GeneDx today introduced GenomeDx Prenatal™, a whole-genome sequencing test designed for use when ultrasound or other imaging identifies possible fetal anomalies. The new offering expands GeneDx’s portfolio beyond its FDA-designated Breakthrough Device–ranked ExomeDx™ and GenomeDx™ tests for rare pediatric disease, positioning the company to capture an estimated $350 million prenatal genetic testing market. With a targeted turnaround of two weeks from sample receipt to comprehensive variant analysis, GenomeDx Prenatal™ integrates proprietary interpretation algorithms and leverages GeneDx Infinity™, the company’s database of nearly one million sequenced exomes and genomes. Early pilot data from three major U.S. maternal-fetal medicine centers demonstrate a 25% increase in diagnostic yield over standard microarray and gene panel assays, underscoring the potential for earlier clinical decision-making and cost savings in high-risk pregnancies. GeneDx plans to roll out the test commercially in Q2 2026, supported by payer coverage discussions already underway with several national and regional insurers.

GeneDx has appointed Dr. Linda Genen, MD, MPH, as Chief Medical Officer, elevating the company’s clinical leadership to accelerate the adoption of genomic testing across health systems, payers, and policy channels. Dr. Genen brings over two decades of experience in neonatology, maternal-infant health management, and payer strategy, most recently serving as CMO at ProgenyHealth, where she led quality and analytics programs that reduced NICU readmissions by 15%. At GeneDx, she will oversee Medical and Clinical Affairs, shape real-world evidence initiatives, and spearhead payer engagement to secure reimbursement pathways for exome and genome sequencing. Her tenure at UnitedHealth Group and Optum, where she launched digital care models in women’s health, is expected to bolster GeneDx’s market access efforts. Company leadership projects that under Dr. Genen’s guidance, genomic testing penetration in neonatal intensive care and perinatal units could grow from the current 10% to 30% of eligible cases within two years, reinforcing GeneDx’s position as a pioneer in precision medicine for early-life diagnostics.