Click here to close now.

SYS-CON MEDIA Authors: XebiaLabs Blog, Pat Romanski, Elizabeth White, Liz McMillan, Carmen Gonzalez

News Feed Item

Simple blood test can detect lung cancer with high sensitivity and specificity - results from large clinical validation study published in the Journal of Clinical Oncology

-- GENSIGNIA plans to introduce minimally invasive diagnostic test which is urgently needed to improve the diagnostic performance of high resolution imaging for lung cancer detection

LONDON, MILAN, and SAN DIEGO, Jan. 13, 2014 /PRNewswire/ -- GENSIGNIA Ltd, a London-based, privately held molecular diagnostics company with laboratory operations in San Diego, CA, and Fondazione IRCCS, Istituto Nazionale dei Tumori (INT), Milan, a National Cancer Research Center in Italy, announced today that positive clinical validation results for the microRNA signature classifier (MSC) Lung Cancer assay were published in the Journal of Clinical Oncology (JCO). The results demonstrate for the first time that a blood-based test can significantly reduce the high false positive rate associated high resolution imaging, specifically with Low-Dose Computed Tomography (LDCT or Spiral CT), the current recommended lung cancer screening methodology for heavy smokers.  The MSC Lung Cancer assay had high sensitivity and detected lung cancer up to 2 years prior to diagnosis by LDCT. Aspects of the study results were presented on January 8th in San Diego as a plenary talk at the AACR-IASLC Molecular Origins of Lung Cancer meeting by Gabriella Sozzi, Ph.D., Professor, Head of Cancer Genomics at INT. In 2014, GENSIGNIA intends to introduce a lung cancer diagnostic test initially in the U.S.

(Logo:  http://photos.prnewswire.com/prnh/20140113/LA41250LOGO)

Prospectively collected blood samples from 939 heavy smokers from the randomized lung cancer screening trial comparing LDCT versus observation (Multicentric Italian Lung Detection [MILD] trial; INT) were used to validate the diagnostic performance and demonstrate clinical utility of the MSC Lung Cancer assay, a 24 microRNA expression signature assay. Heavy smokers from the MILD trial that were cancer-free (n=870) or diagnosed with lung cancer (n=69) were examined in this correlative study. The MSC Lung Cancer assay demonstrated an overall sensitivity of 87% for the presence of lung cancer. For all subjects, the MSC Lung Cancer assay had negative predictive values (NPVs) of 99% and 99.86% for detection and death-by-disease (lung cancer), respectively, indicating the test's high specificity for correctly identifying subjects without lung cancer.  The high specificity of the MSC Lung Cancer assay resulted in a 5-fold reduction in the false positive rate of LDCT-identified suspicious lung nodules in heavy smokers that did not have lung cancer.

"The 5-fold reduction in false positives obtained by combining the MSC Lung Cancer assay to the results of the LDCT scan is of great clinical relevance in the context of reducing the false positive rate and the potential side effects associated with repeated LDCT scans or other unnecessary invasive diagnostic follow-ups." stated Dr. Ugo Pastorino, Head of Thoracic Surgery Unit, Chairman of Department of Surgery, Istituto Nazionale dei Tumori, Milan, Italy.

This correlative study in lung cancer is the first of its kind, clinically validating a biomarker using prospectively collected blood samples from a large randomized lung cancer screening trial. In addition to a significant reduction in the rate of false positive results, the performance of the MSC Lung Cancer assay was independent of the stage of lung cancer and time prior to detection of cancer with LDCT (up to two years prior). This suggests additional potential utility for diagnosis and early detection with the MSC Lung Cancer assay.

"We have developed a minimally invasive molecular diagnostic assay that quantifies the expression of specific miRNAs which are freely circulating in blood and indicate the presence of lung cancer." stated Gabriella Sozzi, Ph.D., Professor, Head of Cancer Genomics at INT. "Overall, the results of our study support the use of the assay as a tool to improve the early detection of lung cancer."

Globally, approximately 1.1 billion people smoke, and in the U.S, there are approximately 19 million heavy smokers, or those that smoke at least 1 pack per day. LDCT is a recommended method for screening lung cancer in high risk individuals, primarily heavy smokers. Published in June 2011 in New England Journal of Medicine, the landmark NCI-sponsored National Lung Screening Trial (NLST) reported a 20% relative reduction in mortality with LDCT screening of high risk individuals with a history of ≥30 pack-years and ≤15 years since they quit smoking, versus annual chest X-rays. In the NLST, 24.2% of subjects screened were deemed positive for lung cancer, and the majority of positive screens led to additional tests. When a positive screening result was found, 96.4% of the LDCT tests were deemed "false" positives. As a result, the cost of screening large numbers of high risk individuals, the potential harm associated with LDCT screening, and the high false positive rate with LDCT highlight the need for complementary biomarkers to improve diagnostic performance.

"Screening heavy smokers with Spiral CT scans saves many lives, but the cost-effectiveness of this approach has been questioned due to the high rate of false positives." stated Gabriele Cerrone, Founder and Executive Chairman of GENSIGNIA. "In combination with a Spiral CT, the MSC Lung Cancer assay significantly reduces the false positive rate, which can translate in substantial savings for the global healthcare system by avoiding the need for additional workups and scans required to confirm diagnosis."

About Lung Cancer

According to the World Cancer Research Fund International, lung cancer is the most common cancer in the world and it is estimated that smoking will kill up to a billion people worldwide this century. In the U.S., it is the second most common cancer, but according to the American Cancer Society, lung cancer is by far the leading cause of cancer-associated death. More people in the U.S. die of lung cancer than colon, breast, and prostate cancers combined. The symptoms of lung cancer typically do not appear until the disease is already in an advanced, non-curable stage. Even when the symptoms of lung cancer do appear, they are often mistaken for other problems such as an infection or the long-term effects from smoking, which often delays diagnosis. As a result, over 80% of lung cancer patients die within two years of diagnosis.

About miRNAs and the MSC Lung Cancer Assay

MicroRNAs (miRNAs) are small noncoding ribonucleic acids (RNAs) that modulate gene activity and are aberrantly expressed in cancer. They are tissue- and disease-specific molecules actively released by tumor cells and their microenvironment into the circulation packaged in exosomes or associated with ribonucleoprotein complexes to protect them from degradation. Due to their small size and stability, miRNAs can be measured in biological fluids such as plasma and serum and can serve as circulating biomarkers. Drs. Sozzi and Pastorino had reported the development and validation of plasma-based miRNA signatures from subjects in two independent LDCT screening studies, demonstrating that quantitative measurement by real-time RT-PCR of 24 circulating miRNAs is diagnostic and prognostic in lung cancer (Boeri et al., 2011). This biomarker assay is designed to offer the potential for early detection of lung cancer thereby avoiding the costs and complications associated with unnecessary tests following a false positive diagnosis using LDCT or chest X-rays.

About Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Fondazione IRCCS, Istituto Nazionale dei Tumori (INT), Milan, was founded in 1928 and has become a national center of excellence for academic research and cancer treatment, and has been awarded the qualification of Comprehensive Cancer Center by the Organisation of European Cancer Institutes (OECI). INT delivers outstanding patient care through technological avant-guard, groundbreaking research, and continuous personnel development.

About GENSIGNIA

GENSIGNIA Ltd is a London-based molecular diagnostics company with operations in San Diego, USA and Milan, Italy. GENSIGNIA focuses on the development and commercialization of novel molecular diagnostic blood tests designed to provide more accurate detection of cancers.  In 2014, GENSIGNIA intends to introduce a lung cancer diagnostic test initially in the U.S.

Statements in this press release about the Company's expectations, applications of its technology, markets, launch of tests and other statements that are not historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management's current beliefs, assumptions, estimates and projections. Actual results could differ materially from those projected in the forward-looking statements for various reasons, including risks associated with product and test development, test transfer to contracting labs, government regulation, market acceptance, limited commercial experience and dependence on key personnel and financing.

Contact

 

Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan

Gabriella Sozzi, Ph.D.

Professor, Head of Cancer Genomics

[email protected]

www.istitutotumori.mi.it  


GENSIGNIA Inc.

Elisa Romeo, Ph.d.

Sr. Director Research

[email protected]

www.gensignia.com   


Maitland

Martin Barrow

Partner

[email protected]

www.maitland.co.uk

 

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
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Malcolm Rieke, the Director of Product Management at Catbird, discussed the impact of this new paradigm and what organizations can do today to safely move to software-defined network and compute architectures, including: ...
Containers Expo Blog covers the world of containers, as this lightweight alternative to virtual machines enables developers to work with identical dev environments and stacks. Containers Expo Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Bookmark Containers Expo Blog ▸ Here Follow new article posts on Twitter at @ContainersExpo
The cloud is everywhere and growing, and with it SaaS has become an accepted means for software delivery. SaaS is more than just a technology, it is a thriving business model estimated to be worth around $53 billion dollars by 2015, according to IDC. The question is - how do you build and scale a profitable SaaS business model? In his session at 15th Cloud Expo, Jason Cumberland, Vice President, SaaS Solutions at Dimension Data, discussed the common mistakes businesses make when transitioning t...
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial C...
Cloud and Big Data present unique dilemmas: embracing the benefits of these new technologies while maintaining the security of your organization's assets. When an outside party owns, controls and manages your infrastructure and computational resources, how can you be assured that sensitive data remains private and secure? How do you best protect data in mixed use cloud and big data infrastructure sets? Can you still satisfy the full range of reporting, compliance and regulatory requirements? In...
Storage administrators find themselves walking a line between meeting employees’ demands to use public cloud storage services, and their organizations’ need to store information on-premises for security, performance, cost and compliance reasons. However, as file sharing protocols like CIFS and NFS continue to lose their relevance, simply relying only on a NAS-based environment creates inefficiencies that hurt productivity and the bottom line. IT wants to implement cloud storage it can purchase a...
There has been a lot of discussion recently in the DevOps space over whether there is a unique form of DevOps for large enterprises or is it just vendors looking to sell services and tools. In his session at DevOps Summit, Chris Riley, a technologist, discussed whether Enterprise DevOps is a unique species or not. What makes DevOps adoption in the enterprise unique or what doesn’t? Unique or not, what does this mean for adopting DevOps in enterprise size organizations? He also explored differe...
The move to the cloud brings a number of new security challenges, but the application remains your last line of defense. In his session at 15th Cloud Expo, Arthur Hicken, Evangelist at Parasoft, discussed how developers are extremely well-poised to perform tasks critical for securing the application – provided that certain key obstacles are overcome. Arthur Hicken has been involved in automating various practices at Parasoft for almost 20 years. He has worked on projects including database dev...
In this scenarios approach Joe Thykattil, Technology Architect & Sales at TimeWarner / Navisite, presented examples that will allow business-savvy professionals to make informed decisions based on a sound business model. This model covered the technology options in detail as well as a financial analysis. The TCO (Total Cost of Ownership) and ROI (Return on Investment) demonstrated how to start, develop and formulate a business case that will allow both small and large scale projects to achieve...
Cloud Foundry open Platform as a Service makes it easy to operate, scale and deploy application for your dedicated cloud environments. It enables developers and operators to be significantly more agile, writing great applications and deliver them in days instead of months. Cloud Foundry takes care of all the infrastructure and network plumbing that you need to build, run and operate your applications and can do this while patching and updating systems and services without any downtime.
Are your Big Data initiatives resulting in Big Impact or Big Mess? In her session at Big Data Expo, Penelope Everall Gordon, Emerging Technology Strategist at 1Plug Corporation, shared her successes in improving Big Decision outcomes by building stories compelling to the target audience – and her failures when she lost sight of the plotline, distracted by the glitter of technology and the lure of buried insights. The cast of characters includes the agency head [city official? elected official?...
Building low-cost wearable devices can enhance the quality of our lives. In his session at Internet of @ThingsExpo, Sai Yamanoor, Embedded Software Engineer at Altschool, provided an example of putting together a small keychain within a $50 budget that educates the user about the air quality in their surroundings. He also provided examples such as building a wearable device that provides transit or recreational information. He then reviewed the resources available to build wearable devices at ...
After a couple of false starts, cloud-based desktop solutions are picking up steam, driven by trends such as BYOD and pervasive high-speed connectivity. In his session at 15th Cloud Expo, Seth Bostock, CEO of IndependenceIT, cut through the hype and the acronyms, and discussed the emergence of full-featured cloud workspaces that do for the desktop what cloud infrastructure did for the server. He also discussed VDI vs DaaS, implementation strategies and evaluation criteria.
The emergence of cloud computing and Big Data warrants a greater role for the PMO to successfully manage enterprise transformation driven by these powerful trends. As the adoption of cloud-based services continues to grow, a governance model is needed to orchestrate enterprise cloud implementations and harness the power of Big Data analytics. In his session at Cloud Expo, Mahesh Singh, President of BigData, Inc., discussed how the Enterprise PMO takes center stage not only in developing the app...
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...