Highlights

  • GeneDx introduced GenomeDx Prenatal™, a whole genome sequencing test for pregnancies with fetal anomalies
  • The test is phenotype-informed and trio-based, with results targeted in under two weeks
  • GenomeDx Prenatal is scheduled to be available for clinical ordering from February 2026

GeneDx (NASDAQ:WGS) announced the launch of GenomeDx Prenatal™, a whole genome sequencing (WGS) test designed to support prenatal diagnostic evaluation when fetal anomalies are identified through ultrasound. The test is intended for use in time-sensitive pregnancy care settings, where rapid and reliable genomic insights may inform clinical decision-making.

Unlike carrier screening or noninvasive prenatal screening, which identify risk of a genetic condition, prenatal diagnostic testing determines whether a pregnancy is affected by a genetic disorder. GenomeDx Prenatal is phenotype-informed and trio-based, analyzing fetal and parental samples together to provide a comprehensive assessment.

Foundation in Prenatal Genomics

The new offering builds on GeneDx’s experience of more than a decade in prenatal diagnostics, including over 10 years of prenatal exome testing and more than 4,000 prenatal exomes completed. The company stated that GenomeDx Prenatal integrates this experience with GeneDx Infinity™, its rare disease dataset, to combine broad variant detection with detailed clinical interpretation.

According to GeneDx, the test is designed to help inform diagnosis, guide prenatal and postnatal care planning, and support clinical discussions when timing is critical.

“Families and clinicians facing complex fetal findings need precise, fast, and actionable answers they can trust,” said Katherine Stueland, President and CEO of GeneDx. “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.”

Clinical Context and Intended Use

Structural anomalies detected on prenatal ultrasound are frequently associated with genetic conditions and are identified in up to 4% of pregnancies. When anomalies are detected, parents often seek detailed information to reduce uncertainty and avoid delayed or incorrect diagnoses. GeneDx cited published research indicating that prenatal genomic sequencing can influence clinical management in up to 70% of cases, including situations with inconclusive findings.

GenomeDx Prenatal is designed to deliver clinically relevant information that may help clarify prognosis, guide pregnancy and delivery planning, and support considerations related to in-utero therapy, palliative care, or postnatal evaluation.

“There is nothing more hopeless than being told something is likely wrong with your baby while pregnant, without clarity or details,” said Lisa Gurry, Chief Business Officer of GeneDx. “This was my family’s experience and is part of why I’m so passionate about empowering families with precise knowledge as soon as possible. GenomeDx Prenatal can give families the information they deserve, when they need it.”

Test Features and Availability

GeneDx stated that GenomeDx Prenatal delivers broad variant detection in a single assay, with results in less than two weeks, avoiding delays associated with stepwise testing. The test covers indications such as congenital heart disease, skeletal dysplasia, brain and kidney malformations, increased nuchal translucency, and hydrops.

The company also noted that the service includes free postnatal reanalysis and optional lifetime reanalysis, supported by clinical assistance, transparent billing, and an integrated ordering and results platform. GenomeDx Prenatal is expected to be available for clinicians to order in February 2026.

WGS closed at USD 9.57 on January 06, 2026.