PerkinElmer Receives CE-IVD Mark for Its Vanadis Fully Automated NIPT Platform
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.
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.
Brian Willinsky, +1-781-663-5728
Om Business Wire
(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
Akaal Pharma Pty Ltd Announces Licensing Agreement for its First-in-Class, Topical Spingosine-1-Phosphate-1 (S1P1) Receptor Modulator for Atopic Dermatitis and Psoriasis18.12.2018 23:56 | Pressemelding
Akaal Pharma Pty Limited (Akaal Pharma) today announced that it has entered into a licensing agreement for Akaal Pharma’s First-in-Class, topical Spingosine-1-Phosphate-1 (S1P1) modulator, AKP-11, with Boston Pharmaceuticals, Inc. (Boston Pharmaceuticals). AKP-11 is a differentiated S1P1 modulator, which potentially has clinical applications in a number of inflammatory, immune and vascular diseases. Akaal Pharma has demonstrated the clinical activity of AKP-11 in multiple Phase-1 clinical studies. Under the terms of the license, Boston Pharmaceuticals is responsible for the further clinical development and commercialisation of AKP-11 for the Americas and Europe. Akaal Pharma has the rights for the rest of the world. Financial terms of the agreement were not disclosed. "We continue to actively prioritize and expand our dermatology and pain programs to serve the wider global community suffering from these diseases and where there is need of safe and effective treatment,” said Chairman of
Takeda Announces Listing of American Depositary Shares on the New York Stock Exchange18.12.2018 22:33 | Pressemelding
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced that the listing and trading of its American Depositary Shares (“ADSs”) on the New York Stock Exchange (“NYSE”) is expected to commence on December 24, 2018. Takeda’s ADSs currently trade over-the-counter. The ADSs will now trade under the ticker symbol “TAK” and The Bank of New York Mellon will continue to act as the depositary bank for the ADS program. Takeda will maintain its headquarters in Japan and its primary listing on the Tokyo Stock Exchange (the “TSE”), as well as its current listings on local Japanese stock exchanges. “Our dual listing on the NYSE and TSE reflects our position as a leading global biopharmaceutical company and will provide wider capital markets access with expanded trading hours for our in
Sestek Speech Analytics Scores the Highest Overall Vendor Satisfaction Mark from Customers in DMG Consulting Survey18.12.2018 19:00 | Pressemelding
Sestek today announced that it was recognized for getting the highest overall vendor satisfaction rating from customers in DMG Consulting’s 2018 – 2019 Speech Analytics Product and Market Report. Compared to the featured competitors, Sestek Speech Analytics achieved the highest customer ratings in 8 major vendor categories out of 10. Here are the 7 categories in which Sestek Speech Analytics received a perfect score of 5.0 by the customer satisfaction ratings: • Training and workshops • Ongoing service and support • Professional services • Innovation • Responsiveness to product enhancement requests • Vendor communication • Overall vendor satisfaction Donna Fluss, the President of DMG Consulting -providing comprehensive coverage and authoritative analysis for the market- stated the importance of speech analytics: “Speech analytics has always been interesting because of its unique contributions to the understanding of voice interactions in the contact center. Companies that invest in the
Brand Marketing and Social Purpose Veteran Larry Koffler Joins BCW18.12.2018 18:31 | Pressemelding
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Larry Koffler has joined as Executive Vice President, Managing Director in the agency’s Brand Solutions Practice in New York. He will join BCW on January 14, 2019. “Larry has had an extraordinary career leading integrated communications programs that bridge brand, corporate and purpose for some of the world’s most iconic brands and organizations,” said Chris Foster, President, North America, BCW. “His award-winning experience across a wide variety of industries will be invaluable to clients – and in particular purpose-driven clients – that need powerful programs that exceed expectations and drive meaningful results. I am excited for what he will add to BCW’s celebrated brand solutions business.” Koffler will report to Thomas Bunn, Executive Vice President, Managing Director, Brand Solutions. Koffler joins BCW from Edelman, where he spent the entirety of his career and most recently served as Executi
Skitude Premium Launches, Offering Personalised 3D Mapping, 3D Tracks, Advanced Statistics, Speed Heat Maps and Apple Watch Compatibility18.12.2018 15:58 | Pressemelding
Skitude, the world’s largest apps community of digitally-connected snow sport lovers, with over a million users, has launched a premium version of its popular profile. Skitude apps are available for Android and Apple devices, and the premium upgrade offers the option to see your day’s skiing/boarding as an interactive 3D map, a speed ‘heat map’ or by statistical analysis of descents, slopes and distances covered. There is also Apple Watch compatibility, so your smartphone battery won’t be dead by lunchtime, as can often be the case with tracking apps. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181218005591/en/ (Photo: Skitude) Premium also offers 3D maps and advanced statistics for over 2,500 resorts worldwide, with real time information on slope conditions and whether runs are open. There are ‘points of interest’, webcams and a wealth of other useful information to help you make the most of your time on the slopes. Skit
PSB Names Mike Chuter Chief Executive Officer18.12.2018 14:15 | Pressemelding
PSB, a global research-based consultancy within BCW, announced today that Mike Chuter has joined the firm as Chief Executive Officer, effective immediately. Chuter is based in New York and reports to Donna Imperato, Global CEO of BCW. He is responsible for the global growth and development of the organization across its Corporate, Political, Media and Entertainment practices. “Mike is exceptionally well-suited to lead PSB given his deep experience interpreting data through both analytical and creative lenses and in driving integrated communications programs rooted in analytics,” said Imperato. “Mike is the right person to help PSB advise on holistic creative communications solutions that leverage the firm’s industry-leading expertise in primary research and behavioral, social and other third-party data analysis.” Chuter is a 25-year agency veteran who joins PSB from global social impact organization Thankful, which he co-founded in 2013, a one-half commercial enterprise, one-half socia