CDNA on Nasdaq

CareDx, Inc

Logo: caredx.com4

Medical transplant company based in Brisbane, founded in 20001

In its 2026 annual report the company says: “CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. We deliver solutions designed to empower clinicians and improve patient outcomes. Our headquarters is located in Brisbane, California, and we have other primary operations in Omaha, Nebraska and Stockholm, Sweden.”7 Its shares trade on Nasdaq under the symbol CDNA.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Jan 1, 2000Founded1

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  • TickerCDNA on Nasdaq1
  • IndustryServices-Medical Laboratories1
  • HeadquartersBrisbane1
  • Websitewww.caredx.com
  • Legal formDelaware corporation1
  • Incorporated inDE5
  • Business address8000 Marina Blvd, 4Th Floor, Brisbane, Ca 940055
  • Filer categoryLarge accelerated filer5
  • LEI549300NQOFKL9NON0U063
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 29824853

CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. We deliver solutions designed to empower clinicians and improve patient outcomes. The Company's integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. Our headquarters is located in Brisbane, California, and we have other primary operations in Omaha, Nebraska and Stockholm, Sweden.7 From its latest annual report

Financials

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

Key numbers, fiscal 2025

-8.1%Operating margin8
-5.6%Net margin8
13.8%Revenue growth, 20258
-7.0%Return on equity8

What sells

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

Products and services

Service brought in 72% of the revenue CareDx, Inc broke down this way in fiscal 2025.

  1. Service$274.5M872%up 10% from 2024
  2. Patient And Digital Solutions$56.9M815%up 31% from 2024
  3. Product$48.4M813%up 19% from 2024
Products and services by year
Products and services202320242025
Service$209.7M$249.4M$274.5M
Patient And Digital Solutions$37.1M$43.6M$56.9M
Product$33.5M$40.8M$48.4M

Regions

United States brought in 95% of the revenue CareDx, Inc broke down this way in fiscal 2025.

  1. United States$359.9M895%up 13% from 2024
  2. Outside the United States$19.9M85%up 24% from 2024
Regions by year
Regions202320242025
United States$265.6M$317.7M$359.9M
Outside the United States$14.7M$16.1M$19.9M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development19¢$71.4M
  • Other costs81¢$308.1M
  • Income tax0¢$271.0K

Out of $379.8M in revenue.8 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Share buybacks100¢$87.8M

Out of $42.0M of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.8

Financial statements

Revenue91011128$379.8M in 2025+199% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $127.1M$127.1M20192020: $192.2M$192.2M2020+51%2021: $296.4M$296.4M2021+54%2022: $321.8M$321.8M2022+9%2023: $280.3M$280.3M2023−13%2024: $333.8M$333.8M2024+19%2025: $379.8M$379.8M2025+14%
Operating income91011128-$30.8M in 2025+25% since 2019
-$300.0M-$200.0M-$100.0M0$100.0M2019: -$24.5M-$24.5M20192020: -$22.5M-$22.5M2020−8%2021: -$29.7M-$29.7M2021+32%2022: -$77.2M-$77.2M2022+160%2023: -$203.4M-$203.4M2023+163%2024: $40.8M$40.8M20242025: -$30.8M-$30.8M2025
Net income91011128-$21.4M in 2025−3% since 2019
-$200.0M-$100.0M0$100.0M2019: -$22.0M-$22.0M20192020: -$18.7M-$18.7M2020−15%2021: -$30.7M-$30.7M2021+64%2022: -$76.6M-$76.6M2022+150%2023: -$190.3M-$190.3M2023+148%2024: $52.5M$52.5M20242025: -$21.4M-$21.4M2025

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

Period ending2025-12-312024-12-312023-12-31
Total revenue$379.8M$333.8M$280.3M
Research and development$71.4M$72.5M$82.4M
Sales and marketing$102.6M$82.0M$84.1M
General and administrative$107.6M$125.1M$118.8M
Litigation settlement expense$5.7M-$96.3M$96.3M
Total operating expenses$410.6M$293.0M$483.7M
(Loss) income from operations-$30.8M$40.8M-$203.4M
Interest income, net$9.2M$11.8M$11.9M
Other income, net$524.0K$329.0K$1.4M
Total other income$9.7M$12.1M$13.2M
(Loss) income before income taxes-$21.1M$52.9M-$190.1M
Income tax expense-$271.0K-$310.0K-$141.0K
Net (loss) income-$21.4M$52.5M-$190.3M
Basic (in dollars per share)-$0.40$1.00-$3.54
Diluted (in dollars per share)-$0.40$0.93-$3.54
Basic (in shares)53.3M shares52.8M shares53.8M shares
Diluted (in shares)53.3M shares56.6M shares53.8M shares

Compare CareDx, Inc with another company

Corporate structure

CareDx, Inc sits at the top of its group. 4 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of CareDx, Inc

  • CareDx, Inc Brisbane, California, United States
    • CareDx Lab Solutions, Inc. Subsidiary · Delaware, United States
    • CareDx Transplant Management, Inc. Subsidiary · Nebraska, United States
    • The Transplant Pharmacy Subsidiary · Mississippi, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What CareDx, Inc 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, net$33.0M8 Dec 31, 2025$33.6M8 Dec 31, 2024−1.7%
Operating-lease assets (leased space)$22.8M8 Dec 31, 2025$24.3M8 Dec 31, 2024−6.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$65.4M8 Dec 31, 2025$114.7M8 Dec 31, 2024−43.0%
Marketable securities, current$111.8M8 Dec 31, 2025$146.0M8 Dec 31, 2024−23.4%
Marketable securities, non-current$24.2M8 Dec 31, 2025$08 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$40.3M8 Dec 31, 2025$40.3M8 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$32.0M8 Dec 31, 2025$38.2M8 Dec 31, 2024−16.3%
Indefinite-lived intangibles (excluding goodwill)$3.5M8 Dec 31, 2025$3.5M8 Dec 31, 2024−0.4%
Finite-lived intangibles, gross$78.5M8 Dec 31, 2025$79.9M8 Dec 31, 2024−1.7%
Accumulated amortization$46.0M8 Dec 31, 2025$40.0M8 Dec 31, 2024+15.0%
Finite-lived intangibles, net$28.5M8 Dec 31, 2025$34.7M8 Dec 31, 2024−17.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$26.7M8 Dec 31, 2025$19.5M8 Dec 31, 2024+36.9%
Raw materials$13.2M8 Dec 31, 2025$10.9M8 Dec 31, 2024+20.8%
Work in process$3.7M8 Dec 31, 2025$3.8M8 Dec 31, 2024−1.4%
Finished goods$9.8M8 Dec 31, 2025$4.8M8 Dec 31, 2024+103.4%

Properties, in its own words

Location · Function · Square Footage

United States

The rest of Item 2

Brisbane, California · Corporate headquarters · 26,506

Brisbane, California · Research & development and clinical laboratories · 61,444

West Chester, Pennsylvania · Sales office and distribution · 6,336

Omaha, Nebraska · Digital solutions office · 24,984

Flowood, Mississippi · Transplant pharmacy · 4,800

Europe

Stockholm, Sweden · Research & development and product manufacturing · 24,940

Australia

Fremantle · Research & development · 5,199

We do not own any real property. We believe that our leased facilities are adequate to meet our current needs and that additional facilities are available for lease to meet future needs.

Item 2 of the 10-K filed Feb 25, 2026.7

Leadership

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

Board members and other officers (27)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • CareDx AB Sweden6
  • CareDx Lab Solutions, Inc. Delaware6
  • CareDx Pty Ltd. Australia6
  • CareDx Transplant Management, Inc. Nebraska6
  • The Transplant Pharmacy Mississippi6

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • XDx, Inc.Oct 23, 2007 to Nov 15, 20115
  • EXPRESSION DIAGNOSTICS INCJan 31, 2003 to Dec 14, 20055

Timeline

  1. Sep 16, 20268-K Completed an acquisition or sale50
  2. Jul 30, 20268-K Results of operations; Regulation FD disclosure51
  3. Jul 7, 20268-K Completed an acquisition or sale; Regulation FD disclosure52
  4. Jun 15, 20268-K Executive or director change; Shareholder vote53
  5. Apr 28, 20268-K Entered a material agreement; Results of operations; Regulation FD disclosure54
  6. Apr 23, 20268-K Executive or director change55
  7. Apr 16, 20268-K Entered a material agreement; Results of operations; Regulation FD disclosure56
  8. Feb 25, 20268-K Results of operations; Executive or director change; Regulation FD disclosure57
  9. Feb 24, 20268-K Results of operations58
  10. Jan 12, 20268-K Results of operations59
  11. Dec 18, 20258-K Other events60
  12. Dec 15, 20258-K Bylaws or fiscal year changed61
  13. Apr 25, 2024New chief executive John Walter Hanna Jr. becomes CEO17
  14. Jun 3, 2015New chief executive Peter Maag becomes CEO18
  15. Jan 1, 2000Founded Founded1

Calendar

Coming up

  1. Oct 29, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported $0.03 a share, on Nov 4, 2025.62

When it reported results

  1. Jul 30, 2026Reported quarterly or annual results51
  2. Apr 28, 2026Reported quarterly or annual results54
  3. Apr 16, 2026Reported quarterly or annual results56
  4. Feb 25, 2026Reported quarterly or annual results57
  5. Feb 24, 2026Reported quarterly or annual results58
  6. Jan 12, 2026Reported quarterly or annual results59
  7. Nov 4, 2025Reported quarterly or annual results63
  8. Aug 6, 2025Reported quarterly or annual results64

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

Filings

548 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 323 insider forms, 44 large holders, 98 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Oct 5, 20264 EDGAR
  3. Oct 5, 20264 EDGAR
  4. Oct 5, 20264 EDGAR
  5. Oct 5, 20264 EDGAR
  6. Sep 16, 20268-K/A EDGAR
  7. Sep 15, 20264 EDGAR
  8. Sep 15, 20264 EDGAR
  9. Aug 17, 2026144 EDGAR
  10. Aug 14, 2026144 EDGAR
  11. Aug 14, 2026SCHEDULE 13G/A EDGAR
  12. Aug 13, 2026144 EDGAR
  13. Aug 12, 2026144 EDGAR
  14. Aug 11, 2026144 EDGAR
  15. Aug 10, 2026144 EDGAR
  16. Aug 10, 2026144 EDGAR
  17. Aug 7, 2026144 EDGAR
  18. Aug 7, 2026SCHEDULE 13G/A EDGAR
  19. Aug 7, 2026SCHEDULE 13G EDGAR
  20. Aug 6, 20264 EDGAR

The 548 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

93 open-market trades by officers, directors and large owners since October 2021: 2 buys and 91 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 5, 2026Novack Jeffrey AdamSecretary and General CounselSale2,688$46.26$124.4KForm 4
Aug 5, 2026Bickerstaff GeorgeDirectorSale20,000$46.29$925.8KForm 4
Aug 4, 2026Goldberg MichaelDirectorSale44,700$47.06$2.1MForm 4
Aug 4, 2026COURNOYER CHRISTINEDirectorSale16,000$46.94$751.0KForm 4
Jul 16, 2026Valantine HannahDirectorSale28,779$36.14$1.0MForm 4
Jul 16, 2026Hanna John Walter JRPresident and CEOSale118,000$37.78$4.5MForm 4
Jun 29, 2026Hanna John Walter JRPresident and CEOSale39,900$29.24$1.2MForm 4
Jun 26, 2026Hanna John Walter JRPresident and CEOSale100$29.00$2.9KForm 4
Jun 15, 2026Valantine HannahDirectorSale12,103$23.11$279.7KForm 4
Jun 15, 2026Hanna John Walter JRPresident and CEOSale17,683$24.03$424.9KForm 4
Jun 11, 2026Hanna John Walter JRPresident and CEOSale21,998$24.02$528.4KForm 4
Jun 4, 2026Hanna John Walter JRPresident and CEOSale4,835$24.00$116.0KForm 4
May 15, 2026TORRES ARTHUR ADirectorSale6,484$19.89$129.0KForm 4
May 14, 2026TORRES ARTHUR ADirectorSale4,086$20.97$85.7KForm 4
May 5, 2026Novack Jeffrey AdamSecretary and General CounselSale2,688$20.68$55.6KForm 4
Apr 16, 2026Hanna John Walter JRPresident and CEOSale10,282$21.12$217.2KForm 4
Feb 3, 2026Novack Jeffrey AdamSecretary and General CounselSale4,441$20.56$91.3KForm 4
Jan 22, 2026Hanna John Walter JRPresident and CEOSale19,280$21.16$408.0KForm 4
Jan 21, 2026Hanna John Walter JRPresident and CEOSale200$21.00$4.2KForm 4
Jan 15, 2026Hanna John Walter JRPresident and CEOSale10,156$21.05$213.8KForm 4

All 93 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.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025John W. HannaPresident and Chief Executive Officer46$693.3K$7.2M77
2025Keith KennedyChief Operating Officer and Chief Financial Officer56$587.6K$3.2M77
2025Abhishek JainFormer Chief Financial Officer$282.1K$2.6M77
2025Jessica MengChief Commercial Officer51$485.4K$2.6M77
2025Jeffrey NovackGeneral Counsel and Secretary43$361.9K$1.2M77
2025Nathan SmithFormer Chief Financial Officer$141.5K$968.0K77
2024John W. HannaPresident and Chief Executive Officer46$454.3K$9.4M77
2024Keith KennedyChief Operating Officer and Chief Financial Officer56$148.2K$4.5M77
2024Jessica MengChief Commercial Officer51$122.4K$3.4M77
2024Abhishek JainFormer Chief Financial Officer$411.2K$2.8M77
2024Jeffrey NovackGeneral Counsel and Secretary43$326.9K$1.3M77
2023Abhishek JainFormer Chief Financial Officer$405.0K$3.1M77

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.4,814,709$137.2M0.0%+292,613
State Street Corp2,468,858$70.4M0.0%−291,527
Vanguard Capital Management LLC2,197,475$62.6M0.0%+37,018
Deerfield Management Company, L.P.1,997,618$56.9M0.7%−193,382
ARK Investment Management LLC1,953,531$55.7M0.4%−274,025
Boston Partners1,937,601$55.2M0.0%+54,067
Bamco Inc /ny/1,937,326$55.2M0.1%−1,399,083
Gagnon Securities LLC1,770,735$50.5M9.7%+8,861
Chevy Chase Trust Holdings, LLC1,437,416$41.0M0.1%−66,659
Geode Capital Management, LLC1,328,037$37.9M0.0%+73,923
Ophir Asset Management Pty Ltd1,264,809$36.0M3.0%+276,758
Renaissance Technologies LLC1,242,959$35.4M0.0%+58,561
Braidwell LP1,220,602$34.8M1.3%−952,544
First Eagle Investment Management, LLC1,196,994$34.1M0.0%+621,629
Sumitomo Mitsui Trust Group, Inc.1,191,630$34.0M0.0%−283,496
Blue Water Life Science Advisors, LP1,190,000$33.9M21.4%+255,000
Amova Asset Management Americas, Inc.1,188,075$33.8M0.4%−287,051
Dimensional Fund Advisors LP1,181,077$33.7M0.0%−280,837
D. E. Shaw & Co., Inc.1,137,660$32.4M0.0%+262,752
Jacobs Levy Equity Management, Inc995,669$28.4M0.1%+131,201
Vanguard Portfolio Management LLC989,529$28.2M0.0%+138,096
Morgan Stanley774,299$22.1M0.0%+348,950
Divisadero Street Capital Management, LP700,938$20.0M0.5%New
Goldman Sachs Group Inc699,993$19.9M0.0%−33,339
Portolan Capital Management, LLC684,805$19.5M0.7%+344,453

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

Members of Congress who traded it

14 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
Mar 6, 2023Daniel S. GoldmanDemocratic, HouseSale$1,001 - $15,000−410.1%Report
Mar 2, 2021Tom MalinowskiDemocratic, HouseBuy$15,001 - $50,000−122.9%Report
Jan 11, 2021Tom MalinowskiDemocratic, HousePartial sale$1,001 - $15,000+124.5%Report
Jan 8, 2021Tom MalinowskiDemocratic, HousePartial sale$1,001+123.2%Report
Jan 6, 2021Tom MalinowskiDemocratic, HousePartial sale$15,001 - $50,000+118.9%Report
Dec 29, 2020Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−120.4%Report
Dec 23, 2020Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−126.2%Report
Dec 7, 2020Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−114.4%Report
Nov 16, 2020Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−96.6%Report
Oct 9, 2020Tom MalinowskiDemocratic, HousePartial sale$1,001 - $15,000+103.9%Report
Jun 19, 2019Tom MalinowskiDemocratic, HouseSale$1,001 - $15,000+102.4%Report
Jun 17, 2019Tom MalinowskiDemocratic, HouseSale$1,001 - $15,000+99.4%Report
Apr 1, 2019Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−64.6%Report
Mar 11, 2019Tom MalinowskiDemocratic, HouseSale$15,001 - $50,000+93.3%Report

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

SEC filer profile

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

  • Name on EDGARCareDx, Inc.2
  • CIK0001217234
  • Employer ID (EIN)94-33168397
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsDecember 312
  • Industry code (SIC)8071 Services-Medical Laboratories2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address8000 Marina Blvd, 4Th Floor, Brisbane, CA 940052
  • Phone415-287-23002
  • Shares outstanding51,734,223 as of Jul 27, 202615
  • Public float$1.0B as of Jun 30, 20257
  • AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; it also attests to the company’s internal control over financial reporting7
  • On EDGAR sinceJan 31, 20032
  • Filings1,399 in all: 4 (773), 8-K (162), 144 (65), SC 13G/A (53), 3 (41), 10-Q (37), 4/A (28), SC 13G (28)2
    All 53 form types

    S-8 (17), CORRESP (15), DEFA14A (14), UPLOAD (14), DEF 14A (13), 10-K (12), 424B5 (10), SCHEDULE 13G/A (10), EFFECT (9), CT ORDER (7), S-1/A (7), 8-K/A (6), ARS (5), S-1 (5), SC 13D/A (5), POS AM (4), PRE 14A (4), REGDEX (4), SCHEDULE 13G (4), 10-K/A (3), 10-Q/A (3), 424B3 (3), D (3), NT 10-Q (3), S-3 (3), S-3/A (3), S-3ASR (3), 424B4 (2), CB (2), REGDEX/A (2), SC 13D (2), SC TO-I/A (2), 3/A (1), 5 (1), 8-A12B (1), CERTNAS (1), D/A (1), DRS (1), DRS/A (1), FWP (1), NT 10-K (1), POSASR (1), RW (1), S-1MEF (1), SC TO-I (1)

  • Latest filingsAnnual report (10-K) Feb 25, 2026
    Quarterly report (10-Q) Jul 30, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Jul 30, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareCDNAThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks CareDx, Inc names in Item 1A of its 10-K filed Feb 25, 2026: 66 risks under these headings, as written.7

  • Risks Related to Our Business
  • We have a history of losses, and we expect to incur net losses for the next several years.
  • We receive a substantial portion of our revenues from Medicare, and the loss of, or a significant reduction in, reimbursement from Medicare would severely and adversely affect our financial performance.
  • Our financial results currently are largely dependent on sales of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung tests and products, and we will need to generate sufficient revenues from these and other solutions and tests we develop to grow our business.
  • Health insurers and other third-party payers may decide to revoke coverage of our existing tests, decide not to cover our future solutions or may provide inadequate reimbursement, which could jeopardize our commercial prospects.
  • We are and could become subject to legal proceedings that could be time-consuming, result in costly litigation and settlements/judgments, require significant amounts of management attention and result in the diversion of significant operational resources, which could adversely affect our business, financial condition and results of operations.
  • The development and commercialization of additional diagnostic solutions are key to our growth strategy. New test or product development involves a lengthy and complex process, and we may not be successful in our efforts to develop and commercialize additional diagnostic solutions.
  • The field of diagnostic testing in transplantation is evolving and is subject to rapid technological change. If we are unable to develop solutions to keep pace with rapid medical and scientific change, our operating results could be harmed.
  • If clinicians, hospital administrators, medical centers and laboratories do not adopt our diagnostic solutions, we will not achieve future sales growth.
  • Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • Transplant centers may not adopt AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or our other solutions due to historical practices or due to more favorable reimbursement policies associated with other means of monitoring transplants.
  • If we are unable to successfully compete with established players in the clinical surveillance of the transplantation field, we may be unable to increase or sustain our revenues or achieve profitability.
The other 55 risks
  • If we are unable to successfully and continually update our products on a timely basis, our ability to attract and retain customers could be impaired and our competitive position could be harmed.
  • Our research and development efforts will be hindered if we are not able to acquire or contract with third parties for access to tissue and blood samples.
  • If we cannot maintain existing clinical collaborations and enter into new ones, our efforts to commercialize and develop products could be delayed.
  • If we are unable to successfully manage our growth and support demand for our tests, our business may suffer.
  • Our past revenue growth rates may not be indicative of future growth, and we may not grow at all, and revenue may decline.
  • If our laboratory facility in the United States becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and future testing solutions, if any, and our business will be harmed.
  • Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.
  • Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.
  • Our ability to commercialize our testing solutions that we develop is dependent on our relationships with laboratory services providers and their willingness to support our current and future solutions.
  • If we seek to and are unable to raise additional capital on acceptable terms in the future, it may limit our ability to develop and commercialize new diagnostic solutions and technologies, and we may have to curtail or cease operations.
  • The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists, clinicians and laboratory and field personnel could adversely affect our business.
  • Undetected errors or defects in our products could result in voluntary corrective actions or agency enforcement actions, including recall of our products, as well as harm our reputation, decrease market acceptance of our products and expose us to product liability or professional liability claims, which could exceed our resources.
  • We rely extensively on third-party service providers. Failure of these parties to perform as expected, or interruptions in our relationship with these providers or their provision of services or supplies to us, could interfere with our ability to provide test results for our testing services business and kits for our products business.
  • 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 are incorporating, and may in the future further incorporate, AI technologies into some of our internal processes. These technologies may present business, compliance and reputational risks.
  • Disputes with labor unions may adversely affect our ability to operate in our Sweden facility and may impact our financial results.
  • Our operating results may be adversely affected by unfavorable economic and market conditions.
  • Our effective tax rate may fluctuate and we may incur obligations in tax jurisdictions in excess of amounts that have been accrued.
  • If we use hazardous materials in a manner that causes injury, we could be liable for damages.
  • Changes in, or interpretations of, accounting rules and regulations could result in unfavorable accounting changes or require us to change our compensation policies.
  • Risks Related to Acquisitions, Partnerships and Investments
  • Intangibles, including goodwill, acquired in connection with acquisitions may subsequently be impaired and, if so, could increase our net accumulated deficit.
  • Recent and future acquisitions and investments could disrupt our business, harm our financial condition and operating results, dilute your ownership of us and increase our debt or cause us to incur significant expense.
  • We may not be able to achieve the anticipated strategic benefits from our acquisition of Ottr, XynManagement, TransChart, MedActionPlan, TTP, HLA Data Systems, or any other businesses or assets that we may acquire.
  • Our License and Commercialization Agreement with Illumina may not result in material benefits to our business.
  • Risks Related to Billing and Reimbursement
  • Billing complexities associated with obtaining payment or reimbursement for our current and future solutions may negatively affect our revenue, cash flows and profitability.
  • Healthcare reform measures could hinder or prevent the commercial success of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung.
  • Risks Related to the Healthcare Regulatory Environment
  • To operate our laboratory, we have to comply with the CLIA and federal and state laws and regulations governing clinical laboratories and laboratory-developed tests, including FDA regulations.
  • If we are required to conduct additional analytical studies and clinical trials prior to marketing our solutions under development, those trials could lead to delays or a failure to obtain necessary regulatory approvals and harm our ability to be profitable.
  • We are subject to numerous fraud and abuse and other laws and regulations pertaining to our business, the violation of any one of which could harm our business.
  • Foreign governments may impose reimbursement standards, which may adversely affect our future profitability.
  • Risks Related to Our Intellectual Property
  • Our competitive position depends on maintaining intellectual property protection.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • We may face intellectual property infringement claims that could be time-consuming and costly to defend and could result in our loss of significant rights and the assessment of treble damages.
  • We may be required to take further action to maintain and protect our intellectual property rights against third parties.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • If we are unable to protect or enforce our intellectual property rights effectively in all major markets, our business would be harmed.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.
  • We may be subject to claims by third parties that we or our employees have wrongfully used or disclosed alleged trade secrets or misappropriated intellectual property, or claiming ownership of what we view as our own intellectual property.
  • Our business is dependent on licenses from third parties.
  • Risks Related to Information Technology, Cybersecurity, and Data Privacy
  • Security breaches, loss of data, or other disruptions could compromise sensitive information, prevent access to critical information, expose us to liability, and adversely affect our business and our reputation.
  • We are subject to changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions, fines, sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business.
  • Risks Related to Our Common Stock
  • Our operating results may fluctuate, which could cause our stock price to decrease.
  • The market price of our common stock has been and will likely continue to be volatile, and you could lose all or part of your investment.
  • If our principal stockholders, executive officers and directors choose to act together, they may be able to control our management and operations, which may prevent us from taking actions that may be favorable to you.
  • Sales of substantial amounts of our common stock in the public markets, or sales of our common stock by our executive officers and directors under Rule 10b5-1 plans, could adversely affect the market price of our common stock.
  • We do not expect to pay dividends in the foreseeable future. As a result, you must rely on stock appreciation for any return on your investment.
  • We may elect to repurchase shares of our common stock, which might limit our ability to pursue other growth opportunities.
  • If we are unable to substantially utilize our net operating loss carryforwards, our financial results could be harmed.
  • Our organizational documents and Delaware law make a takeover of our company more difficult, which may prevent certain changes in control and limit the market price of our common stock.
  • Our amended and restated bylaws designate the federal district courts of the United States of America as the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
  • General Risk Factors
  • We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies in the United States, which may adversely affect our operating results.
  • If equity research analysts do not publish research or reports about our business, or if they issue unfavorable commentary or downgrade our common stock, the price of our common stock could decline.
  • If we fail to maintain an effective system of internal controls, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.
  • Techniques employed by short sellers may drive down the market price of our common stock.

Legal proceedings

The information set forth in Note 8, Commitments and Contingencies, to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K under the caption “Litigation and Indemnification Obligations” is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.7

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