Welcome!

News Feed Item

Castle Biosciences' Non-Invasive Gene Expression Profile Test Shown to Identify Sentinel Lymph Node Negative Melanoma Patients at High Risk of Metastasis

Data presented at the Latest in Dermatology Research Symposia session of 72nd Annual Meeting of the American Academy of Dermatology

DENVER, March 22, 2014 /PRNewswire/ -- Castle Biosciences Inc. today announced study results showing its gene expression profile (GEP) test (DecisionDx-Melanoma) can identify primary cutaneous (skin) melanoma tumors that are likely to metastasize in patients who had a negative sentinel lymph node biopsy. The data are being presented at the Latest in Dermatology Research Symposia session of the 72nd Annual Meeting of the American Academy of Dermatology. The DecisionDx-Melanoma test completed validation in 2013 and is widely used to determine metastatic risk in Stage I and II melanoma patients.

"Although sentinel lymph node biopsy has traditionally been the best prognostic test available for melanoma patients, two out of three patients who eventually develop distant metastasis had a negative SLNB result," said Pedram Gerami, M.D., study author and Associate Professor of Dermatology, Director of Melanoma Research at the Northwestern Skin Cancer Institute, Northwestern University. "The results from this study show the GEP test is an independent predictor of metastasis and death, and significantly improves upon sentinel lymph node biopsy for staging melanoma patients."

Study Details
Researchers compared the results of the non-invasive 31-gene GEP test to sentinel lymph node biopsy (SLNB) results in 134 patients with Stage I, II, or III cutaneous melanoma. These 134 patients represented all patients in the initial clinical validation studies who had a documented sentinel lymph node procedure.

In patients with a negative sentinel lymph node biopsy (SLNB-), a result interpreted as a lower risk for metastasis, the GEP test identified the vast majority of melanomas that ultimately progressed over the subsequent 5-year period. According to study results, the rate of 5-year metastasis-free survival (MFS) was 55% for SLNB- patients compared to 37% for SLNB+ patients (p=0.003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the low-risk (Class 1) patients and 31% for the high risk (Class 2) patients (p<0.0001).

Differences in overall survival (OS) paralleled the MFS rates, with SLNB- patients having a 5-year OS of 67% and SLNB+ having a 5-year OS of 55% (p=0.024). The GEP test again showed improved prognostic accuracy, with an OS for GEP Class 1 patients of 92% compared to 49% for Class 2 patients (p<0.0001).

Use of the GEP test was also analyzed in combination with SLNB status. As expected, the 20% of patients who had high risk results for both tests (GEP Class 2 and SLNB+) had lower survival rates (MFS=34%; OS=53%). Similarly, the 31% of patients who had low risk results for both tests (GEP Class 1 and SLNB-) had higher survival rates (MFS=86%; OS=92%).

Importantly, in the 49% of patients who had results that were discordant (high risk outcome for one test, low risk for the other) the GEP test result correctly predicted the patients' clinical outcomes. Net reclassification improvement of GEP class over SLNB status was greater than 50%.

Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (p<0.000003).

Continued Dr. Gerami, "Based upon this data, optimal use of the GEP test may be to identify high risk patients among those with a negative SLNB result, or for patients who are ineligible for or who decline a SLNB procedure."

GEP + SLNB 5-Year Metastasis-Free and Overall Survival  (n=134)

Class / SLNB

n

5-Year MFS

5-Year OS

Class 1/SLNB -

42

86%

92%

Class 1/SLNB+

1

100%

100%

Class 2/SLNB -

64

31%

49%

Class 2/SLNB +

27

34%

53%

SLNB 5-Year Metastasis-Free and Overall Survival  (n=134)

SLNB Status

n

MFS

p<0.003

OS

p=0.024

SLNB-

106

55%

67%

SLNB+

28

37%

55%

GEP 5-Year Metastasis-Free and Overall Survival  (n=134)

GEP PREDICTION

n

MFS 

p<0.0001

OS 

p<0.0001

Class 1 (low risk)

43

87%

92%

Class 2 (high risk)

91

31%

49%

"These results in patients who underwent sentinel node biopsies build on data we presented at ASCO last year showing the GEP test accurately identifies patients with Stage I and II tumors who are likely to metastasize," said Derek Maetzold, President and Chief Executive Officer of Castle Biosciences. "The non-invasive GEP test is now widely used clinically, and we continue to explore additional uses such as combination with sentinel lymph node biopsy where decision making can be improved through the use of more accurate test results."

About DecisionDx-Melanoma
The DecisionDx-Melanoma is validated for clinical use in Stage I, II, and III melanoma patients. The test is designed to predict metastasis by measuring the level of expression of 31 genes from a sample of the primary melanoma tumor. The test stratifies patients as Class 1 (low risk of metastasis), or Class 2 (high risk of metastasis). To date, the test has analyzed archived tumor samples from more than 600 melanoma patients. More information about the test and disease can be found at www.skinmelanoma.com.

About Castle Biosciences
Castle Biosciences is a molecular diagnostics and prognostics company dedicated to helping patients and their physicians make the best possible decisions about their treatment and follow-up care based on the individual molecular signature of their tumor. The Company currently offers tests for patients with rare cancers including uveal and cutaneous melanoma, thymoma, esophageal and brain cancers. More information can be found at www.castlebiosciences.com.

SOURCE Castle Biosciences Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The dynamic nature of the cloud means that change is a constant when it comes to modern cloud-based infrastructure. Delivering modern applications to end users, therefore, is a constantly shifting challenge. Delivery automation helps IT Ops teams ensure that apps are providing an optimal end user experience over hybrid-cloud and multi-cloud environments, no matter what the current state of the infrastructure is. To employ a delivery automation strategy that reflects your business rules, making r...
Nordstrom is transforming the way that they do business and the cloud is the key to enabling speed and hyper personalized customer experiences. In his session at 21st Cloud Expo, Ken Schow, VP of Engineering at Nordstrom, discussed some of the key learnings and common pitfalls of large enterprises moving to the cloud. This includes strategies around choosing a cloud provider(s), architecture, and lessons learned. In addition, he covered some of the best practices for structured team migration an...
You know you need the cloud, but you're hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You're looking at private cloud solutions based on hyperconverged infrastructure, but you're concerned with the limits inherent in those technologies. What do you do?
As many know, the first generation of Cloud Management Platform (CMP) solutions were designed for managing virtual infrastructure (IaaS) and traditional applications. But that's no longer enough to satisfy evolving and complex business requirements. In his session at 21st Cloud Expo, Scott Davis, Embotics CTO, explored how next-generation CMPs ensure organizations can manage cloud-native and microservice-based application architectures, while also facilitating agile DevOps methodology. He expla...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
Recently, REAN Cloud built a digital concierge for a North Carolina hospital that had observed that most patient call button questions were repetitive. In addition, the paper-based process used to measure patient health metrics was laborious, not in real-time and sometimes error-prone. In their session at 21st Cloud Expo, Sean Finnerty, Executive Director, Practice Lead, Health Care & Life Science at REAN Cloud, and Dr. S.P.T. Krishnan, Principal Architect at REAN Cloud, discussed how they built...
In a recent survey, Sumo Logic surveyed 1,500 customers who employ cloud services such as Amazon Web Services (AWS), Microsoft Azure, and Google Cloud Platform (GCP). According to the survey, a quarter of the respondents have already deployed Docker containers and nearly as many (23 percent) are employing the AWS Lambda serverless computing framework. It’s clear: serverless is here to stay. The adoption does come with some needed changes, within both application development and operations. Tha...
DevOps promotes continuous improvement through a culture of collaboration. But in real terms, how do you: Integrate activities across diverse teams and services? Make objective decisions with system-wide visibility? Use feedback loops to enable learning and improvement? With technology insights and real-world examples, in his general session at @DevOpsSummit, at 21st Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, explored how leading organizations use data-driven DevOps to close th...
"I focus on what we are calling CAST Highlight, which is our SaaS application portfolio analysis tool. It is an extremely lightweight tool that can integrate with pretty much any build process right now," explained Andrew Siegmund, Application Migration Specialist for CAST, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
SYS-CON Events announced today that Evatronix will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Evatronix SA offers comprehensive solutions in the design and implementation of electronic systems, in CAD / CAM deployment, and also is a designer and manufacturer of advanced 3D scanners for professional applications.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone inn...
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.