GeneDx Accelerates Genomic Testing Leadership with 65% Revenue Growth and FDA Breakthrough Device Designation
Rapid Expansion in Genomic Test Volumes Drives Margin Gains and Profitability
GeneDx (NASDAQ: WGS) posted third quarter 2025 results underscoring its lead in clinical genomics. The company’s exome and genome testing revenue climbed 65% year-over-year to $98.9 million, powered by a 33% volume increase to 25,702 tests. These tests now make up 43% of all company testing, up from 33% a year earlier, reflecting industry-wide shifts to more advanced genetic diagnostics.
Adjusted gross margin rose to 74%, up 10 percentage points from the third quarter of 2024, while adjusted net income grew more than seven-fold to $14.7 million. Operating expense efficiency improved slightly, with adjusted total operating expenses at 61% of revenue, down from 62% the year prior.
| Q3 2025 | Q3 2024 | % Change | |
|---|---|---|---|
| Revenue ($M) | $116.7 | $76.9 | +52% |
| Exome/Genome Revenue ($M) | $98.9 | $60.0 | +65% |
| Exome/Genome Volumes | 25,702 | 19,262 | +33% |
| Adjusted Gross Margin | 74% | 64% | +10pts |
| Adjusted Net Income ($M) | $14.7 | $2.0 | +635% |
| Cash, Equiv. & Securities ($M) | $156.1 | - | - |
Upward Guidance Signals Continued Market Expansion in Genomics
On the strength of accelerating demand, GeneDx lifted full-year 2025 revenue guidance to $425-$428 million. The company projects 53%-55% annual growth in exome and genome revenues and expects to remain adjusted net income positive for the remainder of the year.
| Guidance Metric | Previous | Updated |
|---|---|---|
| Total Revenue ($M) | $400–$415 | $425–$428 |
| Exome/Genome Revenue Growth | 48%–52% | 53%–55% |
| Adjusted Gross Margin | 68%–71% | 70%–71% |
| Adjusted Net Income | Positive | Positive |
Clinical Innovation: FDA Breakthrough Status and Expanding Newborn Screening
A key milestone for the quarter was the FDA Breakthrough Device Designation for GeneDx’s ExomeDx™ and GenomeDx™ platforms—both targeting life-threatening and rare diseases where timely diagnosis is critical. GeneDx has also solidified its lead in newborn genomic screening, serving as the sole commercial testing provider for national initiatives including the NIH BEACONS and Florida’s Sunshine Genetics Network, together enrolling up to 30,000 newborns in multi-state pilots.
The company further expanded its AI-driven dataset, GeneDx Infinity™, powering new diagnostic and research breakthroughs—such as studies linking more than 250 genes to autism and refining machine learning for variant identification in rare diseases.
Financial Health and Market Position Strengthen Growth Prospects
GeneDx finished the quarter with $156.1 million in cash, equivalents, and securities, with free cash flow generation of $8.8 million and an additional $11.8 million raised via equity issuance. Total assets rose to $493.9 million as of September 30, 2025, providing ample resources for future investment and R&D expansion.
GeneDx’s rising volume and robust margin profile, together with industry recognition and expanding partnerships, reinforce its strategic advantage as precision medicine gains traction nationwide.
Key Takeaway: Scaling with Industry Tailwinds in Precision Medicine
The company’s continued margin improvement, profitability, and leadership in high-impact programs put it in a favorable position as more states and payers expand access to advanced genomics. As U.S. health policy and practice shift to make genetic sequencing a first-tier tool for complex conditions, GeneDx appears well-positioned for sustained growth—underscored by its upgraded 2025 outlook and rapid execution across clinical and commercial milestones.
For investors and observers, GeneDx’s third quarter report offers a lens on how genomics is transforming clinical care standards, while highlighting the importance of innovation and operational leverage in capturing growth opportunities within healthcare technology.
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