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Item 1. Business

2026-02-23 compared with 2025-02-20 · 155 added, 152 removed, 313 unchanged (50% of the section changed)

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(“CMLS”) on July 22, 2021 (the “Business Combination”);

• “Fabric Genomics” refer to Fabric Genomics, Inc., a Delaware corporation, which we acquired on May 5, 2025 (the “Merger”);

• “we,” “us” and “our,” the “Company” and “GeneDx” refer, as the context requires, to GeneDx Holdings and its consolidated subsidiaries.

The Company’s Class A common stock and public warrants are listed on the Nasdaq Global Select Market under the symbols “WGS” and “WGSWW,” respectively.

At GeneDx, we believe that everyone deserves personalized, targeted medical care—and that it all begins with a genetic diagnosis.

Fueled by one of the world’s largest rare disease data sets, our industry-leading exome and genome tests translate complex genomic data into clinical answers that unlock personalized health plans, accelerate drug discovery, and improve health system efficiencies.

We operate with conviction that what is best for patients must be embedded in every aspect of our work.

In support of these beliefs, we value equitability, simplicity and transparency.

GeneDx was founded in 2000 by scientists from the National Institutes of Health whose mission was making genetic testing accessible for patients with rare diseases.

At GeneDx, our mission is to empower everyone to live their healthiest life through genomics.

GeneDx combines clinical expertise, advanced technology, and the proprietary GeneDx Infinity™ dataset to power the ExomeDx™ and GenomeDx™ tests – ranked #1 by expert geneticists and granted FDA Breakthrough Device Designation – enabling clinicians to deliver precise, fast, and actionable diagnoses.

GeneDx Infinity TM also fuels discovery for biopharma while supporting the network that we believe will drive the future of precision genetic medicine.

We believe that what is best for patients must be embedded in every aspect of our work, and in support of these beliefs, we value equitability, simplicity, and transparency.

GeneDx was founded in 2000 by scientists from the National Institutes of Health whose mission was to make genetic testing accessible for patients with rare diseases.

The company quickly became a leader in genomics, creating the foundation for how to provide genomic information at scale and pioneering exome and genome sequencing for rare and ultra-rare genetic pediatric disorders.

25 years later, we have amassed one of the world’s largest rare disease datasets and remain a leader in genomics.

Today, we are powered by our industry-leading genomic interpretation platform, and we believe exome and genome testing will become the standard for diagnosis of genetic disease, with the potential to transform healthcare and improve patients’ quality of life.

25 years later, we have amassed one of the world’s largest rare disease datasets, GeneDx Infinity TM , and remain a leader in genomics.

We believe exome and genome testing will become the standard for diagnosing genetic disease, with the potential to transform healthcare from reactive to proactive.

We believe that we are positioned to usher in the next era of precision medicine by offering genetic diagnoses at the earliest moments, creating a patient-centric network to drive improved outcomes, and fueling discovery with the most powerful genomic intelligence.

Industry Background

Targeted genetic tests and panel testing make up the vast majority of diagnostics tests ordered today.

While panel testing can be useful, it has an increasing limitation as we move towards genetic-based healthcare.

Panels only allow you to test for insights that physicians predefine based on symptoms, which can lead to inconclusive results and an inefficient process.

It is hypothesis-based medicine based on symptoms that may overlap across diseases.

We firmly believe that an affordable, scalable and actionable genome is the future of medicine.

The barrier to having actionable information from a genomic sequence is significant—and not just due to costs, which are coming down.

The less-discussed barrier to having actionable information lies in the ability to process a genome’s worth of information—quickly and scalably—and to deliver both a result that a clinician can easily act upon to help a patient and a robust dataset that enables clinicians to drive precise diagnosis and personalized health plans, and researchers to develop and advance therapeutics.

Most companies in today’s genetics industry are taking a test-by-test approach to cross the chasm from genetics early adopters to genome-guided healthcare in the mainstream market.

We believe that driving clinician and patient awareness and influencing policy decisions may facilitate uptake within the industry.

In addition, making genetics part of mainstream medicine requires advancing the technology to provide personalized and actionable health insights.

It also requires having a robust, well-characterized dataset that can maximize answers and minimize unknowns to drive a new era of discovery.

Exome and whole genome sequencing provide the broadest view into the genomic variant—we are looking comprehensively into over 20,000 genes, while panels look at anywhere from two to a few hundred genes.

While most of the industry has focused on panels, we have focused on exome and whole genome developing structured gene-disease knowledge curated by our team of experts to power automated interpretation and reporting.

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Targeted genetic tests and panel testing still represent a meaningful portion of diagnostic tests ordered today.

However, as healthcare increasingly moves toward genetics-informed and preventive care, the limitations of panel-based testing have become more pronounced, and exome and genome sequencing are moving closer to standard of care.

Panels restrict analysis to a predefined set of genes based on an initial clinical hypothesis, which can result in inconclusive findings and delayed diagnoses—particularly for patients with overlapping, atypical, or evolving symptoms.

This hypothesis-based approach is increasingly misaligned with the complexity of genetic disease and increasing access to high-quality exome and genome sequencing.

We believe that an affordable, scalable, and clinically actionable genome sequence will be a central element in the future of medicine.

Historically, cost was one of the greatest barriers to broad adoption, but sequencing costs continue to decline with advancements in sequencing technology, competition, and scale.

The more significant challenge today lies in transforming a genome’s vast volume of data into insights that are timely, accurate, and actionable in routine clinical care.

This requires the ability to rapidly interpret genomic data at scale and continuously improve interpretation based on new data and outcomes.

Accurate and scalable interpretation depends on robust, well-curated gene–disease knowledge, continuously updated with real-world evidence, and supported by large, diverse datasets that reduce uncertainty and improve diagnostic yield.

As datasets grow and interpretation improves, genomics increasingly enables earlier diagnoses, fewer uncertain results, and more informed clinical decision-making from the earliest moments.

In recent years, the genetic diagnostics industry has seen increasing momentum from several converging forces:

growing clinician familiarity with genomics, expanding newborn and pediatric screening programs, improving reimbursement pathways for comprehensive testing, and the integration of artificial intelligence and automation into variant interpretation and reporting.

Together, these trends are helping shift genomics from a specialized diagnostic tool toward a foundational layer of modern healthcare, supporting precise diagnoses, guiding personalized care plans, and accelerating therapeutic discovery.

The Genome Future

The genome is composed of 3 billion “letters”, or base pairs, of DNA.

The exome is a portion of the genome that encodes proteins, which are involved in many different types of cellular functions.

Changes in a genome or exome can change the way proteins are formed or utilized by the cell, potentially causing disease.

Changes in DNA can change the way proteins are formed or utilized by the cell, potentially causing disease.

When patients present with complex issues, a genetic diagnosis may be available, but a traditional genetic panel test may be too narrow to identify the cause.

Some genetic disorders present with very specific symptoms, so tests that read the “letters” of a single gene or a small panel of genes, may make sense for physicians to use in diagnosis.

But for many other genetic diseases, patients can present with overlapping symptoms so finding the correct diagnosis is not always straightforward and may require multiple tests, costly evaluations, invasive procedures, and long hospital stays.

Exome and genome sequencing can find different genetic alterations, or variants, that more targeted tests miss and are especially useful when the timing is critical to directing or altering medical management.

With 25 years of operation, GeneDx has a proven track record of expertise in genetic testing.

We launched the industry’s first commercially available next generation sequencing panels in 2008, pioneered exome sequencing in 2012 and have sequenced over 750,000 exomes and genomes to date.

We have performed over one million genetic tests and worked tirelessly to develop:

• A curated database of disease-associated genomic variants;

• Proprietary bioinformatics and variant interpretation pipelines;

• Rapid exome and whole genome sequencing testing options.

The status quo of genetic testing requires repeated and fragmented testing which, in many cases, is conducted too late for physicians to use in treatment of patients.

Targeted genetic tests and panels have been largely commoditized leaving physicians, healthcare partners and patients searching for deeper answers and enhanced utility.

The scalable exome and whole genome interpretation that we can deliver at speed do not require a long, complex, expensive, expert-guided search and may make most other genetic tests obsolete.

In addition, using whole genome testing is incredibly simple:

it’s designed to be Just One Test.

Advanced Technology with a Human Touch

Our team includes over 200 genetic counselors, physicians, scientists, and clinical and molecular genomics specialists.

We believe we are one of the industry’s leading genetic testing experts.

We share the same goal as healthcare providers, patients, and families:

to provide personalized and actionable health insights.

Our years of exome and genome sequencing experience have provided us with a substantial dataset, including over 6 million structured phenotypes with approximately 60% of all exomes/genomes to date processed as parent-child trios.

We have invested resources over time to annotate the phenotypes and sequence the parents of patients, because their genetic sequences can often provide additional diagnostic information, potentially improving the precision of genetic analysis.

Importantly, we have served the Medicaid population for nearly a decade ahead of the first state to enact health coverage for exome/genome and as such, our data set is highly diversified matching the demographic dispersion of the United States.

In addition, the data from more families allows us to continually improve interpretation of genetic code and variants that may cause disease.

We believe we have more expertly annotated disease-causing variants than the largest public archive.

Internally developed with over one million sequenced specimens, our database is designed to lead to increasingly reliable diagnostic test results.

The structured gene-disease knowledge curated by our team of experts is powering automated interpretation and reporting built to handle genomic data at scale.

Combined with our proprietary, state-of-the-art variant identification software, our ability to deliver highly accurate test results makes finding definitive diagnoses, even in complex cases, possible.

Implemented with expert oversight, our advanced interpretation methods incorporate automation, bioinformatics, and cloud-based machine learning, enabling efficient discovery of genetic differences at previously undetectable levels.

With 25 years of operation, GeneDx has a proven track record of expertise in genetic testing, particularly exome and genome testing.

We launched the industry’s first commercially available Next Generation Sequencing panels in 2008 and pioneered exome sequencing in 2012.

We have worked tirelessly to develop:

• One of the largest rare disease datasets in the world, GeneDx Infinity TM ;

• A laboratory operation that delivers accuracy, speed, and cost efficiency;

• Proprietary bioinformatics, AI, and variant interpretation pipelines;

• High-quality standard exome and genome products as well as rapid and ultraRapid genomes;

• Genomic newborn screening protocols using a whole genome backbone.

We regularly enrich our products with new genomic technologies, including medium and long-read sequencing, and adding multimodal analysis beyond DNA to enhance our ability to serve more patients with speed, accuracy, and scale over time.

These R&D programs generate data that compounds upon our library of over 1,100 peer-reviewed publications, further exemplifying our position at the forefront of genomic innovation.

The scalable exome and whole genome interpretation that we deliver at speed does not require a long, complex, and expensive step-wise testing approach and may make most other genetic tests obsolete.

Additionally, exome and genome testing provide a streamlined test selection and ordering process for non-genetics clinicians who are increasing the utilization of genetic testing for their patients.

We believe that we are positioned to continue leading the industry into the genome future.

GeneDx Infinity TM

Over our 25-year history, we have amassed one of the largest rare disease datasets in the world, if not the largest.

GeneDx Infinity TM is powered by data from over 2.5 million tests – including over 1 million exomes and genomes – and supplemented with more than 8 million phenotypic datapoints and billions of datapoints from longitudinal patient data, clinical data, claims data, and more.

60% of the exomes and genomes in GeneDx Infinity TM represent relative samples from trio testing, where biological relative samples are used as comparators to improve diagnostic quality.

Importantly, the genomic data in GeneDx Infinity TM is incredibly diverse, with more than 50% of exomes and genomes representing individuals of non-European descent.

Each patient enriches the data density of GeneDx Infinity TM , improving our ability to offer fast, actionable, and accurate diagnoses to the next patients.

This flywheel effect further differentiates our interpretation capabilities across diverse populations.

This flywheel is also accelerating – in 2025 alone, we added 30% more rare disease exomes and genomes into GeneDx Infinity TM than in the previous 24 years combined.

Our team of more than 100 MDs and PhDs and 150 genetic counselors transform GeneDx Infinity TM into clear, trusted answers that clinicians can act on with confidence.

We are also applying AI tools – like our machine learning powered gene ranker, Multiscore – on top of GeneDx Infinity TM to harness the power of our data, scale our platform and increase speed and turnaround time.

The structured gene-disease knowledge curated by our team of experts is being enhanced through cutting edge tools to deliver even greater speed, scale, and operational efficiency.

Implemented with a human in the loop, our advanced interpretation methods incorporate automation, bioinformatics, and cloud-based machine learning, enabling efficient discovery of genetic differences at previously undetectable levels.

As the number of new patients we test grows, so does our database, and the new data increases the potential for greater insights.

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Market Opportunity

Our primary growth engine in the short term will be expanding our current market-leading exome and genome sequencing capabilities in the outpatient setting, including geneticists, pediatric development specialists, and other pediatric specialists, as well as the neonatal in-patient setting, also referred to as Neonatal Intensive Care Units (“NICU”).

Over time we fully expect more and more use cases and reimbursement pathways for exome and genome to open up across a wide spectrum of pediatric and adult diseases, conditions and disorders.

As we plan for longer-term growth, we aim to bring whole genome newborn screening to

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the market, supported with the launch of a new customer experience platform for non-geneticists, patients and caregivers, and evidence generation to establish the clinical and economic benefits of screening.

Also, as we plan for longer-term growth, we believe there is a large data partnership opportunity with biopharmaceutical (“biopharma”) companies, international testing opportunities, as well as a market to provide interpretation and information services for customers that sequence locally but look to GeneDx for analysis and interpretation.

We believe we are particularly well-suited for helping rare disease and pediatric developmental disorder patients, their care teams and biopharma companies today.

This is a large market with immense unmet medical need.

There are over 7,000 individual diseases affecting nearly 10% of the total population in the United States, of which 50% are children.

As a result, there are over 700 medicines in development for these diseases, with a regulatory pathway facilitated by the Orphan Drug Act of 1983.

By providing the precise genetic diagnosis of patients with rare disease, our expertise and technology may provide researchers and biopharma companies with the information needed to develop and commercialize a new treatment for the disease.

By unlocking the value of the products, our knowledge base, network of relationships, and expertise, our team is well positioned to lead what we believe is a nearly a $25 billion global market opportunity in pediatric and rare disease and a nearly $20 billion global market opportunity for adult disease and disorders.

Our primary growth engine in the short term will be expanding adoption of our market-leading exome and genome testing in the pediatric outpatient setting among geneticists, pediatric neurologists, other pediatric specialists, and general pediatricians.

General pediatricians represents the largest opportunity.

Additionally, we plan to continue to expand into the Neonatal Intensive Care Unit (“NICU”), supplement our prenatal exome testing with a genome product for that setting, and translate our leadership to international markets via our recently acquired Fabric Genomics platform.

Longer-term, we remain optimistic about our leading position in genomic newborn screening (“gNBS”) and see the adult market as a future opportunity.

Over time we expect more and more use cases and reimbursement pathways for exome and genome products to open up across a wide spectrum of pediatric and adult diseases, conditions and disorders.

As we plan for longer-term growth, we aim to bring whole genome newborn screening to the market and are engaged in three programs to build the body of evidence needed to make genomic newborn screening mainstream.

Those programs include the GUARDIAN study, the BEACONS study, and the Sunshine Genetics Network.

Additionally, we believe there is a large data partnership opportunity with biopharmaceutical (“biopharma”) companies and precision medicine leaders.

By unlocking the value of our diagnostics products, GeneDx Infinity TM , our network of relationships, and internal expertise, GeneDx is well positioned to lead in what we believe is a nearly $25 billion market opportunity in pediatric and rare disease and a nearly $20 billion market opportunity for adult disease and disorders.

In tandem with these testing markets, we see potential upside as we put a growth strategy behind our data and biopharma partnerships business, expand internationally with Fabric Genomics, and unlock precision medicine opportunities.

We believe that the span and depth of our experience and dataset allows us to return more positive findings and thus clinical utility, both immediately and over time through reanalysis, than other sources.

Importantly, we believe that we return fewer uncertain findings compared to public datasets, which makes our analysis easier to interpret outside of the medical genetics community.

At the same time, we have improved quality and speed to delivery of exome and genome tests and have significantly lowered the associated sequencing costs since initial launch in 2013.

Importantly, we believe that we return fewer uncertain findings compared to public datasets and competitors, which makes our analysis easier to interpret outside of the medical genetics community.

At the same time, we have improved quality and speed to delivery of exome and genome tests while significantly lowering sequencing costs since inception.

Much of this decline was driven by reduced sequencing costs shared across the industry;

however, we have reduced wet labor and processing costs and in the interpretation layer through accumulating data and experience, and we expect further decline in costs going forward.

however, we have reduced wet labor, processing, and interpretation costs through accumulating data and experience, and we expect a further decline in costs going forward.

Leveraging these capabilities, we aim to be the global market leader in the development and delivery of reliable, actionable, scalable exome and genome sequencing and interpretation and information services.

Our strategy focuses on the following objectives:

• Expand the utilization of exome and genome sequencing as the first- or second-tier test over most other genetically targeted tests by leveraging decades of earned trust amongst expert geneticists;

• Expand the utilization of industry-leading exome and genome sequencing beyond the genetic experts into the non-expert setting, potentially creating a new standard of care which enables faster diagnoses, reduces suffering, and helps healthcare systems save money.

In the near term, our principal target markets will be settings with the most vulnerable patients who can benefit the most including, but not limited to, NICU and patients with pediatric developmental disorders (“Pediatric Developmental Disorders”).

• Expand the utilization of exome and genome sequencing as the first-tier test over most other genetically targeted tests by leveraging product enhancements and decades of earned trust amongst expert geneticists;

• Expand the utilization of industry-leading exome and genome sequencing beyond geneticists, creating a new standard of care which enables faster diagnoses, reduces suffering, and helps healthcare systems save money.

In the near term, our principal target markets will be general pediatrics, other pediatric specialists, the NICU, and late-stage prenatal testing.

We expect those markets to expand over time as clinical utility and reimbursement evolve.

To achieve these objectives, we:

• Deploy our team of approximately 70 field-based sales representatives and medical science liaisons, and plan to construct an industry-leading brand, product, marketing, communications and market access platform by leveraging decades of earned trust across the genetics community.

• Deploy our team of approximately 120 field-based sales representatives and medical science liaisons, and construct an industry-leading brand, product, marketing, communications and market access platform that leverages our expertise, rich data, and decades of earned trust across the genetics community.

• Partner with leaders across health systems, manufacturers, commercial and governmental payors and advocacy groups.

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Such programs will focus on:

◦ support for rapid whole genome sequencing in the NICU and Pediatric Developmental Disorder settings;

◦ health economic data supporting rapid whole genome sequencing in the NICU;

◦ diagnosis of disease and prevention of chronic conditions in adults;

◦ use of rapid whole genome sequencing for broad newborn screening.

◦ use of whole genome sequencing for broad newborn screening.

• Plan to open new markets and geographies and unlock the value of our dataset with independently scalable cloud-based interpretation and information service offerings.

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• Plan to launch a new provider and patient experience with the eventual goal of providing lifelong access and portability of genomic information.

At initial sequence, rapid results provide clinicians simple, actionable, easy to understand results for non-geneticists and tailored resources for patients and caregivers.

At initial sequence, rapid results provide clinicians with simple, actionable, easy to understand results for non-geneticists and tailored resources for patients and caregivers.

On an ongoing basis, reanalysis unlocks a renewable source of insight, replacing any future germline screening.

We will sequence once, and analyze for life.

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• Plan to optimize our services to become a solutions provider of choice for biopharma companies.

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◦ Supporting research and development for targeted therapies with analytic reports leveraging clinicogenomics data across multiple therapeutic areas with an initial emphasis in rare disease.

◦ Providing a therapeutic area agnostic platform to access to data, patients and insights for real world evidence and data to support end-to-end drug discovery pipeline.

◦ Providing a therapeutic area agnostic platform to access data, patients and insights for real world evidence and data to support end-to-end drug discovery pipeline.

• Plan to leverage our position at the nexus of rare disease to create a network effect - uniting patients, researchers, biopharma, payers, policymakers, and health systems - and create solutions for some of the greatest challenges in the rare disease space and increase access to precision genetic medicine.

Research and Development

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The goals of these studies are to drive earlier diagnosis and treatment to improve the health of the newborns who participate in such studies, generate evidence to support the expansion of newborn screening through genomic sequencing, and characterize the prevalence and natural history of rare genetic conditions.

Our competitors include companies that offer molecular genetic testing and consulting services, including specialty and reference laboratories that offer traditional single- and multi-gene tests and biopharma companies.

Our competitors include companies that offer molecular genetic testing and consulting services, including specialty and reference laboratories that offer traditional single- and multi-gene tests.

In addition, there are a large number of new entrants into the market for genetic information ranging from informatics and analysis pipeline developers to focused, integrated providers of genetic tools and services for health and wellness, including Illumina, Inc., which is also one of our suppliers.

In addition to the companies that currently offer traditional genetic testing services and research centers, other established and emerging healthcare, information technology and service companies may commercialize competitive products including informatics, analysis, integrated genetic tools and services for health and wellness.

Principal competitors include companies such as Baylor Genetics, Exact Sciences Corp.

(via Prevention), Rady Children’s Hospital and Tempus (via Ambry Genetics) as well as other commercial and academic labs.

Principal competitors include companies such as Baylor Genetics, Tempus (via Ambry Genetics), Variantyx, and Rady Children’s Hospital as well as other commercial and academic labs.

Customers and Seasonality

We receive payment for our products and services from third-party payors, patients, business-to-business clients, and from other healthcare partners.

Substantially all of our revenue for the year ended December 31, 2024 has been primarily derived from diagnostic test reports and we expect this trend to continue in the near-term.

We expect over time to achieve a mix of revenue from diagnostic tests, data and information solutions, newborn screening products and information and interpretation services.

Substantially all of our revenue for the year ended December 31, 2025 was derived from diagnostic test reports and we expect this trend to continue in the near-term.

Over time we expect to achieve a mix of revenue from diagnostic tests, data and information solutions, newborn screening products and information and interpretation services.

Approximately 1.5% of our revenues today are derived from referral sources outside of the United States.

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Raw Materials and Suppliers

We rely on a limited number of suppliers, including Illumina, Inc., Integrated DNA Technologies Incorporated, Agilent Technologies, Roche Holdings Ltd., QIAGEN, Inc.

and Twist Biosciences, for certain laboratory reagents, as well as sequencers and other equipment and materials, which we use in our laboratory operations.

Our operations could be interrupted if we

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encounter delays or difficulties in securing reagents, sequencers or other equipment or materials, and if we cannot obtain an acceptable substitute.

We rely on a limited number of suppliers, including Illumina, Inc., Life Technologies Corporation, Twist Biosciences Corporation, Path-Tec LLC and Agilent Technologies.

for certain laboratory reagents, as well as sequencers and other equipment and materials, which we use in our laboratory operations.

Our operations could be interrupted if we encounter delays or difficulties in securing reagents, sequencers or other equipment or materials, and if we cannot obtain an acceptable substitute.

Any such interruption could significantly affect our business, financial condition, results of operations and reputation.

We believe that there are only a few other manufacturers that are currently capable of supplying and servicing the equipment necessary for our operations, including sequencers and various associated reagents and enzymes.

We believe that there are only a few other manufacturers outside of those listed above that are currently capable of supplying and servicing the equipment necessary for our operations, including sequencers and various associated reagents and enzymes.

The use of equipment or materials provided by these replacement suppliers would require us to alter our operations.

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Our patent protection strategy has focused on seeking protection for certain of our non-gene specific technology and our specific biomarkers.

In this regard, we have three pending U.S.

non-provisional utility patent applications and seven U.S.

provisional patent applications.

The utility patent applications include a U.S.

patent application related to generating a cancer determination from electronic health records using a cancer determination analysis system, a U.S.

patent application related to providing a homologous recombination DNA repair deficiency score for a cancer patient, and a U.S.

patent application related to therapeutic treatment for subjects having certain polymorphic markers associated with specific human leukocyte antigen alleles.

In this regard, we have one issued U.S.

design patent, fourteen pending U.S.

non-provisional utility patent applications, four pending U.S.

provisional patent applications, and three pending international PCT patent applications.

The issued U.S.

design patent relates to a display screen with a graphical user interface.

The utility patent applications include an international PCT patent application and a U.S.

patent application related to performing phenotypic fit analysis, an international PCT patent application and two U.S.

patent applications related to analyzing genetic variations and phenotypes, a U.S.

patent application related to modeling inference of mutation impact, two U.S.

patent applications related to generating a cancer determination from electronic health records using a cancer determination analysis system, a U.S.

patent application related to providing a homologous recombination DNA repair deficiency score for a cancer patient, a U.S.

patent application related to therapeutic treatment for subjects having certain polymorphic markers associated with specific human leukocyte antigen alleles, two U.S.

patent applications relating to analyzing phenotype-causing genomic variants, two U.S.

patent applications relating to prioritizing phenotype-causing genomic variants in combination with biomedical ontologies, two U.S.

patent applications relating to prioritizing phenotype-causing genomic variants in combination with clinical information, and an international PCT patent application relating to analyzing long biological sequence data.

If patents are issued from the currently pending applications, the earliest patents will begin expiring in the early 2030s, subject to potential extensions of the patent term that will be calculated based on the length of the patent examination process.

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Accordingly, we may not be able to meaningfully protect our trade secrets.

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We own or are applying for various trademarks, service marks, trade names, and product service names in the U.S and other commercially important markets.

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Our trademark portfolio is designed to protect the brands for our products and services, both current and in the pipeline.

Human Capital Resources

We aim to recruit, develop, and retain diverse, high-quality talent and are committed to creating a workplace that supports the success of its people by investing in their personal development and career growth.

Human Capital Management

We believe that human capital management, including attracting, retaining, and developing a high-quality workforce, is critical to our long-term success.

We are committed to creating a workplace that supports the success of its people by investing in their personal development and career growth.

Our team of nearly 1,300 individuals are champions of not only our organization, but our patients, providers and partners.

We are committed to developing our workforce.

Our talent development programs provide employees with the resources they need to achieve their career goals, build management skills and lead their teams.

Managers coach and hold conversations with employees’ regarding their career and development plans, thereby staying true to our belief in accountability and openness.

Total Rewards

We offer competitive compensation to attract and retain high quality talent, and we care for our people so they can focus on our mission.

Our employees' total compensation package includes competitive salary, bonuses or sales incentives, equity through our equity incentive plans, 401(K) plan with matching opportunities, and the opportunity to participate in our employee stock purchase plan.

Equity participation is provided for certain positions because ownership in the company drives commitment to our long-term success.

We provide programs including healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, flexible work schedules, fertility, adoption and surrogacy assistance, employee assistance and wellness support, among many others.

Our development, performance, and compensation programs are designed to attract and reward talented individuals from a broad range of backgrounds and experiences who possess the skills necessary to support our business objectives, assist in the achievement of their career goals, our strategic goals, and ultimately create long term value for our stockholders.

We offer competitive compensation to attract and retain high quality talent, supported by a comprehensive total rewards package.

In addition to base compensation, our employees may be eligible for bonuses or sales incentives, and equity awards under our equity incentive plans.

We also provide the opportunity to participate in our employee stock purchase plan and a 401(k) plan with employee matching opportunities.

We offer equity for certain positions because we believe ownership in the company strengthens alignment and commitment to our long-term success.

We provide programs including healthcare and insurance benefits, wellness, health savings and flexible spending accounts, paid time off, family and parental leave, flexible work schedules, fertility, adoption and surrogacy assistance, and employee assistance programs.

We operate in an industry in which competition for highly qualified personnel is significant.

In addition to compensation and benefits, we focus on talent acquisition, retention and development.

We periodically conduct employee engagement surveys and use the results to inform internal priorities and management goals, including actions responsive to employee feedback.

Our employee evaluation is intended to support development, identify and develop high performers, and strengthen leadership and management capabilities as the organization grows.

We believe that our engagement survey results reflect our commitment to fostering a thriving workplace culture, even amidst significant organizational growth.

Government Regulation

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Laboratories in the United States that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment, or the assessment of health are subject to the Clinical Laboratory Improvement Amendments of 1988, as amended, and its implementing regulations (“CLIA”).

CLIA requires such laboratories to be certified by the federal government and mandates compliance with various operational, personnel, facilities administration, inspections, quality control, quality assessment and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely.

CLIA requires such laboratories to be certified by the federal government and mandates compliance with various operational, personnel, facilities administration,

inspections, quality control, quality assessment and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely.

CLIA certification also is a prerequisite to be eligible to bill state and federal health care programs, as well as many commercial third-party payors, for laboratory testing services.

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CLIA does not preempt state laws that have established laboratory quality standards that are at least as stringent as the federal law requirements under CLIA.

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may require that nonresident laboratories, or out-of-state laboratories, maintain a laboratory license to perform tests on samples from patients who reside in that state.

State laws may require that nonresident laboratories, or out-of-state laboratories, maintain a laboratory license to perform tests on samples from patients who reside in that state.

As a condition of state licensure, these state laws may require that laboratory personnel meet certain qualifications, specify certain quality control procedures or facility requirements, or prescribe record maintenance requirements.

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Historically, the FDA has exercised a policy of enforcement discretion with respect to most LDTs, whereby the FDA did not actively enforce its medical device regulatory requirements for such tests.

However, at various points in recent years, FDA has indicated that it intends to end enforcement discretion for many tests offered as LDTs, and to require such tests to comply with certain FDA regulatory requirements.

However, at various points in recent years, the FDA has indicated that it intends to end enforcement discretion for many tests offered as LDTs, and to require such tests to comply with certain FDA regulatory requirements.

Agency officials have previously expressed significant concerns regarding performance disparities between some LDTs and in vitro diagnostics that have been reviewed, cleared, authorized or approved by the FDA.

Most recently, on April 29, 2024, the FDA published a final rule on LDTs, in which FDA outlines its plans to end enforcement discretion for many LDTs in five stages over a four-year period.

In Phase 1 (effective May 6, 2025), clinical laboratories would be required to comply with medical device (adverse event) reporting, correction/removal reporting, and certain quality systems complaint handling requirements.

In Phase 2 (effective May 6, 2026), clinical laboratories would be required to comply with all other device requirements (e.g., registration/listing, labeling, investigational use), except for remaining quality systems requirements and premarket review.

In Phase 3 (effective May 6, 2027), clinical laboratories would be required to comply with all remaining applicable quality systems requirements.

In Phase 4 (effective November 6, 2027), clinical laboratories would be required to comply with premarket submission requirements for high-risk tests (i.e., tests subject to premarket approval (PMA) requirement).

Finally, in Phase 5 (effective May 6, 2028), clinical laboratories would be required comply with premarket submission requirements for moderate- and low-risk tests (i.e., tests subject to de novo or 510(k) requirement).

The final rule potentially extends enforcement discretion for certain tests – e.g., LDTs approved by the New York State Department of Health, and LDTs first marketed prior to May 6, 2024 which are not modified or are modified in certain limited ways – from certain FDA regulatory requirements, provided certain important limitations have been met.

We are actively reviewing the final rule to evaluate its applicability to our operations, and the extent to which we may be required to modify our operations to comply with its requirements.

Multiple lawsuits have been filed challenging the FDA’s authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act.

On April 29, 2024, the FDA published a final rule on LDTs, in which the FDA outlined its plans to end enforcement discretion for many LDTs in five stages over a four-year period.

In response, multiple lawsuits were filed challenging the FDA’s authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

On March 31, 2025, the U.S.

District Court for the Eastern District of Texas struck down the 2024 final rule on the grounds that the FDA exceeded its authority under the FDCA.

The FDA did not appeal the court’s ruling.

As a result, clinical laboratories offering LDTs are not required to comply with any of the phases of the final rule.

Legislative proposals addressing the FDA’s oversight of LDTs have also been introduced in previous Congresses, and we expect that new legislative proposals will be introduced from time-to-time.

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The VALID Act, as most recently proposed, would create a new category of medical products separate from medical devices called “in vitro clinical tests,” or IVCTs.

As most recently proposed, the VALID Act would modify the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and establish a risk-based approach to imposing requirements related to premarket review, quality systems, and labeling requirements on all IVCTs, including LDTs, but a grandfathering provision would create exemptions from certain requirements for certain LDTs (e.g., LDTs first offered for clinical use not later than May

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The likelihood that Congress will pass such legislation and the extent to which such legislation may affect the FDA’s plans to regulate certain LDTs as medical devices is difficult to predict at this time.

If the FDA ultimately regulates certain LDTs as medical devices, whether via final guidance, final regulation, or as instructed by Congress, our tests may be subject to certain additional regulatory requirements.

Complying with the FDA’s requirements for medical devices can be expensive, time-consuming, and subject us to significant or unanticipated delays.

As most recently proposed, the VALID Act would modify the FDCA and establish a risk-based approach to imposing requirements related to premarket review, quality systems, and labeling requirements on all IVCTs, including LDTs, but a grandfathering provision would create exemptions from certain requirements for certain LDTs (e.g., LDTs first offered for clinical use not later than May 6, 2024).

The likelihood that Congress will pass such legislation is difficult to predict at this time.

If the FDA ultimately regulates certain LDTs, our tests may be subject to certain additional regulatory requirements.

Complying with the FDA’s requirements can be expensive, time-consuming, and subject us to significant or unanticipated delays.

Insofar as we may be required to obtain premarket clearance or approval to perform or continue performing an LDT, we cannot be sure that we will be able to obtain such authorization.

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Additionally, certain of our diagnostic products in development may be subject to regulation by the FDA and similar international health authorities.

For these products, we would have an obligation to adhere to the FDA’s current Good Manufacturing Practices and diagnostic product regulations, including providing for an establishment and product listing with the FDA.

For these products, we would have an obligation to comply with applicable premarket review requirements, and adhere to the FDA’s current Good Manufacturing Practices and diagnostic product regulations, including providing for an establishment and product listing with the FDA.

Additionally, we would be subject to periodic FDA inspections, quality control procedures, and other detailed validation procedures.

If the FDA finds deficiencies in the validation of our manufacturing and quality control practices, it may impose restrictions on marketing specific products until corrected.

If the FDA finds deficiencies in the validation of our manufacturing and/or our quality control practices, it may impose restrictions on marketing specific products until corrected.

Regulation by governmental authorities in the United States and other countries may be a significant factor in how we develop, test, produce and market our diagnostic test products.

In October 2025, we received Breakthrough Device Designation from the FDA for the analysis of DNA extracted from human blood specimens from pediatric or adult patients with unexplained constitutional or heritable disorders or syndromes, nonspecific or atypical clinical presentations, or for differential diagnoses including rapid neonatal testing in critical care, or postnatal detection of germline variants associated with causes of life-threatening diseases or genetic disorders in symptomatic patients (the “Breakthrough Device Designation Indications”) using our ExomeDx TM and GenomeDx TM tests.

Breakthrough Device Designation provides certain benefits, including more interactive and timely communications with FDA staff, potential use of post-market data collection to facilitate expedited development and review, opportunities for more efficient and flexible clinical study design, and prioritized review of premarket submissions.

However, there can be no guarantee that these benefits will materialize or significantly impact our development and regulatory authorization process.

We may not experience a faster development process, review, or authorization compared to conventional FDA procedures.

Breakthrough Device Designation does not alter the regulatory standards for marketing authorization or guarantee that we will ultimately obtain FDA authorization for the Breakthrough Device Designation Indications using our ExomeDx TM and GenomeDx TM tests.

Furthermore, the FDA may rescind Breakthrough Device Designation if it believes that the designation is no longer supported by data from our clinical development program.

As with all FDA marketing authorizations, we will need to continue to comply with applicable regulations and standards, which may change over time.

Corporate Practice of Medicine

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These laws are intended to prevent interference in the medical decision-making process by anyone who is not a licensed physician.

For example, California’s Medical Board has indicated that determining what diagnostic tests are appropriate for a particular condition and taking responsibility for the ultimate overall care of the patient, including providing treatment options available to the patient, would constitute the unlicensed practice of medicine if performed by an unlicensed person.

For example, California law establishes that determining what diagnostic tests are appropriate for a particular condition and taking responsibility for the ultimate overall care of the patient, including providing treatment options available to the patient, would constitute the unlicensed practice of medicine if performed by an unlicensed person.

Violation of these corporate practice of medicine prohibitions may result in civil or criminal fines, as well as sanctions imposed against us and/or the professional through licensure proceedings.

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The Stark Law also prohibits us from billing for any such prohibited referral.

These prohibitions apply regardless of any intent by the parties to induce or reward referrals or the

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reasons for the financial relationship and the referral.

These prohibitions apply regardless of any intent by the parties to induce or reward referrals or the reasons for the financial relationship and the referral.

Several Stark Law exceptions are relevant to many common financial relationships involving clinical laboratories and referring physicians and may be relied upon if all of the elements of the applicable exception are satisfied.

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The EKRA applies to all payors including commercial payors and government payors, and EKRA violations result in significant fines and/or up to 10 years in jail, separate and apart from existing AKS liability.

Several EKRA exceptions are relevant to many common financial relationships involving clinical laboratories and may be relied upon if all of the elements of the applicable exception are satisfied.

Several EKRA exceptions are relevant to many common financial

relationships involving clinical laboratories and may be relied upon if all of the elements of the applicable exception are satisfied.

Failure to meet the requirements of an exception, however, does not render an arrangement illegal.

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Several states have enacted comparable false claims laws which may be broader in scope and apply regardless of payor.

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The Social Security Act includes civil monetary penalty provisions that impose penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.

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The privacy regulations also set forth certain rights that an individual has with respect to his or her PHI maintained by a covered entity or business associate, including the right to access or amend certain records containing his, her or their PHI, request restrictions on the use or disclosure of his, her or their PHI, or request an accounting of disclosures of his or her PHI.

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Covered entities and business associates also must comply with the security regulations, which establish requirements for safeguarding the confidentiality, integrity, and availability of PHI that is electronically transmitted or electronically stored.

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HHS announced on December 27, 2024, and published in the Federal Register on January 6, 2025, a Notice of Proposed Rulemaking proposing extensive modifications to the HIPAA security regulations.

If finalized, these modifications and could entail significant additional compliance obligations and costs for HIPAA-regulated covered entities and business associates.

If finalized, these modifications could entail significant additional compliance obligations and costs for HIPAA-regulated covered entities and business associates.

Further, there are a number of state laws regarding the privacy and security of health information and personal data that are applicable to our clinical laboratories.

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However, we are required to comply with the CCPA insofar as we collect other categories of California consumers’ personal information, such as information about California-based employees, contractors, business contacts and website visitors.

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The CCPA is enforceable through administrative fines of up to $2,663 for each violation, or $7,988 for intentional violations or where the violator has actual knowledge that the personal information relates to an individual under 16 years of age.

In addition to the CCPA, by the end of 2024, there were eight other states that had consumer privacy laws come into effect, including Colorado, Connecticut, Florida, Montana, Oregon, Texas, Utah, and Virginia.

Eight more states will have comprehensive consumer data privacy laws that come into effect in 2025, and many other states have introduced or enacted similar consumer privacy laws.

In addition to the CCPA, by the end of 2025, there were sixteen other states that had consumer privacy laws come into effect, including Colorado, Connecticut, Delaware, Florida, Iowa, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Tennessee, Texas, Utah, and Virginia.

Three more states will have comprehensive consumer data privacy laws that come into effect in 2026, and many other states have introduced or enacted similar consumer privacy laws.

These new state privacy laws and any potential federal consumer privacy law will and would impose additional data protection obligations on covered businesses, including additional consumer rights, limitations on data uses, new audit requirements for higher risk data and opt outs for certain uses of sensitive data.

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There are a growing number of jurisdictions around the globe that have privacy and data protection laws that may apply to us as we enter or expand our business in jurisdictions outside of the United States.

These laws are typically triggered by a company’s establishment or physical location in the jurisdiction, data processing activities that take place in the jurisdiction, and/or the processing of personal information about individuals located in that jurisdiction that are targeted, for example, by an offer of goods or services.

Certain data protection laws, such as those in the European Union, (the “EU”) and United Kingdom (the “UK”), are comprehensive in nature and include significant requirements around the processing of personal information, while other jurisdictions may have laws less restrictive or prescriptive than those in the United States.

Enforcement of these laws varies from jurisdiction to jurisdiction, with a variety of consequences, including civil or criminal penalties, litigation private rights of action, or damage to our reputation.

For example, the EU’s General Data Protection Regulation (“GDPR”), including as implemented and amended through the UK Data Protection Act 2018 (“UK GDPR”), applies to any data collection, use and sharing in the context of an establishment in the EU or UK as well as extraterritorially to any entity outside the EU and UK when they process personal information related to an offer of goods or services to, or monitoring the behavior of, individuals who are located in the EU or UK.

goods or services or by monitoring their activities.

Certain data protection laws, such as those in the European Union, (the “EU”) and United Kingdom (the “UK”), are comprehensive in nature and include significant requirements around the processing of personal information, while other jurisdictions may have no privacy and data protection laws or privacy and data protection laws less restrictive or prescriptive than those in the United States.

Enforcement of these laws varies from jurisdiction to jurisdiction, with a variety of consequences, including civil or criminal penalties or the loss of a license to operate in the jurisdiction, individual litigation rights, or damage to our reputation.

The GDPR and UK GDPR impose requirements on controllers and processors of personal data, including when personal information is transferred outside of the EU or the UK to another country and enhanced protections for “special categories” of personal data, which include sensitive information such as health and genetic information of data subjects.

The GDPR and UK GDPR also grant individuals various rights in relation to their personal data including the rights of access, rectification, objection to certain processing and deletion.

The GDPR and UK GDPR provide an individual with an express right to seek legal remedies if the individual believes his or her rights have been violated.

Failure to comply with the requirements of the GDPR or the related national data protection laws of the member states of the EU, which may deviate from or be more restrictive than the GDPR, or a failure to comply with the UK GDPR may result in significant administrative fines issued by EU or UK regulators.

The GDPR and UK GDPR provide individuals with an express right to seek legal remedies if the individual believes his or her rights have been violated.

Failure to comply with the requirements of the GDPR or the related national data protection laws of the member states of the EU, which may deviate from or be more restrictive than the GDPR, or a failure to comply with the UK GDPR may also result in significant administrative fines and restrictions on our business operations issued by EU or UK regulators.

Information Blocking Prohibition

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technology, health information networks/health information exchanges, and health care providers, from engaging in activities that are likely to interfere with the access, exchange, or use of electronic health information (information blocking).

On May 1, 2020, the Office of the National Coordinator for Health Information Technology (“ONC”) promulgated final regulations under the authority of the 21st Century Cures Act to impose new conditions to obtain and maintain certification of certified health information technology and prohibit certain covered actors, including developers of certified health information technology, health information networks/health information exchanges, and health care providers, from engaging in activities that are likely to interfere with the access, exchange, or use of electronic health information (information blocking).

The final regulations further defined exceptions for activities that are permissible, even though they may have the effect of interfering with the access, exchange, or use of electronic health information.

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These cases often involve a failure on the part of a company to adhere to its own privacy and data protection principles set forth in its policies or other statements made to consumers.

To avoid Section 5 violations, the FTC encourages companies to build privacy protections and safeguards into relevant portions of their business, and to consider privacy and data protection as the company grows and evolves.

To avoid Section 5 violations, the FTC encourages companies to build privacy protections

and safeguards into relevant portions of their business, and to consider privacy and data protection as the company grows and evolves.

In addition, privacy notices should clearly and accurately disclose the type(s) of personal information the company collects, how the company uses and shares that information, and the security measures used by the company to protect that information.

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The FTC has not provided bright line rules defining what constitutes “reasonable and necessary measures” for implementing a cybersecurity program, but it has provided guidance, tips and advice for companies.

The FTC has also published past complaints and consent orders, which it urges companies use as guidance to help avoid an FTC enforcement action, even if a data breach or loss occurs.

The FTC has also published past complaints and consent orders, which it urges companies to use as guidance to help avoid an FTC enforcement action, even if a data breach or loss occurs.

In addition to the FTC Act, most U.S.

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Under PAMA (as amended) and its implementing regulations, laboratories that realize at least $12,500 in Medicare Clinical Laboratory Fee Schedule (“CLFS”) revenues during the six month reporting period and that receive the majority of their Medicare revenue from payments made under the CLFS or the Physician Fee Schedule must report, beginning in 2017, and then in 2026 and every three years thereafter (or annually for “advanced diagnostic laboratory tests”), private payor payment rates and volumes for their tests.

None of our tests meet the current definition of advanced diagnostic laboratory tests, and therefore we believe we are required to report private payor rates

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for our tests on an every-three-years basis, starting next in 2026.

None of our tests meet the current definition of advanced diagnostic laboratory tests, and therefore we believe we are required to report private payor rates for our tests on an every-three-years basis, starting next in 2026.

The Centers for Medicare & Medicaid Services (“CMS”) use the rates and volumes reported by laboratories to develop Medicare payment rates for the tests equal to the volume-weighted median of the private payor payment rates for the tests.

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Rates were held at 2020 levels during 2021 through 2025 and will continue to be held at such levels in 2026.

Then, where applicable based upon median private payor rates reported in 2017 or 2026, reduced by up to 15% per test per year in each of 2026 through 2028 (with a second round of private payor rate reporting in 2026 to establish rates for 2027 through 2029).

Then, where applicable based upon median private payor rates reduced by up to 15% per test per year for each of 2027 through 2029.

PAMA codified Medicare coverage rules for laboratory tests by requiring any local coverage determination to be made following the local coverage determination process.

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Available Information

We make our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to these reports, as well as our other SEC filings, available on our website, free of charge, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.

Our website address is www.genedx.com.

Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to these reports, as well as our other SEC filings, are available free of charge on our website, www.genedx.com, as soon as reasonably practicable after such reports are electronically filed with or furnished to the SEC.

The information contained on our website is not incorporated by reference in this document.

We have used, and intend to continue to use, our website, investor relations website (accessible via our website), and social media accounts, including our X, formerly Twitter, feed @GeneDx, our LinkedIn page and our Facebook page, as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD.

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We have used, and intend to continue to use, our website, investor relations website (accessible via our website), and social media accounts, including our LinkedIn page, our Instagram page, and our Facebook page, as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business