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Fujirebio gets breakthrough designation for Alzheimer’s IVD

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Feb. 15, 2019—Fujirebio Diagnostics received breakthrough device designation from the FDA for its Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test.

“We are very pleased that the FDA has granted us breakthrough status for this important new diagnostic tool in the fight against Alzheimer’s disease,” Monte Wiltse, president and CEO of Fujirebio Diagnostics, said in a statement. “The entire Fujirebio group of companies are committed to bringing novel diagnostic tools for Alzheimer’s disease to health care systems globally, we look forward to working closely with the FDA to provide both physicians and patients this innovative, new test.”

The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the results of Lumipulse G β-Amyloid 1-42 and β-Amyloid 1-40 using the Lumipulse G System. Results are intended to aid in the assessment of adult patients, aged 50 years and over, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test is not intended as a screening or standalone diagnostic assay.