CareDx
37 named things its latest annual report says its results depend on, each in the company's own words. 21 of them are also named by other companies we've read.
Customers
Medicare
earns from · 46% of testing services revenuenamed as a riskFor 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 livesCoverage 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)
Suppliers
Thermo Fisher Scientific
depends onnamed as a riskWe 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)
Becton, Dickinson and Company
depends onnamed as a riskWe 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)
Streck
depends onnamed as a riskThese 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 riskWe 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 riskWe 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 riskIn 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 riskThese 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 riskWe 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 riskWe 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 riskThese 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 riskThese 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 riskThe 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 onIn 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 riskOur production group in Sweden is represented by an IF Metall collective bargaining agreement.Risk factors (Item 1A)
Competitors
Natera
competes withnamed as a riskThis 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 riskIn 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 withThe market leader in HLA typing and third-party distributors is Thermo Fisher through its One Lambda business.Business (Item 1)
Epic Systems Corporation
competes withOur 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 riskWe 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 riskrisks 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 riskOur 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
Commodities and inputs
Euro
exposed to its price · $1.9 millionnamed as a riskAn 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 riskThe 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 riskIn 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 riskFor 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 riskAlthough 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 riskWe 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 riskOn 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)
Medicare Clinical Laboratory Fee Schedule
exposed to its price · approximately $2,753named as a riskAlloSure, 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 riskThe 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)
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
subject tonamed as a riskIf 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)
MolDX Local Coverage Determination for Solid Organ Allograft Rejection
subject tonamed as a riskThe 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)