Sign in

IMDX on Nasdaq

Insight Molecular Diagnostics Inc.

In its 2026 annual report the company says: “We are a pioneering diagnostics technology company. We are developing molecular diagnostic test kits designed to empower our customers to run their own tests in-house to participate in the patient-care value chain, which is counter-positioned with the send-out-testing central laboratory model. Our initial targeted customer institutions are hospitals, transplant centers and labs.”5 It is headquartered in Sacramento, United States.2 Its shares trade on Nasdaq under the symbol IMDX.2

$2.95 up 0.16 (5.73%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

Compare with BIOMERICA INC, Anbio Biotechnology or Aspira Women's Health Inc., or pick any stock.

  • TickerIMDX on Nasdaq2
  • IndustryIn Vitro & In Vivo Diagnostic Substances2
  • HeadquartersSacramento, United States2
  • Incorporated inCA4
  • Business address2 International Plaza Dr., Suite 510, Nashville, Tn 372174
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation2
  • LEI549300BIYAW8GO4102872
  • StatusActive2
  • LEI statusIssued and current2
  • Registered addressc/o KOY SAECHAO, 2710 GATEWAY OAKSDRIVE, 95833 Sacramento, United States2
  • Registered withSecretary of State, 32317382

See how the biggest companies compare on our leaderboards

We are a pioneering diagnostics technology company. Our mission is to expand access to novel molecular diagnostic testing, most immediately in the transplanted organ rejection testing category.5 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

56.7%Gross margin6
-1260.8%Operating margin6
-1238.5%Net margin6
115.6%Revenue growth, 20256
-$25.4MFree cash flow6

What sells

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

Products and services

Laboratory Services brought in 99% of the revenue Insight Molecular Diagnostics Inc. broke down this way in fiscal 2025.

  1. Laboratory Services$4.0M699%up 117% from 2024
  2. Kitted Products$24.0K61%
Products and services by year
Products and services20242025
Laboratory Services$1.9M$4.0M
Kitted Products$0$24.0K

Regions

United States brought in 99% of the revenue Insight Molecular Diagnostics Inc. broke down this way in fiscal 2025.

  1. United States$4.0M699%up 141% from 2024
  2. Europe$24.0K61%up 33% from 2024
Regions by year
Regions20242025
United States$1.7M$4.0M
Europe$18.0K$24.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue10¢$1.8M
  • Research and development90¢$15.9M

Out of $4.1M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$4.1M in 2025+233% since 2020
0$2.0M$4.0M$6.0M2020: $1.2M$1.2M20202021: $2.2M$2.2M2021+81%2022: $958.0K$958.0K2022−56%2023: $1.5M$1.5M2023+57%2024: $1.9M$1.9M2024+25%2025: $4.1M$4.1M2025+116%
Gross profit789106$2.3M in 2025
-$1.0M0$1.0M$2.0M$3.0M2020: -$639.0K-$639.0K20202021: $1.4M$1.4M20212022: -$18.0K-$18.0K20222023: $413.0K$413.0K20232024: $740.0K$740.0K2024+79%2025: $2.3M$2.3M2025+211%
Operating income11789106-$51.1M in 2025+130% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$22.2M-$22.2M20192020: -$29.7M-$29.7M2020+34%2021: -$53.7M-$53.7M2021+81%2022: -$18.0M-$18.0M2022−67%2023: -$25.1M-$25.1M2023+40%2024: -$61.0M-$61.0M2024+143%2025: -$51.1M-$51.1M2025−16%
Net income11789106-$50.2M in 2025+124% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$22.4M-$22.4M20192020: -$29.9M-$29.9M2020+33%2021: -$64.1M-$64.1M2021+114%2022: -$72.9M-$72.9M2022+14%2023: -$27.8M-$27.8M2023−62%2024: -$60.7M-$60.7M2024+118%2025: -$50.2M-$50.2M2025−17%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Net revenue$4.1M$1.9M
Cost of revenues$1.8M$1.1M
Cost of revenues amortization of acquired intangibles$7.0K$88.0K
Gross profit$2.3M$740.0K
Research and development$15.9M$9.8M
Sales and marketing$6.3M$3.9M
General and administrative$10.6M$10.2M
Change in fair value of contingent consideration$5.9M-$4.3M
Impairment losses$14.6M$41.9M
Impairment loss on held for sale assets$0$169.0K
Total operating expenses$53.4M$61.8M
Loss from operations-$51.1M-$61.0M
Interest expense-$109.0K-$84.0K
Other income, net$1.0M$462.0K
Total other income, net$902.0K$378.0K
Loss before income taxes-$50.2M-$60.7M
Income taxes$0$0
Net loss-$50.2M-$60.7M
Net loss attributable to common stockholders - basic-$50.2M-$60.9M
Net loss attributable to common stockholders - diluted-$50.2M-$60.9M
Net loss attributable to common stockholders per share - basic-$1.65-$4.66
Net loss attributable to common stockholders per share - diluted-$1.65-$4.66
Weighted average shares outstanding - basic30.5M shares13.1M shares
Weighted average shares outstanding - diluted30.5M shares13.1M shares

Compare Insight Molecular Diagnostics Inc. with another company

Corporate structure

Insight Molecular Diagnostics Inc. 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 Insight Molecular Diagnostics Inc.

  • BROADWOOD PARTNERS, L.P. Filed SCHEDULE 13D/A on Insight Molecular Diagnostics Inc., latest Apr 27, 2026 (7 filings since Apr 15, 2022)
  • AWM Investment Company, Inc. Filed SCHEDULE 13G/A on Insight Molecular Diagnostics Inc., latest May 9, 2025 (4 filings since Feb 14, 2023)
  • Bio-Rad Laboratories Filed SCHEDULE 13G/A on Insight Molecular Diagnostics Inc., latest Mar 4, 2025 (3 filings since Apr 22, 2024)
  • Patrick W. Smith Filed SCHEDULE 13G/A on Insight Molecular Diagnostics Inc., latest Dec 27, 2024 (3 filings since Oct 9, 2024)
  • PURA VIDA INVESTMENTS, LLC Filed SC 13G on Insight Molecular Diagnostics Inc., latest Nov 14, 2024 (5 filings since Feb 14, 2023)
  • Norfield Capital LLC Filed SC 13G on Insight Molecular Diagnostics Inc., latest Nov 25, 2022
  • BlackRock Filed SC 13G on Insight Molecular Diagnostics Inc., latest May 9, 2022 (2 filings since Feb 4, 2022)
  • Halle Special Situations Fund LLC Filed SC 13G on Insight Molecular Diagnostics Inc., latest Apr 18, 2022
  • Insight Molecular Diagnostics Inc. Sacramento, 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 Insight Molecular Diagnostics 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
Machinery and equipment$12.5M6 Dec 31, 2025$8.4M6 Dec 31, 2024+49.6%
Construction in progress$765.0K6 Dec 31, 2025$340.0K6 Dec 31, 2024+125.0%
Accumulated depreciation$9.7M6 Dec 31, 2025$7.7M6 Dec 31, 2024+25.3%
Property and equipment, net$9.2M6 Dec 31, 2025$6.3M6 Dec 31, 2024+46.3%
Finance-lease assets$2.8M10 Dec 31, 2024$1.6M10 Dec 31, 2023+68.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$11.6M6 Dec 31, 2025$8.6M6 Dec 31, 2024+34.1%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$06 Dec 31, 2025$14.6M6 Dec 31, 2024−100.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$446.0K6 Dec 31, 2025$410.0K6 Dec 31, 2024+8.8%
Finished goods$78.0K6 Dec 31, 2025$203.0K6 Dec 31, 2024−61.6%

Properties, in its own words

Our principal executive and administrative offices and our CLIA-certified laboratory are located in the Nashville, Tennessee area under multiple lease arrangements. We maintain an aggregate of 12,881 square feet of rentable space in the Nashville area with expiration dates through September 2028. Lab space represents approximately 6,586 square feet of the total rentable space in the Nashville area.

We also have a research and development laboratory and office space located in Göttingen, Germany, under multiple lease arrangements. We maintain an aggregate of 3,455 square feet of rentable space in Germany with expiration dates through September 2030. Lab space represents approximately 2,077 square feet of the total rentable space in Germany.

The rest of Item 2

Our former principal executive and administrative offices were located in Irvine, California under a 26,800 square feet lease that expires on October 31, 2027. Effective in September 2023, we entered into a sublease agreement with a subtenant to initially sublet approximately 13,400 square feet. In June 2025, the portion of the Irvine lease that was subleased automatically increased to include the remaining portion of the premises, which consists of approximately 13,400 square feet for a term that will continue to the expiration of the Irvine lease on October 31, 2027. The sublease agreement is subject and subordinate to the Irvine lease. In June 2025, in connection with the subtenant's full usage of the Irvine premises, we relocated our offices to Nashville, Tennessee.

See Note 6, “Commitments and Contingencies – Office and Facilities Leases,” to our consolidated financial statements included elsewhere in this Report for additional information regarding our lease arrangements and properties.

Item 2 of the 10-K filed Mar 26, 2026.5

Leadership

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

Chief executive

  1. William Annett2015–2019
  2. Ronald Asbury Andrews2019–2022
  3. Josh Riggs2022–now

President

  1. William Annett2015–2019
  2. Ronald Asbury Andrews2020–2022
  3. Gisela Paulsen2022
  4. Josh Riggs2023–now

Chief financial officer

  1. Russell Skibsted2015
  2. Mitchell S. Levine2017–2022
  3. Anish M. John2022–2023
  4. Andrea S. James2024–now

Chief operating officer

  1. Gisela Paulsen2021–2022
20202025
Board members and other officers (20)

Former names

  • OncoCyte CorpFeb 6, 2020 to Jun 17, 20254

Timeline

  1. Sep 21, 20268-K Entered a material agreement43
  2. Aug 10, 20268-K Results of operations; Regulation FD disclosure; Other events44
  3. Jun 17, 20268-K Executive or director change; Shareholder vote45
  4. May 13, 20268-K Other events46
  5. May 13, 20268-K Results of operations47
  6. Apr 30, 20268-K Other events48
  7. Mar 26, 20268-K Results of operations49
  8. Feb 26, 20268-K Entered a material agreement50
  9. Feb 12, 20268-K Entered a material agreement; Other events51
  10. Feb 11, 20268-K Regulation FD disclosure52
  11. Nov 10, 20258-K Results of operations53
  12. Oct 2, 20258-K Executive or director change54
  13. Dec 9, 2022New chief executive Josh Riggs becomes CEO14
  14. Jul 3, 2019New chief executive Ronald Asbury Andrews becomes CEO15
  15. Dec 30, 2015New chief executive William Annett becomes CEO16
  16. Sep 30, 2009Founded Insight Molecular Diagnostics Inc. is founded2

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/202655

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results44
  2. May 13, 2026Reported quarterly or annual results47
  3. Mar 26, 2026Reported quarterly or annual results49
  4. Nov 10, 2025Reported quarterly or annual results53
  5. Aug 11, 2025Reported quarterly or annual results56
  6. May 12, 2025Reported quarterly or annual results57
  7. Mar 24, 2025Reported quarterly or annual results58
  8. Nov 12, 2024Reported quarterly or annual results59

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

Filings

299 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 83 major events, 117 insider forms, 26 large holders, 3 private raises, 48 other. The latest 20:

  1. Sep 21, 20268-K EDGAR
  2. Aug 10, 202610-Q EDGAR
  3. Aug 10, 20268-K EDGAR
  4. Jul 24, 2026S-8 EDGAR
  5. Jul 6, 20264 EDGAR
  6. Jul 6, 20264 EDGAR
  7. Jul 6, 20264 EDGAR
  8. Jun 17, 20268-K EDGAR
  9. Jun 15, 20264 EDGAR
  10. Jun 15, 20264 EDGAR
  11. Jun 15, 20264 EDGAR
  12. May 13, 202610-Q EDGAR
  13. May 13, 20268-K EDGAR
  14. May 13, 20268-K/A EDGAR
  15. Apr 30, 2026ARS EDGAR
  16. Apr 30, 2026DEFA14A EDGAR
  17. Apr 30, 2026DEF 14A EDGAR
  18. Apr 30, 20268-K EDGAR
  19. Apr 27, 2026SCHEDULE 13D/A EDGAR
  20. Apr 27, 20264 EDGAR

The 299 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

50 open-market trades by officers, directors and large owners since October 2021: 48 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Apr 27, 2026BROADWOOD PARTNERS, L.P.10% ownerBuy250,923$3.64$913.4KForm 4
Apr 24, 2026BROADWOOD PARTNERS, L.P.10% ownerBuy38,880$3.53$137.2KForm 4
Apr 23, 2026BROADWOOD PARTNERS, L.P.10% ownerBuy280,381$3.50$981.3KForm 4
Apr 20, 2026BROADWOOD CAPITAL INC10% ownerBuy40,690$3.88$157.9KForm 4
Apr 17, 2026BROADWOOD CAPITAL INC10% ownerBuy40,114$3.57$143.2KForm 4
Apr 16, 2026BROADWOOD CAPITAL INC10% ownerBuy102,057$3.45$352.1KForm 4
Feb 10, 2026Bradsher Neal C10% ownerBuy521,739$5.75$3.0MForm 4
Feb 7, 2025James Andrea S.Chief Financial OfficerBuy97,561$2.05$200.0KForm 4
Feb 7, 2025SMITH PATRICK W10% ownerBuy1,077,600$2.05$2.2MForm 4
Feb 6, 2025BROADWOOD PARTNERS, L.P.10% ownerBuy5,165,695$2.05$10.6MForm 4
Feb 4, 2025SMITH PATRICK W10% ownerBuy25$2.02$50Form 4
Jan 31, 2025SMITH PATRICK W10% ownerBuy890$2.01$1.8KForm 4
Jan 30, 2025SMITH PATRICK W10% ownerBuy318$2.01$639Form 4
Jan 29, 2025SMITH PATRICK W10% ownerBuy3,880$2.01$7.8KForm 4
Jan 14, 2025SMITH PATRICK W10% ownerBuy10,386$2.15$22.3KForm 4
Jan 13, 2025SMITH PATRICK W10% ownerBuy5,669$2.08$11.8KForm 4
Dec 26, 2024SMITH PATRICK W10% ownerBuy90,219$2.13$192.2KForm 4
Dec 26, 2024Arno AndrewDirectorBuy12,500$2.11$26.4KForm 4
Dec 5, 2024James Andrea S.Chief Financial OfficerBuy20,000$2.29$45.8KForm 4
Oct 2, 2024James Andrea S.Chief Financial OfficerBuy33,670$2.97$100.0KForm 4

All 50 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
2025Joshua Riggs44$472.3K$2.6M68
2025Andrea James44$367.4K$1.7M68
2025James Liu31$221.8K$455.0K68
2024President & Chief Executive Officer$385.0K$786.1K68
2024Chief Financial Officer$175.2K$758.9K68
2024VP of AccountingController, Treasurer & PAO$204.5K$303.9K68

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Feb 10, 2025Raised $21.7 million in a private offering of equity Form D: 12 investors so far Form D
  2. Oct 2, 2024Raised $10.2 million in a private offering of equity Form D: 16 investors so far Form D
  3. Apr 11, 2024Raised $15.8 million in a private offering of equity Form D: 21 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 39. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Broadwood Capital Inc12,684,884$74.8M3.9%+753,045
AWM Investment Company, Inc.2,836,692$16.7M1.5%+30,436
Vanguard Capital Management LLC735,847$4.3M0.0%+198,686
Pura Vida Investments, LLC484,845$2.9M7.7%−462,289
Family Office Research LLC368,849$2.2M0.8%+241,583
Geode Capital Management, LLC256,903$1.5M0.0%−5,150
Jane Street Group, LLC157,682$930.3K0.0%New
BlackRock, Inc.150,521$888.1K0.0%+15,176
Vanguard Fiduciary Trust Co124,576$735.0K0.0%−8,015
State Street Corp92,124$543.5K0.0%+41,370
Millennium Management LLC82,499$486.7K0.0%−20,971
UBS Group AG53,276$314.3K0.0%+30,525
Northern Trust Corp49,090$289.6K0.0%No change
Osaic Holdings, Inc.39,136$230.9K0.0%+15,001
Morgan Stanley35,515$209.5K0.0%−573
Jefferies Financial Group Inc.18,100$106.8K0.0%New
Marshall Wace, Llp16,597$97.9K0.0%New
ExodusPoint Capital Management, LP14,029$82.8K0.0%New
Axq Capital, LP13,407$79.1K0.0%New
Flatrock Wealth Partners LLC13,044$77.0K0.0%No change
Two Sigma Investments, LP11,101$65.5K0.0%New
XTX Topco Ltd10,743$63.4K0.0%−19,610
Private Advisor Group, LLC10,416$61.5K0.0%No change
Bnp Paribas Financial Markets5,801$34.2K0.0%+5,737
Vanguard Global Advisers, LLC5,775$34.1K0.0%No change

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

SEC filer profile

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

  • Name on EDGARInsight Molecular Diagnostics Inc.1
  • CIK0001642380
  • Employer ID (EIN)27-10415635
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inCalifornia5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2835 In Vitro & In Vivo Diagnostic Substances1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2 International Plaza Dr., Suite 510, Nashville, TN 372171
  • Phone949-409-76001
  • Shares outstanding32,724,284 as of Aug 3, 202613
  • Public float$32.4M as of Jun 30, 20255
  • AuditorCBIZ CPAs P.C., Costa Mesa, CA PCAOB ID 199; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceMay 14, 20151
  • Filings688 in all: 4 (214), 8-K (178), 3 (34), 10-Q (32), SC 13D/A (21), 424B5 (19), UPLOAD (15), CORRESP (14)1
    All 45 form types

    DEF 14A (13), SC 13G (12), 10-K (11), DEFA14A (10), EFFECT (10), 4/A (9), D (9), SC 13G/A (9), S-3 (8), 10-K/A (7), S-8 (7), 424B3 (6), 8-K/A (6), PRE 14A (6), SCHEDULE 13G/A (4), SCHEDULE 13D/A (3), 10-12B/A (2), ARS (2), CT ORDER (2), NT 10-K (2), PRE 14C (2), S-1 (2), S-1/A (2), S-3/A (2), SC 13D (2), SEC STAFF LETTER (2), 10-12B (1), 10-12G (1), 25 (1), 8-A12B (1), CERT (1), CERTNYS (1), DEF 14C (1), DEFR14A (1), PRER14A (1), RW (1), S-3MEF (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Sep 21, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, no par valueIMDXNasdaq

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Insight Molecular Diagnostics Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 53 risks under these headings, as written.5

  • Risks Related to Our Capital Resources
  • We have incurred operating losses since inception, and we do not know if we will attain profitability.
  • We have historically been dependent upon outside financing capital to fund our operations and until such time as our revenues are sufficient to finance our operating expenses, we may need to issue additional equity or debt securities to raise the capital needed to pay our operating expenses.
  • We may incur significant cash payment and common stock issuance obligations under our agreements arising from our investments in IGI and Chronix.
  • Risks Related to Our Business Operations
  • Our revenues in the near term will depend on our ability to commercialize a small number of diagnostic tests.
  • The research and development work we are doing is costly, time consuming, and uncertain as to its results.
  • Increased competition from, and technological advances by, our competitors could negatively affect our operating results.
  • Sales of our diagnostic tests could be adversely impacted by the reluctance of physicians to adopt the use of our tests and by the availability of competing diagnostic tests.
  • Defects, failures or quality issues associated with our products could lead to product recalls or safety alerts, adverse regulatory actions, product liability lawsuits and other litigation and negative publicity. If we are unable to obtain or maintain sufficient insurance, a product liability claim against us could adversely affect our business.
  • We have limited capital, marketing, sales, and regulatory compliance resources for the commercialization of our diagnostic tests.
  • We may face technology transfer challenges and expenses in adding new tests to our portfolio and in expanding our reach into new geographical areas on new instrument platforms.
The other 43 risks
  • If our laboratory facilities become damaged or inoperable, or we are required to vacate any facility, our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized.
  • There is a limited number of manufacturers of molecular diagnostic testing equipment and related chemical reagents necessary for the provision of our diagnostic tests.
  • If we fail to enter into and maintain successful strategic alliances for diagnostic tests that we elect to co-develop, co-market, or out-license, we may have to reduce or delay our diagnostic test development or increase our expenditures.
  • We are, and may become, dependent on collaborations to develop and commercialize our diagnostic test candidates and to provide the manufacturing, regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.
  • Our business could be adversely affected if we lose the services of the key personnel upon whom we depend.
  • Our business and operations could suffer in the event of system failures.
  • Security breaches and other disruptions could compromise our information and expose us to liability, and could cause our business and reputation to suffer.
  • Failure of our internal control over financial reporting could harm our business and financial results.
  • We are subject to laws and regulations governing corruption, which may require us to develop, maintain, and implement costly compliance programs.
  • We may become subject to litigation, which could harm our stock price, business, results of operations and financial condition.
  • We may undertake strategic acquisitions in the future, and difficulties integrating such acquisitions could damage our ability to achieve or sustain profitability.
  • Our business could be adversely impacted by inflation.
  • Risks Related to Our Industry
  • Our operations as a clinical laboratory in the United States are subject to oversight by CMS under CLIA, as well as certain state agencies, and our operation of clinical laboratories in any foreign jurisdictions are subject to similar regulatory oversight. Any failure to maintain our CLIA or applicable state or international permits and licenses may affect our ability to commercialize our diagnostic tests.
  • While we believe our LDTs are within the scope of the FDA’s enforcement discretion policy, and therefore not required to obtain clearance or approval before commercialization, the FDA may attempt to regulate LDTs in the future, which could lead to LDT product development delays and increased costs.
  • We currently market certain IVDs for RUO that have not been cleared by the FDA in reliance on the regulatory exemption for IVDs intended for RUO, but if the FDA determines that our RUO tests do not meet the applicable requirements for exemption or have intended uses that are inconsistent with RUO tests, we may be required to suspend commercialization of such products until we can obtain the requisite FDA clearance and/or subject to FDA warning or untitled letters, seizure, injunction, fines, or other enforcement action.
  • We will need to obtain FDA and other regulatory approvals for any IVDs that we may develop in order to market those IVD tests, and we may not be able to obtain those regulatory approvals in a timely manner or at all.
  • Our ability to commercialize our products is dependent on availability and sufficiency of third-party payer coverage and our ability to ensure our tests remain reimbursed or attain reimbursement by Medicare, and the loss of, or a significant reduction in, reimbursement from Medicare or the CMS would have a material adverse impact on our business.
  • Clinical trial failures can occur at any stage of the testing and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of our current or future diagnostic tests.
  • Changes in healthcare laws and policies may have a material adverse effect on our financial condition, results of operations and cash flows.
  • Because of certain Medicare billing policies, we may not receive complete reimbursement for tests provided to Medicare patients.
  • Long payment cycles of Medicare, Medicaid and other third-party payers, or other payment delays, could hurt our cash flows and increase our need for working capital.
  • Private health insurance company policies may deny coverage or limit reimbursement for the performance of our diagnostic tests.
  • We will be required to comply with federal and state laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.
  • We are subject to numerous federal and state statutes and regulations pertaining to our business and are subject to government oversight and scrutiny for our compliance with such laws. Laboratory and health care regulatory compliance efforts are expensive and time-consuming, and failure to maintain compliance with applicable laws could result in enforcement action which could be detrimental to our business.
  • Tariff policies and potential countermeasures could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations.
  • Risks Related to Intellectual Property
  • We rely on patents and trade secrets, and our financial success will depend, in part, on our ability to obtain commercially valuable patent claims, protect our intellectual property rights and operate without infringing upon the proprietary rights of others.
  • We may not be able to obtain patent protection for our diagnostic tests if our pending U.S. patent applications are found to be directed to unpatentable subject matter.
  • Changes to the patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our diagnostic tests.
  • Other companies or organizations may challenge our patent rights or may assert patent rights that prevent us from developing and commercializing our diagnostic tests.
  • 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 would be harmed.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our diagnostic tests.
  • Failure to adequately protect, or disputes relating to, trademarks or patents, could harm our business.
  • Patent terms may be inadequate to protect our competitive position on our diagnostic tests for an adequate amount of time.
  • Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements.
  • Risks Related to Our Common Stock
  • The trading price of our common stock is highly volatile, and purchasers of our common stock could incur substantial losses.
  • Because we do not pay dividends, our stock may not be a suitable investment for anyone who needs to earn dividend income.
  • Securities analysts may not initiate coverage or continue to cover our common stock, and this may have a negative impact on the market price of our shares.
  • You may experience dilution of your ownership interests if we issue additional shares of common stock or preferred stock.
  • We are a “smaller reporting company” under the SEC’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.
  • Failure to establish and maintain adequate finance infrastructure and accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.
  • Failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common stock.

Legal proceedings

From time to time, we may be involved in routine litigation incidental to the conduct of our business. We are not presently involved in any material pending litigation or proceedings. See Note 6, “Commitments and Contingencies – Litigation – General,” to our consolidated financial statements included elsewhere in this Report for additional information.

The opening of Item 3, Legal Proceedings.5

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
    Yahoo FinanceIMDX quote
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
    SEC EDGAROther events
  47. 47
  48. 48
    SEC EDGAROther events
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68