08:53 AM EDT, 10/20/2025 (MT Newswires) -- GeneDx Holdings ( WGS ) said Monday that the US Food and Drug Administration granted breakthrough device designation for its ExomeDx and GenomeDx genetic tests.

The company said the designation applies to its whole genome and exome testing used to identify genetic causes of life-threatening diseases and disorders. GeneDx ( WGS ) said its tests use sequencing technology and are supported by its GeneDx Infinity database, which includes nearly one million sequenced exomes and genomes.

The FDA designation provides an accelerated review process for technologies that may improve the diagnosis or treatment of serious or irreversible conditions, according to the company.

Shares of the company were up more than 2% in recent Monday premarket activity.