Natera
29 named things its latest annual report says its results depend on, each in the company's own words. 17 of them are also named by other companies we've read.
Suppliers
Illumina, Inc.
depends onnamed as a riskFor example, our molecular diagnostics tests are currently only validated to perform on Illumina’s sequencing platform; in addition, Illumina is currently the sole supplier of our sequencers and related reagents for Panorama, Horizon, Signatera and Prospera, along with certain hardware and software, pursuant to a supply agreement that expires in August 2033.Risk factors (Item 1A)
Streck
depends onnamed as a riskStreck is the sole supplier of the blood collection tubes included in Panorama and our other cell-free DNA tests under a supply arrangement with Streck under which we are required to exclusively use Streck tubes for Panorama.Risk factors (Item 1A)
Also named by CDNA
Partners and platforms
Amazon Web Services (AWS)
depends onnamed as a riskAWS HealthOmics is our backup for DNANexus, with both services relying on AWS.Risk factors (Item 1A)
Also named by AAON, ABNB, ADSK, AIOT, BLK, CARR, CG, COF and 56 more
DNAnexus, Inc.
depends onnamed as a riskWe host the majority of these algorithms on a cloud‑based software platform pursuant to an agreement with DNAnexus, Inc., or DNAnexus, and both we and our Constellation licensees access our algorithms through the DNAnexus platform.Risk factors (Item 1A)
BGI Genomics
earns fromnamed as a riskFor example, we have entered into an agreement with BGI Genomics pursuant to which, among others, BGI Genomics commercializes our MRD test in China on its sequencing platform.Risk factors (Item 1A)
Other companies
Ravgen, Inc.
$57 millionnamed as a riskFor example, in January 2024, a jury verdict of $57 million was awarded against us in a patent infringement lawsuit filed by Ravgen, Inc.Risk factors (Item 1A)
Also named by LH
UBS
depends on · $80.3 millionnamed as a riskAs of December 31, 2025, we have $80.3 million of outstanding balance, including accrued interest, under our credit line with UBS.Risk factors (Item 1A)
Foresight Diagnostics
In December 2025, we acquired Foresight Diagnostics, a cancer diagnostics company whose ctDNA-based MRD tests leverage patented technology that targets phased variants.Business (Item 1)
Competitors
Guardant Health, Inc.
competes with · over $292 millionnamed as a riskFor example, in 2024, a jury verdict of $57 million was awarded against us in a patent infringement lawsuit filed by Ravgen, Inc., and a jury verdict of over $292 million was awarded against us in litigation with Guardant Health, Inc.Risk factors (Item 1A)
Also named by TEM
Verinata Health Inc.
competes withnamed as a riskBecause of Illumina’s ownership of Verinata, we face increased risk and uncertainty regarding continuity of a successful working relationship with Illumina under our supply agreement, as well as in our ability to compete with Verinata in the marketplace in view of economic advantages enjoyed by Verinata with respect to the cost of sequencers and related consumables.Risk factors (Item 1A)
CareDx, Inc.
competes withIn organ health, our primary competitor is CareDx, Inc.Business (Item 1)
Places
Austin, Texas
operates innamed as a riskOur laboratory facilities in Austin and San Carlos process Panorama, Horizon, and Signatera tests, which together represent the significant majority of our revenues.Risk factors (Item 1A)
San Carlos, California
operates innamed as a riskAn inability to perform our tests or the backlog of tests that could develop if either our San Carlos or Austin laboratory is inoperable for even a short period of time may result in the loss of customers and an adverse effect on our revenues or harm our reputation.Risk factors (Item 1A)
Hazards
Earthquake
concentrated innamed as a riskOur San Carlos laboratory is situated near active earthquake fault lines, and our laboratories are located in areas that have in recent years experienced, and are likely to experience in the future, severe weather events.Risk factors (Item 1A)
Also named by A, ADBE, AEE, ARE, ARES, BLK, CDNA, CRC and 11 more
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskIf FDA develops an alternate approach to regulating LDTs, or if Congress enacts legislation giving FDA authority to regulate our current or future LDTs, or any components or materials we use in, or software that we or our customers use as part of, our tests, we may be forced to stop selling our tests or we may be required to modify claims for or make other changes to our tests while we or our suppliers work to comply with FDA requirements including, potentially, premarket authorization.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 riskThus, CMS could issue an adverse coverage determination as to Panorama which could influence other third-party payers, including state Medicaid programs, and could have an adverse effect on our revenues.Risk factors (Item 1A)
Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more
New York State Department of Health (NYSDOH)
subject tonamed as a riskIn addition, the New York State Department of Health, or NYSDOH, requires out-of-state laboratories that test specimens originating from New York to hold an NYSDOH permit and to comply with NYSDOH laboratory standards, including prior NYSDOH approval of LDTs.Risk factors (Item 1A)
California Department of Public Health (CDPH)
subject tonamed as a riskIf we are found to be out of compliance with either California or New York requirements, CDPH or NYSDOH may suspend, restrict or revoke our license or laboratory permit, respectively (and, with respect to California, may exclude persons or entities from owning, operating or directing a laboratory for two years following such license revocation), assess civil monetary penalties, or impose specific corrective action plans, among other sanctions.Risk factors (Item 1A)
Laws and programs
Medicare
earns fromnamed as a riskMedicare reimbursement impacts our revenues from our oncology and organ health products, as a large proportion of these patients are covered by Medicare.Risk factors (Item 1A)
Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more
General Data Protection Regulation (GDPR)
subject tonamed as a riskThe GDPR specifies higher potential liabilities for certain data protection violations, and we anticipate that it will result in a greater compliance burden for us as we conduct our business, particularly through our Constellation cloud-based distribution model, in the European Union.Business (Item 1)
Also named by A, AB, ABNB, ADBE, ADP, AGX, AIOT, AJG and 100 more
Medicaid
earns fromnamed as a riskEach state’s Medicaid program has its own coverage determinations related to our testing, and many state Medicaid programs do not provide coverage for our testing.Risk factors (Item 1A)
Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more
Clinical Laboratory Improvement Amendments (CLIA)
subject tonamed as a riskCLIA certification is also required in order for us to be eligible to bill federal health care programs, as well as many commercial third-party payers, for our tests.Risk factors (Item 1A)
EU In Vitro Diagnostic Regulation (IVDR)
subject tonamed as a riskAmong others, the revised regulations introduced risk-based classification for IVDs and require notified body involvement for various classes of devices, including reproductive health tests such as Panorama, which are classified as a Class C product.Risk factors (Item 1A)
Protecting Access to Medicare Act of 2014 (PAMA)
subject tonamed as a riskDue to our increased billing for our Signatera and Prospera testing, and in particular the significant and growing percentage of our revenues attributable to Signatera, any decrease in the reimbursement we receive under the CLFS due to PAMA may negatively impact our revenue when the PAMA rates are implemented.Risk factors (Item 1A)
VALID Act
subject tonamed as a riskIn June 2025 Congress re-introduced the Verifying Accurate, Leading-edge IVCT Development Act, or VALID Act, to establish a new risk-based regulatory framework for in vitro clinical tests, or IVCTs, including IVDs, LDTs, collection devices and instruments used with such tests.Risk factors (Item 1A)
Also named by WGS
Microdeletions CPT code
earns fromnamed as a riskIn addition, although there is a CPT code in place for microdeletions testing, we have experienced low average reimbursement rates for microdeletions under this CPT code, and we expect our microdeletions reimbursement to remain low, at least in the near term, due to third-party payers declining to reimburse and as a result of reduced reimbursement, under the code, which has had, and we expect to continue to have, an adverse effect on our revenues.Risk factors (Item 1A)
Molecular Diagnostic Services Program (MolDx)
earns fromnamed as a riskIn addition, while we have received positive coverage determinations for certain specified uses and indications of our Signatera test from commercial third-party payers as well as the Molecular Diagnostic Services Program, or MolDx, which identifies and establishes Medicare coverage and reimbursement for molecular diagnostic tests, as well as for our Prospera Kidney and Lung tests, we cannot guarantee that our tests will be reimbursed at the rates we expect, or at the same or similar rates as we have received thus far.Risk factors (Item 1A)
Illumina/Sequenom NIPT patent pool
named as a riskThis additional fee has dissuaded and could continue to dissuade potential or current licensees from licensing from us or launching a test based on our technology.Risk factors (Item 1A)
Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
subject tonamed as a riskWe cannot assure you that our relationships with physicians, hospitals, customers, or sales personnel will not be subject to scrutiny or will survive a challenge under EKRA.Business (Item 1)