\nGeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced GenomeDx Prenatal\u2122, whole genome sequencing (WGS) designed to deliver clear, reliable answers during one of the most critical moments in pregnancy care. The phenotype-informed, trio-based test is intended for pregnancies with fetal anomalies identified via ultrasound, enabling clinicians and expecting families to access actionable genomic insights with a rapid turnaround time. In contrast to carrier or noninvasive prenatal screening that identifies pregnancies at risk of having a genetic disorder, prenatal diagnostic testing can determine whether a pregnancy is affected by a genetic disorder.<\/p>\n
\nWith more than a decade of experience in prenatal diagnostics \u2013 including over 10 years of prenatal exome testing and more than 4,000 prenatal exomes performed \u2013 GeneDx brings its proven genomic expertise and the power of GeneDx Infinity \u2122, the largest rare disease dataset, into prenatal care. GenomeDx Prenatal builds on this foundation, combining comprehensive variant detection with deep clinical interpretation to help inform diagnosis, guide prenatal and postnatal care, and support care decision-making when time matters most.<\/p>\n
\n\u201cFamilies and clinicians facing complex fetal findings need precise, fast, and actionable answers they can trust,\u201d said Katherine Stueland, President and CEO of GeneDx. \u201cGenomeDx 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.\u201d<\/p>\n
\nStructural anomalies detected on prenatal ultrasound are frequently linked to an underlying genetic condition. Overall, significant fetal structural anomalies are identified in up to 4% of pregnancies.1<\/sup> When fetal anomalies are identified, most parents want as much information as possible to inform the best care, reduce the diagnostic odyssey, and avoid misdiagnosis. Even when results are uncertain, parents view genomic insights as empowering.2<\/sup> GenomeDx Prenatal is designed to meet this need by delivering clinically relevant information that supports time-sensitive patient counseling and care planning.<\/p>\n \nPrenatal genomic sequencing has been shown to influence clinical management in up to 70 percent of cases, including both diagnostic and inconclusive results.3 <\/sup>Genomic insights can help clarify fetal prognosis, guide pregnancy and delivery planning, and support considerations related to in-utero therapy, palliative care, and postnatal evaluation. Earlier, more comprehensive insights also help reduce morbidity and mortality while supporting families\u2019 psychological preparation.2<\/sup><\/p>\n \n\u201cThere is nothing more hopeless than being told something is likely wrong with your baby while pregnant, without clarity or details. Families suffer through months of worry and can receive poor results from limited tests, resulting in devastation and surprise later in the child\u2019s life,\u201d said Lisa Gurry, Chief Business Officer of GeneDx. \u201cThis was my family\u2019s experience and is part of why I\u2019m 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.\u201d<\/p>\n \nGenomeDx Prenatal sets a new standard for prenatal genomic testing, delivering broad variant detection in a single, comprehensive assay with results in less than two weeks, eliminating delays from stepwise testing approaches. The test provides robust detection across critical prenatal indications, including congenital heart disease, skeletal dysplasia, brain and kidney malformations, increased nuchal translucency, and hydrops.<\/p>\n \nBuilt to support families beyond the prenatal moment, GeneDx extends care through free postnatal reanalysis and optional lifetime reanalysis, delivered through a seamless, provider-friendly experience with clear sample requirements, responsive clinical support, proactive communication, transparent billing, and an intuitive ordering and results portal that ensures continuity from prenatal findings through long-term care. GenomeDx Prenatal will be available for clinicians to order in February 2026.<\/p>\n About GeneDx<\/b><\/p>\n \nGeneDx (Nasdaq: WGS) is the global leader in rare disease diagnosis, with a mission to empower everyone to live their healthiest life through genomics. GeneDx combines unmatched clinical expertise, advanced technology, and the power of GeneDx Infinity\u2122 \u2013 the world\u2019s largest rare disease genomic dataset. This unparalleled foundation powers GeneDx\u2019s ExomeDx\u2122 and GenomeDx\u2122 tests \u2013 ranked #1 by expert geneticists and granted FDA Breakthrough Device designation \u2013 enabling clinicians to deliver precise, fast, and actionable diagnoses. GeneDx Infinity also fuels discovery for biopharma, with the most powerful AI-driven genomic intelligence. A genomics pioneer over the last 25 years, diagnosing more than 4,800 genetic diseases and publishing more than 1,000 research publications, GeneDx is building the network that will drive the future of genomic precision medicine. For more information, visit genedx.com<\/a> and connect with us on LinkedIn<\/a>, Facebook<\/a>, and Instagram<\/a>.<\/p>\n Forward Looking Statements<\/b><\/p>\n \nThis press release may contain \u201cforward-looking statements\u201d within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words \u201cbelieve,\u201d \u201cproject,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cstrategy,\u201d \u201cfuture,\u201d \u201copportunity,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cwill be,\u201d \u201cwill continue,\u201d \u201cwill likely result,\u201d and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) our ability to successfully launch new product offerings, (ii) the risk of downturns and a changing regulatory landscape in the highly competitive healthcare industry, (iii) the size and growth of the market in which we operate, (iv) our ability to pursue our new strategic direction. The foregoing list of factors is not exhaustive. A further list and description of risks, uncertainties and other matters can be found in the \u201cRisk Factors\u201d section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025, June 30, 2025, and September 30, 2025, and other documents filed by us from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and we assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. We do not give any assurance that we will achieve our expectations.<\/p>\n \n1. Salomon LJ, Alfirevic Z, Berghella V, et al. Practice guidelines for performance of the routine mid-trimester fetal ultrasound scan. Ultrasound Obstet Gynecol. 2011 Jan;37(1):116-26. doi: 10.1002\/uog.8831.<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n2. Jeanne M, Chung WK. Prenatal genomic sequencing: Navigating uncertainty. Semin Perinatol. 2025 Apr;49(3):152058. doi: 10.1016\/j.semperi.2025.152058.<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n3. Deden C, Neveling K, Zafeiropopoulou D, et al. Rapid whole exome sequencing in pregnancies to identify the underlying genetic cause in fetuses with congenital anomalies detected by ultrasound imaging. Prenat Diagn. 2020 Jul;40(8):972-983. doi: 10.1002\/pd.5717.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260107735253\/en\/<\/a><\/span><\/p>\n Investor Relations:\n
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