GeneDx today unveiled GenomeDx Prenatal™, a whole genome sequencing assay designed to deliver rapid, comprehensive diagnostic insights when fetal anomalies are detected. The test leverages GeneDx’s deep dataset of nearly one million sequenced genomes and exomes, enabling variant interpretation across more than 4,800 genetic disorders. With an anticipated turnaround time of under two weeks from sample receipt and integration into existing obstetric workflows, the new offering targets the estimated 3–5% of pregnancies in which structural abnormalities arise on ultrasound. By addressing an underserved prenatal segment and positioning GenomeDx Prenatal alongside its FDA Breakthrough Device–designated ExomeDx™ and GenomeDx™ postnatal tests, GeneDx aims to capture a growing share of the $1.6 billion global noninvasive and invasive prenatal testing market while strengthening relationships with maternal–fetal medicine specialists and health systems.

GeneDx has appointed Dr. Linda Genen, MD, MPH as Chief Medical Officer, charging her with leading the company’s medical and clinical affairs, shaping payer engagement, and advancing real-world evidence initiatives. Dr. Genen arrives from ProgenyHealth, where she oversaw maternity and NICU care management programs that reduced neonatal complications by more than 15% across partnered health plans. Her background at UnitedHealth Group and Optum in digital care and maternal-infant health positions her to accelerate integration of genomic testing into standard care pathways. Management expects Dr. Genen’s leadership to drive faster adoption of early exome and genome sequencing by payers and providers, underpinning revenue growth in both the direct-to-clinic and biopharma-collaboration segments.

Building on its GeneDx Infinity™ platform—the largest rare-disease genomic dataset—GeneDx is forging partnerships with top‐tier health systems and academic centers to expand reference data and drive AI-powered discovery. This quarter, GeneDx announced collaborations with three major children’s hospitals and two university medical centers to contribute de-identified genomic and phenotypic data, enhancing variant curation capabilities. These alliances position GeneDx to sustain its leadership in rare disease diagnosis and support biopharma clients seeking patient stratification biomarkers, a segment projected to grow at a mid-20% CAGR through 2028.

With GenomeDx Prenatal entering validation studies this month and Dr. Genen’s onboarding, GeneDx is poised to accelerate commercial adoption of its prenatal and neonatal testing services. The company forecasts double-digit revenue growth in the next fiscal year driven by increased utilization in maternal-fetal medicine clinics and expanded reimbursement coverage. GeneDx’s focus on building payer relationships and producing outcome data aims to secure new contracts with commercial and public payers, potentially unlocking a broader addressable market estimated at over 10 million births annually in the U.S. alone.