GeneDx Holdings (WGS): what its 10-K says it depends on

Suppliers

Illumina, Inc.

depends onnamed as a risk

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.Business (Item 1)

Also named by GH, NTRA, TEM

Agilent Technologies

depends onnamed as a risk

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.Business (Item 1)

Also named by KEYS

Life Technologies Corporation

depends onnamed as a risk

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.Business (Item 1)

Twist Bioscience Corporation

depends onnamed as a risk

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.Business (Item 1)

Path-Tec LLC

depends onnamed as a risk

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.Business (Item 1)

Partners and platforms

Cloud storage providers

depends onnamed as a risk

Nearly all of our data storage and analytics are conducted on, and the data and content we generate on our platforms are processed through, servers hosted by these providers.Risk factors (Item 1A)

Commercial delivery services

depends onnamed as a risk

We rely on commercial delivery services to transport samples to our facilities in a timely and cost-efficient manner and if these delivery services are disrupted, our business could be harmed.Risk factors (Item 1A)

Other companies

Perceptive Credit Holdings IV, LP

depends on · not less than $5.0 millionnamed as a risk

Our credit agreement with Perceptive Credit Holdings IV, LP (“Perceptive”) contains operating and financial restrictions that may limit our business and financing activities.Risk factors (Item 1A)

Competitors

Illumina, Inc.

competes withnamed as a risk

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.Business (Item 1)

Also named by GH, NTRA, TEM

Baylor Genetics

competes withnamed as a risk

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.Business (Item 1)

Tempus (Ambry Genetics)

competes withnamed as a risk

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.Business (Item 1)

Variantyx

competes withnamed as a risk

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.Business (Item 1)

Rady Children's Hospital

competes withnamed as a risk

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.Business (Item 1)

Places

International markets (outside the United States)

earns from · Approximately 1.5% of our revenues

Approximately 1.5% of our revenues today are derived from referral sources outside of the United States.Business (Item 1)

Also named by ABNB, ADSK, BSX, CROX, CRWD, DOCU, DXCM, EFX and 18 more

Gaithersburg, Maryland

concentrated innamed as a risk

We perform all of our exome sequencing and whole genome sequencing tests at our production facilities in Gaithersburg, Maryland.Risk factors (Item 1A)

Hazards

Earthquakes

operates innamed as a risk

Some of our data centers are located in areas with a high risk of major earthquakes or other natural disasters.Risk factors (Item 1A)

Also named by AAPL, AMKR, AN, ANET, APP, BRO, CDNS, CEG and 37 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

If the FDA were to actively regulate our LDTs, we could experience reduced revenue or increased costs, which could adversely affect our business, prospects, results of operations and financial condition.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Centers for Medicare & Medicaid Services (CMS)

subject tonamed as a risk

Because Medicare currently covers a significant number of patients, any reduction in the CMS reimbursement rate for our tests would negatively affect our revenues and our business prospects.Risk factors (Item 1A)

Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more

College of American Pathologists (CAP)

subject tonamed as a risk

Failure to maintain CAP accreditation could have a material adverse effect on the sales of our tests and the results of our operations.Risk factors (Item 1A)

Also named by DGX, GH, TEM

New York State Department of Health

subject tonamed as a risk

In addition to having a laboratory license in New York, our clinical reference laboratory is approved on test-specific bases for the tests it runs as LDTs, by the New York State Department of Health (“NYDOH”).Risk factors (Item 1A)

Also named by GH, NTRA, TEM

Laws and programs

Medicare

earns from · a small percentage of our revenuesnamed as a risk

Currently, a small percentage of our revenues are generated by payments from Medicare.Risk factors (Item 1A)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

Protecting Access to Medicare Act of 2014 (PAMA)

subject to · reduced by up to 15% per test per year for each of 2027 through 2029named as a risk

PAMA presents significant uncertainty for future CMS reimbursement rates for our tests.Risk factors (Item 1A)

Also named by CDNA, DGX, DHR, GH, NTRA

EU General Data Protection Regulation (GDPR)

subject tonamed as a risk

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.Business (Item 1)

Also named by ACN, ADSK, AIG, ALK, AMG, ANET, APG, AXON and 61 more

HIPAA

subject tonamed as a risk

In addition, the Company has experienced a number of “security incidents” (as defined under HIPAA) that involved the unauthorized disclosure of PHI.Risk factors (Item 1A)

Also named by AFL, BAX, BBSI, CI, DHR, DOC, DOCN, DOCU and 19 more

Patient Protection and Affordable Care Act (ACA)

subject tonamed as a risk

The ACA has also been the subject of various legal challenges, and if the plaintiffs in any case challenging the ACA are ultimately successful, insurance coverage for our tests could be materially and adversely affected.Risk factors (Item 1A)

Also named by BAX, CI, DHR, MCK, UNH

Clinical Laboratory Improvement Amendments of 1988 (CLIA)

subject tonamed as a risk

Our laboratory located in Gaithersburg, Maryland is CLIA certified to perform high complexity tests.Business (Item 1)

Also named by CDNA, HIMS

Eliminating Kickbacks in Recovery Act (EKRA)

subject tonamed as a risk

We cannot assure you that our relationships with healthcare providers, hospitals, customers, our own sales representatives, or any other party will not be subject to scrutiny or will survive regulatory challenge under EKRA or other anti-kickback laws.Risk factors (Item 1A)

Also named by LH, TEM

VALID Act

subject tonamed as a risk

Furthermore, legislative proposals, if enacted, such as the VALID Act, could create new or different regulatory and compliance burdens on us and could have a negative effect on our ability to keep products on the market or develop new products, which could have a material effect on our business.Risk factors (Item 1A)

Also named by NTRA

FDA Breakthrough Device Designation

subject tonamed as a risk

In October 2025, we received Breakthrough Device Designation from the FDA for the “Breakthrough Device Designation Indications” using our ExomeDxTM and GenomeDxTM tests.Risk factors (Item 1A)

GUARDIAN study

Two such studies currently underway include the SeqFirst study—in collaboration with Seattle Children’s Hospital and University of Washington—which is designed to demonstrate the broad utility of rapid whole genome sequencing for critically ill newborns and, the Genomic Uniform-Screening Against Rare Diseases In All Newborns (“GUARDIAN”) study—in collaboration with New York-Presbyterian, Columbia University, New York State Department of Health and Illumina, Inc.—which is designed to assess whole genome sequencing to screen newborns for more conditions than those currently included in standard newborn screening in the United States.Business (Item 1)

Technology

Sequencing platforms

depends onnamed as a risk

In particular, while we are seeking to validate our tests on additional sequencing platforms, we have not, to date, validated a viable alternative sequencing platform on which our testing could be run in a commercially viable manner.Risk factors (Item 1A)

Fabric Genomics

depends onnamed as a risk

In addition, we plan to use Fabric Genomics as our platform for international expansion.Risk factors (Item 1A)