Welcome!

News Feed Item

Metamark Genetics Receives Laboratory License In Preparation To Launch ProMark™ Prostate-Cancer Assay

Novel Prognostic Test Is Designed to Guide Optimal Decision-Making at Diagnosis

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.

About ProMark:

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.

About Metamark

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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Enterprise architects are increasingly adopting multi-cloud strategies as they seek to utilize existing data center assets, leverage the advantages of cloud computing and avoid cloud vendor lock-in. This requires a globally aware traffic management strategy that can monitor infrastructure health across data centers and end-user experience globally, while responding to control changes and system specification at the speed of today’s DevOps teams. In his session at 20th Cloud Expo, Josh Gray, Chie...
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, shared examples from a wide range of industries – including en...
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. Jack Norris reviews best practices to show how companies develop, deploy, and dynamically update these applications and how this data-first...
Intelligent Automation is now one of the key business imperatives for CIOs and CISOs impacting all areas of business today. In his session at 21st Cloud Expo, Brian Boeggeman, VP Alliances & Partnerships at Ayehu, will talk about how business value is created and delivered through intelligent automation to today’s enterprises. The open ecosystem platform approach toward Intelligent Automation that Ayehu delivers to the market is core to enabling the creation of the self-driving enterprise.
"At the keynote this morning we spoke about the value proposition of Nutanix, of having a DevOps culture and a mindset, and the business outcomes of achieving agility and scale, which everybody here is trying to accomplish," noted Mark Lavi, DevOps Solution Architect at Nutanix, in this SYS-CON.tv interview at @DevOpsSummit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We're here to tell the world about our cloud-scale infrastructure that we have at Juniper combined with the world-class security that we put into the cloud," explained Lisa Guess, VP of Systems Engineering at Juniper Networks, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"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.
In his session at 20th Cloud Expo, Mike Johnston, an infrastructure engineer at Supergiant.io, discussed how to use Kubernetes to set up a SaaS infrastructure for your business. Mike Johnston is an infrastructure engineer at Supergiant.io with over 12 years of experience designing, deploying, and maintaining server and workstation infrastructure at all scales. He has experience with brick and mortar data centers as well as cloud providers like Digital Ocean, Amazon Web Services, and Rackspace. H...
Consumers increasingly expect their electronic "things" to be connected to smart phones, tablets and the Internet. When that thing happens to be a medical device, the risks and benefits of connectivity must be carefully weighed. Once the decision is made that connecting the device is beneficial, medical device manufacturers must design their products to maintain patient safety and prevent compromised personal health information in the face of cybersecurity threats. In his session at @ThingsExpo...
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Detecting internal user threats in the Big Data eco-system is challenging and cumbersome. Many organizations monitor internal usage of the Big Data eco-system using a set of alerts. This is not a scalable process given the increase in the number of alerts with the accelerating growth in data volume and user base. Organizations are increasingly leveraging machine learning to monitor only those data elements that are sensitive and critical, autonomously establish monitoring policies, and to detect...
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.