GeneDx Holdings Corp. has introduced GenomeDx Prenatal™, a rapid whole‑genome sequencing test that delivers comprehensive diagnostic results in under two weeks for fetuses with ultrasound‑identified anomalies. The test, which will be available to clinicians beginning in February 2026, is positioned as a diagnostic alternative to non‑invasive prenatal screening and targets the 4 % of pregnancies that present structural abnormalities on routine ultrasound. By leveraging its decade‑long experience in exome and genome diagnostics and its extensive GeneDx Infinity™ dataset, the company aims to capture a high‑margin segment that has traditionally been dominated by screening platforms such as Natera’s NIPT.
The appointment of Dr. Linda Genen, MD, MPH, as Chief Medical Officer further underscores GeneDx’s strategy to accelerate genomic adoption in health systems and payers. Dr. Genen brings a background in neonatology, payer strategy, and maternal‑infant health, having led clinical initiatives at ProgenyHealth, UnitedHealth Group, and Optum. Her expertise is expected to guide the integration of GenomeDx Prenatal™ into clinical workflows, negotiate coverage with payers, and expand the company’s reach into the prenatal market, a move that aligns with the broader industry shift toward early, actionable genetic information for families and clinicians.
GeneDx’s recent financial performance provides context for the expansion. In Q3 2025 the company generated $116.7 million in revenue—up 12 % YoY—and raised its full‑year 2025 revenue guidance to $428 million, reflecting strong demand for its exome and genome services. Adjusted gross margin expanded to 74 % in Q3, a lift from 71 % in Q2, driven by higher‑margin genome testing and improved operational leverage. Exome and genome revenue grew 66 % YoY to $98.9 million, and test volumes accelerated 33 %. The new prenatal offering is expected to add a high‑margin revenue stream that complements the company’s existing rare‑disease diagnostics portfolio and supports the raised guidance.
CEO Katherine Stueland highlighted the strategic importance of the launch, noting that “Families and clinicians facing complex fetal findings need precise, fast, and actionable answers they can trust. GenomeDx Prenatal extends our industry‑leading diagnostic capabilities into prenatal care, helping identify rare disease at the earliest moment possible while creating a seamless bridge from prenatal diagnosis through lifelong patient support.” The appointment of Dr. Genen was described as a “passion for how genomics can improve health outcomes for everyone,” positioning GeneDx to drive broader adoption of genomic medicine across payers and health systems. Analysts have responded positively to the company’s momentum, citing the combination of strong revenue growth, margin expansion, and a clear strategic focus on high‑impact, high‑margin markets as key drivers of investor confidence.
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