Announced details
Assessment of amyloid accumulation in the brain associated with Alzheimer's disease (amyloid pathology). To be used as an aid to other diagnostic methods under specialist medical care for patients aged 50 and older who show signs or symptoms of cognitive decline
Fujirebio Holdings Inc. is a consolidated subsidiary of our company. Fujirebio Europe N.V. (FRE) is a company within its group.
CE marking (under the In Vitro Diagnostic Medical Devices Regulation (IVDR))
Fujirebio Europe N.V.: Ghent, Belgium
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Assay reagent for measuring phosphorylated tau protein at position 217 (pTau217) in plasma, LUMIPULSE® G1200, LUMIPULSE® G600II |
| Relationship with the Company | Fujirebio Holdings Inc. is a consolidated subsidiary of our company. Fujirebio Europe N.V. (FRE) is a company within its group. |
| Launch date | Sales within the EU are scheduled to begin once preparations are complete |
| Applicable area | Assessment of amyloid accumulation in the brain associated with Alzheimer's disease (amyloid pathology). To be used as an aid to other diagnostic methods under specialist medical care for patients aged 50 and older who show signs or symptoms of cognitive decline |
| Award/certification name | CE marking (under the In Vitro Diagnostic Medical Devices Regulation (IVDR)) |
| Location | Fujirebio Europe N.V.: Ghent, Belgium |
Items this document does not state (12)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To support assessment of amyloid accumulation in the brain associated with Alzheimer's disease and contribute to the clinical care of patients aged 50 and older who show signs or symptoms of cognitive decline.