|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.
SOURCE Johnson & Johnson and Janssen
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Nov. 25, 2015 10:00 AM EST Reads: 423
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 25, 2015 09:45 AM EST
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, 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. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Nov. 25, 2015 09:30 AM EST Reads: 265
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Nov. 25, 2015 09:00 AM EST Reads: 261
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Nov. 25, 2015 08:15 AM EST Reads: 342
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
Nov. 25, 2015 07:45 AM EST Reads: 340
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 25, 2015 07:30 AM EST Reads: 246
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Nov. 25, 2015 07:15 AM EST Reads: 154
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which...
Nov. 25, 2015 06:45 AM EST
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Nov. 25, 2015 05:45 AM EST Reads: 287
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Nov. 25, 2015 05:45 AM EST Reads: 375
Continuous processes around the development and deployment of applications are both impacted by -- and a benefit to -- the Internet of Things trend. To help better understand the relationship between DevOps and a plethora of new end-devices and data please welcome Gary Gruver, consultant, author and a former IT executive who has led many large-scale IT transformation projects, and John Jeremiah, Technology Evangelist at Hewlett Packard Enterprise (HPE), on Twitter at @j_jeremiah. The discussion...
Nov. 25, 2015 02:30 AM EST Reads: 681
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Nov. 25, 2015 02:00 AM EST Reads: 288
In today's enterprise, digital transformation represents organizational change even more so than technology change, as customer preferences and behavior drive end-to-end transformation across lines of business as well as IT. To capitalize on the ubiquitous disruption driving this transformation, companies must be able to innovate at an increasingly rapid pace. Traditional approaches for driving innovation are now woefully inadequate for keeping up with the breadth of disruption and change facin...
Nov. 25, 2015 12:30 AM EST Reads: 416
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound...
Nov. 25, 2015 12:30 AM EST Reads: 410