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NEW YORK ─ Fujirebio Diagnostics expects a decision during the first quarter of this year about a submission to the US Food and Drug Administration for clearance for its Lumipulse G β-Amyloid Ratio (1-42/1-40) diagnostic test.

A green light from the FDA would represent the first such clearance for an Alzheimer's diagnostic assay in the US and, according to Hiroshi Sekiya, Fujiribio's senior manager of product and customer management, broaden adoption of the firm's in vitro diagnostic assays for Alzheimer's that are already gaining traction in Europe.

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