New offering integrates virtual clinicians to create a scalable channel to increase availability of GeneDx exome testing for eligible children facing specialty-care barriers

Company Website: https://ir.genedx.com
GAITHERSBURG, Md. -- (Business Wire)

GeneDx (Nasdaq: WGS), the leader in rare disease diagnosis and improving health through the power of genomic data, today announced the launch of a new online offering designed to expand accessibility of exome testing across the U.S. at scale for pediatric patients with global developmental delay (GDD), intellectual disability (ID) or epilepsy.

Families can now initiate a genetic test directly from GeneDx.com, providing underserved children and families who face barriers to local specialty care with a faster path to clinician-guided exome testing. Exome testing is widely recognized as a first-tier tool for children with GDD, ID, and epilepsy, since up to 50% of causes are estimated to be genetic.^1,2

The new offering enables eligible families to access clinician-guided exome testing without first navigating lengthy specialty-care wait times, helping expand GeneDx’s reach to pediatric patients who may otherwise go untested. With over 450,000 children living with epilepsy in the U.S. and more than 1 million children in the U.S. with ID,³ the need for a precise and fast diagnosis is urgent. Across the U.S., wait times for an appointment with a geneticist continue to increase, with about 25% of pediatric patients waiting more than a year and about 50% waiting more than 6 months for a clinical genetics appointment.

In 2025, the American Academy of Pediatrics (AAP) updated its clinical guidance to recommend exome sequencing as a first-tier test for children with GDD or ID. For epilepsy and developmental delay, earlier diagnosis can guide treatment decisions, reduce unnecessary testing, and improve long-term management.

“For too many families, the path to answers is defined by delays, barriers, and a system that isn’t built for the realities they face,” said Katherine Stueland, CEO of GeneDx. “By making exome testing simpler and easier to access, we can reach more children who need answers and move closer to a healthcare system that delivers on the promise of precision medicine.”

The new offering enables families to initiate genetic testing through a simplified, digital experience on the GeneDx website – connecting them directly with licensed healthcare providers who can review medical information, order testing, and deliver results without requiring traditional in-person visits. Designed to complement a child’s pediatrician, neurologist, or specialist, the offering expands access beyond traditional referral channels while supporting coordinated, ongoing care.

“Exome testing can provide critical answers for children with developmental delay, intellectual disability and epilepsy, but too many families still face barriers to timely access,” said Linda Genen, M.D., MPH, Chief Medical Officer of GeneDx. “This offering removes friction by creating a clinically guided path to appropriate testing that complements a child’s existing care and helps families get answers sooner.”

By removing friction and enabling faster access to expert-guided testing, this new offering advances GeneDx’s commitment to expanding access to precision medicine and delivering earlier, more accurate diagnoses. The offering is now available to eligible pediatric patients across the United States, subject to provider availability, clinical appropriateness, and applicable state requirements. To learn more visit, https://www.genedx.com/patients/access-genetic-testing.

About GeneDx

GeneDx's (Nasdaq: WGS) mission is to empower everyone to live their healthiest life through genomics. GeneDx combines unmatched clinical expertise, advanced technology, and the power of GeneDx Infinity™ — the world's largest rare disease genomic dataset. This unparalleled foundation powers GeneDx's ExomeDx™ and GenomeDx™ tests — ranked #1 by expert geneticists and granted FDA Breakthrough Device designation — 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 and connect with us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

This press release contains “forward-looking statements” 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 “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” 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, and (iv) future expansion of insurance coverage for exome and genome testing. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 23, 2026, our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026, filed with the SEC on May 4, 2026, our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2026, filed with the SEC on August 3, 2026, 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.

1. Sheidley BR, Malinowski J, Bergner AL, et al. Genetic testing for the epilepsies: A systematic review. Epilepsia. 2022 Feb;63(2):375-387. doi: 10.1111/epi.17141. Epub 2021 Dec 10
2. Srour M, Shevell M. Genetics and the investigation of developmental delay/intellectual disability. Arch Dis Child. 2014 Apr;99(4):386-9. doi: 10.1136/archdischild-2013-304063
3. Zablotsky B, Ng AE, Black LI, Blumberg SJ. Diagnosed developmental disabilities in children aged 3–17 years: United States, 2019–2021. NCHS Data Brief, no 473. Hyattsville, MD: National Center for Health Statistics. 2023. DOI: https://dx.doi.org/10.15620/cdc:129520

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Source: GeneDx