What changed in this filing

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Item 1A. Risk Factors

2026-02-19 compared with 2025-02-20 · 95 added, 71 removed, 1207 unchanged (12% of the section changed)

9 unchanged sentences

As of December 31, 2025, we had an accumulated deficit of $3.0 billion.

To date, we have financed our operations principally from the sale of stock or convertible securities, and revenue from precision oncology testing, and development services and other.

To date, we have financed our operations principally from the sale of stock or convertible securities, and generation of our revenue.

We have devoted substantially all of our resources to the development and commercialization of our current products and to research and development activities related to our future products, including clinical and regulatory initiatives to obtain marketing approval and sales and marketing activities.

We will need to generate substantial revenue to achieve and then sustain profitability, and even if we achieve profitability, we cannot be sure that we will remain profitable for any period of time.

Our failure to achieve or maintain profitability could negatively impact the value of our common stock.

Our failure to achieve or maintain profitability could negatively impact the trading price of our common stock.

We may not be able to generate sufficient revenue to achieve and maintain profitability and our current or future products may not achieve or maintain sufficient commercial market acceptance.

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• the timing and cost of, and level of investment in, research, development, regulatory approval or certification and commercialization activities relating to our products, which may change from time to time;

• the volume and customer mix of our precision oncology testing;

• the volume and customer mix of our products;

• the start and completion of projects in which our development services and other are utilized;

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However, if we are unable to generate additional or compatible data and insights, then we may not be able to advance our products under development as quickly, or at all, or without significant additional investment.

In addition, we recently migrated some of our existing products to our Smart Liquid Biopsy platform.

In addition, we recently migrated some of our existing products to our Smart Platform.

While we believe that this platform improves the tests and adds value, the tests may not perform as well as expected on the platform and the market might not accept the value proposition that we believe the platform provides.

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If our products do not meet the expectations of patients and our customers, our operating results, reputation and business could suffer.

Our success depends on the market’s confidence that we can provide reliable, high-quality precision oncology products that will improve clinical outcomes, lower healthcare costs and enable better biopharmaceutical development.

We believe that patients, clinicians and biopharmaceutical companies are likely to be particularly

sensitive to product defects and errors in the use of our products, including if our products fail to detect genomic alterations with high accuracy from samples or if we fail to list or inaccurately include certain treatment options and available clinical studies in our test reports, and there can be no guarantee that our products will meet their expectations.

Our success depends on the market’s confidence that we can provide reliable, high-quality products that will improve clinical outcomes, lower healthcare costs and enable better biopharmaceutical development.

We believe that patients, clinicians and biopharmaceutical companies are likely to be particularly sensitive to product defects

and errors in the use of our products, including if our products fail to detect genomic alterations with high accuracy from samples or if we fail to list or inaccurately include certain treatment options and available clinical studies in our test reports, and there can be no guarantee that our products will meet their expectations.

Furthermore, if our competitors’ products do not perform to expectations, it may result in lower confidence in our tests as well.

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As our volume of test sales grows, we will need to continue to increase our workflow capacity for sample intake, customer service, billing and general process improvements, expand our internal quality assurance program and extend our platform to support comprehensive genomic analysis at a larger scale within expected turnaround times.

We will need additional certified laboratory scientists and other scientific and technical personnel to process higher volumes of our precision oncology products.

We will need additional certified laboratory scientists and other scientific and technical personnel to process higher volumes of our products.

Portions of our process are not automated and will require additional personnel to scale.

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Some of our biopharmaceutical customers have contracted with us to provide testing for large numbers of samples, which could strain our testing capacity and restrict our ability to perform tests for other customers.

Furthermore, biopharmaceutical companies may decline to do business with us or decrease or discontinue their use of our tests

due to their broad strategic collaboration with any of our competitors.

In addition to reducing our revenue, the loss of one or more of these relationships may reduce our exposure to research and clinical studies that facilitate the collection and incorporation of new information into our platform and tests.

Furthermore, biopharmaceutical companies may decline to do business with us or decrease or discontinue their use of our tests due to their broad strategic collaboration with any of our competitors.

In addition to reducing our revenue, the loss of one or more of these relationships may reduce our exposure to research and clinical studies that facilitate the

collection and incorporation of new information into our platform and tests.

We engage in conversations with biopharmaceutical companies regarding potential commercial opportunities on an ongoing basis.

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If commercial payers were to decide not to include us as a participating provider, cease paying us altogether, drastically reduce the amount they were willing to pay us or attempt to recover any amounts they had already paid, it could cause significant fluctuations in our quarterly results and could harm our business and results of operations.

In September 2018, we began to receive reimbursement from Medicare for claims submitted with respect to our precision oncology tests.

Precision oncology revenue from clinical tests for patients covered and administered by Medicare represented approximately 39%, 43% and 45% of our precision oncology revenue from clinical customers for the years ended December 31, 2024, 2023 and 2022, respectively.

In September 2018, we began to receive reimbursement from Medicare for claims submitted with respect to our tests.

Revenue attributable to Medicare accounted for more than 10% of our total revenue in each of the years ended December 31, 2025, 2024 and 2023.

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This may change over the next few years as a result of new competitors entering through investment and acquisition activity.

For example, recent merger and acquisition activity includes both completed and potential transactions with new and larger participants, some with greater resources than our legacy competitors.

Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc.

Caris Life Science;

Caris Life Sciences, Inc.;

Tempus AI, Inc.;

NeoGenomics Laboratories, Inc.;

Exact Sciences Corp.;

Myriad Genetics, Inc.;

NeoGenomics, Inc.;

Exact Sciences Corporation;

BillionToOne, Inc.;

Quest Diagnostics, Inc.;

and Laboratory Corporation of America.

In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corp., Myriad Genetics, Inc., Caris Life Science, Foundation Medicine, Inc.

In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corporation, Myriad Genetics, Inc., Caris Life Sciences, Inc., Foundation Medicine, Inc., BillionToOne, Inc., Personalis, Inc.

and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection.

Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corp., Freenome Holdings, Inc., and Delfi Diagnostics.

Competitors within the broader genomics profiling space based on tissue include laboratory companies such as Bio-Reference Laboratories, Inc., Laboratory Corporation of America and Quest Diagnostics, Inc., and most if not all of the competitors within the liquid biopsy space for therapy selection, that sell molecular diagnostic tests for cancer to physicians and have or may develop tests that compete with our tests.

Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corporation, Freenome Holdings, Inc., and Delfi Diagnostics.

physicians and have or may develop tests that compete with our tests.

In addition, we are aware that certain of our customers are also developing their own tests and may decide to enter our market or otherwise stop using our tests.

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We rely on a limited number of suppliers or, in some cases, sole suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or promptly transition to alternative suppliers.

We rely on a limited number of suppliers or, in some cases, sole suppliers, including Illumina Inc., or Illumina, for certain sequencers, reagents, blood tubes and other equipment, instruments and materials that we use in our laboratory operations.

An interruption in our laboratory operations could occur if we encounter delays or difficulties in securing these laboratory equipment, instruments or materials, and if we cannot then obtain an acceptable substitute.

We rely on a limited number of suppliers or, in some cases, sole suppliers, including Illumina Inc., or Illumina, for certain sequencers, reagents, blood tubes and other equipment, software, instruments and materials that we use in our laboratory operations.

An interruption in our laboratory operations could occur if we encounter delays or difficulties in securing these laboratory equipment, instruments or materials, and if we cannot then obtain an

acceptable substitute.

Any such interruption could significantly and adversely affect our business, financial condition, results of operations and reputation.

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Any disruption in operations of Illumina or other sole or limited suppliers or termination or suspension of our relationships with them could materially and adversely impact our supply chain and laboratory operations and thus our ability to conduct our business and generate revenue.

These limited or sole suppliers could engage in diverse types of businesses, including selling products or providing services in competition with us, and there can be no assurance that we can continue to receive required equipment, instruments or materials from them.

We believe that there are only a limited number of other manufacturers that are capable of supplying and servicing the equipment and materials necessary for our laboratory operations, including sequencers and various associated reagents, and potentially replacing our current suppliers.

The use of equipment or materials furnished by these replacement suppliers would require us to alter our laboratory operations.

We believe that there are only a limited number of other manufacturers that are capable of supplying and servicing the equipment, software, and materials necessary for our laboratory operations, including sequencers and various associated reagents, and potentially replacing our current suppliers.

The use of equipment , software, or materials furnished by these replacement suppliers would require us to alter our laboratory operations.

Transitioning to a new supplier would be time-consuming and expensive, may result in interruptions in our laboratory operations, could affect the performance specifications of our laboratory operations or could require that we revalidate our tests.

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We currently derive the majority of our revenue from tests performed at a single laboratory facility located in Redwood City, California.

Our facility and equipment could be harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications failure or terrorism, which may render it difficult or impossible for our laboratory operations.

Our facility and equipment could be harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications failure or terrorism, which may render operations difficult or impossible for our laboratory facility.

The inability to perform our tests or to reduce the backlog that could develop if our facility is inoperable, for even a short period of time, may result in the loss of customers or harm to our reputation, and we may be unable to regain those customers or repair our reputation.

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Similarly, our contracts with physician owned phlebotomy providers to collect blood could be scrutinized under federal and state healthcare laws such as the federal Anti-Kickback Statute, or AKS, and the federal law prohibiting physician self-referral, or Stark Law, to the extent these services to us are deemed to provide a financial benefit to or relieve a financial burden for a potential referral source, or are subsequently found not to be for fair market value.

If our operations are found to be in violation of any of these laws and regulations, we may be subject to administrative, civil and criminal penalties, damages, fines, individual imprisonment, exclusion from participation in federal healthcare programs or from coverage of commercial payers, refunding of payments received by us, and curtailment or cessation of our operations, any of which could harm our reputation and adversely affect our business, financial condition and results of operations.

operations are found to be in violation of any of these laws and regulations, we may be subject to administrative, civil and criminal penalties, damages, fines, individual imprisonment, exclusion from participation in federal healthcare programs or from coverage of commercial payers, refunding of payments received by us, and curtailment or cessation of our operations, any of which could harm our reputation and adversely affect our business, financial condition and results of operations.

We rely on commercial courier delivery services to transport samples to our laboratory facility in a timely and cost-efficient manner and if these delivery services are disrupted, our business will be harmed.

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• financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations, currency controls and cash repatriation restrictions;

• natural disasters, political and economic instability, including wars, terrorism, and political unrest, boycotts, curtailment of trade and other business restrictions;

• natural disasters, political and economic instability, including wars, terrorism, and political unrest, boycotts, tariffs, curtailment of trade and other business restrictions;

• public health or similar issues, such as epidemics or pandemics, that could cause business disruption for our offices in Japan and Singapore, and make it more difficult to sell our tests in the affected countries or regions, and

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Our clinical laboratory tests are in vitro diagnostic products that are considered by the FDA to be medical devices.

Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, design, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion and sales and distribution of medical devices in the United States to ensure that medical devices distributed domestically are safe and effective for their intended uses.

Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, design, testing, manufacturing, safety, labeling, storage,

recordkeeping, premarket clearance or approval, marketing and promotion and sales and distribution of medical devices in the United States to ensure that medical devices distributed domestically are safe and effective for their intended uses.

In addition, the FDA regulates the import and export of medical devices.

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Certain of our tests are currently marketed as LDTs, and future changes in FDA enforcement discretion for LDTs could subject our operations to much more significant regulatory requirements.

We market some of our tests, Guardant360, Guardant360 Response, Guardant360 Tissue Next, Guardant Reveal and Shield, as LDTs.

We market some of our tests, Guardant360 Liquid, Guardant360 Tissue, Guardant Reveal and Shield, as LDTs.

LDTs are in vitro diagnostic tests that are intended for clinical use and are designed, manufactured, and used within a single laboratory.

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In order to sell our products in member states of the EU, our products must comply with the essential requirements of the new In Vitro Diagnostic Regulation (IVDR) 2017/746 issued and implemented by the European Union (EU) in May 2022.

These regulations introduced risk-based classification for IVDs and require notified body involvement for various high complexity devices including next generation sequencing tests such as Guardant360, Guardant360 Response, Guardant360 Tissue Next, and Guardant Reveal.

Compliance with these requirements is a prerequisite to be able to affix the European Conformity, or CE, mark to our products, without which they cannot be sold or marketed in the EU.

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If we are unable to obtain clearance or approval or certification for any tests for which we plan to seek clearance or approval or certification, our business may be harmed.

Changes to FDA Regulation of Companion Diagnostics Could Adversely Affect Our Business and Competitive Position

The FDA has proposed reclassifying certain companion diagnostic tests from Class III devices requiring PMA to Class II devices subject to special controls and the 510(k) process.

Although the proposal is not final and its scope and implementation remain uncertain, any change to the regulatory framework for companion diagnostics could materially affect our business.

We have historically pursued the PMA pathway for our companion diagnostic tests, including liquid biopsy–based, next-generation sequencing assays developed in collaboration with biopharmaceutical partners.

If companion diagnostics are down-classified, regulatory barriers to entry may be reduced, potentially increasing competition from new and existing diagnostic developers and leading to pricing pressure, reduced market share, or the need for increased investment to maintain differentiation.

In addition, changes in regulatory classification may require us to reassess our development strategies, evidentiary standards, quality systems, and lifecycle management plans.

Uncertainty regarding the applicable regulatory pathway could complicate co-development timelines with pharmaceutical partners and affect contractual arrangements, launch sequencing, or the timing of associated revenues.

Because the proposal is subject to further review and potential modification, we cannot predict its final form or impact.

Any significant changes to the regulation of companion diagnostics could have a material adverse effect on our business, financial condition, and results of operations.

Modifications to our FDA-cleared or approved products may require new 510(k) clearances or premarket approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.

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Becoming a participating provider can result in higher reimbursement amounts for covered uses of our test and, potentially, no reimbursement for non-covered uses identified under the payer’s policies or the contract.

Although we are a participating provider with some commercial payers, certain other large, national commercial payers, including Anthem, Aetna and Humana, have issued non-coverage policies that consider tissue and liquid CGP testing which are not FDA approved, including our Guardant360 and TissueNext test, as experimental or investigational.

If we are not successful in obtaining coverage from such payers, or if other payers issue similar non-coverage policies, our business and results of operations could be materially and adversely affected.

Medicare’s National Coverage Determination, or NCD, for Next Generation Sequencing, or NGS, first established in 2018 and subsequently updated in 2020 states that NGS tests, such as our Guardant360 test, are covered by Medicare nationally, when:

Medicare’s National Coverage Determination, or NCD, for Next Generation Sequencing, or NGS, states that NGS tests, such as our Guardant360 test, are covered by Medicare nationally, when:

(1) performed in a CLIA-certified laboratory, (2) ordered by a treating physician, (3) the patient meets certain clinical and treatment criteria, including having recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer, (4) the test is approved or cleared by the FDA as a companion in vitro diagnostic for an FDA approved or cleared indication for use in that patient’s cancer, and (5) results are provided to the treating physician for management of the patient using a report template to specify treatment options.

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Noridian finalized this LCD in November 2022.

In March 2022, Palmetto GBA established coverage for our Guardant360 TissueNext test under an existing LCD.

The coverage, which is also applicable to Noridian, covers our Guardant360 TissueNext test for Medicare fee-for-service patients with advanced solid tumor cancers.

In March 2022, Palmetto GBA established coverage for our Guardant360 Tissue test under an existing LCD.

The coverage, which is also applicable to Noridian, covers our Guardant360 Tissue test for Medicare fee-for-service patients with advanced solid tumor cancers.

In July 2022, Palmetto GBA established coverage under an existing LCD for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy.

This coverage, which also applies to Noridian, has an effective date of December 2021.

In April 2023, Palmetto GBA established coverage for Guardant360 Response under an existing LCD for tracking patient response to immunotherapy after an initial Guardant therapy selection test.

This coverage also applies to Noridian.

Under Medicare, payment for laboratory tests like ours is generally made under the Clinical Laboratory Fee Schedule, or CLFS, with payment amounts assigned to specific procedure billing codes.

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Separately, in response to the global COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.

Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays.

Other regulatory authorities may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic.

If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays.

If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

In the EU, notified bodies must be officially designated to certify products and services in accordance with the IVDR.

Only a few notified bodies have been designated to date.

Without IVDR designation, notified bodies may not yet start certifying devices in accordance with the new regulation.

As only a few notified bodies has been IVDR-designated they are facing a heavy workload and their review times have lengthened.

As only a few notified bodies have been IVDR-designated to date, they are facing a heavy workload and their review times have lengthened.

This situation could impact the way we are conducting or intend to conduct our business in the EU and the EEA.

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In April 2022, a CPT PLA code was issued for Guardant360 with an effective date in July 2022.

In July 2022, a CPT PLA code was issued for Guardant360 TissueNext with an effective date in October 2022.

In October 2023, a CPT PLA code was issued for Guardant360 Response with an effective date in January 2024.

Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 LDT test to the same rate as our Guardant360 CDx test.

In July 2022, a CPT PLA code was issued for Guardant360 Tissue with an effective date in October 2022.

Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 Liquid test to the same rate as our Guardant360 CDx test.

Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received for a test differs from the revenue recorded for the test.

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States are also constantly amending existing laws, and creating new data privacy and security laws, requiring attention to frequently changing regulatory requirements.

For example, the California Consumer Privacy Act, or CCPA went into effect on January 1, 2020, and creates certain data privacy rights for California residents.

For example, the California Consumer Privacy Act, or CCPA, creates certain data privacy rights for California residents.

The CCPA increases the privacy and security obligations of entities handling certain personal information, and provides for civil penalties for violations, as well as a private right of action for data breaches that has increased the likelihood of, and risks associated with data breach litigation.

Further, the California Privacy Rights Act, or CPRA, generally went into effect in January 2023, and imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.

Further, the California Privacy Rights Act, or CPRA, imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.

It has also created a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement.

Additional compliance investment and potential business process changes may be required.

Similar laws have passed in Virginia, Colorado, Connecticut, and Utah and have been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States.

Similar laws have passed or been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States.

These laws and regulations are not necessarily preempted by HIPAA, particularly if a state affords greater protection to individuals than HIPAA.

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For example, EEA member states have specific requirements relating to cross-border transfers of personal data to certain jurisdictions, including to the United States where our laboratory resides.

In addition, some countries have stricter consumer notice and/or consent requirements relating to personal data collection, use or sharing, more stringent

requirements relating to organizations’ privacy programs and provide stronger individual rights.

In addition, some countries have stricter consumer notice and/or consent requirements relating to personal data collection, use or sharing, more stringent requirements relating to organizations’ privacy programs and provide stronger individual rights.

Moreover, international privacy and data security regulations may become more complex and have greater consequences.

For instance, the General Data Protection Regulation, or GDPR, went into effect in May 2018 and imposes stringent data protection requirements for the processing of personal data of persons within the EEA.

instance, the General Data Protection Regulation, or GDPR, imposes stringent data protection requirements for the processing of personal data of persons within the EEA.

The GDPR applies to any company established in the EEA as well as to those outside the EEA if they collect and use personal data in connection with the offering of goods or services to individuals in the EEA or the monitoring of their behavior.

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For example, in July 2020, the Court of Justice of the EU, or the CJEU, limited how organizations could lawfully transfer personal data from the EEA to the United States by invalidating the Privacy Shield for purposes of international transfers and imposing further restrictions on use of the standard contractual clauses, or SCCs.

In March 2022, the United States and EU announced a new regulatory regime intended to replace the invalidated regulations;

In October 2022, President Biden signed an executive order to implement the EU-U.S.

Data Privacy Framework, which serves as a replacement to the Privacy Shield.

The European Commission adopted the adequacy decision on July 10, 2023.

While the United States and EU have since adopted the EU-U.S.

Data Privacy Framework, which serves as a replacement to the Privacy Shield, it is uncertain whether this framework will be overturned in court like the previous two EU-U.S.

bilateral cross-border transfer frameworks.

As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.

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New laws, amendments to or reinterpretations of existing laws, regulations, standards and other obligations may require us to incur additional costs and restrict our business operations.

obligations may be interpreted and applied in a manner that is inconsistent with our data processing practices and policies or the features of our products.

If so, in addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded to require changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business, financial condition and results of operations.

Because the interpretation and application of laws, regulations, standards and other obligations relating to data privacy and security are still uncertain, it is possible that these laws, regulations, standards and other obligations may be interpreted and applied in a manner that is inconsistent with our data processing practices and policies or the features of our products.

changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business, financial condition and results of operations.

We may be unable to make such changes and modifications in a commercially reasonable manner, or at all.

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We may not develop additional proprietary products, services, methods and technologies that are patentable.

Assuming that other requirements for patentability are met, prior to March 16, 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent.

On or after March 16, 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in September 16, 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.

A third party that files a patent application in the USPTO on or after March 16, 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party.

This will require us to be cognizant of the time from invention to filing of a patent application.

Assuming that other requirements for patentability are met, in the United States, the first inventor to file a patent application is entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.

A third party that files a patent application in the USPTO before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party.

This requires us to be cognizant of the time from invention to filing of a patent application.

Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our product candidates or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications.

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The market price of our common stock has been volatile and may fluctuate substantially in the future due to many factors, including:

• volume and customer mix for our precision oncology testing;

• volume and customer mix for our products;

• the introduction of new products or product enhancements by us or others in our industry;

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Our indebtedness could expose us to risks that could adversely affect our business, financial condition and results of operations.

In 2020, we sold $1,150,000,000 aggregate principal amount of 0% convertible senior notes due 2027, or the 2027 Notes.

In February 2025, we issued $600 million aggregate principal amount of 1.25% convertible senior notes due 2031, or the 2031 Notes (together with the 2027 Notes, the Notes) in exchange for the retirement of approximately $659.3 million aggregate principal amount of the 2027 Notes, or the Note Exchange.

We may also incur additional indebtedness to meet future needs.

In 2020, we sold $1.15 billion aggregate principal amount of 0% convertible senior notes due 2027, or the 2027 Notes.

In February 2025, we issued $600 million aggregate principal amount of 1.25% convertible senior notes due 2031, or the 2031 Notes in exchange for the retirement of approximately $659.3 million aggregate principal amount of the 2027 Notes, or the Note Exchange.

In November 2025, we sold $402.5 million aggregate principal amount of 0% convertible senior notes due 2033, or the 2033 Notes (together with the 2027 Notes and 2031 Notes, the Notes).

We may incur additional indebtedness to meet future needs.

Our indebtedness could have significant negative consequences for our security holders, business, results of operations and financial condition by, among other things:

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In the event the conditional conversion feature of the Notes is triggered, the conversion of some or all of the Notes will dilute the ownership interests of our existing stockholders to the extent we deliver shares of our common stock upon such conversion.

The 2027 Notes and the 2031 Notes may become in the future convertible at the option of the holders thereof prior to August 15, 2027 and November 15, 2030, respectively, under certain circumstances as provided in the respective indentures.

The 2027 Notes, the 2031 Notes and the 2033 Notes may become in the future convertible at the option of the holders thereof prior to August 15, 2027, November 15, 2030 and February 15, 2033, respectively, under certain circumstances as provided in the respective indentures.

Any sales in the public market of shares of our common stock issuable upon such conversion could adversely affect the price of our common stock.

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The convertible note hedge may affect the value of the 2027 Notes and our common stock.

In connection with the sale of the 2027 Notes, we entered into convertible note hedge, the 2027 Note Hedge, transactions with certain financial institutions, or option counterparties, certain of which are expected to be cancelled in connection with the Note Exchange.

The 2027 Note Hedge transactions are expected generally to reduce the potential dilution upon any conversion of the 2027 Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted 2027 Notes.

In connection with the sale of the 2027 Notes, we entered into convertible note hedge, or the 2027 Note Hedge, transactions with certain financial institutions, or option counterparties, certain of which were cancelled in connection with the Note Exchange.

The remaining 2027 Note Hedge transactions are expected generally to reduce the potential dilution upon any conversion of the 2027 Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted 2027 Notes.

The option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock in secondary market transactions prior to the maturity of the 2027 Notes (and are likely to do so during any observation period related to a conversion of the Notes, or following any repurchase of the 2027 Notes by us on any fundamental change repurchase date (as provided in the indenture governing the 2027 Notes) or otherwise).

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We are subject to counterparty risk with respect to the 2027 Note Hedge transactions.

The option counterparties are financial institutions, and we will be subject to the risk that any or all of them may default under the 2027 Note Hedge transactions.

The option counterparties are financial institutions, and we are subject to the risk that any or all of them may default under the 2027 Note Hedge transactions.

Our exposure to the credit risk of the option counterparties will not be secured by any collateral.

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The failure to obtain any required future financing may require us to reduce or curtail existing operations and could contribute to negative market perceptions about us or our securities.

As a result of adverse geopolitical and macroeconomic developments, including economic inflation and the responses by central banking authorities to control such inflation, the global credit and financial markets have experienced extreme volatility and disruptions and there has been increasing uncertainty about economic stability.

As a result of adverse geopolitical and macroeconomic developments, including tariffs and other trade actions and economic inflation and the responses by central banking authorities to control such inflation, the global credit and financial markets have experienced extreme volatility and disruptions and there has been increasing uncertainty about economic stability.

If the equity and credit markets remain depressed or further deteriorate as a result of this global uncertainty, it may make any necessary debt or equity financing more difficult, more costly and more dilutive.

116 unchanged sentences

however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.

Our increasing usage of artificial intelligence technologies may expose us to operational, regulatory, legal, and reputational risks.

We currently utilize, and expect to increasingly rely on, artificial intelligence (AI) in our operations and certain of our products, and we may continue to adopt and integrate AI, including generative AI and broadly available foundation models from third parties, into our operations and products in the future.

As adoption of AI technologies expands, our business may become dependent on the availability, performance, and integrity of these technologies, and integration challenges or failures could disrupt our operations.

There is also a risk that we may not have access to the technology and resources to adequately incorporate ongoing advancements into our AI initiatives.

If we are unable to match or surpass AI advances that our competitors implement, our competitive position could be impacted.

AI technologies may generate inaccurate, incomplete, biased, or otherwise misleading outputs.

If we rely on flawed or deficient AI‑generated outputs, we could experience operational errors, diminished product performance, damage to our reputation and brand, and potential regulatory penalties or legal exposure.

Our reliance on third parties presents additional risks.

Our partners and vendors are increasingly incorporating AI into their offerings, which may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.

We have limited control over our partners’ and vendors’ data practices, security measures, and review processes, and unfavorable changes in accuracy or functionality could harm our operations.

We also use AI technologies licensed from third parties, and our ability to continue to use such technologies at scale may be dependent on access to specific third-party software and infrastructure.

We cannot control the availability or pricing of such third-party AI technologies, and we may be unable to negotiate favorable economic terms with the applicable providers.

If any such third-party AI technologies become incompatible with our operations or unavailable for use, our business may be adversely affected.

Additionally, the use of sensitive or proprietary data in AI workflows, by either us or third parties, may increase risks relating to privacy, cybersecurity, confidentiality, and intellectual property, including inadvertent disclosures or use of data for model training in ways that conflict with our legal obligations or customer expectations.

The legal and regulatory landscape for AI is rapidly evolving and may impose new requirements related to transparency, validation, documentation, governance, and data usage.

Complying with these obligations could increase costs, slow product development and deployment, and create additional liability if we or our vendors fail to meet them.

AI also presents emerging ethical and social issues and if our use of AI becomes controversial, we may experience competitive or reputational harm.

If we are unable to effectively manage the risks associated with our increasing usage of AI technologies, including ensuring the accuracy and reliability of outputs, safeguarding data, and maintaining robust governance, our business, financial condition, and results of operations could be adversely affected.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors