Fujirebio Announces CE Marking of the Fully Automated Lumipulse® G pTau 217 Plasma Assay
11.5.2026 09:00:00 CEST | Business Wire | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Fujirebio Europe N.V. has obtained a CE certificate of the Lumipulse G pTau 217 Plasma assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This CLEIA (chemiluminescent enzyme immunoassay) test allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K2EDTA).
“With Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma now CE‑marked on our LUMIPULSE G platform, we are advancing a new era of neurology diagnostics—one where blood‑based biomarkers enable earlier, broader, and more accessible insights into Alzheimer’s disease and neurodegeneration.” said Christiaan De Wilde, CEO at Fujirebio Europe N.V. “By delivering fully automated and scalable solutions, we are helping clinicians move decisively toward more timely and informed decision‑making. This milestone underscores our long‑term vision to reimagine the diagnostic pathway and to fundamentally improve patient care across Europe through innovation, precision, and partnership.”
About Lumipulse G pTau 217 Plasma
The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers to identify patients with amyloid pathology associated with Alzheimer’s disease. The test is indicated for patients aged 50 years and over, presenting with signs and symptoms of cognitive decline in a specialized care setting. The Lumipulse G pTau 217 Plasma assay is to be used as an adjunct to other diagnostic evaluations and is for professional use only.
About Fujirebio
Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and in vitro diagnostics (IVD) partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust LUMIPULSE G platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry.
Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster—driving better decisions, treatments, and patient outcomes.
More information can be found at http://www.fujirebio.com.
Lumipulse is a registered trademark of Fujirebio Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260511348690/en/
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
New Summer Program from Corona Invites the World to Experience “This Is Living”11.5.2026 10:00:00 CEST | Press release
The brand moves from inspiration to action with “Living Is Calling,” a campaign to enjoy the outdoors through a global partnership with Tripadvisor Today, Corona, the world’s most valuable beer brand*, unveils “Living is Calling” – a new global call to action inviting consumers to step outside and live life to the fullest this summer. As a powerful extension of its “This Is Living” platform, the new campaign invites the world to put living first through a partnership with Tripadvisor featuring over 300,000 experiences, and a new global film. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511429135/en/ “For the past 100 years, Corona has inspired the world to come outside and feel more moments of ‘This Is Living,’ and we believe the next chapter is about helping people take action and embrace the outdoors,” said Clarissa Pantoja, Global Vice President of Corona. “‘Living is Calling’ is our worldwide call to action, and we’
Braskem Celebrates Naming of Beautiful Future and Blooming Future, Next‑Generation Tankers for Cleaner Global Trade11.5.2026 10:00:00 CEST | Press release
Beautiful Future and Blooming Future combine cutting‑edge efficiency and emissions‑reduction technologies to support more responsible global trade. Braskem (B3: BRKM3, BRKM5, and BRKM6; NYSE: BAK; LATIBEX: XBRK), the largest polyolefins producer in the Americas and global leader in the production of biopolymers on an industrial scale announces today that Braskem Trading & Shipping (BT&S) has reached a major milestone in its fleet modernization and sustainability journey with the naming of Beautiful Future and Blooming Future, next‑generation chemical and product oil tankers designed to move essential raw materials more efficiently and with a significantly lower environmental footprint. Both vessels were formally named at a ceremony in China on May 8. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511112306/en/ Beautiful Future Beautiful Future and Blooming Future are LR1 (Long Range 1) vessels that will transport naphtha,
Kiabi Selects Navan to Centralise Global Travel Program11.5.2026 09:00:00 CEST | Press release
Fashion retailer targets high employee adoption and efficiency with AI-powered travel platform Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced it has been selected by Kiabi, the French multinational fashion retailer, to consolidate its global travel with one unified platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511547434/en/ Fashion retailer targets high employee adoption and efficiency with AI-powered travel platform To support its workforce of nearly 10,000 “Kiabers,” the retailer required a solution capable of providing an easy-to-use travel platform. Navan was selected due to its intuitive AI-powered interface and ability to integrate with Kiabi’s travel policies directly in-app. “Managing travel was becoming an administrative burden that slowed our teams down,” said Denise Maurice, Indirect Procurement Director at Kiabi. “We wanted to give our ‘Kiabers’ the
Owl Labs partners with Westcoast to expand access to seamless hybrid meeting experiences in the UK and Ireland11.5.2026 09:00:00 CEST | Press release
Partnership aims to reduce the ‘meeting tax’ by expanding access to Owl Labs products through Westcoast’s extensive distribution network Owl Labs, a global leader in AI-powered, 360-degree video conferencing solutions, today announced a new UK and Ireland distribution partnership with Westcoast Limited, one of the country’s largest and most trusted IT distributors. The agreement will see Westcoast distribute the full range of Owl Labs’ award-winning Meeting Owl and Owl Bar products across the UK and Ireland, providing greater choice, availability, and dedicated support for resellers and end customers navigating the demands of hybrid work. The partnership aims to address the technical setup challenges that plague meetings across the UK. Owl Labs’ recent State of Hybrid Work report found that nearly 8 in 10 workers (79%) lose time in meetings due to technical difficulties such as connecting to a meeting or setting up a camera. By making Owl Labs’ solutions simpler to source, deploy and s
Mevion Introduces the First Proton Therapy System Designed for a LINAC Vault at ESTRO 202611.5.2026 08:00:00 CEST | Press release
The MEVION S250-FIT™ creates a new pathway for European cancer centers to integrate proton therapy into existing radiotherapy programs Proton therapy is entering the LINAC vault. At ESTRO 2026, Mevion Medical Systems will introduce the MEVION S250-FIT Proton Therapy System to the European radiation oncology community, the first proton therapy system designed for installation in a standard radiation therapy vault. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507172087/en/ The MEVION S250-FIT™ Proton Therapy System Now both U.S. FDA-cleared and CE-marked under Regulation (EU) 2017/745, the S250-FIT creates a new pathway for cancer centers to bring proton therapy into existing LINAC-based treatment environments, aligning advanced proton capability with the infrastructure, workflows, and capital planning of modern radiation oncology. Stanford Medicine: First S250-FIT Installation On April 7, 2026, Stanford Medicine unveiled
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