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Home » Sponsors » Genomics: Clinical Implementation » Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test

Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test

Jan 11, 2021
|
Julia Karow

This article has been updated to include a comment from a Helix customer and to correct that it is whole-exome sequencing, not Helix's Exome+ assay, that was authorized by the FDA.

NEW YORK – Helix said on Monday that it has received de novo authorization from the US Food and Drug Administration for its whole-exome sequencing platform, as well as 510(k) clearance for a direct-to-consumer genetic risk test for late-onset Alzheimer's disease.

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