Fujirebio Europe N.V. Obtains CE Mark for in Vitro Diagnostic Medical Device to Measure pTau217 in Blood for Alzheimer's Disease Pathological Changes in Europe
Fujirebio Europe N.V., a subsidiary of Fujirebio Holdings Inc., has received CE Marking in Europe for its in vitro diagnostic reagent that measures pTau217 in plasma, used with the LUMIPULSE® G1200 and LUMIPULSE® G600II automated chemiluminescent enzyme immunoassay systems, aiding in the diagnosis of Alzheimer's disease in patients aged 50 and older.
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- 📰 Published: May 12, 2026 at 01:05
- 🔍 Collected: May 11, 2026 at 16:32
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Fujirebio Europe N.V. (CEO: Christiaan De Wilde, location: Ghent, Belgium, hereinafter "FRE"), a subsidiary of Fujirebio Holdings Inc. (Representative Director and President: Tadashi Ninomiya, Headquarters: Minato-ku, Tokyo), is pleased to announce that it has obtained CE Marking*2 under the In Vitro Diagnostic Medical Devices Regulation (IVDR*1) for its diagnostic reagent (hereinafter "this reagent") used with the fully automated chemiluminescent enzyme immunoassay systems "LUMIPULSE® G1200" and "LUMIPULSE® G600II" to measure 217-phosphorylated tau protein (pTau217) in plasma. Sales in the EU region are planned to commence as soon as preparations are complete.
This reagent is used to assess amyloid accumulation in the brain (amyloid pathology) associated with Alzheimer's disease and will be utilized as an aid to other diagnostic methods for patients aged 50 and older who show signs and symptoms of cognitive decline, under expert medical care.
The Fujirebio Group will continue its efforts to further expand its product lineup in the field of neurodegenerative diseases, including Alzheimer's disease, by collaborating with related organizations worldwide, thereby contributing further to the diagnosis and treatment of these diseases.
*1 In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746), a legal regulation applicable to the sale of in vitro diagnostic medical devices in the EU market. Applied from May 2022.
*2 A marking indicating conformity with relevant legal regulations (such as IVDR) required for selling products in the EU.
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This reagent is used to assess amyloid accumulation in the brain (amyloid pathology) associated with Alzheimer's disease and will be utilized as an aid to other diagnostic methods for patients aged 50 and older who show signs and symptoms of cognitive decline, under expert medical care.
The Fujirebio Group will continue its efforts to further expand its product lineup in the field of neurodegenerative diseases, including Alzheimer's disease, by collaborating with related organizations worldwide, thereby contributing further to the diagnosis and treatment of these diseases.
*1 In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746), a legal regulation applicable to the sale of in vitro diagnostic medical devices in the EU market. Applied from May 2022.
*2 A marking indicating conformity with relevant legal regulations (such as IVDR) required for selling products in the EU.
End