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Two Roche Alzheimer’s Assays Win US FDA Breakthrough Device Status

 
• By Sue Darcey

The company is getting its data ready for submission to FDA for the Elecsys cerebrospinal fluid assays and hopes the new Breakthrough Device designation will increase interaction with the agency and speed the path to approval.

Human brain illustrated with millions of small nerves - Conceptual 3d render

Roche says it has already collected key data to support regulatory approvals of its two Alzheimer’s disease assays, but US FDA's recent designation of the tests as Breakthrough Devices will help expedite its development efforts by allowing enhanced interaction with the agency.

The company announced the Breakthrough designation July 20 for the Elecsys β-Amyloid [1-42] CSF and the Elecsys Phospho-Tau [181P] CSF...

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