|By PR Newswire||
|December 13, 2012 05:22 AM EST||
RARITAN, New Jersey, December 13, 2012 /PRNewswire/ --
Veridex, LLC today announced approval from the China State Food & Drug Administration (SFDA) for the CellSearch® circulating tumor cell (CTC) test as an in vitro diagnostic for women with metastatic breast cancer. This makes CellSearch® the first and only approved CTC test for cancer patients in China, which is the seventh country outside of the United States and European Union to clear CellSearch® for use as an aid in the monitoring of patients.
The SFDA approval is based on the results of a multi-center, prospective study of 294 women with metastatic breast cancer. The objective of the study was to evaluate whether CTC count, using the CellSearch® test, is predictive of progression-free survival (PFS) and overall survival (OS) in Chinese metastatic breast cancer patients. Results of the study confirmed that women with fewer than 5 CTCs have a more favorable prognosis compared to women with 5 or more CTCs. Median PFS was 42.0 weeks for the group with fewer than 5 CTCs compared to 24.9 weeks for those with 5 or more CTCs. The risk of death in the group with 5 or more CTCs was 4.85 times that of the group with fewer than 5 CTCs.
CellSearch® is administered as a routine blood test, a highly sensitive liquid biopsy that can identify as few as one CTC in 7.5 ml of blood. Oncologists can use this information, in combination with other diagnostic tests and clinical methods for monitoring metastatic breast cancer, to assess a patient's overall prognosis and help predict progression free survival and overall survival.
An estimated 189,500 women in China are expected to be diagnosed with breast cancer by 2013. Nearly two-thirds of Chinese women with breast cancer are diagnosed in the later stages of the disease. Further, the incidence of breast cancer is rising sharply at a rate of 4 percent per year.
"CellSearch® is a useful new tool to help improve the care provided to China's growing number of women affected by metastatic breast cancer," said Minetta C. Liu, M.D., of the clinical molecular diagnostics laboratory at Georgetown University's Lombardi Comprehensive Cancer Center and a key investigator in the CTC study. "The use of CellSearch® in conjunction with other diagnostic tests, such as imaging and routine blood work, provides oncologists with a more accurate and comprehensive understanding of their patients' prognoses."
"We are thrilled to make CellSearch® available for women in China with metastatic breast cancer," said Robert McCormack, Ph.D., Head of Technology Innovation at Veridex. "Oncologists tell us that knowing a patient's CTC count provides them with a second measurement, complementary to traditional imaging, to help them assess the prognosis of a patient."
About Circulating Tumor Cells
Circulating tumor cells are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs is evolving as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.
About CELLSEARCH® CTC Test
CELLSEARCH® is the first and only U.S. Food and Drug Administration-cleared in vitro diagnostic (IVD) test to capture and count CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer. The test can be administered at any time during the course of therapy as a routine blood test. It is used in combination with other tests and a clinician's assessment, to provide a more complete picture of a patient's prognosis.
About Veridex, LLC
Veridex, LLC, a Johnson & Johnson company, is an organization dedicated to providing physicians with high-value diagnostic oncology products. Veridex's IVD products may significantly benefit patients by helping physicians make more informed decisions that enable better patient care. Veridex's Clinical Research Solutions provide tools and services that may be used for the selection, identification and enumeration of targeted rare cells in peripheral blood for the identification of biomarkers, aiding scientists in their search for new, targeted therapies. For more information, visit http://www.veridex.com.
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 9, 2016 01:15 PM EST Reads: 367
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 9, 2016 01:00 PM EST Reads: 182
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 9, 2016 12:45 PM EST Reads: 224
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 9, 2016 12:30 PM EST Reads: 178
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
Feb. 9, 2016 12:15 PM EST Reads: 162
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 9, 2016 12:00 PM EST Reads: 143
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, will discuss using predictive analytics to ...
Feb. 9, 2016 11:45 AM EST Reads: 384
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 9, 2016 11:45 AM EST Reads: 185
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 9, 2016 11:45 AM EST
SYS-CON Events announced today that iDevices®, the preeminent brand in the connected home industry, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. iDevices, the preeminent brand in the connected home industry, has a growing line of HomeKit-enabled products available at the largest retailers worldwide. Through the “Designed with iDevices” co-development program and its custom-built IoT Cloud Infrastruc...
Feb. 9, 2016 11:45 AM EST
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 9, 2016 11:30 AM EST Reads: 398
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...
Feb. 9, 2016 11:30 AM EST Reads: 474
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Feb. 9, 2016 11:30 AM EST Reads: 159
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 9, 2016 11:00 AM EST Reads: 252
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 9, 2016 10:45 AM EST Reads: 186