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]