Release Details

• Reported third quarter 2025 revenues of $116.7 million with 65% year-over-year growth in exome and genome test revenue
• Accelerated exome and genome volume growth to 33% year-over-year
• Expanded adjusted gross margin to 74% and generated adjusted net income¹ of $14.7 million for the third quarter 2025
• Raised guidance to deliver between $425 and $428 million in revenue with between 53% to 55% full year growth in exome and genome revenue
• Granted FDA Breakthrough Device Designation for GeneDx ExomeDx™ and GenomeDx™
• Leading the nation in genomic newborn screening (gNBS) as the sole commercial testing provider for new gNBS programs, including the NIH BEACONS initiative and Sunshine Genetics Network
• Hosting conference call today at 8:30 a.m. ET

GAITHERSBURG, Md.--(BUSINESS WIRE)--Oct. 28, 2025-- GeneDx Holdings Corp. (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the third quarter of 2025.

“GeneDx’s accelerated growth reflects more than business momentum - it’s proof of the profound impact we’re making for families navigating rare disease and the broader transformation underway across healthcare,” said Katherine Stueland, President and CEO of GeneDx. “The FDA’s Breakthrough Device Designation for our ExomeDx™ and GenomeDx™ tests underscores our innovative leadership in delivering faster, more accurate diagnoses when every day matters. Powered by GeneDx Infinity™, we’re helping usher in a new era of proactive, personalized care that begins at birth - advancing precision medicine to improve outcomes and change lives.”

Third Quarter 2025 Financial Results (Unaudited)^1,2

Revenues

• Revenues grew to $116.7 million, an increase of 52% year-over-year.
• Exome and genome test revenue grew to $98.9 million, an increase of 65% year-over-year.

Exome and genome volume

• Exome and genome test results volume grew to 25,702, an increase of 33% year-over-year.
• Exome and genome represented 43% of all tests, up from 33% in the third quarter of 2024.

Gross margin

• Adjusted gross margin expanded to 74%, up from 64% in the third quarter of 2024.
  • GAAP gross margin was 72%.

Operating expenses

• Adjusted total operating expenses were $71.2 million, representing 61% of revenue in the third quarter of 2025, compared to 62% of revenue in the third quarter of 2024.
  • GAAP operating expenses were $87.8 million.

Net Income

• Adjusted net income was $14.7 million compared to $2.0 million in the third quarter of 2024.
  • GAAP net loss was $7.6 million.

Cash position

• Cash, cash equivalents, marketable securities and restricted cash was $156.1 million as of September 30, 2025.
• Cash flow for the third quarter 2025 primarily included:
  • $8.8 million in free cash flow generated; and
  • $11.8 million in proceeds, net of fees, from the issuance of 101,367 shares of Class A common stock in connection with sales pursuant to our “at-the-market” offering.

“The third quarter delivered volume acceleration coupled with gross margin expansion, and we’ve established a powerful scale advantage that sets the stage for profitable growth,” said Kevin Feeley, CFO of GeneDx. “As we capitalize on a rapidly expanding market, we’re investing to unlock sustainable, high growth with attractive margins.”

GeneDx Full Year 2025 Guidance

GeneDx has raised certain elements of its full year 2025 guidance and expects to deliver:

Third Quarter 2025 and Recent Business Highlights

Strategic Expansion and Market Leadership

• Introduced GeneDx Infinity™, the largest rare disease dataset, which serves as the foundation for rare disease insights and powers GeneDx's ExomeDx™ and GenomeDx™.
• Exhibited at the American Academy of Pediatrics (AAP) Annual Meeting, educating pediatricians about the updated AAP guidance recommending exome and genome sequencing as first-tier tests for children with global developmental delay or intellectual disability.
• Expanded coverage of whole genome sequencing with California Medicaid (Medi-Cal), opening access to testing in the nation’s most populous state and bringing the number of states covering exome or genome testing in the outpatient setting to 36.
• Announced the Autism Partnership Program in partnership with Jaguar Gene Therapy, expanding access to exome and genome testing for patients suspected of having SHANK3-related autism spectrum disorder (ASD) and Phelan-McDermid syndrome - the leading single-gene cause of ASD.
• Appointed Lisa Gurry as Chief Business Officer and Dr. Mimi Lee as Chief Precision Medicine Officer to accelerate precision medicine across policymakers, health systems, biopharmaceutical companies, advocacy groups, and payers to help more families with the power of data, AI, and clinical expertise.
• Appointed Dr. Thomas Fuchs, MD, PhD, to the board of directors, contributing his background at the intersection of AI and human health to support GeneDx’s business and mission.

Innovation & Clinical Leadership

• Granted FDA Breakthrough Device Designation for GeneDx ExomeDx™ and GenomeDx™ associated with causes of life-threatening diseases or genetic disorders to aid in diagnosis of symptomatic patients, underscoring GeneDx’s leadership in genomic medicine and critical role in delivering fast, accurate answers for patients with rare diseases.
• Expanded leadership in genomic newborn screening through participation in key programs, including:
  • Announced participation in the nation’s first multi-state genomic newborn screening initiative, BEACONS (Building Evidence and Collaboration for GenOmics in Nationwide Newborn Screening), which was launched with a $14.4 million NIH award to enroll up to 30,000 newborns in as many as 10 states over the next three years.
  • Announced a partnership with Florida’s Sunshine Genetics Network to launch the nation’s first state-backed genomic newborn screening program and offer whole genome sequencing for newborns at select academic medical centers and hospitals, providing families and clinicians the opportunity for early detection and diagnosis of rare diseases.
• Added to the company’s 1,000+ publications and growing by showcasing pioneering research at the American Society of Human Genetics (ASHG) Annual Meeting including:
  • AI and machine learning approaches in rare disease diagnosis: In a study of over 250,000 exome and genome trios, GeneDx’s machine learning approach addresses challenges of identifying de novo variants with high accuracy and throughput, enabling greater efficiency and scalability.
  • The genetic causes of autism: In a study of over 62,000 individuals affected with autism, researchers highlight a core set of over 250 genes associated with autism and found moderate genetic correlations between autism and schizophrenia, epilepsy, and bipolar disorder.
  • Genomic newborn screening (gNBS): Updated results from the GUARDIAN study reports data from 15,000 newborns and demonstrates high enrollment rates, positive parental experiences, and meaningful follow-up outcomes – reinforcing the value of gNBS in accelerating time to diagnosis.
  • Clinical validation for long read sequencing: Long-read sequencing approaches demonstrate strong potential to improve clinical diagnostics, accurately detecting repeat expansions and resolving difficult-to-sequence regions.
• Showcased leadership in genomic newborn screening at the International Consortium of Newborn Sequencing (ICoNS), with data presented on GeneDx’s more than 22,000 newborns sequenced.

Webcast and Conference Call Details

GeneDx will host a conference call today, October 28, 2025, at 8:30 a.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the “Events” section of the GeneDx investor relations website at https://ir.genedx.com/.

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, including statements regarding our future performance and our market opportunity, including our expected full year 2025 reported revenue, growth in exome and genome revenue and volume, adjusted gross margin and adjusted net income guidance. 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 implement business plans, goals and forecasts, and identify and realize additional opportunities, (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) 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 “Risk Factors” 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.

About GeneDx

GeneDx (Nasdaq: WGS) is the global leader in rare disease diagnosis, transforming the way medicine is practiced by making genomics the starting point for health, not the last resort. We bring together unmatched clinical expertise, advanced technology, and the power of GeneDx Infinity™ – the largest rare disease dataset – built over 25 years from millions of genomic tests and deep clinical insights. This unparalleled foundation powers our ExomeDx™ and GenomeDx™ tests, giving clinicians the highest likelihood of delivering a timely, accurate diagnosis. GeneDx is shaping the future of healthcare by moving the standard of care from sick care to proactive healthcare. While our roots are in rare disease diagnosis, our commitment extends beyond – growing with the families we serve – as a trusted partner at every stage of life. For more information, visit genedx.com and connect with us on LinkedIn, Facebook, and Instagram.

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Source: GeneDx