Business Wire

PerkinElmer Receives CE-IVD Mark for Its Vanadis Fully Automated NIPT Platform

Del

PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, today announced that its Vanadis® NIPT system has obtained CE-IVD mark for commercialization and distribution throughout Europe and other countries that accept CE marking. This non-invasive test provides screening results for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome). The Vanadis NIPT system has been validated in an external clinical study conducted in France. The blinded study analyzed 80 samples from pregnancies affected by trisomy 21 and 670 samples from unaffected pregnancies, classifying all cases correctly, with only one sample failing to generate a result. In addition to trisomy 21, PerkinElmer conducted clinical studies to demonstrate high sensitivity and specificity for trisomies 18 and 13.

Generally, non-invasive prenatal testing (NIPT) analyzes cell-free DNA (cfDNA) circulating in the maternal blood and has rapidly become the standard follow-up procedure for women classified as high risk following traditional prenatal screening. Measuring cfDNA from a standard blood draw to detect common chromosomal trisomies has been demonstrated with high sensitivity and specificity.

“NIPT has been previously limited by the complexity, cost and capacity of existing commercially available technologies, which prevented many laboratories and obstetricians from offering reliable, and cost-effective solutions for aneuploidy screening,” said Olle Ericsson, General Manager at Vanadis Diagnostics, a PerkinElmer company. “With our Vanadis platform, we are taking the technical complexity out of NIPT while breaking down the cost barriers. This will enable more women to gain access to NIPT and improve the level of prenatal care on a global level.”

Unlike existing NIPT technologies, which require more complex platforms such as sequencing or microarrays, the Vanadis NIPT platform is the first of its kind designed to simplify screening for trisomies 21, 18 and 13. The Y chromosome can be measured as an optional marker. This cost-effective, high-throughput scalable platform measures fetal chromosomal trisomies in maternal plasma by targeted fluorescent labeling and counting specific cfDNA fragments—removing the costly and data-intensive steps required for gene sequencing or microarray solutions.

“The promising results we’ve seen lead us to believe that a broad range of women throughout Europe and around the world now stand to benefit significantly from being able to have NIPT as a key component of prenatal care,” said Jérémie Gautier, head of the project management team at CerbaXpert, which played a leading role in the evaluation study in France.

PerkinElmer is also currently collaborating with Women & Infants Hospital (WIH) of Rhode Island, a Care New England hospital, in a clinical validation study to evaluate an innovative test method using the Vanadis NIPT system.* The VALUE (Validation of a Lower Cost Aneuploidy Screen) study aims to test samples from approximately 2,500 women, most from an average risk pregnancy population, with additional high-risk cases added to determine performance characteristics such as detection rates and false positive rates.

“The Vanadis technology has the potential to bring cfDNA screening for common trisomies to the general pregnancy population who cannot readily access NIPT at this time due to the high cost of available tests,” said Glenn Palomaki, PhD, Associate Director of the Division of Medical Screening and Special Testing at WIH, and Professor, Department of Pathology and Laboratory Medicine at the Warren Alpert Medical School of Brown University. “This platform has the potential to be as efficient as current next generation sequencing offerings—yet could be cost-competitive with current first trimester combined screening.”

For more information on the Vanadis NIPT system, please visit: www.prenataltesting.perkinelmer.com/vanadis.

About PerkinElmer
PerkinElmer, Inc. is a global leader committed to innovating for a healthier world. Our dedicated team of about 11,000 employees worldwide is passionate about providing customers with an unmatched experience as they help solve critical issues especially impacting the diagnostics and discovery and analytical solutions markets. Our innovative detection, imaging, informatics, and service capabilities, combined with deep market knowledge and expertise, help customers gain earlier and more accurate insights to improve lives and the world around us. The Company reported revenue of approximately $2.3 billion in 2017, serves customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com .

*PerkinElmer’s Vanadis NIPT system is not available for clinical use in the United States.

Products may not be licensed in accordance with the laws in all countries, such as the United States and Canada. Please check with your local representative for availability.

Contact information

PerkinElmer, Inc.
Brian Willinsky, +1-781-663-5728
brian.willinsky@perkinelmer.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

SFL: strong financial position and results in 2018, consolidating the Group’s position as a prime player15.2.2019 18:01:00Pressemelding

Regulatory News: The financial statements for the year ended 31 December 2018 were approved by the Board of Directors of Société Foncière Lyonnaise (Paris:FLY) on 15 February 2019 at a meeting chaired by Juan José Brugera. 2018 business indicators were very robust, with further underlying growth in rental income and historically high EPRA earnings. The portfolio's appraisal value and the Company's net asset value also continued to grow, attesting to SFL’s excellent positioning. The auditors have completed their audit of the annual financial information and are in the process of issuing their report. Consolidated data (€ millions) 2018 2017 Change Rental income 193.5 195.8 -1.2% Adjusted operating profit* 162.1 164.1 -1.2% Attributable net profit 351.6 685.3 - EPRA earnings 106.7 102.4 +4.1% * Operating profit before disposal gains and losses and fair value adjustments 31/12/2018 31/12/2017 Change Attributable equity 4,010 3,763 +6.6% Consolidated portfolio value excluding transfer cost

5 Happening Cultural Destinations to Visit in 201915.2.2019 10:11:00Pressemelding

Hong Kong There’s never really a sleepy year to visit Hong Kong, but 2019 is particularly ripe for visitors. Spearheaded by the dynamic entrepreneur Adrian Cheng of K11 and New World Development, the rejuvenation of Tsim Sha Tsui harbourfront is just the starting point. The city’s iconic harbourside walkway, Avenue of Stars, has just received a much-awaited makeover that’s the brainchild of Cheng and visually conceived by James Corner, the landscape architect responsible for the High Line in New York. It sees the addition of design-driven rest areas, kiosks featuring homegrown brands, hand prints from Asian film stars and interactive digital elements. Featuring Hong Kong’s first wave energy demonstrator that produces electricity for the Avenue, the place is turned into one of the most sustainable promenades in Hong Kong. This is just one part of Cheng and his company’s grander urban revitalisation plan, Victoria Dockside, a new art and design district which will fully open in the third

ISAE-SUPAERO Launches a New MOOC about Flight Mechanics15.2.2019 09:36:00Pressemelding

"ABC of Flight Mechanics: How Do Planes Fly?": a MOOC dedicated to flight mechanics. The notion of flight often defies our human terrestrial instincts. How does an airplane fly? How can a pilot maintain control? How high in the sky can an aircraft climb? How does a fighter pilot fly while spinning? This online course (available in English) will cover many topics, such as atmospheric physics and Newton's laws applied to aircraft, as well as propulsion forces and longitudinal stability the question of traction. The MOOC "ABC of Flight Mechanics" is aimed at general public with a specific level of scientific knowledge. Nevertheless, various levels of learning are available, thus it allows all students to take the course without needing to plenty understand the mathematical principles. Undergraduate students in aerospace engineering, trainees as well as novice and experienced pilots, journalists and professionals in the aeronautics domain (business, engineering, marketing, communications,

REPLY: Red Reply Wins the Oracle “Partner of the Year Autonomous” Award15.2.2019 09:30:00Pressemelding

Red Reply, the Reply group company that specialises in the Oracle Cloud IaaS and PaaS platform has been named as Oracle “Partner of the Year: Autonomous.” The award recognises Red Reply for its work as an Oracle Cloud Managed Service Provider Partner in developing highly innovative projects using the Oracle Autonomous Database technology. Red Reply has launched a project aimed at re-engineering the Policy Enterprise DataWarehouse of Verti Assicurazioni, company operating in the online insurance sector, using the Oracle Cloud Autonomous DataWarehouse service. The Autonomous DataWarehouse is a cloud-based database that uses machine learning to eliminate manual labour in operations such as tuning, security, backups, updates and other routine activities. This selected Oracle solution is the only one of its kind capable of addressing aspects such as security, performance and high availability of data, using automatic update and tuning mechanisms, while maximising the protection of data in l

Posiflex showcases new Interactive Self-Service Kiosks and IoT Retail Product Innovations at EuroCIS 201915.2.2019 08:00:00Pressemelding

The Posiflex Group — a synergy of world-leading POS, kiosk, and industrial computing technologies — will introduce its full product portfolio and latest innovations at EuroCIS, the leading trade fair for retail technology, from February 19th – 21st in Düsseldorf. With a product strategy focus on serviced IoT, the Posiflex Group will be displaying smart and connected retail solutions with fully-integrated middleware, RMS (Remote Monitoring System) and hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190215005008/en/ Posiflex at EuroCIS Hall 9 / C42 (Graphic: Business Wire) “I am excited to introduce the Posiflex Group portfolio to the European market,” says Hans Peter Nüdling, the newly appointed Chief Strategy Officer for the Posiflex Group. “The Posiflex Group references the collective brands of the corporation, including Posiflex, Portwell and KIOSK Information Systems (KIOSK) – all under one corporate umbrella. As

OpenGate Capital Signs Agreement to Acquire SMAC Waterproofing Business from Colas Group15.2.2019 07:00:00Pressemelding

OpenGate Capital, a global private equity firm, announced today that Colas Group (EPA: RE) has agreed to sell SMAC to an affiliate of OpenGate Capital. Financial terms of the agreement were not disclosed. The divestiture is expected to be complete in the next 60-90 days. SMAC is headquartered in Issy-les-Moulineaux, France, and is a global manufacturer of waterproofing and building envelope solutions with two divisions: SMAC Travaux and SMAC Industrie. After Colas Group’s acquisitions of Miller McAsphalt and Alpiq's rail subsidiaries in 2018, Colas is refocusing on its strategic activities: transport infrastructure and construction materials. The sale of SMAC will reduce Colas’ revenues by an estimated €600 million but is not expected to have a significant impact on Colas' operating income. Upon OpenGate Capital’s completion of acquiring SMAC, the business will join a global portfolio of businesses which includes other industrial companies that provide building materials and solutions.