Organization (Industry)
BIOFIRE DIAGNOSTICS, LLC
ClinicalTrials.gov lists BIOFIRE DIAGNOSTICS, LLC as lead sponsor of 10 trials.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. 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 0.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers BIOFIRE DIAGNOSTICS, LLC: 10 lead-sponsored trials and 2 legal-entity registrations. Part of INSTITUT MERIEUX.
Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.
Disease areas (12)
Shown in this order: most trials first (counted at this company's own legal-entity record, not the consolidated group).
| Disease area | Trials |
|---|---|
| Dysentery | 2 |
| Emergencies | 2 |
| Arthritis, Infectious | 1 |
| Common Cold | 1 |
| Community-Acquired Pneumonia | 1 |
Showing 5 of 12 disease areas.
Trials by start year as sponsor or collaborator (9)
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
| Year | Trials started |
|---|---|
| 2022 | 1 |
| 2021 | 1 |
| 2020 | 1 |
| 2019 | 2 |
| 2018 | 1 |
| 2017 | 5 |
| 2016 | 3 |
| 2015 | 3 |
| 2014 | 1 |
Recruitment duration, a model prediction: none of the 10 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 5 |
FDA recalls (44)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic | Class II | 2026-06-24 |
| BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | Class II | 2026-04-22 |
| Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 | Class II | 2026-04-01 |
| BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) | Class II | 2025-10-22 |
| BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems | Class II | 2025-04-30 |
Showing 5 of 44 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 3 | 2020-04-23 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| BioFire Diagnostics, LLC | Salt Lake City, US | FDA |
Biomarker capability evidence (4)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CRP | Trial collaborator | Named in trial inclusion criteria |
| EDNRA | Trial sponsor | Named in trial inclusion criteria |
| CRP | Trial collaborator | Mentioned in trial text |
| EDNRA | Trial sponsor | Mentioned in trial text |
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, active development programs, approved assets, sponsor delivery record, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, and clia clinical laboratory certificates.
Counted at group level under Institut Mérieux (France): journals published in, us granted patents, latest dated events, and biomarkers this organization publishes on.