CareDx (CDNA): what its 10-K says it depends on

Customers

Medicare

earns from · 46% of testing services revenuenamed as a risk

For the year ended December 31, 2025, revenue from Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung represented 46% of testing services revenue.Risk factors (Item 1A)

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

Blue Cross Blue Shield

earns from · nearly 90% of all covered lives

Coverage policies approving AlloMap Heart have approached nearly 90% of all covered lives and are published by many of the largest private payers, including Blue Cross Blue Shield, or BCBS payers as well as national payers and by more than half of the state Medicaid agencies in the U.S.Business (Item 1)

Medicare Advantage

earns fromnamed as a risk

For example, we are currently involved in a dispute with a significant Medicare Advantage payer concerning payment of claims.Risk factors (Item 1A)

Also named by BWIN, CHE, CNC, CVS, DGX, DOC, DVA, ELV and 3 more

Suppliers

Thermo Fisher Scientific

depends onnamed as a risk

We do not have guaranteed supply agreements with Thermo Fisher, Becton, Dickinson and Company or Avantor, which exposes us to the risk that these suppliers may choose to discontinue doing business with us at any time.Risk factors (Item 1A)

Also named by IQV, IR, SOLV

Becton, Dickinson and Company

depends onnamed as a risk

We do not have guaranteed supply agreements with Thermo Fisher, Becton, Dickinson and Company or Avantor, which exposes us to the risk that these suppliers may choose to discontinue doing business with us at any time.Risk factors (Item 1A)

Also named by EW, WAT

Streck

depends onnamed as a risk

These sole source suppliers include Thermo Fisher, which supplies us with instruments, laboratory reagents and consumables; Roche Molecular Systems, which supplies us with laboratory reagents and consumables; Illumina, Inc., or Illumina, which supplies us with instruments, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which supplies us with cell preparation tubes; Beckman Coulter, which provides laboratory reagents and consumables; and Qiagen N.V., which supplies us with a proprietary buffer reagent and reagent kits.Risk factors (Item 1A)

Also named by NTRA

Shipping carriers

depends onnamed as a risk

We rely heavily on providers of transport services for reliable and secure point-to-point transport of recipient samples to our laboratory and enhanced tracking of these recipient samples.Risk factors (Item 1A)

Also named by EBAY

Epic Systems Corporation

depends onnamed as a risk

We are highly dependent on information technology, or IT, networks and systems for significant elements of our operations, including our laboratory information management system and certain software provided by Epic Systems Corporation.Risk factors (Item 1A)

Also named by ORCL

Roche Molecular Systems

depends onnamed as a risk

In 2023, we received FDA approval for an updated AlloMap that uses a real-time PCR platform from Roche and we are able to switch to that analytical platform and reduce reliance on the ABI 7900.Risk factors (Item 1A)

Illumina

depends onnamed as a risk

These sole source suppliers include Thermo Fisher Scientific, Inc., or Thermo Fisher, which supplies us with instruments, laboratory reagents and consumables; Roche Molecular Systems, which supplies us with laboratory reagents and consumables; Hamilton Robotics, which supplies equipment and consumables; Illumina, which supplies us with instruments, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which supply us with cell preparation tubes; Beckman Coulter, which provides laboratory equipment, reagents and consumables; and Qiagen N.V., which supplies us with a proprietary buffer reagent.Business (Item 1)

Avantor

depends onnamed as a risk

We do not have guaranteed supply agreements with Thermo Fisher, Becton, Dickinson and Company or Avantor, which exposes us to the risk that these suppliers may choose to discontinue doing business with us at any time.Risk factors (Item 1A)

Qiagen N.V.

depends onnamed as a risk

We believe that there are relatively few suppliers other than Thermo Fisher, Roche, Illumina, Becton, Dickinson and Company and Qiagen N.V. that are currently capable of supplying the instruments, reagents and other supplies necessary for our current products and services.Risk factors (Item 1A)

Beckman Coulter

depends onnamed as a risk

These sole source suppliers include Thermo Fisher, which supplies us with instruments, laboratory reagents and consumables; Roche Molecular Systems, which supplies us with laboratory reagents and consumables; Illumina, Inc., or Illumina, which supplies us with instruments, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which supplies us with cell preparation tubes; Beckman Coulter, which provides laboratory reagents and consumables; and Qiagen N.V., which supplies us with a proprietary buffer reagent and reagent kits.Risk factors (Item 1A)

Hamilton Robotics

depends onnamed as a risk

These sole source suppliers include Thermo Fisher Scientific, Inc., or Thermo Fisher, which supplies us with instruments, laboratory reagents and consumables; Roche Molecular Systems, which supplies us with laboratory reagents and consumables; Hamilton Robotics, which supplies equipment and consumables; Illumina, which supplies us with instruments, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which supply us with cell preparation tubes; Beckman Coulter, which provides laboratory equipment, reagents and consumables; and Qiagen N.V., which supplies us with a proprietary buffer reagent.Business (Item 1)

Partners and platforms

Illumina License and Commercialization Agreement

depends on · royalties in the mid-single to low-double digitsnamed as a risk

The failure to meet any such milestones could result in the loss of exclusivity for the affected licensed products.Risk factors (Item 1A)

Cornell University

depends on

In April 2020, we entered into a license agreement with Cornell University pursuant to which we were granted exclusive rights to four U.S. patents covering methods and technology for the measurement of gene expression in urine to diagnose kidney transplant rejection.Business (Item 1)

Other companies

IF Metall

named as a risk

Our production group in Sweden is represented by an IF Metall collective bargaining agreement.Risk factors (Item 1A)

Competitors

Natera

competes withnamed as a risk

This ruling may limit our ability to prevent Natera and other competitors and third parties from developing and marketing products similar to ours and we may not be able to prevent Natera and others from developing or selling products that are covered by our products or technologies without payment to us.Risk factors (Item 1A)

Eurofins Transplant Genomics

competes withnamed as a risk

In the field of post-transplant surveillance, Natera, Eurofins, iMDx, and Verici have commercially available molecular diagnostics tests.Risk factors (Item 1A)

Thermo Fisher Scientific (One Lambda)

competes with

The market leader in HLA typing and third-party distributors is Thermo Fisher through its One Lambda business.Business (Item 1)

Also named by IQV, IR, SOLV

Epic Systems Corporation

competes with

Our primary competitor for our patient management EMR solution is Phoenix, Epic's transplant application.Business (Item 1)

Also named by ORCL

Places

Brisbane, California

concentrated in · approximately 200,000 commercial testsnamed as a risk

We perform all of our testing services for the United States in our laboratory located in Brisbane, California.Risk factors (Item 1A)

Russia

operates innamed as a risk

risks related to our operations in Russia and Iran, including restrictions on our access to banking services, changes in the United States, EU or other sanctions laws that limit financial transactions or increase or compliance burden and potential legal exposure and counterparty risk;Risk factors (Item 1A)

Also named by ALSN, ATR, AVY, AXP, BKR, BSX, C, CEG and 50 more

Stockholm, Sweden

operates innamed as a risk

Our manufacturing facility in Stockholm, Sweden is used to support the production, packaging and labeling of our proprietary test kits: Olerup SSP, QTYPE, AlloSeq Tx, AlloSeq cfDNA and HCT.Business (Item 1)

Also named by NDAQ

Hazards

Earthquake

operates innamed as a risk

Brisbane, California is situated on or near earthquake fault lines.Risk factors (Item 1A)

Also named by A, ADBE, AEE, ARE, ARES, BLK, CRC, DOCU and 11 more

Commodities and inputs

Euro

exposed to its price · $1.9 millionnamed as a risk

An unfavorable 10% change in foreign currency exchange rates for our assets and liabilities denominated in foreign currencies at December 31, 2025, would have negatively impacted our consolidated balance sheets for the year ended December 31, 2025 by $0.2 million and would have negatively impacted our product and patient and digital solutions revenue by $1.9 million for the year ended December 31, 2025.Market risk (Item 7A)

Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more

Regulators

Centers for Medicare and Medicaid Services (CMS)

subject to · $88 decreasenamed as a risk

The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test, and no change to the current pricing for AlloSure Heart and AlloSure Lung tests.Business (Item 1)

Also named by ABBV, CHE, DGX, DOC, ENSG, GD, GEHC, GHC and 6 more

Unified Program Integrity Contractors (UPIC)

subject to · $38,975.02named as a risk

In the third quarter of 2023, the UPIC provided us with notice that we had received Medicare payments in error, resulting in an overpayment of $38,975.02.Risk factors (Item 1A)

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

For AlloSure Kidney and other similar testing solutions, if required by the FDA or if new laws are enacted we may be required to conduct additional analytical studies and clinical trials to demonstrate clinical validity and safety and effectiveness of our tests, and submit to the FDA a premarket approval application, or PMA, or 510(k) premarket notification application.Risk factors (Item 1A)

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

U.S. Department of Justice

subject tonamed as a risk

Although we remain committed to compliance with all applicable laws and regulations, we cannot predict the outcome of the DOJ investigation or any other requests or investigations that may arise in the future regarding these or other subject matters.Risk factors (Item 1A)

Also named by AAPL, ACN, AMAT, ASO, BEN, BSX, CAH, CDW and 21 more

Noridian Healthcare Solutions

subject tonamed as a risk

We cannot predict whether Noridian or any future MAC will continue to provide reimbursement for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, or AlloSure Lung at the same payment amount or with the same breadth of coverage in the future, if at all.Risk factors (Item 1A)

Also named by GH

Laws and programs

Medicare sequestration

subject to · 2% cutnamed as a risk

On April 1, 2013, cuts to the federal budget resulting from sequestration were implemented, requiring a 2% cut in Medicare payment for all services, including AlloSure Kidney and AlloMap Heart, and is expected to remain in effect through at least 2032.Risk factors (Item 1A)

Also named by CNC, ENSG, OHI, RMD

Medicare Clinical Laboratory Fee Schedule

exposed to its price · approximately $2,753named as a risk

AlloSure, PLA Code 0540U, was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753.Business (Item 1)

Protecting Access to Medicare Act of 2014 (PAMA)

subject tonamed as a risk

The volume-weighted median of the rates reported for each test would set the Medicare Clinical Laboratory Fee Schedule rate for certain of our tests in calendar years 2027 to 2029.Risk factors (Item 1A)

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

Clinical Laboratory Improvement Amendments of 1988 (CLIA)

subject tonamed as a risk

If we were to lose our CLIA accreditation or California license, whether as a result of a revocation, suspension or limitation, we would no longer be able to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, or AlloSure Lung which would limit our revenues and materially harm our business.Risk factors (Item 1A)

Also named by HIMS, WGS

MolDX Local Coverage Determination for Solid Organ Allograft Rejection

subject tonamed as a risk

The Proposed LCD introduced new coverage criteria, utilization limitations, and a new bundled payment concept for certain CareDx testing in a “surveillance” setting, which could lead to fewer surveillance tests being reimbursed.Business (Item 1)

EU In Vitro Diagnostic Regulation (IVDR)

subject to

These CE-labeled products are also falling under the requirements of the In Vitro Diagnostic Regulation (2017/746) (IVDR).Business (Item 1)

Also named by A, BDX, COO, GH, LH, NTRA