FDA Grants GeneDx Breakthrough Device Designation

Rare Daily Staff

The U.S. Food and Drug Administration has granted GeneDx Breakthrough Device designation for its whole genome and exome tests to aid in the diagnosis of life-threatening genetic disorders.

“The FDA Breakthrough Device designation for our ExomeDx and GenomeDx tests underscores what clinical practice has shown for years: comprehensive genomic testing should be the starting point, not the last resort, for patients with rare diseases and unexplained symptoms,” said Mimi Lee, chief precision medicine officer at GeneDx.

FDA Breakthrough Device designation is granted to technologies that have demonstrated the potential to provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The designation provides GeneDx with an expedited pathway for FDA review, including prioritized feedback and closer collaboration with the agency, designed to accelerate the availability of safe, effective, and innovative diagnostic devices for patients in all 50 states.

The GeneDx ExomeDx test covers the protein-coding regions, where most disease-causing variants occur, while GenomeDx sequences the entire genome to detect structural and non-coding variants often missed by other genetic testing methods, such as targeted panels and chromosomal microarray.