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Organization (Industry)

ILLUMINA, INC.

ClinicalTrials.gov lists ILLUMINA, INC. as lead sponsor of 15 trials, counting the companies grouped under it.

US Industry Manufacturer CIK 0001110803
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4 0 2009 2026

Trials started per year with this organization as sponsor or collaborator, 1990 onward. Companies grouped under this one are not included. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.

2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.0 trial starts a year over the five years to September, under the 5 a year the method needs.

Logo Illumina, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers ILLUMINA, INC. and 2 companies grouped under it: 15 lead-sponsored trials (12 its own, 3 in the grouped companies) and 9 legal-entity registrations (7 its own, 2 in the grouped companies).

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Companies grouped under this page (2)

Shown in this order: most lead trials first.

Companies grouped under this page
Company Lead trials Legal entities
Verinata Health, Inc. 3 0
ILLUMINA CAMBRIDGE LIMITED 0 2

Disease areas (121)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Anemia 2
Breast Neoplasms 2
Coronary Artery Disease 2
Coronary Disease 2
Diabetes Mellitus 2

Trials by start year as sponsor or collaborator (13)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2024 1
2023 4
2022 4
2021 3
2020 2
2019 1
2018 2
2017 2
2016 1
2014 1

Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Sponsor delivery record (1)

Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.

Sponsor delivery record
Enrollment Timeline
63% hit target (n=8) 25% on time (n=8)

Journals published in (27)

Shown in this order: most published in first.

Journals published in
Journal Publications
Fertility and sterility 5
Nature genetics 3
Journal of the American College of Cardiology 2
Lancet (London, England) 2
The New England journal of medicine 2

US granted patents (1)

Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.

US granted patents
US patents granted Granted in the last 5 years Most recent grant
1,366 612 2025-12-30

SEC-reported annual financials (9)

Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.

SEC-reported annual financials
Fiscal year Revenue (USD) Net income (USD) R&D (USD)
2025 4,343,000,000 850,000,000 967,000,000
2024 4,372,000,000 -1,223,000,000 1,169,000,000
2023 4,504,000,000 -1,161,000,000 1,354,000,000
2022 4,526,000,000 762,000,000 1,185,000,000
2021 3,239,000,000 656,000,000 682,000,000
2019 3,543,000,000 1,002,000,000 647,000,000
2018 3,333,000,000 826,000,000 623,000,000
2017 2,752,000,000 726,000,000 546,000,000
2016 2,220,000,000 462,000,000 401,000,000

Financing and grant events (39)

Shown in this order: most recent first.

Financing and grant events
Date Round type Amount (USD) Source
2026-04-28 Other financing not disclosed Sec extracted
2026-01-30 Other financing not disclosed Sec extracted
2025-11-25 Debt financing 500,000,000 Sec extracted
2025-11-12 Debt financing 499,810,000 Edgar offerings
2025-11-10 Other financing not disclosed Edgar offerings

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
NAI 7

FDA recalls (9)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205 Class II 2025-10-28
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software Class II 2023-04-05
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. Class II 2023-04-05
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx Class II 2022-05-03
illumina Model NextSeq 550 Dx REF 20005715 Class II 2022-05-03

Manufacturing and distribution sites (1)

Manufacturing and distribution sites
Facility Location Regulators Member organization
Illumina, Inc. San Diego, US FDA

Climate targets, as filed (1)

Climate targets, as filed
Reporting year Net-zero target
2025 2050

Workforce and board diversity, as filed (1)

Workforce and board diversity, as filed
Reporting year Workforce % women Board % women
2025 not disclosed not disclosed

Organization relationships (18)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
Duke University Co sponsors trial with 2
Government of the United States of America Co sponsors trial with 2
GeneDx Holdings Corp. Co sponsors trial with 1
Janssen (France) Co sponsors trial with 1
BIO-TECHNE Corp Co sponsors trial with 1

Latest dated events (1,447)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-04-28 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2026-01-30 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2025-12-30 Patent granted Granted US patents (PatentsView / USPTO)
2025-12-30 Patent granted Granted US patents (PatentsView / USPTO)
2025-12-23 Patent granted Granted US patents (PatentsView / USPTO)

CLIA clinical laboratory certificates (1)

CLIA clinical laboratory certificates
Lab Certificate Status
ILLUMINA LLC Certificate of waiver Terminated

Biomarker capability evidence (1,813)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
NTRK1 Diagnostics manufacturer FDA-authorized companion diagnostic
NTRK2 Diagnostics manufacturer FDA-authorized companion diagnostic
RET Diagnostics manufacturer FDA-authorized companion diagnostic
Diagnostics manufacturer FDA-authorized companion diagnostic
AAAS Testing lab / CRO (runs the assay) Clinical-testing interpretation submitted (ClinVar)

Not on this page

Checked, with nothing recorded for this organization: related companies not grouped here, active development programs, approved assets, fda warning letters, fda untitled letters, fda import refusals, and biomarkers this organization publishes on.