GeneDx reports GUARDIAN study enrolls 30,000 infants, with 72.3% participation
WGS•GeneDx reported that its GUARDIAN genomic newborn screening study enrolled 30,000 infants, with a 72.3% participation rate.
1. Study enrollment and findings
GUARDIAN results indicated consistent performance across diverse ancestries and meaningful clinical findings alongside existing newborn screening. Screening also identified inherited cardiac-risk cases that prompted preventive treatment in infants, while follow-on testing identified at-risk relatives.
2. Next study updates
GeneDx said study updates would be presented at ICoNS on Oct. 7-8 in Boston. The nationwide, NIH-funded BRIDGES-NBS initiative is scheduled to begin enrolling this month to test a multi-state rollout within public screening programs.
