|By PR Newswire||
|September 28, 2012 02:01 AM EDT||
REDWOOD CITY, California and VIENNA, Austria, September 28, 2012 /PRNewswire/ --
Large Prospective Study Validates Use of the Oncotype DX test in Stage II and Stage III Colon Cancer and Identifies Genes that May Indicate Effectiveness of Oxaliplatin
Results from Europe and Mexico-Based Studies Reconfirm the Impact of the Oncotype DX test on Guiding Treatment Decisions in Invasive Breast Cancer Patients
Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of data that support expanded use of the Oncotype DX® tests in optimising treatment decisions for breast and colon patients at various stages of disease. The new data confirm the ability of the Oncotype DX colon cancer test to predict recurrence risk in stage II and stage III colon cancer patients, and exploratory analyses have identified 16 genes strongly associated with oxaliplatin treatment benefit. Additionally, two studies reconfirm the clinical utility of the Oncotype DX breast cancer test in treatment decision making in women with early-stage invasive breast cancer.
The study results are being presented at the 2012 European Society for Medical Oncology (ESMO) Congress taking place September 28-October 2 in Vienna, Austria.
"Personalised medicine requires accurate assessment of the patient's individual tumor biology," said Christer Svedman, director, medical affairs in Europe, Genomic Health. "The new data add to a large body of evidence demonstrating that the Oncotype DX test is an important tool enabling more informed treatment decisions in early-stage breast and colon cancer patients worldwide."
Colon Cancer: Findings Provide Third Successful Prospectively Designed Study of Oncotype DX Colon Cancer Test in Patients with Stage II Disease, First Validation Study in Patients with Stage III Disease; Identify Genes that May Predict Patient Benefit from Oxaliplatin
A large, independent validation study involving 892 patients demonstrates that the Oncotype DX Colon Cancer Recurrence Score® results predict risk of recurrence, disease-free survival and overall survival in stage II and stage III colon cancer patients receiving adjuvant chemotherapy in the landmark randomised NSABP C-07 clinical trial. The study also indicates that risk assessment with the Recurrence Score assay enables better discrimination of the expected absolute benefit of adding oxaliplatin to adjuvant 5FU chemotherapy.
Additionally, an exploratory component of this study, researchers analysed 735 genes and identified 16 genes as being predictive of oxaliplatin benefit, narrowing down specific genes and pathways associated with sensitivity or resistance to oxaliplatin when added to adjuvant 5-fluorouracil chemotherapy. The company will utilize these positive results to develop an algorithm and a standardised quantitative laboratory process with the plan to initiate a validation study in 2013.
"The Recurrence Score has shown us that there is a continuous biology in colon cancer versus a high or low ranking, and understanding where a patient falls on that continuum is going to help both stage II and stage III colon cancer patients make more informed decisions regarding adjuvant therapy," said principal investigator Michael O'Connell, M.D., associate chairman of The National Surgical Adjuvant Breast and Bowel Project (NSABP). "The discovery of new genes holds promise for the development of a genomic test that would benefit a broader Stage II and Stage III patient population by providing better understanding of oxaliplatin benefit."
The poster and discussion presentation titled, "The 12-gene Colon Cancer Recurrence Score (RS) Predicts Recurrence in Stage II and III Colon cancer Patients Treated with 5FU/LV (FU) and 5FU/LV + Oxaliplatin (FU+Ox): Validation in NSABP C-07" (Abstract #523PD), will take place on Sept. 29, 1-2 p.m., Hall C.
Breast Cancer: Growing Evidence Continues to Reinforce the Impact of the Oncotype DX test on Treatment Decisions in Patients with Early-Stage Invasive Breast Cancer
"Genomic testing reveals the patient's individual tumor biology, enabling more informed treatment decisions," said Simon Holt, MA, MB, BChir, FRCS, Lead Breast Surgeon, Hywel Dda Health Board, Wales, United Kingdom. "Oncotype DX is the only clinically validated multi-gene assay that has proved predictive of chemotherapy treatment benefit and new data reinforces the important role this test can play in ultimately enhancing the quality of care for breast cancer patients."
- A meta-analysis of four prospective studies from the United Kingdom, Germany, France, and Spain including 565 patients with node-negative, estrogen receptor-positive breast cancer, showed that based on knowledge of the Recurrence Score result, 48 percent of patients initially recommended chemotherapy were advised to omit chemotherapy and 18 percent of patient who were initially advised hormonal therapy alone were advised to add chemotherapy. These results further demonstrate that use of the Oncotype DX test is associated with a significant change in treatment decisions and an overall reduction in chemotherapy use in the studied European countries regardless of different local treatment traditions.
The poster and discussion titled, "Meta-analysis of Prospective European Studies Assessing the Impact of Using the 21-Gene Recurrence Score Assay on Clinical Decision Making in Women with ER-positive, HER2-negative Early Stage Breast Cancer" (Abstract #252PD), will take place on Sept. 29, 1-2 p.m., Hall G.
- Results of the first Oncotype DX breast cancer test treatment decision impact study from Mexico showed that in 96 patients who used the test in a public hospital setting, the knowledge of the Recurrence Score result changed physicians' treatment recommendations for 32 percent of early-stage invasive breast cancer patients. This study demonstrated that, based on the Recurrence Score result, 46 percent of patients initially recommended chemotherapy were advised to omit chemotherapy and use hormonal therapy alone, and 16 percent of patients initially recommended hormonal therapy alone were advised to add chemotherapy to their treatment regimen. These results suggest that use of the Oncotype DX test in the Mexican public health system has an impact on adjuvant treatment recommendations and may reduce the need and use of chemotherapy.
The poster presentation titled, "A study of the impact of the 21-gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital" (Abstract #289P), will take place on Oct. 1, 1-2 p.m., Hall XL.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a global health company that provides actionable genomic information to personalize genomic health decisions. The company's lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease. As of June 30, 2012, more than 10,000 physicians in over 65 countries had ordered more than 295,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, http://www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: http://www.OncotypeDX.com and http://www.mybreastcancertreatment.org.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the ability of the Company's tests to optimize cancer treatment in patients with breast and colon cancer; the ability of the Oncotype DX Breast Cancer test Recurrence Score to impact treatment decisions in a clinical setting; the ability of the Oncotype DX Colon Cancer test to individualize cancer treatment decisions stage II and III colon cancer patients treated with Oxaliplatin; the potential of the Company's tests to change medical practice ; the applicability of study results to clinical practice; the timing and results of future studies; the focus of the company's product pipeline, the ability of the company to develop additional tests in the future , and the ability of any potential tests the company may develop to optimize cancer treatment. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the applicability of clinical study results to actual outcomes; the risks and uncertainties associated with possible additional regulation of our tests both in the United States and abroad; the risks associated with the commercialization of current and future products; the risks associated with competition; the risks and potential delays associated with such studies; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
Between 2005 and 2020, data volumes will grow by a factor of 300 – enough data to stack CDs from the earth to the moon 162 times. This has come to be known as the ‘big data’ phenomenon. Unfortunately, traditional approaches to handling, storing and analyzing data aren’t adequate at this scale: they’re too costly, slow and physically cumbersome to keep up. Fortunately, in response a new breed of technology has emerged that is cheaper, faster and more scalable. Yet, in meeting these new needs they...
Dec. 6, 2016 01:00 AM EST Reads: 1,836
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 12:45 AM EST Reads: 800
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 6, 2016 12:30 AM EST Reads: 3,856
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Dec. 6, 2016 12:30 AM EST Reads: 1,189
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
Dec. 6, 2016 12:30 AM EST Reads: 4,569
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Dec. 6, 2016 12:00 AM EST Reads: 852
SaaS companies can greatly expand revenue potential by pushing beyond their own borders. The challenge is how to do this without degrading service quality. In his session at 18th Cloud Expo, Adam Rogers, Managing Director at Anexia, discussed how IaaS providers with a global presence and both virtual and dedicated infrastructure can help companies expand their service footprint with low “go-to-market” costs.
Dec. 5, 2016 11:45 PM EST Reads: 4,290
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
Dec. 5, 2016 10:45 PM EST Reads: 2,069
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 10:30 PM EST Reads: 1,051
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 10:30 PM EST Reads: 975
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, discussed using predictive analytics to mon...
Dec. 5, 2016 09:00 PM EST Reads: 4,953
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
Dec. 5, 2016 08:45 PM EST Reads: 494
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Dec. 5, 2016 07:45 PM EST Reads: 2,224
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Dec. 5, 2016 07:45 PM EST Reads: 2,087
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Dec. 5, 2016 07:15 PM EST Reads: 393