|By PR Newswire||
|January 13, 2014 04:56 PM EST||
-- 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.
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.
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.
Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan
Gabriella Sozzi, Ph.D.
Professor, Head of Cancer Genomics
Elisa Romeo, Ph.d.
Sr. Director Research
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
Sep. 24, 2016 08:30 PM EDT Reads: 1,426
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Sep. 24, 2016 08:00 PM EDT Reads: 1,636
SYS-CON Events announced today the Enterprise IoT Bootcamp, being held November 1-2, 2016, in conjunction with 19th Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA. Combined with real-world scenarios and use cases, the Enterprise IoT Bootcamp is not just based on presentations but with hands-on demos and detailed walkthroughs. We will introduce you to a variety of real world use cases prototyped using Arduino, Raspberry Pi, BeagleBone, Spark, and Intel Edison. Y...
Sep. 24, 2016 07:00 PM EDT Reads: 2,765
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Sep. 24, 2016 06:45 PM EDT Reads: 1,460
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
Sep. 24, 2016 06:30 PM EDT Reads: 1,574
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
Sep. 24, 2016 04:30 PM EDT Reads: 1,495
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Sep. 24, 2016 04:30 PM EDT Reads: 1,684
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
Sep. 24, 2016 04:00 PM EDT Reads: 1,527
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Sep. 24, 2016 03:00 PM EDT Reads: 1,016
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Sep. 24, 2016 02:15 PM EDT Reads: 1,183
SYS-CON Events announced today that China Unicom 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. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE F...
Sep. 24, 2016 01:30 PM EDT Reads: 1,671
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
Sep. 24, 2016 01:00 PM EDT Reads: 1,475
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
Sep. 24, 2016 12:00 PM EDT Reads: 739
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Sep. 24, 2016 12:00 PM EDT Reads: 750
Digital innovation is the next big wave of business transformation based on digital technologies of which IoT and Big Data are key components, For example: Business boundary innovation is a challenge to excavate third-party business value using IoT and BigData, like Nest Business structure innovation may propose re-building business structure from scratch, as Uber does in the taxicab industry The social model innovation is also a big challenge to the new social architecture with the design fr...
Sep. 24, 2016 11:45 AM EDT Reads: 1,019