GeneDx Showcases Leadership in Genomic Newborn Screening at ICoNS 2025

GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced data and presentations at the International Consortium on Newborn Sequencing (ICoNS), underscoring the company’s leadership in driving genomic newborn screening (gNBS) from research into real-world clinical implementation.

As the laboratory partner behind the leading gNBS programs – including the Genomic Uniform-screening Against Rare Diseases In All Newborns (GUARDIAN) Study, Early Check’s pilot phase, the NIH’s Building Evidence and Collaboration for GenOmics in Nationwide Newborn Screening (BEACONS) Network, and Florida’s Sunshine Genetics Program – GeneDx is powering the future of genomic sequencing from research to real-word clinical adoption. Collectively, these programs represent the largest and most comprehensive gNBS efforts in the U.S., with approximately 22,000 newborns screened to date.

Earlier this year GeneDx acquired Fabric Genomics enabling flexible solutions – from comprehensive end to end testing to interpretation-as-a-service – supporting partners and health systems globally and accelerating GeneDx’s international expansion and driving further adoption of gNBS.

“GeneDx is proud to be the trusted partner behind major gNBS programs in the U.S.,” said Katherine Stueland, President and Chief Executive Officer of GeneDx. “Our leadership in this space – from supporting pioneering research to enabling clinical adoption in Florida – reflects our mission to make genomic insights available to every family at birth and drive true longevity from the earliest moment possible. Genomic newborn screening represents the next frontier in preventive medicine, and GeneDx is uniquely equipped to deliver it at scale.”

At ICoNS, Britt Johnson, PhD, FACMG, Senior Vice President of Medical Affairs at GeneDx, will present during the Fast Track session: Laboratory Insights from GUARDIAN: Scalable, Equitable Approach to Genomic Newborn Screening in over 17,000 Newborns Reveals Actionable Insights. The presentation will highlight real-world learnings from GeneDx’s laboratory implementation of gNBS for the GUARDIAN study, including the operational, technical, and equity frameworks that are informing national and state-level programs. Powered by GeneDx Infinity and advanced clinical analysis automation, the GUARDIAN study demonstrates that gNBS can be performed with short turnaround times, equitable access, and high diagnostic yield.