GH on Nasdaq

Guardant Health

Logo: Guardant Health, Public domain, via Wikimedia Commons5

American biotechnology company

Guardant Health, Inc. is an American biotechnology company based in Palo Alto, California. Co-founders Helmy Eltoukhy and AmirAli Talasaz serve as co-chief executive officers.3 Its shares trade on Nasdaq under the symbol GH.1 Wikipedia text CC BY-SA 4.0

Price unavailable

Last updated Oct 21, 2026.

Overview

2012Founded1

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  • TickerGH on Nasdaq1
  • Industrybiotechnology1
  • HeadquartersRedwood City1
  • Websiteguardanthealth.com
  • Incorporated inDE6
  • Business address3100 Hanover Street, Palo Alto, Ca 943046
  • Filer categoryLarge accelerated filer6
  • Legal formCorporation4
  • LEI254900M8C3E5VC8BR1864
  • StatusActive4
  • LEI statusIssued and current4
  • Registered addressC/O INCORPORATING SERVICES, LTD., 19901 Dover, United States4
  • Registered withDivision of Corporations, Department of State, 50775374

Guardant Health, Inc. is an American biotechnology company based in Palo Alto, California. Co-founders Helmy Eltoukhy and AmirAli Talasaz serve as co-chief executive officers.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-44.5%Operating margin8
-42.4%Net margin8
32.9%Revenue growth, 20258
-$233.1MFree cash flow8

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Oncology brought in 70% of the revenue Guardant Health broke down this way in fiscal 2025.

  1. Oncology$683.6M870%up 26% from 2024
  2. Biopharma & Data$210.1M821%up 18% from 2024
  3. Screening$79.7M88%up 1456% from 2024
  4. Licensing & Other$8.6M81%down 37% from 2024
Products and services by year
Products and services202320242025
Oncology$403.9M$542.8M$683.6M
Biopharma & Data$136.4M$177.6M$210.1M
Screening$0$5.1M$79.7M
Licensing & Other$23.7M$13.5M$8.6M

Regions

United States brought in 94% of the revenue Guardant Health broke down this way in fiscal 2025.

  1. United States$923.3M894%up 32% from 2024
  2. Outside the United States$58.7M86%up 40% from 2024
Regions by year
Regions202320242025
United States$526.5M$697.2M$923.3M
Outside the United States$37.4M$41.9M$58.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue36¢$349.0M
  • Research and development37¢$364.2M
  • Other costs27¢$267.6M
  • Income tax0¢$1.3M

Out of $982.0M in revenue.8 The company lost money this year.

Financial statements

Revenue91011128$982.0M in 2025+358% since 2019
0$250.0M$500.0M$750.0M$1.0B2019: $214.4M$214.4M20192020: $286.7M$286.7M2020+34%2021: $373.7M$373.7M2021+30%2022: $449.5M$449.5M2022+20%2023: $563.9M$563.9M2023+25%2024: $739.0M$739.0M2024+31%2025: $982.0M$982.0M2025+33%
Operating income91011128-$437.2M in 2025+431% since 2019
-$600.0M-$400.0M-$200.0M02019: -$82.4M-$82.4M20192020: -$254.9M-$254.9M2020+210%2021: -$411.0M-$411.0M2021+61%2022: -$544.4M-$544.4M2022+32%2023: -$564.7M-$564.7M2023+4%2024: -$443.6M-$443.6M2024−21%2025: -$437.2M-$437.2M2025−1%
Net income131011128-$416.3M in 2025+450% since 2019
-$800.0M-$600.0M-$400.0M-$200.0M02019: -$75.7M-$75.7M20192020: -$246.3M-$246.3M2020+226%2021: -$384.8M-$384.8M2021+56%2022: -$654.6M-$654.6M2022+70%2023: -$479.4M-$479.4M2023−27%2024: -$436.4M-$436.4M2024−9%2025: -$416.3M-$416.3M2025−5%

Every line of the income statement as filed: the last 3 fiscal years, latest first.8

Period ending2025-12-312024-12-312023-12-31
Revenue$982.0M$739.0M$563.9M
Cost of revenue$349.0M$289.8M$227.1M
Research and development expense$364.2M$347.8M$367.2M
Sales and marketing expense$494.7M$364.9M$295.2M
General and administrative expense$211.4M$180.1M$155.8M
Other operating expense$0$0$83.4M
Total costs and operating expenses$1.4B$1.2B$1.1B
Loss from operations-$437.2M-$443.6M-$564.7M
Interest income$34.1M$53.7M$35.4M
Interest expense-$3.9M-$2.6M-$2.6M
Other income (expense), net-$10.5M-$42.6M$53.2M
Loss before (benefit from) provision for income taxes-$417.5M-$435.1M-$478.8M
(Benefit from) provision for income taxes-$1.3M$1.3M$685.0K
Net loss-$416.3M-$436.4M-$479.4M
Net loss per share, basic (in usd per share)-$3.32-$3.56-$4.28
Net loss per share, diluted (in usd per share)-$3.32-$3.56-$4.28
Weighted-average shares used in computing net loss per share, basic (in shares)125.4M shares122.7M shares112.0M shares
Weighted-average shares used in computing net loss per share, diluted (in shares)125.4M shares122.7M shares112.0M shares

Compare Guardant Health with another company

Corporate structure

Guardant Health sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Guardant Health

  • Guardant Health Redwood City, California, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Guardant Health reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$344.8M8 Dec 31, 2025$302.3M8 Dec 31, 2024+14.0%
Accumulated depreciation$198.9M8 Dec 31, 2025$165.5M8 Dec 31, 2024+20.2%
Property and equipment, net$145.9M8 Dec 31, 2025$136.8M8 Dec 31, 2024+6.7%
Operating-lease assets (leased space)$158.8M8 Dec 31, 2025$142.3M8 Dec 31, 2024+11.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$378.2M8 Dec 31, 2025$525.5M8 Dec 31, 2024−28.0%
Marketable securities, current$823.4M8 Dec 31, 2025$314.4M8 Dec 31, 2024+161.9%
Debt securities available for sale$1.3B8 Dec 31, 2025$904.5M8 Dec 31, 2024+39.0%
Equity securities at fair value$6.5M8 Dec 31, 2025$16.1M8 Dec 31, 2024−59.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$77.3M8 Dec 31, 2025$3.3M8 Dec 31, 2024+2248.2%
Intangible assets, net (excluding goodwill)$25.9M8 Dec 31, 2025$6.8M8 Dec 31, 2024+283.4%
Finite-lived intangibles, gross$17.0M8 Dec 31, 2025$18.6M8 Dec 31, 2024−8.6%
Accumulated amortization$11.9M8 Dec 31, 2025$11.8M8 Dec 31, 2024+0.6%
Finite-lived intangibles, net$5.1M8 Dec 31, 2025$6.8M8 Dec 31, 2024−24.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$85.9M8 Dec 31, 2025$71.1M8 Dec 31, 2024+20.8%

Properties, in its own words

Our headquarters are located in Palo Alto, California, where we lease approximately 249,500 square feet of office and lab space. The lease for the Palo Alto office was entered into in July 2020 and has a term of 12 years with an option to renew the lease term for an additional 10 years. In addition, we have approximately 205,000 square feet of additional office and lab space in Redwood City and San Diego, California, and Long Island City, New York, with current lease expiration dates ranging from 2028 to 2031. We also maintain several additional domestic leased office and warehouse spaces and international leased office spaces.

Item 2 of the 10-K filed Feb 19, 2026.17

The story

The American biotechnology company Guardant Health, which produces liquid biopsy tests to detect cancer from mutations and other modifications in blood samples, was co-founded by Helmy Eltoukhy and AmirAli Talasaz during 2012–2013. According to John Dorfman of the Pittsburgh Tribune-Review, Talasaz and Eltoukhy discovered a technique which "involves detecting and monitoring tumor fragments circulating in the patient's bloodstream", as an alternative to traditional tissue biopsies. The duo met at Stanford University in 2002 and worked together at Illumina, until Talasaz left in 2012.

Early in its history, Guardant Health acquired multiple patents by Swiss biochemist Maurice Stroun, who became a founding advisor. In 2015, the company had 40 patents and was developing a blood test to "identify all classes of actionable tumor genomic alterations", according to VentureBeat. Guardant Health said the test would be the "first and only comprehensive biopsy-free cancer test available". In 2016, the company announced clinical trial results demonstrating the test "detected disease-associated genetic mutations that were also present in 94% to 100% of the solid tissues extracted from the study's subjects".

The company's U.S. initial public offering in 2018 raised $237.5 million, valuing Guardant Health at $3.3 billion. In December 2022, Guardant Health announced the results of a study on its blood-based screening test for colorectal cancers, which it began in 2019. The study included 20,000 participants identified as having an average risk for colorectal cancer. Results showed the test was 83 percent accurate at detecting the presence of cancer, with a 10 percent false positivity rate. Bloomberg reported that the results were short of the 85 percent accuracy rate that investors expected, and the company's stock price fell following the news. A competitor's stool-based test for the same cancer is 92 percent accurate.

Funding

Guardant Health raised approximately $550 million in funding in its first six years. Aydin Senkut was an early investor. The company raised $30 million in 2014, including $10 million from Sequoia Capital. In 2015, Guardant Health raised $50 million in a venture round led by Lightspeed Venture Partners. The funding was used for infrastructure and growing operations. Guardant Health's Series D round in January 2017 raised approximately $100 million, bringing total funding to $190 million.

In 2017, the company raised $360 million in a round led by a subsidiary of SoftBank Group. The funding supports an attempt to sequence the DNA of 1 million cancer patients in five years, bring to market a blood test to screen for early signs of cancer, and a blood test to detect residual disease in cancer survivors. Guardant Health and SoftBank formed the joint venture to expand the use of Guardant360 in Africa, Asia, and the Middle East. The joint venture, called Guardant Health AMEA, launched in 2018 and was purchased by Guardant Health for approximately $178 million in 2022.

From Wikipedia’s article on Guardant Health, shared under CC BY-SA 4.0.7

Leadership

Who has led Guardant Health, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (27)

Products and brands

Guardant Health has partnered with the National Cancer Institute and large pharmaceutical companies on product improvement. The business began selling Guardant360 tests to oncologists in 2014. Medicare began covering the test for select lung cancer patients in 2018, prior to Food and Drug Administration approval (which is not required) in 2020. By 2019, the Guardant360 genomic test, which requires two blood samples and examines 73 genes, had been used for 50 types of cancer by 6,000 oncologists to assess samples from 100,000 patients. The test had also been used by 50 biopharmaceutical companies for drug development purposes. In late 2019, the Guardant360 test received expanded Medicare coverage for solid tumors.

Guardant Health launched Project Lunar, which studied hundreds of "pre-symptomatic, high-risk" people for breast, colorectal, lung, ovarian, and pancreatic cancer, in May 2016 in collaboration with the University of California, San Francisco, the Seoul-based Samsung Medical Center, the University of Colorado, and the University of Pennsylvania. The GuardantOMNI test launched in 2017 and has been used for biopharmaceutical research. Guardant Health launched the early-stage cancer assay called Lunar for academic and biopharmaceutical research in 2019.

Japan's Ministry of Health, Labour and Welfare granted regulatory approval of Guardant360 CDx as a companion diagnostic "for identifying patients with metastatic non-small cell lung cancer who may benefit from treatment with Lumakras (sotorasib)" in late 2021. The agency granted regulatory approval of the test in 2022 for patients with "advanced solid tumors" and as a companion diagnostic "to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo (nivolumab)".

In 2021, Guardant Health introduced Guardant Reveal, the first blood-only liquid biopsy test for the detection of residual and recurrent disease in colorectal cancer (CRC). The test helps oncologists improve the management of early-stage CRC patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.

Read the full text

In 2022, Guardant Health enrolled the first patient in the Screening for High-Frequency Malignant Disease (SHIELD) Lung study to evaluate its blood-based screening technology for lung cancer. Guardant Health also launched a colon cancer detection test called Shield. The company partnered with the Vall d'Hebron Institute of Oncology to launch the first blood-based cancer testing services in Barcelona in mid 2022. Guardant Health also licensed cancer tests to the clinical laboratory company Adicon for research testing in China. In 2024 Guardant's Shield, colon cancer test received FDA approval. In May 2025, coverage by TIME magazine reported that the test was covered by Medicare and has had 6,400 tests administered since its approval in July of 2024. On May 27, 2026, the American Cancer Society included it as an option for colon cancer screenings.

From Wikipedia’s article on Guardant Health, shared under CC BY-SA 4.0.7

Timeline

  1. Jul 30, 20268-K Results of operations49
  2. Jun 18, 20268-K Shareholder vote50
  3. May 7, 20268-K Results of operations51
  4. Apr 27, 20268-K Executive or director change52
  5. Feb 19, 20268-K Results of operations53
  6. Jan 12, 20268-K Results of operations; Regulation FD disclosure54
  7. Nov 7, 20258-K Entered a material agreement; New debt or obligation; Unregistered sale of shares55
  8. Oct 29, 20258-K Results of operations56
  9. Sep 24, 20258-K Regulation FD disclosure57
  10. Sep 15, 20258-K Executive or director change58
  11. Jul 30, 20258-K Results of operations59
  12. Jun 20, 20258-K Shareholder vote60
  13. Aug 17, 2021New chief executive AmirAli Talasaz becomes CEO18
  14. Oct 3, 2018New chief executive Helmy Eltoukhy becomes CEO19
  15. 2012Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.74) a share, on Oct 29, 2025.61

When it reported results

  1. Jul 30, 2026Reported quarterly or annual results49
  2. May 7, 2026Reported quarterly or annual results51
  3. Feb 19, 2026Reported quarterly or annual results53
  4. Jan 12, 2026Reported quarterly or annual results54
  5. Oct 29, 2025Reported quarterly or annual results56
  6. Jul 30, 2025Reported quarterly or annual results59
  7. Apr 30, 2025Reported quarterly or annual results62
  8. Feb 20, 2025Reported quarterly or annual results63

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

861 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 611 insider forms, 36 large holders, 131 other. The latest 20:

  1. Oct 15, 20264 EDGAR
  2. Oct 14, 2026144 EDGAR
  3. Oct 13, 20264 EDGAR
  4. Oct 2, 20264 EDGAR
  5. Oct 2, 20264 EDGAR
  6. Oct 2, 20264 EDGAR
  7. Oct 2, 20264 EDGAR
  8. Oct 2, 20264 EDGAR
  9. Oct 2, 20264 EDGAR
  10. Oct 2, 20264 EDGAR
  11. Oct 2, 20264 EDGAR
  12. Sep 22, 20264 EDGAR
  13. Sep 21, 20264 EDGAR
  14. Sep 17, 20264 EDGAR
  15. Sep 17, 20264 EDGAR
  16. Sep 17, 20264 EDGAR
  17. Sep 17, 20264 EDGAR
  18. Sep 16, 2026144 EDGAR
  19. Sep 16, 2026144 EDGAR
  20. Sep 16, 2026144 EDGAR

The 861 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

123 open-market trades by officers, directors and large owners since October 2021: 11 buys and 112 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 16, 2026Tariq MusaDirectorSale116$175.00$20.3KForm 4
Sep 16, 2026Krognes Steve E.DirectorSale6,674$175.74$1.2MForm 4
Sep 16, 2026Azar Alex M IIDirectorSale826$175.00$144.6KForm 4
Sep 15, 2026Chudova DaryaChief Technology OfficerSale7,738$178.00$1.4MForm 4
Sep 11, 2026Kalia KumudChief Information OfficerSale4,000$158.05$632.2KForm 4
Aug 21, 2026Talasaz AmirAliCo-Chief Executive OfficerSale37,500$169.16$6.3MForm 4
Aug 17, 2026Tariq MusaDirectorSale116$156.45$18.1KForm 4
Aug 12, 2026Monroe Terilyn J.Chief People OfficerSale46,300$165.12$7.6MForm 4
Aug 10, 2026Freeman ChrisChief Commercial OfficerSale63,605$169.58$10.8MForm 4
Aug 5, 2026Hidalgo Medina ManuelDirectorSale1,700$164.24$279.2KForm 4
Aug 4, 2026CLARK IAN TDirectorSale14,180$158.92$2.3MForm 4
Jul 16, 2026Tariq MusaDirectorSale116$163.29$18.9KForm 4
Jun 29, 2026Talasaz AmirAliCo-Chief Executive OfficerSale143,028$151.54$21.7MForm 4
Jun 26, 2026Talasaz AmirAliCo-Chief Executive OfficerSale116,972$150.79$17.6MForm 4
Jun 22, 2026Tariq MusaDirectorSale1,951$131.16$255.9KForm 4
Jun 22, 2026POTTER MYRTLE SDirectorSale1,556$131.16$204.1KForm 4
Jun 16, 2026Tariq MusaDirectorSale116$130.19$15.1KForm 4
Jun 15, 2026Kalia KumudChief Information OfficerBuy600$130.76$78.5KForm 4
Jun 15, 2026Kalia KumudChief Information OfficerSale600$131.08$78.6KForm 4
Jun 11, 2026Kalia KumudChief Information OfficerSale3,418$130.24$445.2KForm 4

All 123 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.7,622,935$1.1B0.0%−3,930,824
Vanguard Capital Management LLC5,755,857$863.6M0.0%+131,677
Fmr LLC5,488,272$823.4M0.0%+1,372,191
Vanguard Portfolio Management LLC5,445,785$817.0M0.0%−392,207
Invesco Ltd.4,429,755$664.6M0.1%−516,714
Goldman Sachs Group Inc3,775,895$566.5M0.1%−659,944
Two Sigma Investments, LP3,719,301$558.0M0.4%−510,230
Capital International Investors3,399,604$510.0M0.1%−81,714
Deep Track Capital, LP3,393,312$509.1M7.5%+55,071
Franklin Resources Inc3,236,065$485.5M0.1%−212,128
Ameriprise Financial Inc3,150,897$472.8M0.1%+1,736,011
Fuller & Thaler Asset Management, Inc.2,629,007$394.4M1.1%+78,693
Geode Capital Management, LLC2,521,596$378.4M0.0%−987,287
Baillie Gifford & Co2,284,127$342.7M0.3%−1,574,919
State Street Corp2,263,504$339.6M0.0%−621,116
Federated Hermes, Inc.1,999,178$299.9M0.4%+111,594
Eventide Asset Management, LLC1,957,828$293.8M3.9%−404,551
Jane Street Group, LLC1,783,444$267.6M0.2%+1,778,641
Westfield Capital Management Co LP1,624,459$243.7M0.8%+261,920
Millennium Management LLC1,622,458$243.4M0.2%+701,063
Norges Bank1,548,518$232.3M0.0%New
Driehaus Capital Management LLC1,533,985$230.1M1.3%+9,703
Rtw Investments, LP1,481,033$222.2M1.9%No change
Artisan Partners Limited Partnership1,478,928$221.9M0.4%+664,357
Citadel Advisors LLC1,449,534$217.5M0.1%+673,593

13F reports cover disclosed long positions in U.S. stocks only.

Members of Congress who traded it

3 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Nov 21, 2025Sheldon WhitehouseDemocratic, SenateBuy$1,001 - $15,000+40.2%Report
Oct 22, 2020Donald S. Beyer, Jr.Democratic, HouseBuy$1,001 - $15,000−62.4%Report
Oct 5, 2020Donald S. Beyer, Jr.Democratic, HouseBuy$1,001 - $15,000−77.4%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Guardant Health is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARGuardant Health, Inc.2
  • CIK0001576280
  • Employer ID (EIN)45-413925417
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company17
  • Incorporated inDelaware17
  • Fiscal year endsDecember 312
  • Industry code (SIC)8071 Services-Medical Laboratories2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address3100 Hanover Street, Palo Alto, CA 943042
  • Phone855-698-88872
  • Shares outstanding134,196,170 as of Jul 24, 202615
  • Public float$6.2B as of Jun 30, 202517
  • AuditorDeloitte & Touche LLP, San Jose, California PCAOB ID 34; it also attests to the company’s internal control over financial reporting17
  • On EDGAR sinceFeb 14, 20142
  • Filings1,239 in all: 4 (808), 144 (98), 8-K (98), 3 (38), 10-Q (24), SC 13G/A (22), SC 13G (21), 5 (9)2
    All 39 form types

    CORRESP (9), DEFA14A (9), S-8 (9), 10-K (8), 424B5 (8), DEF 14A (8), SCHEDULE 13G/A (7), 3/A (6), 4/A (6), SC 13D/A (6), UPLOAD (6), D (5), ARS (4), S-3ASR (3), 424B4 (2), 424B7 (2), CT ORDER (2), DRS (2), DRS/A (2), EFFECT (2), FWP (2), S-1 (2), S-1/A (2), SCHEDULE 13G (2), 144/A (1), 5/A (1), 8-A12B (1), 8-K/A (1), CERT (1), DRSLTR (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 19, 2026
    Quarterly report (10-Q) Jul 30, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Jul 30, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.00001GHThe Nasdaq Global Select Market

From the cover page of the 10-K filed Feb 19, 2026 (Section 12(b) of the Exchange Act).17

Risk factors and legal proceedings

The risks Guardant Health names in Item 1A of its 10-K filed Feb 19, 2026: 70 risks under these headings, as written.17

  • Risks related to our business and strategy
  • We have incurred significant losses since inception, we may continue to incur losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability.
  • 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.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • New product development and commercialization involve a lengthy and complex process and we may be unable to develop or commercialize new products on a timely basis, or at all.
  • Our current revenue is primarily generated from sales of our tests and we are highly dependent on them for our success.
  • If our products do not meet the expectations of patients and our customers, our operating results, reputation and business could suffer.
  • If we are unable to support demand for our current and future products, including ensuring that we have adequate capacity to meet increased demand, or we are unable to successfully manage our anticipated growth, our business could suffer.
  • If we cannot maintain our current relationships, or enter into new relationships, with biopharmaceutical companies, our revenue prospects could be reduced.
  • Our payer concentration may materially adversely affect our financial condition and results of operations.
  • If we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue or to achieve and then sustain profitability.
  • The sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.
The other 59 risks
  • The precision oncology industry is subject to rapid change, which could make our current products and any future products we may develop, obsolete.
  • If we continue to experience challenges attracting and retaining qualified personnel due to competitive labor markets, we may be unable to manage our future growth effectively, all of which could make it difficult to execute our business strategy.
  • We may not be able to successfully market, sell or distribute our products, and if we are unable to expand our sales organization to adequately address our customers’ needs, our business may be adversely affected.
  • 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.
  • If our existing laboratory facility becomes damaged or inoperable or we are required to vacate our existing facility, our ability to perform our tests and pursue our research and development efforts may be jeopardized.
  • We are dependent on third parties for the collection of blood samples for our tests.
  • 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.
  • International expansion of our business exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States.
  • We could be adversely affected by violations of the FCPA and other anti-bribery laws.
  • Risks related to our highly regulated industry
  • We conduct business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, reduce our revenue, adversely affect our results of operations and financial condition, and harm our business.
  • 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.
  • There is no guarantee that the FDA will grant 510(k) clearance or a premarket approval of our products or that similar foreign authorities or notified bodies will grant premarket approval or certify our products and failure to obtain necessary clearances or approvals or certifications for our products would adversely affect our ability to grow our business.
  • Changes to FDA Regulation of Companion Diagnostics Could Adversely Affect Our Business and Competitive Position
  • 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.
  • If third-party payers, including commercial payers and government healthcare programs, do not provide coverage of, or adequate reimbursement for, our tests, our business and results of operations will be negatively affected.
  • Our products may in the future be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and studies may not be predictive of future study results.
  • Interim, "topline" and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our “research use only” and “investigational use only” products could become subject to more onerous regulation by the FDA or other regulatory agencies in the future, which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results of operations.
  • Even if we receive regulatory approval or certification of our products, we will continue to be subject to extensive regulatory oversight.
  • Changes in funding for, or disruptions caused by global health concerns impacting, the FDA and other government agencies or notified bodies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new medical device products from being developed, authorized or commercialized in a timely manner, which could negatively impact our business.
  • Failure to comply with federal, state and foreign laboratory licensing requirements and the applicable requirements of the FDA or any other regulatory authority, could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial sanctions.
  • We are subject to numerous federal and state healthcare statutes and regulations; complying with such laws pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties and a material adverse effect to our business and results of operations.
  • If the validity of an informed consent from patients regarding our test was challenged, we could be forced to stop offering our products or using our resources, our business and results of operations will be negatively affected.
  • We may be subject to fines, penalties, licensure requirements, or legal liability, if it is determined that through our test reports we are practicing medicine without a license.
  • Our billing and claim processing are complex and time-consuming, and any delay in submitting claims or failure to comply with applicable billing requirements could hinder collection and have an adverse effect on our revenue.
  • Changes in healthcare laws, regulations and policies could increase our costs, decrease our sales and revenues and negatively impact reimbursement for our tests.
  • Our collection, use and disclosure of personal information, including patient and employee information, is subject to privacy and security laws and regulations, and our actual or perceived failure to comply with those laws and regulations or to adequately secure the information in our possession could result in significant liability or reputational harm.
  • Risks related to our intellectual property
  • If we are unable to obtain and maintain sufficient intellectual property protection for our technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop, manufacture and commercialize products, services or technology similar or identical to ours, and our ability to successfully develop, manufacture or commercialize our products, services or technology may be impaired.
  • Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Issued patents covering our products, services or technology could be found invalid or unenforceable if challenged.
  • We rely on licenses from third parties, and if we lose these licenses then we may be subjected to future litigation. If we cannot license and maintain rights to use third-party intellectual property rights on reasonable terms, we may not be able to successfully develop, manufacture and/or commercialize our products, services or technology. Our licensed intellectual property rights may lose value or utility over time.
  • We may not be able to protect or enforce our intellectual property rights adequately throughout the world.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed trade secrets of their former employers.
  • We may not be able to protect and enforce our trademarks and we could infringe others’ trademarks.
  • We may be subject to claims challenging the inventorship or ownership of our owned or licensed intellectual property.
  • We are and may continue to be involved in litigation and other legal proceedings related to intellectual property, which could be time-intensive and costly and may adversely affect our business, operating results or financial condition.
  • Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position for an adequate amount of time.
  • Risks related to our common stock and indebtedness
  • The price of our common stock has fluctuated substantially and may do so in the future, and you may not be able to resell shares of our common stock at or above the price at which you purchased them.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain.
  • Our indebtedness could expose us to risks that could adversely affect our business, financial condition and results of operations.
  • The conditional conversion features of the Notes, if triggered, may adversely affect our financial condition. Conversion of the Notes, to the extent the Notes are not redeemed or repurchased, will dilute the ownership interest of existing stockholders, and even if anticipated, may otherwise depress the price of our common stock.
  • The convertible note hedge may affect the value of the 2027 Notes and our common stock.
  • We are subject to counterparty risk with respect to the 2027 Note Hedge transactions.
  • Provisions in our corporate charter documents and under Delaware law could make a change in control of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • General Risk Factors
  • We may acquire businesses, form joint ventures or make investments in companies or technologies that could negatively affect our operating results, distract management’s attention from other business concerns, dilute our stockholders’ ownership, and significantly increase our debt, costs, expenses, liabilities and risks.
  • We may need to raise additional capital to fund our existing operations, develop our platform, commercialize new products or expand our operations.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax laws or regulations could harm our financial condition and results of operations.
  • If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.
  • The loss of any member of our senior management team or our inability to attract and retain highly skilled scientists, clinicians, sales representatives and business development managers could adversely affect our business.
  • If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations which may adversely affect investor confidence in us and, as a result, the value of our common stock.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • If we were to be sued for product liability or professional liability, we could face substantial liabilities that exceed our resources.
  • Cybersecurity incidents such as security breaches, loss of data and other disruptions in relation to our information technology systems, as well as those of our third-party service providers, could compromise sensitive information related to our business, prevent us from accessing it and expose us to substantial liability, which could adversely affect our business and reputation.
  • Our increasing usage of artificial intelligence technologies may expose us to operational, regulatory, legal, and reputational risks.

Legal proceedings

The information under the caption “Commitments and Contingencies - Legal Proceedings” in Note 9 to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K, concerning certain legal proceedings in which we are involved, is hereby incorporated by reference. The resolution of any such legal proceeding is subject to inherent uncertainty and could have a material adverse effect on our financial condition, cash flows or results of operations.

The opening of Item 3, Legal Proceedings.17

Sources

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    Wikidata and SEC EDGARAmirAli Talasaz, President
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