|By PR Newswire||
|February 27, 2014 08:04 AM EST||
CAMBRIDGE, Mass., Feb. 27, 2014 /PRNewswire/ -- Metamark Genetics, Inc. today announced that its Cambridge, Mass. laboratory has been licensed for the highest level of clinical testing in the use of ProMark™, the company's prognostic assay to guide the medical management of patients with prostate cancer.
The licensure by the State of Massachusetts for "high-complexity testing" establishes the CLIA-certified laboratory as the national site for processing prostate-tissue samples upon the commercial introduction of ProMark™ planned for early 2014.
The licensure follows the completion last year of a clinical-validation study of ProMark™ that met its primary endpoint in differentiating between aggressive and indolent disease. Altogether, Metamark has completed four clinical studies of ProMark™ comprising 1,275 patients.
Shawn Marcell, President and Chief Executive Officer of Metamark, commented:
"With the licensure of our Cambridge laboratory we have taken another step toward launching ProMark™ so physicians and their patients can use this novel prognostic to address one of the most agonizing questions in men's healthcare—whether a newly diagnosed prostate cancer will spread or whether it will harmlessly remain within the prostate.
"As we prepare to commercialize ProMark™, we are also designing additional clinical studies to further delineate the potential of this new tool to guide the decision whether to treat prostate cancer aggressively or to choose the conservative option of active surveillance.
"We believe the unique format of ProMark™, which enables objective measurement of protein biomarkers in intact prostate tissue, can improve the management of prostate cancer much as other molecular tools have improved the treatment of breast and ovarian cancer."
About prostate cancer
This year some 242,000 men in the United States will be diagnosed with prostate cancer, and many of them will then confront a dilemma. Some prostate tumors are aggressive and life-threatening. Prostate cancer is the second leading cause of cancer deaths among men, after lung cancer, killing about 29,000 men in the United States every year. Yet the majority of prostate tumors are indolent and associated with little risk to health or longevity. The dilemma arises from the difficulty in distinguishing between aggressive and indolent tumors as crucial medical decisions are being made. Aggressive tumors usually necessitate aggressive therapy, most often radical prostatectomy (surgical removal of the entire prostate), sometimes radiation or anti-hormonal treatments. About 87 percent of men, concerned that their tumor will quickly grow and spread, undergo aggressive therapy shortly after diagnosis by needle biopsy (collection of tissue samples for examination). Aggressive therapy carries serious risks, however, including long-lasting urinary incontinence and sexual dysfunction. More accurate prognosis would better stratify patients by risk of tumor progression, so that men with low-risk profiles could more confidently choose a course of active surveillance through periodic monitoring of tumor status instead of aggressive therapy. In addition, men in need of aggressive therapy can be more confident about receiving appropriate treatment based on a high-risk profile. The need for more accurate prognosis is clearly a prevalent issue in men's healthcare: One in every six men will someday be told that he has prostate cancer.
ProMark™ is a proprietary test designed to improve the accuracy of prognosis for men diagnosed with prostate cancer. The test measures the amount of specific protein biomarkers obtained by needle biopsy from regions of prostate tissue where the biomarkers are altered during tumor formation. These "regions of interest" are rendered as intact, paraffin-embedded tissue sections. Quantitative measurements of the biomarkers are then determined by means of imaging technology that is digitized and fully automated. The resulting analysis is thus completely objective and fully reproducible. A large, blinded, clinical-validation study of ProMark™ met its primary endpoint, demonstrating that the test can aid in differentiating between aggressive and indolent disease. The research program supporting ProMark™ has completed four clinical studies altogether, and additional prospective studies are in development or under way. Metamark plans to commercialize ProMark™ in early 2014 through the company's CLIA-certified laboratory in Cambridge, Massachusetts.
Metamark Genetics, Inc. is a privately held biotechnology company founded in 2007 to develop novel, function-based, prognostic and diagnostic tests aimed at improving cancer care. The company's proprietary genomic and proteomic discovery platforms have yielded significant discoveries in several disease areas, including prostate, colon, and breast cancers. Through the acquisition of Healthtronics Laboratory Solutions last year, Metamark has become a leading provider of specialty urological pathology testing services throughout the United States. For more information, please visit the company's Website at www.metamarkgenetics.com. Metamark™ and ProMark™ are trademarks of Metamark Genetics, Inc.
SOURCE Metamark Genetics, Inc.
operations aren’t merging to become one discipline. Nor is operations simply going away. Rather, DevOps is leading software development and operations – together with other practices such as security – to collaborate and coexist with less overhead and conflict than in the past. In his session at @DevOpsSummit at 19th Cloud Expo, Gordon Haff, Red Hat Technology Evangelist, will discuss what modern operational practices look like in a world in which applications are more loosely coupled, are deve...
Oct. 25, 2016 09:45 AM EDT Reads: 1,776
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
Oct. 25, 2016 09:45 AM EDT Reads: 1,367
In his session at 19th Cloud Expo, Nick Son, Vice President of Cyber Risk & Public Sector at Coalfire, will discuss the latest information on the FedRAMP Program. Topics will cover: FedRAMP Readiness Assessment Report (RAR). This new process is designed to streamline and accelerate the FedRAMP process from the traditional timeline by initially focusing on technical capability instead of documentation preparedness. FedRAMP for High-impact level systems. Early in 2016 FedRAMP officially publishe...
Oct. 25, 2016 09:42 AM EDT
What are the successful IoT innovations from emerging markets? What are the unique challenges and opportunities from these markets? How did the constraints in connectivity among others lead to groundbreaking insights? In her session at @ThingsExpo, Carmen Feliciano, a Principal at AMDG, will answer all these questions and share how you can apply IoT best practices and frameworks from the emerging markets to your own business.
Oct. 25, 2016 09:30 AM EDT Reads: 2,576
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Oct. 25, 2016 09:15 AM EDT Reads: 1,062
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
Oct. 25, 2016 09:00 AM EDT Reads: 1,942
DevOps is speeding towards the IT world like a freight train and the hype around it is deafening. There is no reason to be afraid of this change as it is the natural reaction to the agile movement that revolutionized development just a few years ago. By definition, DevOps is the natural alignment of IT performance to business profitability. The relevance of this has yet to be quantified but it has been suggested that the route to the CEO’s chair will come from the IT leaders that successfully ma...
Oct. 25, 2016 08:45 AM EDT Reads: 16,496
In his session at Cloud Expo, Robert Cohen, an economist and senior fellow at the Economic Strategy Institute, will provide economic scenarios that describe how the rapid adoption of software-defined everything including cloud services, SDDC and open networking will change GDP, industry growth, productivity and jobs. This session will also include a drill down for several industries such as finance, social media, cloud service providers and pharmaceuticals.
Oct. 25, 2016 08:45 AM EDT Reads: 1,995
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
Oct. 25, 2016 08:30 AM EDT Reads: 890
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, discussed how research has demonstrated the value of Machine Learning in delivering next generation analytics to impr...
Oct. 25, 2016 08:00 AM EDT Reads: 5,738
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 25, 2016 07:45 AM EDT Reads: 4,909
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, will draw together recent research and lessons learned from emerging and established ...
Oct. 25, 2016 07:45 AM EDT Reads: 1,399
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Oct. 25, 2016 06:45 AM EDT Reads: 4,823
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
Oct. 25, 2016 06:15 AM EDT Reads: 11,433
SYS-CON Events announced today that Interface Masters Technologies, a leader in Network Visibility and Uptime Solutions, 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. Interface Masters Technologies is a leading vendor in the network monitoring and high speed networking markets. Based in the heart of Silicon Valley, Interface Masters' expertise lies in Gigabit, 10 Gigabit and 40 Gigabit Eth...
Oct. 25, 2016 05:45 AM EDT Reads: 3,353