|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.
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 27, 2016 08:45 PM EDT Reads: 2,281
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 27, 2016 08:45 PM EDT Reads: 1,753
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 27, 2016 06:15 PM EDT Reads: 708
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 27, 2016 06:00 PM EDT Reads: 3,080
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
Aug. 27, 2016 06:00 PM EDT Reads: 716
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 27, 2016 05:15 PM EDT Reads: 1,568
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 27, 2016 05:00 PM EDT Reads: 1,874
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Aug. 27, 2016 04:45 PM EDT Reads: 1,621
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 27, 2016 04:00 PM EDT Reads: 566
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 27, 2016 03:15 PM EDT Reads: 754
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 27, 2016 02:45 PM EDT Reads: 3,443
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Aug. 27, 2016 12:45 PM EDT Reads: 2,340
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 27, 2016 12:30 PM EDT Reads: 3,613
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 27, 2016 12:00 PM EDT Reads: 520
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Aug. 27, 2016 12:00 PM EDT Reads: 637