BioFire Diagnostics
BioFire Diagnostics, a wholly-owned subsidiary of bioMérieux SA, develops FDA-cleared multiplex PCR syndromic testing systems (FilmArray and SPOTFIRE) and panels that deliver infectious disease diagnostics in about one hour to hospital laboratories, reference labs, urgent care centers, and government/defense customers worldwide.
- Company typePrivate
- Founded2001
- HeadquartersSalt Lake City, United States
- Headcount501–1,000
- GTM typeB2B
- OfferingHardware or Manufacturing
What BioFire Diagnostics does
BioFire Diagnostics, LLC is a wholly-owned subsidiary of bioMérieux SA (Euronext: BIM) and operates as bioMérieux's Global Center of Excellence for Molecular Diagnostics, headquartered in Salt Lake City, Utah with 1,001–5,000 employees. The company develops and commercializes multiplex PCR-based syndromic infectious disease testing on the BIOFIRE FilmArray System, including the FilmArray 2.0, FilmArray Torch, and the 2024-launched SPOTFIRE point-of-care platform. BioFire sells a menu of FDA-cleared and IVDR-conformant assay panels covering respiratory, blood culture identification, gastrointestinal, meningitis/encephalitis, pneumonia, and joint infection syndromes, plus specialty panels (tropical fever, veterinary, defense).
The company monetizes via a razor-and-blade model: instruments are placed with limited nontransferable licenses while the proprietary single-use pouches (sold in 6-pack and 30-pack formats) generate recurring consumable revenue across hospital labs, reference labs, urgent care centers, and government/defense customers. Go-to-market combines enterprise field sales to hospital systems, inside sales and quote-based pricing, technical/customer support infrastructure, and clinical education programs (P.A.C.E., ACCME-accredited CME). Distribution is global, leveraging bioMérieux's commercial scale in the U.S., EU, and international markets.
In 2025, BioFire rebranded from a corporate subsidiary to a product franchise brand under the unified bioMérieux identity ("BF to bMx Transition"), consolidating brand architecture while preserving the FilmArray and SpotFire product lines, the Syndromic Trends data service, VILINK cloud connectivity, and FIREWORKS analytics. The intellectual property estate is broad, with granted U.S. and foreign patents across instruments and panels, supporting a defensible regulatory and technology moat in syndromic molecular diagnostics.
BioFire Diagnostics firmographics
Firmographics- Name
- BioFire Diagnostics
- Legal name
- BioFire Diagnostics, LLC
- Website
- https://biofiredx.com
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 501–1,000 employees
- Short description
- BioFire Diagnostics, a wholly-owned subsidiary of bioMérieux SA, develops FDA-cleared multiplex PCR syndromic testing systems (FilmArray and SPOTFIRE) and panels that deliver infectious disease diagnostics in about one hour to hospital laboratories, reference labs, urgent care centers, and government/defense customers worldwide.
- Ownership category
- akta.pro rank
BioFire Diagnostics industry classification
Industry- Product category
- Molecular Diagnostics — Syndromic Infectious Disease Testing
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC)
- akta.pro secondary industries
- Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Multiplex Syndromic POCT Panels (Respiratory/GI/meningitis panels) (HLAHAOAJ)
Keywords
Where BioFire Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Salt Lake City
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
BioFire Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Instrument Systems: Sale of BIOFIRE System instruments including FilmArray 2.0, Torch System, and SpotFire System. Instruments are sold to clinical laboratories and healthcare facilities with associated limited, nontransferable instrument licenses.
- Diagnostic Panels and Consumables: Recurring revenue from sale of FDA-cleared assay panels (pouches/kits) including Respiratory 2.1, Blood Culture Identification 2, Gastrointestinal, Meningitis/Encephalitis, Pneumonia, and Joint Infection panels. Panels are sold in pack sizes (6-pack, 30-pack) and require ongoing purchase for each test performed.
- Service and Support: Technical support, customer service, and product support including extended warranty plans, standard limited warranties, and ongoing customer technical support for instrument maintenance and troubleshooting.
- Licensing Royalties: Purchase of instruments and kits includes limited, nontransferable licenses under specific claims of U.S. patents and foreign counterparts for use according to specified protocols.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Quote-based pricing for healthcare providers |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels7 records
BioFire Diagnostics product offering
Product offeringCore offering
BioFire Diagnostics manufactures and sells multiplex PCR-based syndromic infectious disease testing systems — the BIOFIRE FILMARRAY System (including FilmArray 2.0 and Torch instruments) and the BIOFIRE SPOTFIRE point-of-care system — together with FDA-cleared single-use assay panels (respiratory, blood culture ID, gastrointestinal, meningitis/encephalitis, pneumonia, joint infection) and supporting connectivity/data software. Instruments are sold or licensed to clinical laboratories and hospitals, with recurring revenue from consumable pouches required for every test.
Product overview
BioFire Diagnostics, now operating as a product franchise brand under bioMérieux, offers the BIOFIRE FilmArray System as its core molecular diagnostics platform for syndromic infectious disease testing. The portfolio consists of the FilmArray System (including FilmArray 2.0 and FilmArray Torch instruments), the SPOTFIRE System for point-of-care testing, and multiple FDA-cleared multiplex PCR panels (Respiratory 2.1, Respiratory EZ, Blood Culture ID 2, Gastrointestinal, Meningitis/Encephalitis, Pneumonia, Joint Infection). The company also provides connectivity solutions (VILINK cloud platform, FilmArray Link LIS software), data services (BioFire Syndromic Trends), and specialized offerings for veterinary (VETFIRE) and defense (BioFire Defense) markets. All products leverage multiplex PCR technology for comprehensive syndromic testing with results in approximately one hour.
Differentiator
Problem solved
Functional benefit
Brands
- BIOFIRE FILMARRAY: Multiplex PCR syndromic testing system for infectious disease diagnostics
- BIOFIRE SPOTFIRE
- WATCHFIRE
- VETFIRE
- VILINK
Products and services
- BIOFIRE FILMARRAY System Multiplex PCR-based syndromic testing platform that delivers infectious disease diagnostic results in approximately one hour with about two minutes of hands-on time, used by clinical laboratories and hospitals to test for multiple pathogens simultaneously.
- BIOFIRE SPOTFIRE System A compact, FDA-cleared molecular diagnostics platform for rapid syndromic infectious disease testing at point-of-care settings such as urgent care centers, outpatient clinics, and physician offices.
- BioFire Respiratory 2.1 (RP2.1) Panel FDA-cleared multiplex PCR panel run on the BIOFIRE FILMARRAY System to detect viruses and bacteria causing respiratory infections in approximately one hour.
- BioFire Respiratory EZ Panel Streamlined multiplex respiratory pathogen panel for the FilmArray System, designed for simpler workflow and faster adoption in routine testing.
- BioFire Blood Culture Identification 2 (BCID2) Panel FDA-cleared multiplex PCR panel for the FilmArray System that identifies bacteria, yeasts, and antimicrobial resistance genes from positive blood cultures to support sepsis management.
- BioFire Gastrointestinal (GI) Panel FDA-cleared multiplex PCR panel for the FilmArray System that detects viruses, bacteria, parasites, and yeasts causing gastroenteritis from a single stool sample.
- BioFire Meningitis/Encephalitis (ME) Panel FDA-cleared multiplex PCR panel for the FilmArray System that detects bacteria, viruses, and fungi causing meningitis and encephalitis from cerebrospinal fluid.
- BioFire Pneumonia Panel FDA-cleared multiplex PCR panel for the FilmArray System that detects respiratory bacteria and antibiotic resistance markers associated with pneumonia from sputum or bronchoalveolar lavage samples.
- BioFire Joint Infection (JI) Panel FDA-cleared multiplex PCR panel for the FilmArray System that detects bacteria and fungi causing joint infections from synovial fluid.
- BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel FDA-cleared multiplex panel for the SPOTFIRE point-of-care System that simultaneously tests for respiratory pathogens and sore throat pathogens.
- BioFire Syndromic Trends Epidemiological data service that aggregates and analyzes syndromic testing results from BIOFIRE Systems to deliver population-level infectious disease trend insights for healthcare systems and public health.
- VILINK Connectivity Solution Cloud connectivity solution for BIOFIRE Systems that enables remote system monitoring, data management, and over-the-air system updates across deployed FilmArray and SPOTFIRE instruments.
- BIOFIRE FilmArray Link Software Software that enables bidirectional integration of FilmArray systems with laboratory information systems (LIS) for automated result transmission and workflow management.
- BIOFIRE FIREWORKS Data visualization and analysis software that helps laboratories and healthcare providers interpret and report results from BIOFIRE diagnostic testing systems.
- BioFire Defense Products Military and biodefense diagnostic product line including the FilmArray NGDS BT-E Assay, Warrior Panel, Sentinel Panel, BioThreat-E Panel, and COVID-19 Test for biothreat identification by DoD and allied defense customers.
- VETFIRE Equine Respiratory Panel Veterinary diagnostic panel that extends FilmArray syndromic testing to detect respiratory pathogens in horses.
- WATCHFIRE Respiratory (R) Panel International-market respiratory pathogen panel offered on FilmArray systems for syndromic testing outside the U.S.
- WATCHFIRE Gastrointestinal (G) Panel International-market gastrointestinal pathogen panel offered on FilmArray systems for syndromic testing outside the U.S.
- BIOFIRE Tropical Fever Panel Multiplex panel for detection of pathogens causing tropical fevers, expanding BioFire's syndromic testing portfolio to emerging infectious disease markets.
Quantifiable outcome
- Results delivered in approximately one hour compared to traditional methods taking days
- +2 more outcomes
Companies that use BioFire Diagnostics
Customer profileSegments4 records
Ideal customer profiles3 records
BioFire Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature6 records
BioFire Diagnostics partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- ThalescoreBioMérieux maintains a valued partnership with Thales for cybersecurity technology. Thales contributes to bioMérieux's secure product development through collaboration between Patrick Lethenet, VP System Development Clinical Unit at bioMérieux, and Christian Rivierre, VP systems & software engineering at Thales. This partnership supports delivery of secure diagnostic products.
Scale indicators3 records
Recent moves7 records
Expansion highlights6 records
BioFire Diagnostics competitors and assessment
Company assessmentBroad incumbents
- Hologic: Hologic's Panther Fusion system offers modular PCR testing in hospital and reference labs, providing an alternative multiplex platform to FilmArray for respiratory and other infectious disease panels.
- Roche Diagnostics: Roche's cobas Liat system provides rapid PCR at point-of-care (including Strep A, Flu, RSV) and the cobas 6800/8800 systems serve central labs, both adjacent to BioFire's syndromic franchise and now augmented by the GenMark ePlex acquisition.
- Abbott Molecular: Abbott's m2000 and Alinity m systems deliver molecular infectious disease testing in hospital and reference labs, providing broader menu-based PCR competition to BioFire's syndromic panels.
- Becton Dickinson (BD): BD's MAX System and broader molecular diagnostics portfolio compete with FilmArray in the hospital clinical laboratory segment, though BD is a broader incumbent across multiple diagnostics categories rather than a syndromic pure-play.
- QuidelOrtho: QuidelOrtho's Sofia and Triage platforms target rapid immunoassay and molecular diagnostics at point-of-care and clinical labs, including respiratory pathogen testing that competes with SPOTFIRE.
Direct peers
- Cepheid (Danaher): Cepheid's GeneXpert Xpress and Infinity systems compete head-to-head with FilmArray and SPOTFIRE in syndromic respiratory, GI, and meningitis/encephalitis panels, with a similar cartridge-based PCR business model and hospital lab customer base.
- QIAGEN: QIAGEN's QIAstat-Dx Respiratory Panel and growing syndromic menu directly compete with BioFire FilmArray panels, targeting the same hospital clinical laboratory customers with multiplex PCR cartridges.
- GenMark Diagnostics (Roche): GenMark's ePlex system (now under Roche) offers syndromic molecular panels for respiratory, blood culture identification, and GI testing that directly overlap with BioFire's FilmArray menu and target hospital labs.
- DiaSorin (Luminex legacy): DiaSorin acquired Luminex, whose Verigene and NxTAG platforms deliver syndromic and respiratory molecular testing that competes with FilmArray in clinical laboratory settings.
Emerging players
- Mesa Labs (BioFire Defense peer): Mesa Labs and other biodefense-focused diagnostics vendors compete with BioFire Defense products (NGDS BT-E, BioThreat-E) for government and military biothreat detection contracts.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
BioFire Diagnostics social profiles
Digital presenceBioFire Diagnostics compliance and trust
Trust signalCompliance8 records
BioFire Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioFire Diagnostics leadership team
Management profileNumber of profiles
Profiles5 records
BioFire Diagnostics funding detail
Funding detailFunding overview
Funding rounds3 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioFire Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioFire Diagnostics
What does BioFire Diagnostics do?
BioFire Diagnostics manufactures and sells multiplex PCR-based syndromic infectious disease testing systems — the BIOFIRE FILMARRAY System (including FilmArray 2.0 and Torch instruments) and the BIOFIRE SPOTFIRE point-of-care system — together with FDA-cleared single-use assay panels (respiratory, blood culture ID, gastrointestinal, meningitis/encephalitis, pneumonia, joint infection) and supporting connectivity/data software. Instruments are sold or licensed to clinical laboratories and hospitals, with recurring revenue from consumable pouches required for every test.
Is BioFire Diagnostics a public or private company?
BioFire Diagnostics is a private company. It is classified as corporate owned and is currently operating.
When was BioFire Diagnostics founded?
BioFire Diagnostics was founded in 2001. It employs 501 to 1,000 people.
Where is BioFire Diagnostics based?
BioFire Diagnostics is headquartered in Salt Lake City, United States, in the North America region.
How does BioFire Diagnostics make money?
Four revenue lines are on record. Instrument Systems are the primary driver. The others are diagnostic Panels and Consumables, service and Support and licensing Royalties.
Who are BioFire Diagnostics's main competitors?
Broad incumbents on record are Hologic, Roche Diagnostics, Abbott Molecular, Becton Dickinson (BD) and QuidelOrtho. Direct peers are Cepheid (Danaher), QIAGEN, GenMark Diagnostics (Roche) and DiaSorin (Luminex legacy). Mesa Labs (BioFire Defense peer) is listed as an emerging player.
Does BioFire Diagnostics have an API?
No public API is recorded for BioFire Diagnostics.
What industry is BioFire Diagnostics in?
BioFire Diagnostics's product category is Molecular Diagnostics — Syndromic Infectious Disease Testing. Its primary akta.pro industry code is HLAAALAC, Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels), with a secondary code of HLAAALAL, Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays). Its NAICS code is 325413 and its SIC code is 2835.