Core Insights - GeneDx's GUARDIAN study has been recognized in JAMA's annual Research of the Year Roundup, highlighting its significant contributions to genomic newborn screening [1][2][3] Group 1: Study Recognition and Impact - The GUARDIAN study demonstrates the effectiveness of genomic newborn screening in identifying serious childhood conditions more comprehensively than traditional methods [2][3] - The study's findings indicate that early diagnosis through genomic screening can lead to timely interventions, improving clinical outcomes for conditions such as long QT syndrome, Wilson disease, and severe combined immunodeficiency (SCID) [2][4] Group 2: Study Scale and Goals - GUARDIAN is one of the largest genomic newborn screening studies globally, with over 20,000 newborns screened and a long-term goal of enrolling 100,000 newborns [4][10] - The study aims to evaluate the feasibility, clinical impact, and equity of implementing genomic screening alongside existing public health newborn screening programs [4][10] Group 3: Clinical and Economic Benefits - The study reports a 72% parental consent rate, indicating strong family interest in genomic screening, and a 3.7% screen-positive rate, with 92% of screen-positive newborns receiving a confirmed diagnosis for conditions not included in traditional screening [6][7] - Earlier genetic diagnosis can significantly reduce the time and costs associated with reaching an accurate diagnosis, which often takes five years or more [6][7] Group 4: Technological Advancements - Next-generation sequencing technologies, including whole genome sequencing, are expected to enhance the diagnostic yield for pediatric genetic diseases and improve outcomes in genomic newborn screening [8]

Financial Performance - GeneDx grew revenues to $116.7 million, a 52% increase year-over-year[4] - Exome and genome test revenue grew to $98.9 million, a 65% increase year-over-year[4] - The company delivered an adjusted gross margin of 74%, up from 64% in the third quarter of 2024[4] - Adjusted net income was $14.7 million in the third quarter of 2025[4] - Cash, cash equivalents, marketable securities, and restricted cash were $156.1 million as of September 30, 2025[13] Business Highlights - The company's exome and genome volume grew 33% year-over-year[10] - Exome and genome tests accounted for 43% of all tests reported[10] - GeneDx received FDA Breakthrough Device Designation for the GeneDx ExomeDx and GenomeDx[6] Strategic Initiatives and Market Expansion - GeneDx is participating in the NIH's BEACONS Initiative and Florida's Sunshine Genetics Network for genomic newborn screening[6] - The company is strategically investing to accelerate long-term growth drivers, with Q3 2025 adjusted total operating expenses of $71 million[14, 17] - Medicaid programs are expanding access to exome and genome sequencing, with 36 states covering exome or genome testing and 17 states covering rapid genome sequencing[63] Guidance - The company updated its full-year 2025 revenue guidance to $425 to $428 million[18] - The company expects growth in exome and genome revenue of 53% to 55%[18]

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].

Financial Performance - GeneDx grew revenues to $87.1 million, a 42% increase year-over-year[4] - Exome and genome test revenue grew to $71.4 million, a 62% increase year-over-year, representing 40% of all test results[4,9] - The company delivered an adjusted gross margin of 69%, up from 61% in the first quarter of 2024[4] - Adjusted net income for the first quarter of 2025 was $7.7 million[4,13] - Cash, cash equivalents, marketable securities, and restricted cash totaled $160.2 million as of March 31, 2025[13] Guidance and Acquisition - Full year 2025 revenue is projected to be between $360 million and $375 million, including $3 million to $5 million from the Fabric Genomics acquisition[5] - Exome/genome volume and revenue growth is expected to be at least 30%[5] - Adjusted gross margins are projected to be between 66% and 68%[5] - GeneDx announced plans to acquire Fabric Genomics, with the deal expected to close in Q2 2025, for an upfront purchase price of $33 million, potentially reaching $51 million in total consideration[4,30] Market and Strategy - GeneDx has contracted with 80% of covered lives, including all large national commercial payers[58,65,82] - The company estimates a $45 billion total market opportunity for exome/genome use cases, with $25 billion in pediatrics and rare diseases and $20 billion in adult applications[56] - GeneDx has screened 17,000 healthy infants with genome sequencing in the GUARDIAN study, with a goal of >100,000[80]