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Screener / SEC EDGAR /CIK 0001818331 /10-K filed Feb 23, 2026, compared with Feb 20, 2025 /Numbers from the XBRL of the 10-Ks
Nasdaq Health care · Health Services

GeneDx Holdings Corp. WGS

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New in the 10-K 20 paragraphs with nothing like them in the 10-K filed Feb 20, 2025 New in the 10-Q 14 paragraphs not in the 10-Q filed Aug 3, 2026 10-Q against the 10-K 5 risk factor paragraphs and sentences added or reworded

New risk paragraphs, branching off last year

Each branch is a paragraph in Risk Factors with nothing like it in the 10-K filed Feb 20, 2025. A box jumps to the paragraph as filed, below.

20 new
10-K Feb 20 10-K Feb 23 •A breakthrough device designation by the… expected. Any failure to achieve our… Furthermore, under the Tax Cuts and Jobs Act… On April 29, 2024, the FDA published a final… A breakthrough device designation by the FDA… 15 more new paragraphs

Paragraphs with nothing like them in last year's 10-K

Quoted exactly

20 paragraphs in Risk Factors of the 10-K filed Feb 23, 2026 with nothing like them in the 10-K filed Feb 20, 2025. Quoted exactly. Paragraphs that were only edited are under 10-K change.

•A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.

Read in the 10-K

expected. Any failure to achieve our projected operating results could harm the trading price of our securities and our financial position.

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Furthermore, under the Tax Cuts and Jobs Act, NOLs generated in taxable years beginning after December 31, 2017 may offset only up to 80% of current-year taxable income and generally may not be carried back to prior years. State tax laws may impose similar or additional restrictions, and in certain jurisdictions the use of NOLs may be suspended or otherwise limited. As a result of these limitations, we could incur increased federal and state income tax liabilities in future periods, which could materially and adversely affect our results of operations and cash flows.

Declines in the future expected cash flows for the Company’s businesses or changes to underlying assumptions used to calculate fair value could result in impairment charges which could have a material adverse effect on the Company’s financial results of operations.

Our total assets reflect goodwill and amortizable intangible assets, including developed technology, tradenames and trademarks and customer relationships. The Company is required under U.S. GAAP to review its long-lived assets for impairment when events or changes in circumstances indicate the carrying value may not be recoverable, and is also required to conduct impairment tests on goodwill annually or more frequently, if circumstances indicate that the carrying value may not be recoverable or that an other-than-temporary impairment exists.

Future events or factors may occur that could adversely affect the fair value of the Company’s assets and require impairment charges, including, but not limited to, divestitures of certain businesses or product lines, strategic decisions made in response to changes in economic and competitive conditions, the impact of the economic environment on the Company’s sales and customer base, a material adverse change in the Company’s relationship with significant customers or business partners, or a sustained decline in the Company’s stock price. In the event any such impairment indicators become known or are present, the Company may be required to perform impairment tests based on changes in the economic environment and other factors, and these tests could result in impairment charges in the future.

Read in the 10-K

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.

Read in the 10-K

A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.

In October 2025, we received Breakthrough Device Designation from the FDA for the “Breakthrough Device Designation Indications” using our ExomeDxTM and GenomeDxTM 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 ExomeDxTM and GenomeDxTM 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.

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and foreign requirements for laboratory certification may be costly or difficult to meet and could affect our ability to receive specimens from certain states or foreign countries.

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portfolio will not be negatively impacted by the decisions described above, rulings in other cases or changes in guidance or procedures issued by the USPTO.

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Information technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious internal or external human acts and natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins,

Read in the 10-K

Further, as a result of no longer being an emerging growth company, we will incur significant additional expenses that we did not previously incur in complying with the Sarbanes-Oxley Act and rules implemented by the SEC. The cost of compliance with Section 404 of the Sarbanes-Oxley Act has required, and will continue to require, us to incur substantial expense and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements. We have also previously taken advantage of the reduced disclosure requirements of the Jumpstart Our Business Startups Act applicable to emerging growth companies regarding executive compensation disclosures and exemption from the requirements of holding advisory “say-on-pay” votes on executive compensation. We are no longer eligible for such reduced disclosure requirements and exemptions and, as such, we will be required to hold a “say-on-pay” vote and a “say-on-frequency” vote at our 2026 annual meeting of stockholders. We expect that the increased disclosure requirements will require additional attention from management and will result in increased costs to us, which could include higher legal fees, accounting fees, and fees associated with investor relations activities, among others.

The market price of our securities may be volatile or decline due to market conditions, or failure to meet investor, stockholder or analyst expectations, which could result in a loss of your investment.

Read in the 10-K

Future volatility in the market price for our securities may occur in response to factors beyond our control, including actual or anticipated fluctuations in our quarterly financial results, changes in market expectations regarding our operating performance, public reaction to our press releases and SEC filings, competitive developments, changes in financial estimates or recommendations by securities analysts which may result in the loss of investor confidence, and general economic and political conditions. These risk factors, and any other risk factors described in this Annual Report, could materially adversely affect our business and the market price of our securities, which may trade at prices significantly below the price paid for them and may not

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A material weakness is defined by the Public Company Accounting Oversight Board (the “PCAOB”) as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

As further detailed in Item 9A. Controls and Procedures, we identified a material weakness in internal control related to deficiencies in the design and operating effectiveness of IT general controls related to segregation of duties in the program change management process for a single IT system that supports certain aspects of our revenue processes as of December 31, 2025. As a result, certain automated controls and business process controls related to recording revenue that are dependent on the affected IT system or the information from such IT system were also deemed ineffective. Although we have not identified any errors or misstatements in our consolidated financial statements as a result of this material weakness, these deficiencies created a reasonable possibility that a material misstatement of our annual or interim financial statements would not have been prevented or detected on a timely basis as of December 31, 2025.

We are committed to the remediation of the material weakness described above, as well as the continued improvement of our internal control over financial reporting. Our remediation efforts related to the material weakness are described in Item 9A. Controls and Procedures. While we believe that the measures already designed and implemented will be sufficient, the material weakness, in the aggregate, will not be considered fully remediated until all aspects of the control operate for a sufficient period of time and we have concluded, through testing, that these controls are operating effectively.

Any failure to remediate the material weakness, or the identification of new material weaknesses in our internal control over financial reporting, could result in material misstatements in our financial statements that may continue undetected, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our Class A common stock could be negatively affected. Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation. We are also required to disclose changes made in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting on a quarterly basis. To comply with the requirements of being a public company, we have undertaken, and may need to further undertake in the future, various actions, such as implementing new internal controls and procedures and hiring additional accounting staff.

As a public company, significant resources and management oversight are required. As a result, management’s attention may be diverted from other business concerns, which could harm our business, financial condition and operating results.

Read in the 10-K

Paragraphs in the 10-Q filed Nov 9, 2026 that were not in the one before

New in the latest 10-Q

14 paragraphs in the 10-Q filed Nov 9, 2026 with nothing like them in the 10-Q filed Aug 3, 2026 (at least half the words must differ; new numbers alone do not count). Quoted exactly, grouped by the item heading above them. This is text that changed, not a judgement of how serious it is.

Financial statements and notes

Balance at December 31, 2025 $13,520 Impairment charges (11,879) Balance at September 30, 2026 $1,641

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violation of Sections 10(b) and 20(a) of the Exchange Act, and seeks unspecified compensatory damages, fees and costs. The Company’s motion to dismiss the second amended complaint was denied on June 23, 2025, and the parties subsequently engaged in discovery.

Read in the 10-Q

Restricted Stock Units Weighted-Average Grant Date-Fair Value Per Unit Outstanding at December 31, 2025 1,519,733 $42.91 Granted(1) 729,146 $76.95 Vested (579,592) $38.74 Forfeited (199,062) $73.78 Outstanding at September 30, 2026 1,470,225 $57.38

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Non-operating expense of $1.9 million for the three months ended September 30, 2026 reflected net interest expense of $1.8 million, related to borrowing under the Blackstone Loan Agreement entered into during the first quarter of 2026 and subsequently amended and restated during the third quarter of 2026, resulting in aggregate borrowings of $150.0 million.

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each non-GAAP financial measure to the most directly comparable financial measure stated in accordance with GAAP. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business.

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Show the other 9

Controls and procedures

Management believes it has effectively designed and tested the operating effectiveness related to the previously-reported material weakness noted above. Accordingly, management has concluded that the material weakness has been remediated because each component of the material weakness has been operating effectively for a sufficient period of time.

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Risk Factors

We face uncertainty related to healthcare reform, pricing, coverage and reimbursement, which could reduce our revenue.

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Healthcare reform laws, including the Patient Protection and Affordable Care Act (“ACA”) and PAMA, are significantly affecting the U.S. healthcare and medical services industry. Existing legislation, and possible future legal and regulatory changes, including potential repeal or modification of the ACA, elimination of penalties regarding the individual mandate for coverage, or approval of health plans that allow lower levels of coverage for preventive services, could materially change the structure and finances of the health insurance system and the methodology for reimbursing medical services, drugs and devices, including our current and future products and services. 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. Any change in reimbursement policy could result in a change in patient cost-sharing, which could adversely affect a provider’s willingness to prescribe and patient’s willingness and ability to use our tests and any other product or service we may develop. Healthcare reforms, which may intend to reduce healthcare costs, may have the effect of discouraging third-party payors from covering certain kinds of medical products and services, particularly newly developed technologies, or other products or tests we may develop in the future. We cannot predict whether future healthcare reform initiatives will be implemented at the federal or state level or the effect any such future legislation or regulation will have on it. The taxes imposed by new legislation, cost reduction measures and the expansion in the government’s role in the U.S. healthcare industry may result in decreased profits to us, which may adversely affect our business, financial condition and results of operations.

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PAMA presents significant uncertainty for future CMS reimbursement rates for our tests. 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. Under PAMA, unless delayed by an act of Congress, CMS reimbursement rates for clinical diagnostic laboratory tests are updated every three years, or annually for clinical laboratory tests that are considered “advanced diagnostic laboratory tests”. The CMS reimbursement rates for clinical diagnostic laboratory tests are updated based on the volume-weighted median of private payor rates for each clinical diagnostic laboratory test based on data submitted by certain applicable laboratories. Further, laboratories that fail to report or erroneously report required payment information may be subject to substantial civil money penalties. There can be no assurance under PAMA that adequate CMS reimbursement rates will continue to be assigned to our tests.

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Absent Congressional action, the next round of PAMA-based rate updates will take effect on January 1, 2027. In September 2026, CMS published preliminary weighted medians, indicating that a substantial majority of test codes would be subject to reductions starting in January 2027, with the 15% statutory cap on annual payment rate reductions expected to apply to many of these codes. CMS is expected to publish final weighted medians and CY 2027 rates in November 2026. Depending on the scope of these reductions, it will likely impact the amount of revenue we are able to collect under these codes beginning in 2027. Because the reductions are cumulative and may continue through 2029 until CMS fully implements the weighted medians, the aggregate effect on our financial results over the phase-in period could increase over time.

Read in the 10-Q

Congress could modify or repeal PAMA in the future or CMS could modify regulations under PAMA, and any such action could have the effect of reducing the CMS reimbursement rate for our tests. Legislation has been introduced in Congress, including the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, which would modify PAMA’s rate-setting methodology and delay or reduce the scheduled cuts. We cannot predict whether Congress will enact the RESULTS Act, another temporary deferral, or any other PAMA reform before January 1, 2027 or at any time thereafter, or what the terms of any such legislation would be. Further, it is possible that Medicare or other federal payors that provide reimbursement for our tests may suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement rates payable to us. Any such action could also have a negative impact on our revenues.

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Other information

Our patent protection strategy has focused on seeking protection for certain of our non-gene specific technology and our specific biomarkers. In this regard, as of September 30, 2026, we have one issued U.S. utility patent, one issued U.S. design patent, two granted European patents, one granted Canadian patent, sixteen pending U.S. non-provisional utility patent applications, three pending U.S. provisional patent applications, and four pending international PCT patent applications. The issued U.S. utility patent relates to therapeutic treatment for subjects having certain polymorphic markers associated with specific human leukocyte antigen alleles. The issued U.S. design patent relates to a display screen with a graphical user interface. One granted European patent relates to a variant annotation, analysis and selection tool and has been validated in France, Germany, Ireland, Switzerland and the United Kingdom. The other granted European patent relates to genome analysis and has been validated in France, Germany, Italy, the Netherlands, Spain and the United Kingdom. The granted Canadian patent also relates to genome analysis.

Read in the 10-Q

international PCT patent application related to ultra-long context genomic language modeling. Two of the pending U.S. provisional patent applications relate to variant analysis, and one relates to multilayer genomic processing.

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Our issued patents will begin expiring in 2029. 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. The claim scope of any potentially issued patents stemming from the present applications may be narrower than included in the initial filings due to any amendments that may arise throughout their prosecution.

Read in the 10-Q

The 10-Q's risk factors against the 10-K

Item 1A of the 10-Q filed Nov 9, 2026 against Item 1A of the 10-K filed Feb 23, 2026. A 10-Q repeats only the risks that changed, so a 10-K paragraph that is missing from it is not counted as removed. Added is a paragraph with nothing like it in the 10-K, Reworded a sentence that is in both with several words changed, Quiet changes a sentence in both where one to four words changed and one is a hedge or a modal (cut words struck through, new words highlighted). Text on the page, not a score; each links to the filing at sec.gov.

What the 10-Q itself says about its risk factors:Except as set forth below, there have been no material changes in our risk factors from those disclosed in Part I, Item 1A “Risk Factors” of our 2025 Form 10-K and in Part II, Item 1A “Risk Factors” of each of our Quarterly Reports for the quarterly periods ended March 31, 2026, filed with the SEC on May 4, 2026, and June 30, 2026, filed with the SEC on August 3, 2026, which sections are incorporated by reference herein.

Read in the 10-Q
All 5 Added 5Reworded 0Quiet changes 0
Added10-Q Nov 9, 2026 vs 10-K Feb 23, 2026
Absent Congressional action, the next round of PAMA-based rate updates will take effect on January 1, 2027. In September 2026, CMS published preliminary weighted medians, indicating that a substantial majority of test codes would be subject to reductions starting in January 2027, with the 15% statutory cap on annual payment rate reductions expected to apply to many of these codes. CMS is expected to publish final weighted medians and CY 2027 rates in November 2026. Depending on the scope of these reductions, it will likely impact the amount of revenue we are able to collect under these codes beginning in 2027. Because the reductions are cumulative and may continue through 2029 until CMS fully implements the weighted medians, the aggregate effect on our financial results over the phase-in period could increase over time.

Read it in the 10-Q at sec.gov

Added10-Q Nov 9, 2026 vs 10-K Feb 23, 2026
On August 3, 2026, concurrently with the execution of the Amended Loan Agreement, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain affiliates of Blackstone (collectively, the “Investors”), pursuant to which the Investors agreed to purchase 81,967 shares of our Class A common stock at a purchase price of $61.00 per share, for aggregate gross proceeds of approximately $5.0 million, in a private placement transaction. The closing of the private placement occurred on August 7, 2026 substantially concurrently with the funding of the incremental term loan facility under the Amended Loan Agreement.

Read it in the 10-Q at sec.gov

Added10-Q Nov 9, 2026 vs 10-K Feb 23, 2026
The securities issued pursuant to the Purchase Agreement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and were offered and sold in reliance upon Section 4(a)(2) of the Securities Act.

Read it in the 10-Q at sec.gov

Phrases used for the first time

Two-word phrases in Risk Factors of the 10-K filed Feb 23, 2026 that are in none of the 1 earlier 10-Ks stored, back to Feb 20, 2025

breakthrough device ×8device designation ×8faster development ×3regulatory authorization ×3fabric genomics ×3impairment charges ×3disclosure requirements ×3sustain sufficient ×2maintain profitability ×2fda oversight ×2fda even ×2even though ×2though granted ×2regulatory review ×2designation increase ×2product candidates ×2
Where each one is used
  • breakthrough device: •A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.
  • device designation: •A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.
  • faster development: •A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.
  • regulatory authorization: •A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.
  • fabric genomics: We currently incorporate artificial intelligence (“AI”) solutions into our workflows and these applications may become increasingly important in our operations over time. Further, we are in the process of enhancing and broadening our offerings with AI technologies, including through the use of Fabric Genomics’...
  • impairment charges: Declines in the future expected cash flows for the Company’s businesses or changes to underlying assumptions used to calculate fair value could result in impairment charges which could have a material adverse effect on the Company’s financial results of operations.
  • disclosure requirements: Further, as a result of no longer being an emerging growth company, we will incur significant additional expenses that we did not previously incur in complying with the Sarbanes-Oxley Act and rules implemented by the SEC. The cost of compliance with Section 404 of the Sarbanes-Oxley Act has required, and will...
  • sustain sufficient: •We need to scale our infrastructure in advance of demand for our products and services, and our failure to sustain sufficient demand for our products and services would have a negative impact on our business and our ability to maintain profitability.

The 10-K at sec.gov

Used at least twice, small words left out. Counted, not picked: a phrase can be new because the company renamed something.

What was taken out

30 paragraphs of last year's Risk Factors with nothing like them now. The longest are quoted.

Across all companies
We currently qualify as an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act, as modified by the Jumpstart Our Business Startups Act (the “JOBS Act”). As such, we take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies for as long as we continue to be an emerging growth company, including: (i) the exemption from the auditor attestation requirements with respect to internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act; (ii) the exemptions...
In the 10-K filed Feb 20, 2025
In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the exemption from complying with new or revised accounting standards provided in Section 7(a)(2)(B) of the Securities Act as long as we are an emerging growth company. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth...
In the 10-K filed Feb 20, 2025
Our Class A common stock and public warrants are listed on the Nasdaq Global Select Market under the symbols “WGS” and “WGSWW,” respectively. However, we cannot ensure that we will be able to satisfy the continued listing standards of Nasdaq, including the minimum closing bid price requirement, going forward. If we cannot satisfy the continued listing standards going forward, The Nasdaq Stock Market may commence delisting procedures against us, which could result in our Class A common stock or public warrants being removed from listing on Nasdaq. If either of our Class A common stock or...
In the 10-K filed Feb 20, 2025
Testing and maintaining these controls can divert our management’s attention from other matters that are important to the operation of our business. If we identify material weaknesses in the internal control over financial reporting of the company or are unable to comply with the requirements of Section 404 or assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal controls over financial reporting when we no longer qualify as an emerging growth...
In the 10-K filed Feb 20, 2025

Sources

Item 1A of each 10-K and 10-Q on EDGAR, quoted exactly. Each paragraph links to the filing at sec.gov.

Also

10-K change: what was reworded or cut, section by section.

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