guidance to $365-375 million, up from the previous range of $345-355 million, and now expects to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year. The company reported a net loss of $2.1 million, or $0.07 per share, compared to net income of $4.5 million a year ago, while Adjusted EBITDA grew to $12.4 million.

•3mo ago

Castle Biosciences Announces New York State Department of Health Approval of its AdvanceAD-Tx™ Test

Castle Biosciences received assay approval from the New York State Department of Health for its AdvanceAD-Tx test, designed to guide systemic therapy selection for moderate-to-severe atopic dermatitis patients. With this approval, the company now has New York clearance for its full dermatology, ophthalmology, and gastroenterology test portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh. Management highlighted that New York is the only state requiring a formal review of laboratory-developed tests, serving as a key validation of the company's quality and regulatory rigor.

•3mo ago

DecisionDx®-Melanoma's i31-SLNB Outperforms MIA Nomogram in Identifying Patients Who May Safely Forgo Sentinel Lymph Node Biopsy

A prospective multicenter study of 912 patients published in Dermatology and Therapy showed Castle Biosciences' DecisionDx-Melanoma's i31-SLNB test outperformed the MIA nomogram in identifying patients who may safely avoid sentinel lymph node biopsy. Patients classified as low risk by i31-SLNB had a 2.6% observed SLN positivity rate, below the 5% NCCN threshold, compared to 5.8% for the MIA nomogram. The test demonstrated greater discriminative performance than the clinicopathologic-only MIA nomogram (AUC=0.74 vs. 0.61; p=0.001), representing the second multicenter study showing i31-SLNB outperformance.

•4mo ago

Castle Biosciences' Chief Financial Officer Frank Stokes Named a 2026 CFO Awards Honoree by the Houston Business Journal

Castle Biosciences announced that CFO Frank Stokes has been named a 2026 CFO Awards honoree by the Houston Business Journal, recognizing his financial leadership. Stokes has served as CFO since December 2017, overseeing the company's 2019 IPO and subsequent strategic acquisitions. Castle focuses on dermatologic and gastroenterological diagnostics, developing molecular tests to improve patient care.

•4mo ago

Castle Biosciences' TissueCypher® Test Surpasses 100,000 Orders, Advancing Precision Risk Assessment for Patients with Barrett's Esophagus

Castle Biosciences announced that its TissueCypher Barrett's Esophagus Test has surpassed 100,000 clinical test orders, marking a significant milestone in commercial adoption. The AI-derived precision medicine test predicts a patient's five-year risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma. The test is backed by more than 17 peer-reviewed publications and data from over 8,000 patients, serving as the strongest independent predictor of progression compared to traditional methods.

•4mo ago

Castle Biosciences Reports First Quarter 2026 Results

Castle Biosciences reported Q1 2026 revenue of $83.7 million, down from $88.0 million in the prior year due to known headwinds including a Medicare coverage change and IDgenetix discontinuation. Despite the revenue decline, core test reports (DecisionDx-Melanoma and TissueCypher) grew 36% year-over-year, with TissueCypher volumes surging 58% to 11,745 tests. Based on Q1 performance and business confidence, management raised full-year 2026 revenue guidance to $345-355 million from $340-350 million. Net loss narrowed to $14.5 million ($0.49 per share) from $25.8 million ($0.90 per share) in Q1 2025, with cash position remaining strong at $261.7 million.

•5mo ago

New Data at DDW 2026 Show TissueCypher® Testing Improves Risk Stratification and Drives Risk-Aligned Management in Barrett's Esophagus

New data from Mayo Clinic researchers presented at DDW 2026 demonstrates that Castle Biosciences' TissueCypher test improves risk stratification for Barrett's esophagus compared to standard histopathology. One study found physicians modified surveillance intervals in 55% of patients based on TissueCypher results, while a second study showed the test classified 84% of patients as low risk versus just 38% for the standard PIB model. The findings support the test's ability to drive risk-aligned management decisions and are backed by more than 17 peer-reviewed publications involving over 8,000 patients.

•5mo ago