GeneDx Holdings Corp.

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.

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

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.

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.

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.

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.