GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced that the GUARDIAN (Genomic Uniform- screening Against Rare Disease In All Newborns) study has been recognized as part of JAMA's annual Research of the Year Roundup. This highly selective honor is reserved for the most impactful scientific contributions published across all JAMA journals. The recognition highlights the significance of GUARDIAN's peer-reviewed fin ...

Core Insights - GeneDx Holdings Corp. reported strong financial results for Q3 2025, highlighting significant growth in revenue and test volumes, alongside improved gross margins [2][4][7]. Financial Performance - Revenues reached $116.7 million, marking a 52% increase year-over-year [8]. - Exome and genome test revenue grew to $98.9 million, reflecting a 65% year-over-year increase [8]. - Adjusted gross margin expanded to 74%, up from 64% in Q3 2024, while GAAP gross margin was reported at 72% [4][8]. - Adjusted net income for Q3 2025 was $14.7 million, compared to $2.0 million in the same quarter of 2024 [5][8]. Operational Highlights - The volume of exome and genome tests increased to 25,702, a 33% year-over-year growth [8]. - Exome and genome tests accounted for 43% of all tests performed, up from 33% in Q3 2024 [8]. - Adjusted total operating expenses were $71.2 million, representing 61% of revenue, a slight decrease from 62% in Q3 2024 [8]. Strategic Developments - GeneDx received FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ tests, emphasizing its innovative leadership in genomic diagnostics [3][7]. - The company is leading in genomic newborn screening, being the sole commercial testing provider for new programs, including the NIH BEACONS initiative [7][13]. - GeneDx introduced GeneDx Infinity™, the largest rare disease dataset, enhancing its capabilities in rare disease insights [13][15]. Guidance and Future Outlook - GeneDx raised its full-year 2025 revenue guidance to between $425 million and $428 million, with expected growth in exome and genome revenue between 53% to 55% [7][9]. - The company anticipates continued volume growth of at least 30% for exome and genome tests [9].

Core Insights - GeneDx Holdings Corp. reported strong financial results for Q3 2025, highlighting significant growth in genomic testing and improved profitability metrics [2][7][8] - The company received FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ tests, emphasizing its leadership in genomic medicine [3][7][24] Financial Performance - Revenues reached $116.7 million, representing a 52% year-over-year increase [8] - Exome and genome test revenue grew to $98.9 million, a 65% increase year-over-year [8] - Adjusted gross margin expanded to 74%, up from 64% in Q3 2024, while GAAP gross margin was reported at 72% [4][8] - Adjusted net income for Q3 2025 was $14.7 million, compared to $2.0 million in Q3 2024, while GAAP net loss was $7.6 million [5][8] Operational Highlights - The volume of exome and genome tests increased by 33% year-over-year, totaling 25,702 tests [8] - Adjusted total operating expenses were $71.2 million, representing 61% of revenue, a slight decrease from 62% in Q3 2024 [8] - The company ended the quarter with a cash position of $156.1 million, including $8.8 million in free cash flow generated [8] Strategic Initiatives - GeneDx raised its full-year 2025 revenue guidance to between $425 million and $428 million, with expected growth in exome and genome revenue between 53% to 55% [7][9] - The company is leading genomic newborn screening initiatives, including participation in the NIH BEACONS initiative and a partnership with Florida's Sunshine Genetics Network [13] - GeneDx introduced GeneDx Infinity™, the largest rare disease dataset, enhancing its genomic testing capabilities [13][15] Market Position - GeneDx is positioned as a leader in genomic newborn screening, being the sole commercial testing provider for new programs [7][13] - The company is actively expanding its market presence and investing in sustainable growth with attractive margins [6][7]