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.