GeneDx Holdings (WGS) Company Report

GeneDx maintains a dominant market position in rare disease genomics, with 80% market share among geneticists, driven by the accuracy, speed, and cost-effectiveness of its testing.
The company's key competitive differentiator is its Infinity data asset, built from over 2.5 million rare disease patient tests and 7 million phenotypic data points, which enhances diagnostic yield and is difficult for competitors to replicate.
GeneDx is targeting significant growth opportunities in the NICU market, where it has reduced turnaround times to 48 hours, and the general pediatrician market, aiming to address the large population of undiagnosed rare disease patients.
The acquisition of Fabric Genomics supports GeneDx's international expansion strategy by enabling it to offer interpretation as a service, allowing global partners to utilize its data asset for local sequencing efforts.

1 day ago

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GeneDx Discusses Rare Disease Market Leadership and Growth Strategies

WGS

New Projects/Investments

M&A

Revenue Acceleration/Inflection

GeneDx maintains an 80% market share in rare disease diagnosis, leveraging improved technology for faster and more cost-effective testing, with exome results now available in approximately two weeks.
The company's key competitive differentiator is its Infinity data asset, which includes over 2.5 million rare disease tests and nearly one million exomes/genomes, enabling superior accuracy in variant interpretation.
GeneDx is focused on expanding into the NICU and general pediatrician markets, identifying these as significant underutilized opportunities to end the diagnostic odyssey for children.
GeneDx is a leader in newborn screening, supporting landmark studies and influencing legislation, such as Florida's Sunshine Genetics Act, to promote early diagnosis of genetic diseases.
The Fabric Genomics acquisition supports GeneDx's international strategy by enabling interpretation as a service, allowing global partners to utilize GeneDx's data asset and expertise for local sequencing.

1 day ago

Transcript

GeneDx Discusses Growth Momentum and Strategic Initiatives

WGS

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

GeneDx, a leader in rare disease diagnostics, reported 33% volume growth in whole exome/genome testing in Q3, driven by pediatric neurologists and geneticists.
The company expects a significant market expansion, doubling its total addressable market to $2.5 billion, following the American Academy of Pediatrics' June guideline update allowing general pediatricians to order whole exome/genome tests.
GeneDx is investing in educating 60,000 general pediatricians and developing a simplified ordering process, anticipating a ramp-up in volumes from this new segment over 18-24 months.
Financially, GeneDx achieved an average reimbursement rate of approximately $3,800 per test in Q3 and projects gross margins of 70-71%, an increase of 600 basis points, while committing to remain EBITDA positive on an adjusted basis in 2026.

Nov 19, 2025, 11:00 AM

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GeneDx's Strategic Growth Initiatives and Financial Outlook

WGS

New Projects/Investments

Guidance Update

Revenue Acceleration/Inflection

GeneDx is expanding its market opportunity, with the American Academy of Pediatrics' updated guidelines in June allowing whole exome/genome testing for children with global developmental delay (GDD) and intellectual disability (IDD), effectively doubling the total addressable market to $2.5 billion. The company is investing in education and a dedicated sales team to target 25,000 general pediatricians, expecting volumes to ramp in 18-24 months.
GeneDx maintains market leadership among pediatric specialists and geneticists, holding an 80% market share among genetics experts. The majority of current growth is driven by pediatric neurologists.
The company reported an average reimbursement rate of approximately $3,800 per test in Q3, with 55% of all tests being paid. GeneDx aims for a theoretical maximum 80% payment rate over time through continued RCM improvements and reducing denials.
GeneDx anticipates gross margins of 70-71%, an increase of approximately 600 basis points, attributed to RCM improvements and COGS reductions achieved through automation and economies of scale.
The company is committed to maintaining adjusted EBITDA profitability in 2026 while strategically investing in future growth vectors, including the general pediatrician market and the NICU initiative.

Nov 19, 2025, 11:00 AM

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GeneDx Highlights Doubled TAM and Strong Q3 Volume Growth, Targets 70-71% Gross Margins

WGS

New Projects/Investments

Revenue Acceleration/Inflection

Guidance Update

GeneDx has identified a $2.5 billion total addressable market (TAM), which has doubled following a June guideline update by the American Academy of Pediatrics that allows general pediatricians to order whole exome/genome tests for children with global developmental delay and intellectual disability. The company is investing in educating these pediatricians and building a dedicated sales team, anticipating 18-24 months for volumes to ramp from this new segment.
The company reported 33% growth in whole exome and whole genome volumes in the third quarter. While geneticists still account for the majority of overall volume, growth is primarily driven by pediatric neurologists.
GeneDx expects gross margins to reach 70-71%, an increase of 600 basis points, attributing this improvement to cost reductions from automation and scale in the wet lab, with further opportunities in automating post-sequencing analysis using AI and language models.
The average reimbursement rate in Q3 was approximately $3,800 per test, with the company targeting an 80% payment rate (up from 55%) and a theoretical maximum of $7,000 per test when paid. Medicaid coverage is expanding, with California recently adding whole genome coverage, bringing the total to 36 states.
GeneDx is committed to remaining EBITDA positive on an adjusted basis while strategically investing in new growth areas, including the NICU market, where only 5% of babies currently receive genetic testing despite potential annual savings of $150,000 per baby.

Nov 19, 2025, 11:00 AM

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GeneDx Discusses Strategic Expansion and Diagnostic Advancements at Stifel Conference

WGS

New Projects/Investments

Revenue Acceleration/Inflection

GeneDx's mission is to diagnose genetic diseases as early as possible, aiming to eradicate the average five-year diagnostic odyssey for children with rare diseases.
The company's competitive advantage is its Infinity data asset, which includes data from over 2.5 million rare disease patients and 7.2 million phenotypic data points, enabling more accurate diagnoses and fewer Variants of Unknown Significance (VUSs).
GeneDx is expanding its market focus to include general pediatricians, a significant growth opportunity with 25,000 relevant general pediatricians in the U.S., following updated American Academy of Pediatrics (AAP) guidelines.
To support this expansion, GeneDx plans to meaningfully increase its sales team, potentially doubling its current ~100 client-facing individuals over the next 12 months.
Reimbursement for GeneDx's exome and genome tests has improved, with 55% of tests being reimbursed and 36 states now covering Medicaid for these tests, contributing to an average reimbursement rate of $3,800 in the third quarter.

Nov 12, 2025, 7:00 PM

Transcript

GeneDx Discusses Market Expansion and Diagnostic Advancements at Stifel Healthcare Conference

WGS

New Projects/Investments

Revenue Acceleration/Inflection

GeneDx's core mission is to diagnose genetic diseases as early as possible, aiming to eradicate the five-year diagnostic odyssey for rare diseases. The company's competitive advantage is its Infinity data asset, comprising over 2.5 million rare disease patients and 7.2 million phenotypic data points, which enables more accurate diagnoses and fewer Variants of Unknown Significance (VUSs).
The company is expanding its market focus into the general pediatrician segment, a significant opportunity opened by updated AAP guidelines in June 2025 that recommend exomes and genomes as first-line tests for intellectual disabilities.
To support this expansion, GeneDx plans to meaningfully increase its sales team, potentially doubling its current close to 100 client-facing individuals over the next 12 months, with new hires dedicated to the generalist population.
Reimbursement for exome and genome tests is improving, with GeneDx getting paid approximately 55% of the time at an average rate of $3,800 in Q3. 36 states now provide Medicaid coverage for these tests, including California's recent implementation of whole genome coverage for Medi-Cal.
While most current testing volume is exome, GeneDx believes the future is genome testing, particularly in the NICU setting, where fewer than 5% of babies currently receive genetic tests despite 60% potentially benefiting and data showing $40,000 in savings per patient.

Nov 12, 2025, 7:00 PM

Transcript

GeneDx Discusses Strategic Expansion, Data Advantage, and Reimbursement at Stifel Healthcare Conference

WGS

New Projects/Investments

Revenue Acceleration/Inflection

GeneDx's core mission is to accelerate the diagnosis of rare genetic diseases, leveraging its Infinity data asset which includes over 2.5 million rare disease patients and 7.2 million phenotypic data points to provide more accurate diagnoses and reduce variants of unknown significance.
The company is expanding its market focus beyond genetics experts into general pediatrics, a "wide open space," driven by updated American Academy of Pediatrics (AAP) guidelines that recommend exomes and genomes as first-line tests for intellectual disabilities.
GeneDx plans to double its client-facing team over the next 12 months, with new hires primarily targeting general pediatricians, and expects an 18-24 month horizon for significant adoption in this setting.
Reimbursement rates have improved, with GeneDx getting paid approximately 55% of the time for exome and genome tests, and 36 states now provide Medicaid coverage for these tests, including California's recent implementation for Medi-Cal, with an average reimbursement rate of $3,800 in the third quarter.

Nov 12, 2025, 7:00 PM

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GeneDx Reports Strong Q3 2025 Results, Raises Full-Year Guidance, and Achieves FDA Breakthrough Designation

WGS

Earnings

Guidance Update

New Projects/Investments

GeneDx reported Q3 2025 revenues of $116.7 million, a 52% increase year-over-year, with exome and genome revenue up 66% to $98.9 million. The company also achieved an adjusted net income of $14.7 million and adjusted basic EPS of $0.51.
The company raised its full-year 2025 total revenue guidance to between $425 million and $428 million and exome and genome revenue guidance to $358 million-$361 million. Full-year 2025 adjusted gross margin guidance was also raised to between 70% and 71%.
GeneDx received FDA breakthrough device designation for its ExomeDx and GenomeDx tests. Additionally, Medi-Cal, the largest state Medicaid program, will begin covering whole genome testing for its members starting November 1.
Strategic investments include plans to nearly double its sales force over the coming quarters to penetrate new markets, and continued R&D to enhance its GeneDx Infinity database and customer experience. The company currently holds an 80% market share in clinical exome and genome testing in the U.S..

Oct 28, 2025, 12:30 PM

Transcript

GeneDx Reports Strong Q3 2025 Results and Raises Full-Year Guidance

WGS

Earnings

Guidance Update

New Projects/Investments

GeneDx reported Q3 2025 revenue of $116.7 million, a 52% increase year-over-year, driven by $98.9 million in exome and genome revenue, up 66%. The company achieved an adjusted gross margin of 74% and adjusted basic EPS of $0.51 in Q3 2025.
The company raised its full-year 2025 revenue guidance to $425 million to $428 million and reaffirmed its expectation for at least 30% exome and genome volume growth for the full year.
The FDA granted breakthrough device designation to GeneDx's ExomeDx and GenomeDx tests, and Medi-Cal, California's largest state Medicaid program, will begin covering whole genome testing for its members starting November 1, becoming the 36th state to do so.

Oct 28, 2025, 12:30 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for GeneDx Holdings.

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