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Medical Devices / Submissions and Approvals

Fujirebio Gets Breakthrough Designation for In Vitro Diagnostic Test

Feb. 15, 2019
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The FDA has granted Fujirebio Diagnostics breakthrough device designation for its Lumipulse quantitative in vitro diagnostic test.

The Japanese devicemaker’s diagnostic test is used to estimate the presence of β-Amyloid neuritic plaque pathology in the brain. It is used with the company’s Lumipulse G system and is not meant for screening or stand-alone testing.

The test produces results that are meant to help assess patients aged 50 or older experiencing cognitive impairment and being evaluated for Alzheimer’s disease or other conditions that cause cognitive decline.

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