Sentinel lymph node

New Indication Approved for Verdye (Indocyanine Green for Injection, ICG) for Breast Sentinel Lymph Node Mapping

Retrieved on: 
Monday, February 5, 2024

ATHLONE, Ireland, Feb. 5, 2024 /PRNewswire/ -- Diagnostic Green Plc (Diagnostic Green) is pleased to announce the approval of Verdye (ICG) for intraoperative identification of sentinel lymph nodes and visualisation pathways in breast cancer in Spain.

Key Points: 
  • ATHLONE, Ireland, Feb. 5, 2024 /PRNewswire/ -- Diagnostic Green Plc (Diagnostic Green) is pleased to announce the approval of Verdye (ICG) for intraoperative identification of sentinel lymph nodes and visualisation pathways in breast cancer in Spain.
  • The presence of lymphatic metastases is an important prognostic factor for the survival of breast cancer.
  • Sentinel lymph node biopsy (SLNB) continues to be a fundamental component of early breast cancer detection and is the current standard of care to help determine whether cancer has spread to the lymph nodes.
  • Verdye (Indocyanine Green, ICG) is available throughout EMEA and sold through a network of distributors or directly by Diagnostic Green.

Castle Biosciences Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, November 2, 2023

Delivered 18,409 total test reports in the third quarter of 2023, an increase of 52% compared to 12,114 in the same period of 2022:

Key Points: 
  • Delivered 18,409 total test reports in the third quarter of 2023, an increase of 52% compared to 12,114 in the same period of 2022:
    DecisionDx®-Melanoma test reports delivered in the quarter were 8,559, compared to 7,354 in the third quarter of 2022, an increase of 16%.
  • DecisionDx®-SCC test reports delivered in the quarter were 2,820, compared to 1,636 in the third quarter of 2022, an increase of 72%.
  • MyPath® Melanoma test reports delivered in the quarter were 1,011, compared to 834 MyPath Melanoma and DiffDx®-Melanoma aggregate test reports in the third quarter of 2022, an increase of 21%.
  • Castle Biosciences will hold a conference call on Thursday, Nov. 2, 2023, at 4:30 p.m. Eastern time to discuss its third quarter 2023 results and provide a corporate update.

Real World Prospective Study shows clinical implementation of Merlin Assay (CP-GEP) in melanoma care

Retrieved on: 
Tuesday, October 31, 2023

The study, titled "Clinical Evaluation of the Clinicopathologic and Gene Expression Profile (CP-GEP) in Patients with Melanoma Eligible for Sentinel Lymph Node Biopsy: A Multicenter Prospective Dutch Study," [1] aimed to evaluate the clinical use and implementation of the CP-GEP model in a prospective multicenter study in the Netherlands.

Key Points: 
  • The study, titled "Clinical Evaluation of the Clinicopathologic and Gene Expression Profile (CP-GEP) in Patients with Melanoma Eligible for Sentinel Lymph Node Biopsy: A Multicenter Prospective Dutch Study," [1] aimed to evaluate the clinical use and implementation of the CP-GEP model in a prospective multicenter study in the Netherlands.
  • This groundbreaking study aimed to evaluate the clinical utility and feasibility of implementing the CP-GEP model in a prospective multicenter setting in the Netherlands.
  • We are very pleased to see that the data from this prospective real world study confirms what we have seen on the performance in our retrospective studies."
  • The study results validate the model's utility, making it a valuable tool in the management of melanoma patients

Real World Prospective Study shows clinical implementation of Merlin Assay (CP-GEP) in melanoma care

Retrieved on: 
Tuesday, October 31, 2023

The study, titled "Clinical Evaluation of the Clinicopathologic and Gene Expression Profile (CP-GEP) in Patients with Melanoma Eligible for Sentinel Lymph Node Biopsy: A Multicenter Prospective Dutch Study," [1] aimed to evaluate the clinical use and implementation of the CP-GEP model in a prospective multicenter study in the Netherlands.

Key Points: 
  • The study, titled "Clinical Evaluation of the Clinicopathologic and Gene Expression Profile (CP-GEP) in Patients with Melanoma Eligible for Sentinel Lymph Node Biopsy: A Multicenter Prospective Dutch Study," [1] aimed to evaluate the clinical use and implementation of the CP-GEP model in a prospective multicenter study in the Netherlands.
  • This groundbreaking study aimed to evaluate the clinical utility and feasibility of implementing the CP-GEP model in a prospective multicenter setting in the Netherlands.
  • We are very pleased to see that the data from this prospective real world study confirms what we have seen on the performance in our retrospective studies."
  • The study results validate the model's utility, making it a valuable tool in the management of melanoma patients

DecisionDx®-Melanoma Outperforms Memorial Sloan Kettering Cancer Center (MSKCC) Nomogram in Predicting Sentinel Lymph Node Positivity in Patients with Cutaneous Melanoma

Retrieved on: 
Thursday, October 5, 2023

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a new study demonstrating DecisionDx®-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM).

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a new study demonstrating DecisionDx®-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM).
  • The MSKCC nomogram, which uses logistic regression and only clinical and pathologic factors to predict a patient’s SLN positivity risk.
  • Patients from previously published multicenter cohorts with T1-T2 tumors who had undergone the SLNB procedure (n=465) were analyzed using both DecisionDx-Melanoma and the MSKCC nomogram.
  • DecisionDx-Melanoma also demonstrated better accuracy in predicting SLN positivity, including higher sensitivity (95% vs. 81%) and negative predictive value (97% vs. 90%) than the MSKCC nomogram.

Castle Biosciences, Leading Skin Cancer Expert, Darrell Rigel, M.D., M.S., and IMPACT Melanoma Board Member to Ring Nasdaq Closing Bell on Sept. 27, 2023, to Raise Awareness of Melanoma

Retrieved on: 
Monday, September 25, 2023

“Castle is committed to our mission--improving health through innovative tests that guide patient care,” said Derek Maetzold, president and chief executive officer of Castle Biosciences and IMPACT Melanoma board member. “We are grateful for the opportunity to ring the closing bell in honor of patients with melanoma, their families and caregivers, and importantly, their clinicians, who we are privileged to partner with to help improve their care. At the end of the day, we are all working together to make an impact in people’s lives and perhaps provide something even more powerful than that … hope for the future.”

Key Points: 
  • “Castle is committed to our mission--improving health through innovative tests that guide patient care,” said Derek Maetzold, president and chief executive officer of Castle Biosciences and IMPACT Melanoma board member.
  • “We are grateful for the opportunity to ring the closing bell in honor of patients with melanoma, their families and caregivers, and importantly, their clinicians, who we are privileged to partner with to help improve their care.
  • IMPACT Melanoma is the nation’s leading non-profit dedicated to significantly reducing the incidence of melanoma in the United States and saving lives.
  • The live broadcast will begin at 3:50 p.m. Eastern Time from the Nasdaq MarketSite Tower in New York.

Castle Biosciences Reports Second Quarter 2023 Results

Retrieved on: 
Wednesday, August 2, 2023

“Castle delivered an outstanding second quarter, with strength across our entire test portfolio,” said Derek Maetzold, president and chief executive officer of Castle Biosciences.

Key Points: 
  • “Castle delivered an outstanding second quarter, with strength across our entire test portfolio,” said Derek Maetzold, president and chief executive officer of Castle Biosciences.
  • Delivered 16,820 total test reports in the second quarter of 2023, an increase of 52% compared to 11,034 in the same period of 2022:
    DecisionDx-Melanoma test reports delivered in the quarter were 8,597, compared to 7,125 in the second quarter of 2022, an increase of 21%.
  • MyPath® Melanoma test reports delivered in the quarter were 953, compared to 955 MyPath Melanoma and DiffDx®-Melanoma aggregate test reports in the second quarter of 2022.
  • Castle Biosciences will hold a conference call on Wednesday, August 2, 2023, at 4:30 p.m. Eastern time to discuss its second quarter 2023 results and provide a corporate update.

Recommendations by Expert Consensus Panel Relating to Risk-Stratification Tests and Tools for Use in Cutaneous Melanoma Have Been Adopted as an Official Policy Recommendation of the National Society for Cutaneous Medicine

Retrieved on: 
Wednesday, March 8, 2023

The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management.

Key Points: 
  • The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management.
  • Additionally, the consensus report endorses Castle’s DecisionDx®-Melanoma GEP risk stratification test as offering more utility than other existing CM GEP assays or nomograms, supported by extensive, evidence-driven data in current literature.
  • The panel reviewed 32 studies published between 2019 through 2022 assessing the use of GEP testing in CM prognosis.
  • Each of the recommendations was given a strength “A,” “B,” or “C” according to Strength of Recommendation Taxonomy (SORT) criteria.

Data Presentation at 2023 Winter Clinical - Miami™ Highlights Use of DecisionDx®-Melanoma to Guide SLNB Surgery Decisions in Head and Neck Tumors

Retrieved on: 
Wednesday, February 22, 2023

The poster presentation for DecisionDx®-Melanoma strengthens the evidence supporting use of the test to provide risk stratification for patients in order to guide risk-appropriate sentinel lymph node biopsy (SLNB) surgery decisions.

Key Points: 
  • The poster presentation for DecisionDx®-Melanoma strengthens the evidence supporting use of the test to provide risk stratification for patients in order to guide risk-appropriate sentinel lymph node biopsy (SLNB) surgery decisions.
  • This study involved patients with cutaneous melanoma (CM) tumors (T1-T2a) located in the head or neck region who had undergone SLNB (n=159).
  • CM tumors on the head or neck tend to be more aggressive and pose unique challenges for SLNB surgery.
  • Early development data for Castle’s pipeline test for inflammatory skin diseases is expected in 2023, with an expected launch by the end of 2025.

Prospective, Multicenter Study Demonstrates That DecisionDx®-Melanoma Test Results Can Significantly Reduce the Number of Sentinel Lymph Node Biopsy (SLNB) Procedures Performed When Used Within the Context of Current Guidelines

Retrieved on: 
Thursday, February 9, 2023

“DecisionDx-Melanoma is the best-studied molecular test for use in cutaneous melanoma to date, with studies involving more than 10,000 research subjects.

Key Points: 
  • “DecisionDx-Melanoma is the best-studied molecular test for use in cutaneous melanoma to date, with studies involving more than 10,000 research subjects.
  • The data showed that DecisionDx-Melanoma test results influenced 85% of SLNB decisions, the highest percentage reported in the study, followed by patient preference.
  • These data show that use of the test’s results can guide risk-aligned, clinical decision-making regarding the SLNB surgical procedure, within current guidelines.
  • The use of DecisionDx-Melanoma test results within current guidelines resulted in a significant reduction in SLNB procedures performed, compared to SLNB decisions based on a patient’s clinicopathologic risk factors alone (p