Element Biosciences Launches AVITI Dx™, Bringing CE-Marked IVD Sequencing to Ten EU Countries
29.10.2026 10:00:00 EET | Business Wire | Press release
Element Biosciences, Inc. today announced the commercial launch of AVITI Dx, the company's first CE-marked in vitro diagnostic (IVD) sequencing platform under the European Union's In Vitro Diagnostic Regulation (EU IVDR). AVITI Dx integrates Element’s AVITI™ sequencing system, dedicated reagents, and software designed to meet applicable IVDR requirements and support regulated clinical laboratory workflows. The system is launching commercially in ten EU countries: the Netherlands, Germany, France, Italy, Spain, Austria, the Czech Republic, Latvia, Romania, and Poland, with additional markets planned through a phased approach.
Developed and manufactured under Element's ISO 13485-certified quality management system, AVITI Dx is a Class A IVD sequencing system supported by IVDR-compliant reagents and software. Built on the same industry-leading ABC™ chemistry that powers Element's other solutions, AVITI Dx delivers the high-quality performance AVITI is known for, with the flexibility and scalability that the decentralized diagnostics market needs. A dual-boot design lets a single system switch between IVD and research use only modes, with dedicated reagents and software keeping IVD workflows separate from research applications. The AVITI Dx software interface supports multiple languages, so laboratories can work in the language of their region.
“Launching AVITI Dx across ten EU markets reflects years of investment in the quality systems, manufacturing capabilities, and global supply chain needed to support regulated clinical markets,” said Jeff Labbadia, Chief Supply Chain Officer at Element Biosciences. “Our ISO 13485-certified quality management system and established manufacturing controls provide the foundation for delivering an integrated sequencing platform with the consistency, traceability, and reliability that clinical laboratories expect."
Element plans to expand access to AVITI Dx in additional European markets, followed by select markets in the Asia-Pacific region. Contact us to learn more about AVITI Dx link.
About Element Biosciences, Inc.
Element Biosciences is pioneering the technologies that enable a deeper understanding of life. Our platforms capture biology in its full dimensionality—spanning genetic, molecular, and cellular insights—to unlock richer data and drive scientific breakthroughs. From foundational research, to the discoveries that help shape diagnostic and therapeutic development, Element empowers scientists to advance the frontiers of biology and impact every corner of human health. To learn more about Element, please visit www.elementbiosciences.com and follow us on LinkedIn, X (Twitter), Bluesky and Facebook.
View source version on businesswire.com: https://www.businesswire.com/news/home/20261029443673/en/
Contacts
Media Contact
Michael Sullivan
Media@elembio.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Chiesi Group appoints Paolo Paoletti to its Board of Directors29.10.2026 12:01:00 EET | Press release
Chiesi, the international research-focused biopharmaceutical group, today announced the appointment of Paolo Paoletti, M.D. to its Board of Directors, effective as of today. Paoletti is an internationally recognized pharmaceutical executive with more than 30 years of experience across research and development, corporate leadership and biotechnology innovation. Throughout his career, he has held senior leadership positions at Lilly, GlaxoSmithKline (GSK) and GammaDelta Therapeutics, contributing to the development and commercialization of innovative medicines across multiple therapeutic areas, particularly oncology. His appointment further strengthens the Board's scientific, innovation and global healthcare expertise as Chiesi continues to invest in research, international growth and long-term value creation. "On behalf of the Chiesi Board, I am delighted to welcome Paolo, whose commitment to scientific excellence and innovation reflects the same values that have guided Chiesi throughou
Icon Solutions Appoints Raquel Guillot as Southern Europe Sales Director to Drive Global Adoption of the Icon Payments Framework29.10.2026 11:30:00 EET | Press release
Icon Solutions – the UK fintech enabling banks globally to design and implement state-of-the-art payment systems – has appointed Raquel Guillot as Southern Europe Sales Director, to drive adoption of the Icon Payments Framework (IPF) across the region. Guillot brings around 20 years of experience spanning banking, analytics, fraud prevention, payments and core banking technology. She began her career at Citibank before moving into financial technology, holding roles at SAS, ACI Worldwide and other technology providers, including Thought Machine. IPF is the internationally proven payments development framework trusted by banks across the globe, including Citi, UBS, NatWest and BNP Paribas. It enables banks to transform their systems in an accelerated, structured and low-risk way, all on their own terms. Based in Madrid, Guillot will focus on expanding adoption of IPF among Tier 1 financial institutions across Southern Europe and Latin America, allowing them to deploy payment processing
Alushibe Holding Group to Bring 12 Global F&B Brands to Libya by 202829.10.2026 10:00:00 EET | Press release
Alushibe Holding Group today announced plans to bring 12 international food-and-beverage brands to Libya by 2028 through its Retail & Destinations division, beginning with an exclusive master franchise agreement with MADO, the Turkish ice-cream and patisserie house founded in 1850. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029822317/en/ Ahmed Gadalla signs exclusive master franchise agreement with Türkiye's MADO: US$7 million, 7 cafés and 350 jobs in the first phase; 1,000 sq m Benghazi flagship opens Q1 2027 – (Photo: AETOSWire) Signed in Kahramanmaraş on 13 October 2026 by Ahmed Gadalla, Founder and Chairman of Alushibe Holding Group, and Mehmet Sait Kanbur, Chairman of MADO, the agreement grants Alushibe exclusive rights to develop and operate MADO in Libya, the brand's 36th country. Alushibe will invest US$7 million in the first phase: 7 cafés and 350 jobs, beginning in Benghazi before Tripoli and other major cit
U.S. Bancorp Announces New U.S. Bancorp Global Funds Brand29.10.2026 10:00:00 EET | Press release
U.S. Bancorp today announced its new fund platform, U.S. Bancorp Global Funds, and its first offering, an offshore liquidity fund domiciled in Ireland, the U.S. Bancorp Liquidity – USD Treasury CNAV Fund. U.S. Bancorp Global Funds was created to support U.S. Bancorp’s growing international presence. It establishes a framework for future investment offerings and reflects U.S. Bancorp’s expanding presence in global markets. Investment products offered under the brand are established through U.S. Bancorp Global Funds ICAV, an Ireland-domiciled UCITS umbrella fund structure. The U.S. Bancorp Liquidity – USD Treasury CNAV Fund is the first offering introduced under the new brand. The U.S. Bancorp Liquidity – USD Treasury CNAV Fund is designed for investors outside the United States seeking to preserve capital while accessing a U.S. Treasury-focused liquidity solution within a regulated offshore structure. Domiciled in Ireland as a UCITS fund, it invests primarily in short-term U.S. Treasury
Positively Languages Launches, Expands With Malta School and Opens New London Premises29.10.2026 10:00:00 EET | Press release
Positively Languages, a leading language learning business, is unveiling its new brand today. Formerly known as Kaplan Languages Group, (which Inspirit Capital acquired in May 2026), the business is also expanding its portfolio with the opening of a new school in Malta and a new premises in London. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028449595/en/ Positively Languages, formerly known as Kaplan Languages Group, has taught English, French and German to more than one million students from 140 countries over the past 20 years. The new brand name ‘Positively Languages’ is built around the principle that ‘experience moves you forward’ which forms the backbone of the future growth of the business; new products based on experiences, new schools in the heart of key cultural cities. Positively Languages is also excited to announce the opening of a new school on the Mediterranean island of Malta, known as Positively Langu
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom