COMPANY
Fujirebio Diagnostics
Our portfolio includes the fully automated chemiluminescent immunoassay platform, Lumipulse, as well as the rapid diagnostic test series, ESPLINE. From company website Source · Oct 13, 2026
Timeline
- FDA FDA 510(k) clearance: ADVIA Centaur Cytokeratin Fragment 21-1 — K250925, Dec 16, 2025. Applicant at approval: Fujirebio Diagnostics,Inc. source ↗
- Partnership Partnership / licensing announced Jun 5, 2025. Source: company's own press page. source ↗
- FDA FDA 510(k) clearance: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — K242706, May 16, 2025. Applicant at approval: Fujirebio Diagnostics,Inc. source ↗
- Trial start —: Fertility in Healthy Premenopausal Women source ↗
- Trial start —: Blood Collection of Patient Presenting in the ED and Prescribed a BNP source ↗
- Trial start —: A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals source ↗
- Trial start —: Longitudinal Pancreatic Cancer Study source ↗
- Trial start —: A Prospective Longitudinal Breast Cancer Study source ↗
- Trial start —: Study Vitamin D in Healthy Individuals source ↗
- Trial start —: Blood Collection From Heart Failure Patients to Evaluate for Galectin-3 Measurement Differences Using Various Collection Tubes source ↗
- Trial start —: New Biomarkers Evaluating Ovarian Cancer source ↗
- Trial start —: A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell Lung Cancer source ↗
- Trial start —: Ovarian Cancer Risk Estimation in Patients With Pelvic Mass source ↗
- Trial start —: Multiple Biomarkers in Undiagnosed Pleural Effusion source ↗
- Trial start —: Risk of Ovarian Cancer in Patients With a Pelvic Mass source ↗
- Trial start —: Survivin Urine mRNA Assay Risk of Bladder Cancer Study source ↗
Funding
- Partnership / licensing announced Jun 5, 2025. Source: company's own press page. source ↗
Clinical trials (lead sponsor) 13
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT02250638 | Longitudinal Pancreatic Cancer Study | Not listed | Completed | 2014-05 | Jun 30, 2021 (actual) |
| NCT02270931 | A Prospective Longitudinal Breast Cancer Study | Not listed | Completed | 2014-05 | Jun 30, 2021 (actual) |
| NCT02614170 | A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals | Not listed | Completed | 2015-03 | 2016-06 (actual) |
| NCT02614209 | Blood Collection of Patient Presenting in the ED and Prescribed a BNP | Not listed | Completed | 2015-05 | 2016-08 (actual) |
| NCT02772848 | Fertility in Healthy Premenopausal Women | Not listed | Completed | 2016-04 | 2016-07 (actual) |
| NCT02250625 | Study Vitamin D in Healthy Individuals | Not listed | Completed | 2014-05 | 2015-04 (actual) |
| NCT01591512 | A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell Lung Cancer | Not listed | Terminated | 2011-05 | 2012-07 (actual) |
| NCT01466049 | New Biomarkers Evaluating Ovarian Cancer | Not listed | Completed | 2011-12 | 2014-03 (actual) |
| NCT01980862 | Blood Collection From Heart Failure Patients to Evaluate for Galectin-3 Measurement Differences Using Various Collection Tubes | Not listed | Completed | 2013-08 | 2013-11 (actual) |
| NCT00316134 | Multiple Biomarkers in Undiagnosed Pleural Effusion | Not listed | Terminated | 2006-03 | Not listed |
| NCT00315692 | Risk of Ovarian Cancer in Patients With a Pelvic Mass | Not listed | Completed | 2005-12 | Not listed |
| NCT00987649 | Ovarian Cancer Risk Estimation in Patients With Pelvic Mass | Not listed | Completed | 2009-10 | 2010-08 (actual) |
| NCT00315653 | Survivin Urine mRNA Assay Risk of Bladder Cancer Study | Not listed | Completed | 2005-09 | Not listed |
FDA records (last 2 years)
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