This section highlights FDA-related milestones and regulatory updates for drugs developed by Castle Biosciences (CSTL).
Over the past two years, Castle Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DecisionDx-Melanoma, DecisionDx-SCC, and TSP-9. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DecisionDx-Melanoma - FDA Regulatory Timeline and Events
DecisionDx-Melanoma is a drug developed by Castle Biosciences for the following indication: Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DecisionDx-Melanoma
- Announced Date:
- May 29, 2025
- Indication:
- Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity
Announcement
Castle Biosciences, announced that it will present novel research aimed at enhancing the clinical management of patients with cutaneous melanoma (CM) and uveal melanoma (UM) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30-June 3, 2025, in Chicago.
AI Summary
Castle Biosciences announced it will present novel research at the 2025 ASCO Annual Meeting in Chicago from May 30 to June 3, 2025. The research focuses on enhancing the clinical management of patients with cutaneous melanoma (CM) and uveal melanoma (UM). The studies include data from a large, real-world cohort of over 13,500 CM patients, demonstrating that the DecisionDx-Melanoma test provides significant and independent risk stratification. This test helps predict a patient’s risk of mortality and informs treatment decisions such as planning biopsies and determining surveillance intensity. In addition, the research highlights work on a 16-protein test using a minimally invasive liquid biopsy for UM, aiming to identify high-risk lesions earlier. Overall, the findings presented at ASCO could help clinicians tailor individual patient care by refining risk assessments based on unique tumor biology.
Read Announcement- Drug:
- DecisionDx-Melanoma
- Announced Date:
- April 3, 2025
- Indication:
- Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity
Announcement
Castle Biosciences, announced the recent publication of two papers in the World Journal of Surgical Oncology and Cancer Medicine sharing reports from the prospective, multicenter DECIDE study demonstrating the significant impact of the Company's DecisionDx-Melanoma test on SLNB decision-making for patients with melanoma.3,4
AI Summary
Castle Biosciences recently published two papers in the World Journal of Surgical Oncology and Cancer Medicine that report findings from its prospective, multicenter DECIDE study. The research shows that the DecisionDx-Melanoma test has a significant impact on guiding decisions about performing a sentinel lymph node biopsy (SLNB) in melanoma patients. Specifically, the test accurately identifies patients with a less than 5% risk of SLN positivity—indicating that these patients can safely forgo SLNB. One of the studies noted that no patient with a low-risk test result who underwent SLNB had a positive node, and another reported that all patients with a low-risk result were recurrence free over a median follow-up of two years. These results highlight the test’s clinical value in reducing unnecessary surgeries, lowering complication rates, and improving personalized patient care.
Read Announcement- Drug:
- DecisionDx-Melanoma
- Announced Date:
- April 1, 2025
- Indication:
- Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity
Announcement
Castle Biosciences will share data via two poster presentations at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology (EADO) Congress, being held April 3-5, 2025, in Athens, Greece.
AI Summary
Castle Biosciences will present two poster sessions at the 11th World Congress of Melanoma and the 21st European Association of Dermato-Oncology (EADO) Congress in Athens, Greece from April 3–5, 2025. The posters will share data showing how the DecisionDx-Melanoma test helps risk-stratify patients with stage IIB-IIC cutaneous melanoma. One poster focuses on the test’s role in guiding decisions for adjuvant therapy and more intensive monitoring, while the other highlights its ability to identify early-stage patients at high risk of central nervous system metastasis. These findings suggest that the test provides important insights to help clinicians decide which patients may need closer imaging surveillance and personalized treatment plans. Castle Biosciences aims to improve melanoma outcomes by offering a more targeted approach to patient care based on real-world data and advanced risk assessment methods.
Read Announcement- Drug:
- DecisionDx-Melanoma
- Announced Date:
- December 12, 2024
- Indication:
- Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity
Announcement
Castle Biosciences, Inc. announced the publication of a new independent meta-analysis in Cancers assessing the efficacy of its DecisionDx-Melanoma test in predicting melanoma patient outcomes.
AI Summary
Castle Biosciences, Inc. has announced the publication of a meta-analysis in the journal Cancers that examines the performance of its DecisionDx-Melanoma test. The study reviewed 13 peer-reviewed publications involving thousands of patients and confirmed that the test accurately stratifies cutaneous melanoma patients into different risk groups. Findings showed that patients classified in the lowest risk group enjoy nearly 100% melanoma-specific survival, while those in the highest risk group have significantly lower survival rates. This independent research highlights that DecisionDx-Melanoma provides improved risk assessments compared to traditional staging methods. According to company experts, the test not only predicts the likelihood of sentinel lymph node positivity but also offers precise insights for personalized treatment strategies. These results add to the growing evidence that DecisionDx-Melanoma can be a valuable tool in optimizing care for melanoma patients.
Read Announcement- Drug:
- DecisionDx-Melanoma
- Announced Date:
- October 9, 2024
- Indication:
- Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity
Announcement
Castle Biosciences, Inc announced that it will present new data related to its DecisionDx-Melanoma and DecisionDx®-UM tests for patients with cutaneous melanoma (CM) and uveal melanoma (UM), respectively, at the 21st International Congress of the Society for Melanoma Research (SMR), taking place Oct. 10-13, 2024, in New Orleans.
AI Summary
Castle Biosciences, Inc. announced that it will present new data on its DecisionDx-Melanoma and DecisionDx‑UM tests at the 21st International Congress of the Society for Melanoma Research (SMR). The event will take place in New Orleans from October 10 to 13, 2024. The company’s studies focus on improving treatment decisions for patients with cutaneous melanoma (CM) and uveal melanoma (UM). The DecisionDx-Melanoma test has shown clinical value by stratifying patients based on tumor recurrence risk and by adding important insights to standard staging methods. In parallel, DecisionDx‑UM has been used to assess the risk of metastasis in patients with UM. Castle Biosciences will display posters detailing these findings, allowing clinicians and researchers to review how the tests can guide risk-aligned patient care and lead to improved outcomes.
Read Announcement- Drug:
- DecisionDx-Melanoma
- Announced Date:
- September 11, 2024
- Indication:
- Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity
Announcement
Castle Biosciences, Inc. announced the publication of a new study further demonstrating that DecisionDx-Melanoma can precisely predict sentinel lymph node (SLN) positivity risk to help guide risk-aligned SLNB decisions, potentially reducing the number of unnecessary procedures and increasing the SLNB positivity yield if the procedure is performed.
AI Summary
Castle Biosciences, Inc. recently published a study showing that its DecisionDx‑Melanoma test can accurately predict the risk of sentinel lymph node (SLN) positivity in melanoma patients. The test helps guide decisions about whether to perform a sentinel lymph node biopsy (SLNB), a procedure used to detect cancer spread. In this study, the test identified patients with low risk of SLN positivity, suggesting that unnecessary SLNB procedures could be reduced by about 33% for those with T1‐T2 tumors. By combining tumor biology with clinical and pathological factors, DecisionDx‑Melanoma provides personalized risk estimates. This precision approach means that low-risk patients might safely avoid an invasive procedure, while those at higher risk can be confidently recommended for SLNB, leading to improved outcomes and more efficient use of surgical resources.
Read Announcement
DecisionDx-SCC - FDA Regulatory Timeline and Events
DecisionDx-SCC is a drug developed by Castle Biosciences for the following indication: High-risk cutaneous squamous cell carcinoma (SCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DecisionDx-SCC
- Announced Date:
- March 28, 2025
- Indication:
- High-risk cutaneous squamous cell carcinoma (SCC)
Announcement
Castle Biosciences, will share new data on its risk-stratification tests for patients with skin cancers, DecisionDx-SCC and DecisionDx-Melanoma, via two poster presentations at the NCCN 2025 Annual Conference, being held March 28-30 in Orlando, Florida.
AI Summary
Castle Biosciences will present new data on its skin cancer risk-stratification tests, DecisionDx-SCC and DecisionDx-Melanoma, at the NCCN 2025 Annual Conference in Orlando, Florida, from March 28-30, 2025. The company will share its findings through two poster presentations. One top-scoring abstract will focus on DecisionDx-SCC, a test that refines metastatic risk predictions in high-risk squamous cell carcinoma patients by enhancing current staging methods. This new study involved 1,412 patients and shows that the test can significantly improve risk assessment when combined with existing staging criteria. In addition, DecisionDx-Melanoma, which assesses mortality risk in early-stage cutaneous melanoma, will be highlighted in a separate poster, confirming its value in identifying patients who may benefit from more tailored treatment strategies. These presentations underline Castle Biosciences’ commitment to advancing personalized care in skin cancer management.
Read Announcement- Drug:
- DecisionDx-SCC
- Announced Date:
- March 7, 2025
- Indication:
- High-risk cutaneous squamous cell carcinoma (SCC)
Announcement
Castle Biosciences, Inc announced that it will share new data on its DecisionDx-Melanoma and DecisionDx-SCC tests for patients with skin cancers at the 2025 AAD Annual Meeting, taking place March 7-11 in Orlando, Florida.
AI Summary
Castle Biosciences, Inc. announced that it will present new data on its DecisionDx-Melanoma and DecisionDx-SCC tests for skin cancer patients at the 2025 American Academy of Dermatology Annual Meeting. The event will be held in Orlando, Florida, from March 7-11, 2025. These tests are designed to help clinicians better understand a patient’s risk of metastasis from melanoma and high‐risk cutaneous squamous cell carcinoma. The DecisionDx-SCC test, which uses a 40-gene expression profile, and the DecisionDx-Melanoma test, based on a risk-stratification algorithm, have shown promise in guiding treatment decisions and improving patient outcomes. Castle Biosciences representatives highlighted their commitment to advancing evidence-based dermatologic care, emphasizing that the new data will further demonstrate how these tests can empower clinicians and enhance personalized, risk-aligned treatment planning.
Read Announcement- Drug:
- DecisionDx-SCC
- Announced Date:
- September 27, 2024
- Indication:
- High-risk cutaneous squamous cell carcinoma (SCC)
Announcement
Castle Biosciences, Inc announced new data demonstrating the ability of its DecisionDx-SCC test to provide clinically impactful risk stratification in high-risk SCC patient sub-populations (i.e., patients with suppressed immune systems in this study) to guide potential treatment intensification, such as adjuvant radiation therapy (ART).
AI Summary
Castle Biosciences, Inc. announced promising new data on its DecisionDx-SCC test, which could help guide treatment decisions for patients with high-risk cutaneous squamous cell carcinoma (SCC), especially those with suppressed immune systems. The 40-gene expression profile test was shown to effectively stratify risk in patients with lower-stage BWH T1-T2a tumors. In the study, immune suppressed patients with T2a tumors experienced a notably higher risk of metastasis compared to their immune competent counterparts. Importantly, the test separated these patients into groups with more or less favorable metastasis-free survival, suggesting that high-risk patients could benefit from treatment intensification such as adjuvant radiation therapy (ART). These findings underline the clinical value of the DecisionDx-SCC test in identifying patients who may require additional surveillance and targeted therapies, with details to be shared at the ASTRO 2024 Annual Meeting.
Read Announcement- Drug:
- DecisionDx-SCC
- Announced Date:
- September 5, 2024
- Indication:
- High-risk cutaneous squamous cell carcinoma (SCC)
Announcement
Castle Biosciences, Inc announced the publication of a new study in Future Oncology further substantiating use of its DecisionDx-SCC test in guiding patient selection and decision-making related to the use of ART in patients with high-risk SCC based on the ability of the test to identify patients likely to benefit from treatment.
AI Summary
Castle Biosciences, Inc. announced a new study published in Future Oncology that highlights the effectiveness of its DecisionDx-SCC test in guiding treatment decisions for patients with high‐risk cutaneous squamous cell carcinoma (SCC). The study shows that the test, which examines a 40-gene expression profile, can identify patients who are more likely to benefit from adjuvant radiation therapy (ART) after removal of the primary tumor. Specifically, patients with a Class 2B result, indicating the highest metastatic risk, experienced a significant reduction in metastasis progression when treated with ART. In contrast, patients with low-risk (Class 1) results may safely avoid the additional treatment, and those with intermediate risk (Class 2A) did not show a clear benefit. This research supports the clinical use of DecisionDx-SCC in optimizing patient care by tailoring treatment plans based on tumor biology.
Read Announcement
TSP-9 - FDA Regulatory Timeline and Events
TSP-9 is a drug developed by Castle Biosciences for the following indication: In identifying high-risk NDBE patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TSP-9
- Announced Date:
- September 23, 2024
- Indication:
- In identifying high-risk NDBE patients
Announcement
Castle Biosciences, Inc announced that will present new data supporting the ability of its TissueCypher Barrett's Esophagus test (TSP-9) to independently predict risk of progression to esophageal cancer in patients with Barrett's esophagus (BE) at the American Foregut Society (AFS) 2024 Annual Meeting, being held Sept. 25-29, 2024, in Denver.
AI Summary
Castle Biosciences, Inc. will present new data at the American Foregut Society (AFS) 2024 Annual Meeting in Denver from September 25-29. The company will show that its TissueCypher Barrett’s Esophagus test (TSP-9) is the strongest independent predictor of progression to esophageal cancer in patients with Barrett’s esophagus. Testing with TissueCypher alone outperforms the use of traditional clinicopathologic factors such as age and pathology diagnosis, offering a more accurate risk assessment.
The data indicate that the test can help drive critical patient management decisions by identifying high-risk patients who might need more intensive surveillance or early treatment, while supporting longer surveillance intervals for those at low risk. These findings could lead to more tailored treatment plans that improve outcomes and better allocate resources in managing Barrett’s esophagus.
Read Announcement- Drug:
- TSP-9
- Announced Date:
- June 24, 2024
- Indication:
- In identifying high-risk NDBE patients
Announcement
Castle Biosciences, Inc announced that the latest American Gastroenterological Association (AGA) clinical practice guideline recognized that not all patients with non-dysplastic BE (NDBE) are at low risk of developing esophageal cancer. The guideline acknowledges the role that tissue-based biomarkers, including the tissue systems pathology test (TissueCypher, also known as TSP-9), can play in identifying high-risk NDBE patients who may benefit from endoscopic eradication therapy (EET) to prevent disease progression.3
AI Summary
Castle Biosciences, Inc. announced that the new American Gastroenterological Association (AGA) clinical practice guideline highlights that not all patients with non-dysplastic Barrett’s esophagus (NDBE) are at low risk for developing esophageal cancer. The guideline recognizes the importance of tissue-based biomarkers, including the TissueCypher test (also known as TSP-9), in identifying high-risk NDBE patients. These patients may benefit from early intervention with endoscopic eradication therapy (EET), such as ablation, to prevent disease progression.
The acknowledgment of TissueCypher in the guideline supports its ability to provide a deeper analysis of esophageal tissue, helping clinicians pinpoint patients at an increased risk of cancer. This approach aims to ensure that high-risk individuals receive timely treatment while avoiding unnecessary procedures for those with a lower risk of progression.
Read Announcement
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