Expert Melanoma Panel Recommends Castle Biosciences’ DecisionDx®-Melanoma as a Best-Practice Tool for Managing Patients with Melanoma
Rhea-AI Summary
Castle Biosciences (Nasdaq: CSTL) announced an independent expert consensus paper published Dec 9, 2025 endorsing DecisionDx-Melanoma as a best-practice prognostic tool for cutaneous melanoma.
The paper—authored by ten melanoma experts after reviewing 26 studies covering >7,500 patients—reached unanimous agreement on nine statements: DecisionDx-Melanoma provides prognostic information independent of clinicopathologic factors, complements AJCC8 staging, guides sentinel lymph node biopsy (SLNB) decisions in T1b–T3 tumors, informs management of SLNB-negative patients, and is associated with improved melanoma-specific and overall survival versus untested patients.
Positive
- Independent expert panel unanimous on nine consensus statements
- Evidence base: 26 studies covering >7,500 patients
- Validated prognostic performance independent of clinicopathologic factors
- Enhances prognostic precision when combined with AJCC8 staging
- Guides SLNB decisions in T1b–T3 tumors and SLNB-negative care
- Associated with improved melanoma-specific and overall survival
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
CSTL was down 1.4% while peers were mixed: CDNA (+2.11%), PSNL (+1.45%), FLGT (+0.04%), and decliners MYGN (‑1.53%), NEO (‑2.42%). No momentum-clustered sector move was flagged.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 17 | Workplace recognition | Positive | +1.5% | Top Workplaces award for fifth consecutive year with multiple culture honors. |
| Nov 14 | Clinical data update | Positive | -2.0% | New data showing DecisionDx-Melanoma improves SLNB decisions and risk prediction. |
| Nov 11 | Conference participation | Neutral | +0.7% | Management scheduled to present overview at Piper Sandler healthcare conference. |
| Nov 03 | Quarterly earnings | Positive | +1.9% | Q3 revenue reported at $83.0M with raised full‑year 2025 revenue guidance. |
| Nov 03 | Product launch | Positive | +1.9% | Launch of AdvanceAD‑Tx gene expression test targeting large U.S. TAM. |
Across the last five news events, CSTL showed mostly aligned reactions, with four aligned moves and one divergence on positive clinical data.
This announcement reinforces Castle Biosciences’ focus on DecisionDx-Melanoma, following November data showing improved SLNB decision-making and prognostic performance. Earlier, the company reported Q3 2025 revenue of $83.0M and raised full‑year guidance to $327–335M, alongside strong core test volume growth. A new AdvanceAD‑Tx launch targeted a U.S. TAM of $33B. Cultural recognition through multiple Top Workplaces awards and investor outreach via the Piper Sandler conference round out a narrative of operational and commercial momentum into which this expert consensus endorsement now fits.
Market Pulse Summary
This announcement highlights an independent expert panel’s unanimous support for DecisionDx-Melanoma, based on 26 studies and data from more than 7,500 patients. It reinforces prior findings that the test refines SLNB decisions and risk stratification beyond traditional staging. In the months leading up to this news, Castle Biosciences reported $83.0M in Q3 revenue, raised 2025 guidance to $327–335M, and launched AdvanceAD‑Tx into a $33B U.S. TAM. Investors may watch future updates on clinical adoption, reimbursement, and test volumes for this assay.
AI-generated analysis. Not financial advice.
Expert panel offers data-driven guidance for integrating DecisionDx-Melanoma into clinical decision-making for patients with melanoma
FRIENDSWOOD, Texas, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of an independent expert consensus paper titled “31-Gene Expression Profiling for Cutaneous Melanoma: An Expert Consensus Panel,” which endorses the Company’s DecisionDx-Melanoma test. The paper can be viewed here.1
“This consensus translates the robust data supporting DecisionDx-Melanoma into practical direction for clinicians,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “The panel’s unanimous endorsement of DecisionDx-Melanoma underscores its value in supporting informed, personalized care decisions that may help improve outcomes for patients with melanoma.”
Authored by a panel of ten melanoma experts from leading academic and clinical institutions, the paper presents evidence-based recommendations supporting DecisionDx-Melanoma as a best-practice tool for guiding management decisions in patients with cutaneous melanoma. The panel concluded that the test provides prognostic information independent of traditional clinicopathologic factors and can be integrated with existing staging systems to improve patient risk assessment and help optimize clinical decision-making.
Drawing on a comprehensive review of 26 published studies encompassing more than 7,500 patients, the panel used a modified Delphi process to reach unanimous agreement on nine consensus statements defining the test’s role in risk stratification, sentinel lymph node biopsy (SLNB) decision making and long-term patient management.
Key conclusions from the expert panel include the following:
- DecisionDx-Melanoma demonstrates robust clinical utility and validated performance, supported by high-quality (SORT A) evidence showing accurate and consistent prognostic information for patients with invasive melanoma to help clinicians better assess metastatic risk and guide management across a wide range of disease presentations.
- DecisionDx-Melanoma can be used across a broad range of tumor stages. Panelists agreed DecisionDx-Melanoma should be used in earlier-stage patients to identify those who may benefit from escalated care, guide SLNB decisions in T1b–T3 tumors and inform management for SLNB-negative patients.
- Integrating DecisionDx-Melanoma results with the American Joint Committee on Cancer 8th Edition (AJCC8) staging significantly enhances prognostic precision, improving risk stratification and survival prediction when used alongside traditional clinicopathologic factors.
- Integrating DecisionDx-Melanoma results with established staging systems can accurately inform SLNB decisions to help identify low-risk patients who may safely avoid the procedure.
- Patients who undergo DecisionDx-Melanoma testing demonstrate improved melanoma-specific and overall survival compared to patients not tested, likely reflecting the test’s role in supporting more personalized management strategies based on accurate risk information.
- DecisionDx-Melanoma supports clinical decision-making in challenging scenarios, particularly when information about traditional clinicopathologic features, such as tumor thickness or ulceration, is limited or unavailable.
- DecisionDx-Melanoma should be recognized as a best-practice approach for the management of patients with melanoma, guiding evidence-based, patient-centered care.
“Consensus efforts like this are important to help clinicians interpret and apply emerging data in a consistent, evidence-based way,” said Rebecca Critchley-Thorne, Ph.D., vice president, research and development, at Castle Biosciences. “This study in particular can give physicians confidence on when and where DecisionDx-Melanoma fits within current management strategies to support more individualized care for patients with cutaneous melanoma.”
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile (GEP) test designed to analyze tumor biology to deliver a personalized risk assessment for patients with stage I–III cutaneous melanoma, enhancing risk stratification beyond American Joint Committee on Cancer (AJCC) staging alone. By combining molecular insights with select clinicopathologic features, the test provides two distinct outputs: a personalized risk of sentinel lymph node (SLN) positivity and a personalized risk of recurrence and/or metastasis. This clinically actionable information is designed to help guide risk-aligned patient management decisions, including SLN biopsy consideration, follow-up intensity, imaging and referrals.
DecisionDx-Melanoma is supported by more than 50 peer-reviewed publications, including prospective studies and meta-analyses, and was developed in collaboration with more than 100 leading U.S. institutions. The test has been clinically validated in more than 10,000 patient samples, ordered more than 220,000 times since launch, and has been shown to be associated with improved patient survival. Learn more at https://castlebiosciences.com/tests/prognostic/decisiondx-melanoma/overview.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. With a primary focus in dermatologic and gastroenterological disease, we develop personalized, clinically actionable solutions that help improve disease management and patient outcomes.
We put people first—empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Instagram, Facebook and X.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: DecisionDx-Melanoma’s ability to (i) guide risk-aligned management decisions for patients diagnosed with cutaneous melanoma, (ii) provide precise and clinically meaningful risk stratification, and (iii) help improve outcomes for patients with melanoma including melanoma specific and overall survival; and DecisionDx-Melanoma’s recognition as a best-practices approach for the management of patients with melanoma. The words “can,” “may” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each as filed with the SEC, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.
1. Burshtein J, Cockerell C, Cotter D, et al. 31-Gene expression profiling for cutaneous melanoma: an expert consensus panel. Dermatol. Online J. 2025;31(5). doi: https://doi.org/10.25251/c81v6j23
Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact:
Allison Marshall
amarshall@castlebiosciences.com
Source: Castle Biosciences, Inc.
FAQ
What did Castle Biosciences announce about DecisionDx-Melanoma on Dec 9, 2025 (CSTL)?
How large was the evidence base behind the DecisionDx-Melanoma consensus (CSTL)?
How does DecisionDx-Melanoma affect SLNB decisions for T1b–T3 tumors (CSTL)?
Does the consensus recommend integrating DecisionDx-Melanoma with AJCC8 staging (CSTL)?
What clinical outcome association did the expert panel report for DecisionDx-Melanoma (CSTL)?
Who authored the consensus paper endorsing DecisionDx-Melanoma (CSTL)?
