|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.
As machines are increasingly connected to the internet, it’s becoming easier to discover the numerous ways Industrial IoT (IIoT) is helping to shape the business world. This is exactly why we have decided to take a closer look at this pervasive movement and to examine the desire to connect more things! Now if you need a refresher on IIoT and how it is changing the world, take a moment and listen to Greg Gorbach with ARC Advisory Group. Gorbach believes, "IIoT will significantly change the worl...
May. 23, 2016 10:00 PM EDT Reads: 1,744
SYS-CON Events announced today the Docker Meets Kubernetes – Intro into the Kubernetes World, being held June 9, 2016, in conjunction with 18th Cloud Expo | @ThingsExpo, at the Javits Center in New York, NY. Register for 'Docker Meets Kubernetes Workshop' Here! This workshop led by Sebastian Scheele, co-founder of Loodse, introduces participants to Kubernetes (container orchestration). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, participants learn ...
May. 23, 2016 07:00 PM EDT Reads: 1,761
The pace of innovation, vendor lock-in, production sustainability, cost-effectiveness, and managing risk… In his session at 18th Cloud Expo, Dan Choquette, Founder of RackN, will discuss how CIOs are challenged finding the balance of finding the right tools, technology and operational model that serves the business the best. He will discuss how clouds, open source software and infrastructure solutions have benefits but also drawbacks and how workload and operational portability between vendors...
May. 23, 2016 07:00 PM EDT Reads: 1,703
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
May. 23, 2016 06:15 PM EDT Reads: 326
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
May. 23, 2016 05:00 PM EDT Reads: 4,591
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
May. 23, 2016 04:45 PM EDT Reads: 803
The essence of data analysis involves setting up data pipelines that consist of several operations that are chained together – starting from data collection, data quality checks, data integration, data analysis and data visualization (including the setting up of interaction paths in that visualization). In our opinion, the challenges stem from the technology diversity at each stage of the data pipeline as well as the lack of process around the analysis.
May. 23, 2016 04:30 PM EDT Reads: 734
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit y...
May. 23, 2016 04:00 PM EDT Reads: 1,782
Cloud computing changed data analytics for good. It enabled companies to drastically decrease resources and architecture previously assigned with business intelligence departments. It also enabled laymen to run advanced business analytics. Cloud was also the architecture of choice for storing and processing big data. Data piling is a continuous process, which is going to explode with emerging Internet of Things concept. Answer to this issue developers found in new concept called fog computing. ...
May. 23, 2016 03:45 PM EDT Reads: 1,743
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo New York Call for Papers is now open.
May. 23, 2016 03:00 PM EDT Reads: 1,636
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 23, 2016 03:00 PM EDT Reads: 558
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
May. 23, 2016 02:30 PM EDT Reads: 1,674
There are several IoTs: the Industrial Internet, Consumer Wearables, Wearables and Healthcare, Supply Chains, and the movement toward Smart Grids, Cities, Regions, and Nations. There are competing communications standards every step of the way, a bewildering array of sensors and devices, and an entire world of competing data analytics platforms. To some this appears to be chaos. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will discuss the vast to...
May. 23, 2016 02:00 PM EDT Reads: 2,316
SYS-CON Events announced today that Enzu, a leading provider of cloud hosting 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. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to foc...
May. 23, 2016 01:45 PM EDT Reads: 2,030
@DevOpsSummit taking place June 7-9, 2016 at Javits Center, New York City, and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world.
May. 23, 2016 01:00 PM EDT Reads: 3,222