GeneDx Granted FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ Testing

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10/20/2025 - 08:00 AM

Designation highlights GeneDx innovation in clinical whole genome and whole exome testing and accelerates the pathway for FDA authorization of these novel diagnostic tests

GAITHERSBURG, Md.--(BUSINESS WIRE)-- GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its whole genome and exome tests associated with causes of life-threatening diseases or genetic disorders to aid in diagnosis of symptomatic patients.

With more than 2.5 million genetic tests performed in its CLIA certified, CAP accredited clinical laboratory, GeneDx continues to advance clinical genomic testing for rare diseases. The GeneDx ExomeDx 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 like targeted panels and chromosomal microarray.

“Diagnosis informed by an individual’s genetics rather than symptoms alone can lead to improved clinical outcomes and help eliminate the typically years-long ‘diagnostic odyssey’ faced by these patients and families,” said Mimi Lee, MD, PhD, Chief Precision Medicine Officer at GeneDx. “The FDA Breakthrough Device Designation for our ExomeDx and GenomeDx tests underscores what clinical practice has shown for years, that comprehensive genomic testing should be the starting point – not the last resort – for patients with rare diseases and unexplained symptoms.”

GeneDx’s whole genome and whole exome tests are powered by GeneDx Infinity™ – the largest and most diverse rare-disease dataset, with nearly one million sequenced exomes and genomes and over 7 million phenotypic datapoints – and use next generation sequencing technology to deliver fast, reliable results across all populations.

"By combining the industry's largest and most diverse rare-disease dataset with advanced AI and deep clinical expertise, GeneDx is positioned to help clinicians deliver faster, more reliable diagnoses for families who have waited far too long for answers,” said Katherine Stueland, President and Chief Executive Officer at GeneDx.

FDA Breakthrough Device Designation is reserved for 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 and effective innovative diagnostic devices for patients in all 50 states.

“As a trusted partner across the healthcare ecosystem, working collaboratively with clinicians, patients, biopharma – and now with FDA – the Breakthrough designation is another milestone advancing our shared mission of making precision medicine the standard of care for all,” added Stueland.

About GeneDx

GeneDx (Nasdaq: WGS) is the global leader in rare disease diagnosis, transforming the way medicine is practiced by making genomics the starting point for health, not the last resort. We bring together unmatched clinical expertise, advanced technology, and the power of GeneDx Infinity™ – the largest, rare disease dataset – built over 25 years from millions of genomic tests and deep clinical insights. This unparalleled foundation powers our clinical genome and exome tests, giving clinicians the highest likelihood of delivering a timely, accurate diagnosis. GeneDx is shaping the future of healthcare by moving the standard of care from sick care to proactive healthcare. While our roots are in rare disease diagnosis, our commitment extends beyond – growing with the families we serve – as a trusted partner at every stage of life. For more information, visit genedx.com and connect with us on LinkedIn, Facebook, and Instagram.

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