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NeoGenomics

Logo: NeoGenomics, Public domain, via Wikimedia Commons5

Cancer-focused genetic testing and lab services company

NeoGenomics Laboratories, Inc., also known as NeoGenomics or Neo, is an American CLIA-certified clinical laboratory, pharma services and information services company that specializes in cancer genetics diagnostic testing. The company's testing services include cytogenetics, fluorescence in situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology, and molecular genetics.3 Wikipedia text CC BY-SA 4.0

Price unavailable

Last updated Oct 21, 2026.

Overview

2002Founded1

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  • TickerNEO on Nasdaq1
  • Industrybiotechnology1
  • HeadquartersFort Myers1
  • Websiteneogenomics.com
  • Legal formcorporation1
  • Incorporated inNV6
  • Business address9490 Neogenomics Way, Fort Myers, Fl 339126
  • Filer categoryLarge accelerated filer6
  • LEI254900KXWYZIKXNFT5214
  • StatusActive4
  • LEI statusIssued and current4
  • Registered addressc/o Registered Agent Solutions, INC, 89119 Las Vegas, United States4
  • Registered withBusiness Center (Secretary of State), NV199813663274

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NeoGenomics Laboratories, Inc., also known as NeoGenomics or Neo, is an American CLIA-certified clinical laboratory, pharma services and information services company that specializes in cancer genetics diagnostic testing. The company's testing services include cytogenetics, fluorescence in situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology, and molecular genetics.3

Financials

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

Key numbers, fiscal 2025

43.2%Gross margin8
-15.9%Operating margin8
-14.9%Net margin8
10.1%Revenue growth, 20258
-12.9%Return on equity8
0.41×Debt to equity8
-$21.8MFree cash flow8

What sells

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

Products and services

Client Direct Billing brought in 71% of the revenue NeoGenomics broke down this way in fiscal 2025.

  1. Client Direct Billing$518.8M871%up 9% from 2024
  2. Commercial Insurance$117.5M816%up 18% from 2024
  3. Medicare And Other Governmental$90.9M812%up 7% from 2024
  4. Self Pay Services$114.0K80%down 83% from 2024
Products and services by year
Products and services202320242025
Client Direct Billing$428.9M$475.4M$518.8M
Commercial Insurance$88.0M$99.8M$117.5M
Medicare And Other Governmental$74.4M$84.6M$90.9M
Self Pay Services$350.0K$681.0K$114.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue57¢$413.0M
  • Research and development5¢$37.1M
  • Other costs38¢$275.0M
  • Income tax0¢$2.2M

Out of $727.3M in revenue.8 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending100¢$27.0M

Out of $5.2M of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.8

Financial statements

Revenue91011128$727.3M in 2025+78% since 2019
0$200.0M$400.0M$600.0M$800.0M2019: $408.8M$408.8M20192020: $444.4M$444.4M2020+9%2021: $484.3M$484.3M2021+9%2022: $509.7M$509.7M2022+5%2023: $591.6M$591.6M2023+16%2024: $660.6M$660.6M2024+12%2025: $727.3M$727.3M2025+10%
Gross profit91011128$314.3M in 2025+60% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $196.8M$196.8M20192020: $185.9M$185.9M2020−6%2021: $187.1M$187.1M2021+1%2022: $187.9M$187.9M2022+0%2023: $244.6M$244.6M2023+30%2024: $290.1M$290.1M2024+19%2025: $314.3M$314.3M2025+8%
Operating income91011128-$115.9M in 2025
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: $13.0M$13.0M20192020: -$14.0M-$14.0M20202021: -$118.8M-$118.8M2021+749%2022: -$157.6M-$157.6M2022+33%2023: -$107.7M-$107.7M2023−32%2024: -$92.1M-$92.1M2024−15%2025: -$115.9M-$115.9M2025+26%
Net income91011128-$108.0M in 2025
-$150.0M-$100.0M-$50.0M0$50.0M2019: $8.0M$8.0M20192020: $4.2M$4.2M2020−48%2021: -$8.3M-$8.3M20212022: -$144.2M-$144.2M2022+1628%2023: -$88.0M-$88.0M2023−39%2024: -$78.7M-$78.7M2024−11%2025: -$108.0M-$108.0M2025+37%

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

Period ending2025-12-312024-12-312023-12-31
NET REVENUE$727.3M$660.6M$591.6M
COST OF REVENUE$413.0M$370.5M$347.0M
GROSS MARGIN$314.3M$290.1M$244.6M
General and administrative$273.3M$259.7M$243.1M
Research and development$37.1M$31.2M$27.3M
Sales and marketing$92.0M$84.7M$70.8M
Restructuring charges$0$6.7M$11.1M
Impairment charges (Note 3 and Note 7)$27.8M$0$0
Total operating expenses$430.2M$382.2M$352.3M
LOSS FROM OPERATIONS-$115.9M-$92.1M-$107.7M
Interest income-$9.1M-$18.4M-$16.9M
Interest expense$3.8M$6.6M$6.9M
Other (income) expense, net-$296.0K$379.0K-$644.0K
Loss before taxes-$110.3M-$80.7M-$97.1M
Income tax benefit-$2.2M-$1.9M-$9.1M
NET LOSS-$108.0M-$78.7M-$88.0M
Basic (in dollars per share)-$1-$1-$1
Diluted (in dollars per share)-$1-$1-$1
Basic (in shares)128.1M shares126.7M shares125.5M shares
Diluted (in shares)128.1M shares126.7M shares125.5M shares

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Corporate structure

NeoGenomics 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 NeoGenomics

  • NeoGenomics Las Vegas, Nevada, 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 NeoGenomics 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$293.9M8 Dec 31, 2025$284.1M8 Dec 31, 2024+3.4%
Accumulated depreciation$209.1M8 Dec 31, 2025$190.0M8 Dec 31, 2024+10.0%
Property and equipment, net$84.8M8 Dec 31, 2025$94.1M8 Dec 31, 2024−9.8%
Operating-lease assets (leased space)$78.4M8 Dec 31, 2025$79.6M8 Dec 31, 2024−1.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$159.6M8 Dec 31, 2025$367.0M8 Dec 31, 2024−56.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$524.3M8 Dec 31, 2025$522.8M8 Dec 31, 2024+0.3%
Intangible assets, net (excluding goodwill)$286.5M8 Dec 31, 2025$339.7M8 Dec 31, 2024−15.6%
Accumulated amortization$180.9M8 Dec 31, 2025$161.7M8 Dec 31, 2024+11.9%
Finite-lived intangibles, net$273.1M8 Dec 31, 2025$326.2M12 Dec 31, 2024−16.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$28.6M8 Dec 31, 2025$26.7M8 Dec 31, 2024+6.8%

Properties, in its own words

We operate a network of laboratories. Our leases expire at various dates through 2041. We believe that these locations are sufficient to meet our needs at existing volume levels and, if needed, additional space will be available at a reasonable cost.

We maintain laboratories at all of our facilities, as well as administrative offices at four of our locations. The following table summarizes our facilities by location and approximate square footage:

The rest of Item 2

Location · Square Footage

Fort Myers, Florida · 150,000

Aliso Viejo, California · 112,700

Ramsey, New Jersey · 39,100

Houston, Texas · 32,800

Durham, North Carolina · 32,100

Carlsbad, California · 28,600

Cambridge, United Kingdom · 12,500

Nashville, Tennessee · 7,800

Tampa, Florida · 5,600

Phoenix, Arizona · 4,700

Fresno, California · 2,600

Chicago, Illinois · 2,200

Plantation, Florida · 100

Sarasota, Florida · 100

Item 2 of the 10-K filed Feb 17, 2026.16

The story

NeoGenomics first received state and national-level laboratory certifications in 2002. Three years later in 2005, the company developed a technical-only service model using FISH.

In 2013, the company launched its sequencing platform and was listed on the Nasdaq Stock Market as NEO. In 2014, NeoGenomics launched molecular tests including BTK and CALR mutation analysis.

In 2015, NeoGenomics acquired Clarient, Inc. and its subsidiary company, Clarient Diagnostic Services, Inc., a national cancer diagnostics laboratory with capabilities in immunohistochemistry for solid tumor cancers from GE Healthcare. Clarient is headquartered in Aliso Viejo, California; with an ancillary laboratory in Houston, Texas.

In November 2017, NeoGenomics established their first headquarters outside the United States in Rolle, Switzerland.

In September 2024, the District Court for the Middle District of North Carolina entered a permanent injunction against NeoGenomics’ accused RaDaR assay, which was preliminarily enjoined in December 2023.

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

Leadership

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

Chief executive

  1. Oort Douglas M. Van2011–2021
  2. Mark Mallon2021–2022
  3. Anthony P. Zook2025–now

Chair

  1. Oort Douglas M. Van2011–2021

President

  1. Steven G. Brodie2016–2017
  2. Robert J. Shovlin2017–2021
  3. George Cardoza2018–2022
  4. William Bonello2020–2021
  5. Clive Morris2021
  6. Gina M. Wallar2021–2022
  7. David Sholehvar2022
  8. Vishal Sikri2022–2024
  9. Shashikant Kulkarni2022
  10. Warren Stone2022–2024
  11. Melody Harris2022–2024

Chief financial officer

  1. George Cardoza2011–2018
  2. Sharon Virag2018–2019
  3. Kathryn B. McKenzie2020–2021
  4. William Bonello2022

Chief operating officer

  1. Robert J. Shovlin2014–2015
  2. George Cardoza2021–2022
  3. Warren Stone2025–now
20052010201520202025
Board members and other officers (43)

Former names

  • AMERICAN COMMUNICATIONS ENTERPRISES INCApr 8, 1999 to Feb 5, 20026

Timeline

  1. Oct 5, 20268-K Results of operations; Executive or director change; Bylaws or fiscal year changed79
  2. Aug 11, 20268-K Executive or director change80
  3. Jul 28, 20268-K Results of operations81
  4. Jul 22, 20268-K Regulation FD disclosure; Other events82
  5. Jul 20, 20268-K Regulation FD disclosure; Other events83
  6. Jun 25, 20268-K Executive or director change; Regulation FD disclosure84
  7. Jun 22, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares85
  8. Jun 17, 20268-K Other events86
  9. Jun 15, 20268-K Other events87
  10. May 22, 20268-K Executive or director change; Shareholder vote88
  11. Apr 28, 20268-K Results of operations89
  12. Feb 17, 20268-K Results of operations90
  13. Apr 3, 2025New chief executive Anthony P. Zook becomes CEO17
  14. Apr 21, 2021New chief executive Mark Mallon becomes CEO18
  15. May 2, 2011New chief executive Oort Douglas M. Van becomes CEO19
  16. 2002Founded Founded1

Calendar

Coming up

  1. Oct 28, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.05) a share, on Oct 28, 2025.91

When it reported results

  1. Oct 5, 2026Reported quarterly or annual results79
  2. Jul 28, 2026Reported quarterly or annual results81
  3. Apr 28, 2026Reported quarterly or annual results89
  4. Feb 17, 2026Reported quarterly or annual results90
  5. Jan 12, 2026Reported quarterly or annual results92
  6. Oct 28, 2025Reported quarterly or annual results93
  7. Jul 29, 2025Reported quarterly or annual results94
  8. Apr 29, 2025Reported quarterly or annual results95

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

Filings

381 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 67 major events, 224 insider forms, 34 large holders, 36 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Oct 5, 20268-K EDGAR
  3. Sep 3, 20264 EDGAR
  4. Aug 25, 20264 EDGAR
  5. Aug 25, 2026S-8 EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 11, 20268-K EDGAR
  8. Aug 6, 20264 EDGAR
  9. Aug 4, 2026144 EDGAR
  10. Jul 30, 2026SCHEDULE 13G/A EDGAR
  11. Jul 30, 2026144 EDGAR
  12. Jul 30, 2026SCHEDULE 13G EDGAR
  13. Jul 28, 202610-Q EDGAR
  14. Jul 28, 20268-K EDGAR
  15. Jul 22, 20268-K/A EDGAR
  16. Jul 20, 20268-K EDGAR
  17. Jun 25, 20264 EDGAR
  18. Jun 25, 20263 EDGAR
  19. Jun 25, 20268-K EDGAR
  20. Jun 22, 20268-K EDGAR

The 381 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

29 open-market trades by officers, directors and large owners since October 2021: 11 buys and 18 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 4, 2026Aunan Greg DChief Accounting OfficerSale20,000$16.07$321.4KForm 4
Jun 15, 2026TETRAULT LYNN A.DirectorSale5,307$11.10$58.9KForm 4
Jun 9, 2026TETRAULT LYNN A.DirectorSale5,307$11.29$59.9KForm 4
Jan 20, 2026Stone WarrenPres & Chief Operating OfficerSale22,128$12.50$276.6KForm 4
Nov 25, 2025Olivo Alicia CEVP, GC & Business DevelopmentSale20,916$12.00$251.0KForm 4
Oct 16, 2025Olivo Alicia CEVP, GC & Business DevelopmentSale4,918$10.00$49.2KForm 4
Aug 6, 2025Sherman Jeffrey ScottChief Financial OfficerBuy20,000$5.62$112.4KForm 4
Aug 6, 2025Zook Anthony P.Chief Executive OfficerBuy17,900$5.58$99.9KForm 4
May 27, 2025Kelly Michael AaronDirectorBuy5,000$7.60$38.0KForm 4
May 12, 2025Stone WarrenPres & Chief Operating OfficerBuy5,700$8.58$48.9KForm 4
May 9, 2025TETRAULT LYNN A.DirectorBuy7,000$8.14$57.0KForm 4
May 7, 2025KANOVSKY STEPHEN MDirectorBuy4,000$7.78$31.1KForm 4
May 6, 2025Zook Anthony P.Chief Executive OfficerBuy18,900$7.88$148.9KForm 4
May 5, 2025Perez David BrianDirectorBuy10,000$7.63$76.3KForm 4
May 5, 2025Gunn NeilDirectorBuy4,510$7.76$35.0KForm 4
May 2, 2025Sherman Jeffrey ScottChief Financial OfficerBuy20,000$7.51$150.2KForm 4
Nov 15, 2024Olivo Alicia CEVP, GC & Business DevelopmentSale5,175$15.36$79.5KForm 4
Aug 15, 2024Olivo Alicia CEVP, GC & Business DevelopmentSale1,040$16.05$16.7KForm 4
May 15, 2024Olivo Alicia CEVP, GC & Business DevelopmentSale1,049$15.74$16.5KForm 4
Mar 4, 2024TETRAULT LYNN A.DirectorSale6,112$15.97$97.6KForm 4

All 29 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
2025Tony ZookDirector and Chief Executive Officer$601.5K$9.1M110
2025Warren StoneChief Commercial Officer$630.1K$5.1M110
2025Jeffrey ShermanChief Financial Officer$603.7K$4.7M110
2025Christopher SmithFormer Director and Former Chief Executive Officer$311.0K$4.0M110
2025Alicia OlivoExecutive Vice President, General Counsel and Business Development$522.5K$3.0M110
2025Gary PassmanChief Culture Officer$448.0K$2.4M110
2024Christopher SmithFormer Director and Former Chief Executive Officer$1.0M$11.3M110
2024Jeffrey ShermanChief Financial Officer$540.3K$3.5M110
2024Warren StoneChief Commercial Officer$562.5K$3.2M110
2024Alicia OlivoExecutive Vice President, General Counsel and Business Development$512.7K$2.2M110
2023Christopher SmithFormer Director and Former Chief Executive Officer$1.0M$11.7M110
2023Jeffrey ShermanChief Financial Officer$525.0K$3.5M110
2023Warren StoneChief Commercial Officer$525.0K$3.0M110

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.20,868,362$304.5M0.0%+910,860
First Light Asset Management, LLC12,279,523$179.2M10.9%+2,549,545
First Trust Advisors LP10,113,261$147.6M0.1%+3,950,890
Greenhouse Funds LLLP8,574,210$125.1M6.6%−525,893
Vanguard Portfolio Management LLC8,061,362$117.6M0.0%+439,175
Vanguard Capital Management LLC5,763,017$84.1M0.0%+107,194
State Street Corp5,363,784$78.3M0.0%+243,946
Nomura Asset Management International Inc.5,037,787$73.5M0.1%+1,585,200
Braidwell LP4,918,202$71.8M2.8%−699,200
Schroder Investment Management Group4,342,883$61.9M0.0%+774,305
Geode Capital Management, LLC3,428,123$50.0M0.0%+197,051
Millennium Management LLC3,079,542$44.9M0.0%+856,785
Loomis Sayles & Co L P2,537,717$37.0M0.0%+592,329
Driehaus Capital Management LLC2,508,845$36.6M0.2%+787,095
Bank Of America Corp /de/2,436,329$35.5M0.0%−617,869
Dimensional Fund Advisors LP2,399,411$35.0M0.0%−274,924
Arrowstreet Capital, Limited Partnership2,391,784$34.9M0.0%New
American Capital Management Inc2,237,707$32.6M1.5%−13,171
D. E. Shaw & Co., Inc.2,194,758$32.0M0.0%−1,969,425
Samlyn Capital, LLC2,131,337$31.1M0.5%−426,012
Aberdeen Group plc1,931,525$28.2M0.0%−95,368
Morgan Stanley1,898,128$27.7M0.0%−264,655
Goldman Sachs Group Inc1,566,760$22.9M0.0%+563,137
Northern Trust Corp1,539,181$22.5M0.0%−41,646
Glenmede Trust Co Na1,517,586$22.1M0.1%+220,403

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

Members of Congress who traded it

6 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
Aug 7, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+4.3%Report
May 7, 2025Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+78.1%Report
Mar 30, 2022Dwight EvansDemocratic, HouseSale$1,001 - $15,000+35.1%Report
Dec 30, 2021Deborah K. RossDemocratic, HouseBuy$15,001 - $50,000−111.6%Report
Nov 9, 2021Bob Gibbs, HouseSale$1,001 - $15,000+125.4%Report
Mar 2, 2020Dwight EvansDemocratic, HouseBuy$1,001 - $15,000−191.2%Report

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

SEC filer profile

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

  • Name on EDGARNEOGENOMICS INC2
  • CIK0001077183
  • Employer ID (EIN)74-289736816
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company16
  • Incorporated inNevada16
  • Fiscal year endsDecember 312
  • Industry code (SIC)8734 Services-Testing Laboratories2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address9490 Neogenomics Way, Fort Myers, FL 339122
  • Phone23976806002
  • Shares outstanding128,475,440 as of Jul 24, 202614
  • Public float$680.2M as of Jun 30, 202516
  • AuditorDeloitte & Touche LLP, San Diego, California PCAOB ID 34; it also attests to the company’s internal control over financial reporting16
  • On EDGAR sinceFeb 10, 19992
  • Filings1,280 in all: 4 (510), 8-K (245), 3 (59), 10-Q (56), SC 13G/A (31), 10QSB (27), EFFECT (23), SC 13G (23)2
    All 55 form types

    S-8 (21), POS AM (20), 10-K (18), 424B3 (16), NT 10-Q (16), 144 (15), UPLOAD (15), 424B5 (14), DEF 14A (14), CORRESP (13), 8-K/A (11), DEFA14A (11), 4/A (10), SCHEDULE 13G/A (10), 10KSB (9), NT 10-K (8), SCHEDULE 13G (8), 5 (7), 10-K/A (5), ARS (5), S-3ASR (5), SB-2/A (5), SC 13D/A (5), SB-2 (4), 10-Q/A (3), 3/A (3), 424B7 (3), S-1 (3), S-1/A (3), S-3 (3), SC 13D (3), AW (2), CT ORDER (2), FWP (2), REGDEX (2), 10KSB/A (1), 424B8 (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), D (1), DEFM14A (1), DEFR14A (1), PRE 14A (1), PREM14A (1), REGDEX/A (1), RW (1)

  • Latest filingsAnnual report (10-K) Feb 17, 2026
    Quarterly report (10-Q) Jul 28, 2026
    Proxy statement (DEF 14A) Apr 6, 2026
    Latest 8-K (8-K) Oct 5, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Feb 17, 2026 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks NeoGenomics names in Item 1A of its 10-K filed Feb 17, 2026: 43 risks under these headings, as written.16

  • Risks Relating to Our Business and Operations
  • Risks Related to Our Common Stock and Indebtedness
  • Risks Relating to Government Regulation and Reimbursement
  • General Risk Factors
  • We are dependent on key personnel and need to hire additional qualified personnel in order for our business to succeed.
  • If we are unable to keep pace with the rapid scientific and technological change characteristic to our industry, or to develop, or acquire licenses for, new or improved testing technologies, our competitive position, business, results of operations, and financial condition could be harmed.
  • We face the risk of capacity constraints, which could have a material adverse effect on our business, results of operations, and financial condition.
  • If our products do not meet the expectations of our clients and patients, our reputation, business and operating results could suffer.
  • Increased competition, including price competition, could have a material adverse impact on our net revenues and profitability.
  • We expect to make significant investments in the development of new genetic and diagnostic tests and other future products. 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.
  • Ethical, legal and social concerns related to the use of genetic information could reduce demand for our tests.
  • The potential loss or delay of our material client contracts could adversely affect our results.
The other 35 risks
  • We may become involved in litigation, and our insurance may not sufficiently cover all claims brought against us, which will increase our expenses and may adversely affect our business and results of operations.
  • We may be unable to obtain, maintain or enforce our intellectual property rights and may be subject to intellectual property litigation that could adversely impact our business.
  • Our provision of laboratory testing and related services in support of sponsor-led clinical trials and research studies may expose us to contractual, operational, regulatory, or reputational risks, including risks related to data integrity, turnaround times, and compliance with applicable quality standards.
  • Other manufacturers may discontinue or recall testing products used in our business.
  • We depend substantially upon third parties for payment of services, which reliance could have a material adverse effect on our cash flows and results of operations.
  • Business disruptions, including due to natural disasters, power loss, break-ins, global conflicts, political unrest, or unstable economic and market conditions, could have a material adverse effect on our business, results of operations, financial condition, and stock price.
  • International trade disputes, including United States trade tariffs and retaliatory tariffs, could adversely impact our overall financial condition, results of operations, or cash flows.
  • We depend on third parties for our laboratory and research equipment and supplies. If these supplies or services become unavailable or are disrupted, we would have to seek alternate suppliers, and we may not be able to successfully perform our research, operate our business, or perform our tests on a timely basis.
  • We depend on our information technology systems and those of our third-party service providers and maintain protected personal data, and a cyber-attack or other breach affecting these information technology systems or protected data could have a material adverse effect on our business, reputation and results of operations.
  • Our current and potential future use of artificial intelligence and machine learning may not be successful and introduces emerging risks and challenges to our business.
  • Performance issues, service interruptions, or price increases by our shipping carrier could adversely affect our business, results of operations, and financial condition, and harm our reputation and ability to provide our specialized clinical services on a timely basis.
  • We use biological and hazardous materials that require considerable expertise and expense for handling, storage, or disposal and may result in claims against us.
  • If we are unable to successfully manage the implementation of our Laboratory Information Management System (“LIMS”), our business and results of operations may be adversely affected.
  • The price of our common stock has, and may continue to, fluctuate significantly.
  • Servicing our Convertible Notes requires a significant amount of cash. We may not have sufficient cash flow from our business to pay our obligations under the Convertible Notes, which could adversely affect our financial condition and operating results.
  • We may not have the ability to raise the funds necessary to settle conversions of the Convertible Notes in cash or to repurchase the Convertible Notes upon a fundamental change, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the Convertible Notes.
  • The capped call transactions may affect the value of the Convertible Notes and our common stock.
  • Conversion of the Convertible Notes may dilute the ownership interest of our existing stockholders or may otherwise adversely effect the market price of our common stock.
  • If the FDA were to begin to regulate Laboratory Developed Tests as medical devices, it could require us to conduct additional clinical trials and obtain regulatory approvals for our products, which could harm our business.
  • Healthcare reform efforts may impact our business and the pricing we receive for our services.
  • Changes in laws, regulations, contracting arrangements with payers, or payer policies, including steps taken by payers to control utilization and reimbursement of healthcare services, may adversely affect coverage or reimbursement for our specialized clinical services, which may decrease our revenues and adversely affect our results of operations and financial condition.
  • Failure to comply with laws and regulations regarding laboratory licensing and operations, including CLIA environmental, health, and safety laws and regulations such as the federal Occupational Safety and Health Administration Act and the Needlestick Safety and Prevention Act, could result in fines and penalties and loss of licensure, and have a material adverse effect upon our business.
  • Our net revenue will be diminished if payers do not adequately cover or reimburse our services.
  • Our operations are subject to strict laws prohibiting fraudulent billing and other abuse, and our failure to comply with such laws could result in substantial penalties, including exclusion from participation in Medicare, Medicaid, and other governmental payer programs.
  • The failure to comply with fraud and abuse laws, including physician self-referral laws and anti-kickback laws, may subject us to liability, penalties, or limitation of operations.
  • If our agreements or arrangements with certain of our licensed physicians and/or professional associations owned by physicians are deemed invalid under state corporate practice of medicine and similar laws or federal law, or are terminated as a result of changes in state law, it could have a material impact on our results of operations and financial condition.
  • Failure to comply with federal, state and international laws related to privacy and security could result in fines, penalties, and damage to the Company’s reputation with clients and could have a material adverse effect upon the Company’s business.
  • We may not be able to implement our business strategy, which could impair our ability to continue operations.
  • We may form strategic partnerships 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.
  • If we are unable to successfully integrate future acquisitions with our business, the anticipated benefits of such transactions may not be realized and our business, financial conditions, results of operations and cash flows may be adversely affected.
  • If goodwill and intangible assets that we recorded in connection with our acquisitions become impaired, we may have to take significant charges against earnings.
  • We may incur greater costs than anticipated in connection with implementing our business strategy, which could result in sustained losses.
  • We may face fluctuations in our results of operations and we are subject to seasonality in our business which could negatively affect our business operations.
  • The steps we have taken to protect our intellectual property and proprietary rights may not be adequate, which could result in infringement or misappropriation by third parties.
  • We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets.

Legal proceedings

From time to time the Company is engaged in legal proceedings, including proceedings that arise in the ordinary course of business. For further information on legal proceedings, please refer to Note 15. Commitments and Contingencies, in the notes to our Consolidated Financial Statements.

The opening of Item 3, Legal Proceedings.16

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