COMPANY PROFILE / BIOSENSORS
bioMérieux
A specialist in in vitro diagnostics for infectious disease, built on PCR and immunoassay, now moving testing closer to the patient
bioMérieux comes up in any discussion of biosensors because a dedicated infectious-disease diagnostics company is trying to move testing out of the hospital laboratory and toward the patient. According to its 2025 Universal Registration Document, sales were €4,070 million (+6.2% organic) and R&D spending was 12.5% of sales. Its point-of-care products are BIOFIRE SPOTFIRE, a multiplex PCR system that gives results in about 15 minutes (2025 sales of €168 million, about 4% of the total), and SpinChip, a whole-blood immunoassay platform with results in under ten minutes, acquired in January 2025 and CE marked under the IVDR in July 2026. Both belong to the PCR and fluorescence-immunoassay family, not electrochemical sensors. The product closest to a sensor is the laboratory susceptibility test VITEK REVEAL, which detects volatile compounds from growing bacteria with an array of color-changing sensors. This profile sets out what can be confirmed from official documents and what is not disclosed.
- bioMérieux in 30 seconds, and where it stands in biosensors
- The logo and how the name is written
- Where the company sits in the field
- Scale
- Resources committed to biosensors
- What it has done so far
- What comes next
- What the company is aiming for in biosensors
- Map of partnerships in biosensors
- Technologies, products and services
- The risks this company carries
- Glossary, references and claim-to-source audit
1. bioMérieux in 30 seconds, and where it stands in biosensors
(molecular, microbiology, immunoassay)Electrochemical-sensor products are not its main line
bioMérieux is best understood not as "a biosensor company" but as "a specialist maker of instruments and reagents for infectious-disease diagnostics, placed in hospitals around the world" Our calculation. The point-of-care products (SPOTFIRE and SpinChip) are a small part of sales, and only SPOTFIRE had sales in 2025 Sourced. The documents reviewed here list no electrochemical sensor products, such as glucose meters or electrochemical blood gas analyzers Not yet confirmed.
2. The logo and how the name is written
A note on names: the legal entity is bioMérieux SA, a French société anonyme; the logo is set in capitals (BIOMÉRIEUX). Institut Mérieux is a separate entity (a holding company) that owns 58.9% of bioMérieux's shares. BIOFIRE, SPOTFIRE, VIDAS, VITEK and SPINCHIP are product or brand names, not company names. BioFire Diagnostics, LLC and SpinChip Diagnostics ASA are subsidiaries of bioMérieux. The logo image was taken from the company's official website (biomerieux.com).
Official site: https://www.biomerieux.com/3. Where the company sits in the field
4. Scale
About 84% of sales come from clinical applications and about 16% from industrial applications (quality control for food and pharmaceuticals). Molecular diagnostics (PCR) is the largest clinical line, at 43% of sales Sourced.
| Indicator (€ million) | 2024 | 2025 | Change |
|---|---|---|---|
| Sales | 3,979.9 | 4,069.8 | +2.3% (+6.2% organic) |
| Contributive operating income before non-recurring items (CEBIT) | 673 | 728 | 17.9% of sales |
| Operating income | 589 | 521 | -4% (includes the VITEK REVEAL impairment) |
| R&D expenses | - | 507 | 12.5% of sales |
| Free cash flow | 330 | 462 | - |
| Capital expenditure | 346 | 335 | 8% of sales |
| Product line (2025, € million) | Sales | Organic growth | Share of sales |
|---|---|---|---|
| BIOFIRE respiratory panels | 813 | +1% | 20% |
| BIOFIRE non-respiratory panels | 598 | +10% | 15% |
| BIOFIRE instruments and services | 101 | +16% | 2% |
| SPOTFIRE | 168 | +84% | 4% |
| Microbiology | 1,339 | +4% | 33% |
| Immunoassays (VIDAS and others) | 308 | -6% | 8% |
| Industrial applications | 639 | +9% | 16% |
| Other | 104 | - | 3% |
By region, North America was €1.85 billion (45%), Europe, Middle East and Africa €1.31 billion (32%), Asia Pacific €0.63 billion (16%) and Latin America €0.27 billion (7%). In Asia Pacific, China was down 14% (the annual report's word is "activity"). First-half 2026 sales were €1,965 million (+0.2% organic). BIOFIRE respiratory panels fell 17% on a weak respiratory season, while SPOTFIRE reached €90 million Sourced.
Among product lines, the only one used near the patient with disclosed sales is SPOTFIRE. SpinChip had no sales in 2025 and an operating loss of €19 million. The immunoassay line (8% of sales) is laboratory-based. VITEK REVEAL sales are not disclosed separately, and this article does not estimate them Not yet confirmed.
5. Resources committed to biosensors
bioMérieux does not disclose R&D spending or headcount separately for point-of-care or sensor products. The table sets out company-wide figures and the individual acquisitions and investments that are described.
| Resource | What primary sources confirm | Category |
|---|---|---|
| People | About 15,000 employees in 2025 (full-time equivalent), across 21 sites (19 production, 18 R&D). The number of R&D staff could not be confirmed. Headcount for point-of-care products alone is not disclosed | Sourced / partly undisclosed |
| Money (R&D) | R&D expenses were €507 million (12.5% of sales). The annual report's chart splits the budget roughly as molecular biology 34%, microbiology 31%, industrial 12% and immunoassays 12%. In the first half of 2026 R&D was €257 million (13.1% of sales), which the company attributes to more investment in molecular biology, SPINCHIP technology and microbiology | Sourced |
| Money (investment) | Capital expenditure was €335 million in 2025 (8% of sales), with about 9% expected in 2026. Main projects: automating BIOFIRE reagent production (Salt Lake City, United States), preparing industrial production of SpinChip reagents and instruments (Oslo, Norway), and a new building for biological raw materials (Marcy-l'Étoile, France). In May 2026 the company announced an investment of more than €250 million in a new plant for BIOFIRE PCR tests (La Balme-les-Grottes, France), with about 400 jobs | Sourced / partly Not yet confirmed |
| Acquisitions and investments | SpinChip Diagnostics ASA (Norway, whole-blood immunoassay): a 20% stake in March 2024, then the remaining 80% on 20 January 2025. Enterprise value €138 million; cash outflow about €112 million. Neoprospecta (Brazil, January 2025, about €8 million), the assets of Day Zero Diagnostics (United States, June 2025, about €19 million) and Accellix (United States, January 2026, remaining 90% for about €28 million; quality control for cell and gene therapy). The history also lists the acquisitions of Specific Diagnostics (San José, the origin of VITEK REVEAL), BioFire and Lumed (years not checked here) | Sourced |
| Universities, research institutions, public funding | The annual report names collaborations with MILA (the Quebec AI institute), the hospital centers of Washington University and the University of Pittsburgh, Institut Pasteur, the Prometheus IHU (Paris-Saclay University, CEA, Inserm, AP-HP and others) and Oxford Nanopore Technologies (joint announcement, November 2025). It also lists European and French collaborative projects (DIAMONDS, UNDINE, BRAINI-2, ARPEGE, THERAPHAGE, AIRISE). None is specific to point-of-care sensor products, and no public-grant amounts could be found. The SpinChip clinical evaluation (APACE) was carried out with Basel University Hospital and Akershus University Hospital (company statement) | Sourced / partly not found |
| Restructuring | Because the US launch of VITEK REVEAL is slower than expected, the company booked an impairment of €140.7 million on the technology in 2025. In December 2025 it announced the closure of the San José site (end of 2026) and the transfer of VITEK REVEAL R&D and production to St. Louis (impairment of tangible assets €27.5 million; restructuring costs €12.8 million) | Sourced |
Regulatory status (as far as could be confirmed)
The entries below were checked against the U.S. FDA 510(k) database and FDA decision documents. All are 510(k) clearances; none is a PMA approval or De Novo authorization (some SPOTFIRE entries were dual submissions: a 510(k) together with a CLIA waiver, which is a classification of test complexity). The database was last updated on 21 September 2026 at the time of checking Sourced.
| Product | Use (summary of the FDA document) | Category and date | Number |
|---|---|---|---|
| BIOFIRE SPOTFIRE Respiratory (R) Panel | Multiplex PCR. Qualitative detection and identification of respiratory viral and bacterial nucleic acids in nasopharyngeal swabs from people with signs and symptoms of respiratory tract infection, including COVID-19. Designed for use in CLIA-waived environments | 510(k) clearance (Dual Track), Class II. 3 February 2023 | K213954 |
| SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Two menus: respiratory (nasopharyngeal swab) and sore throat (throat swab) | Dual 510(k) and CLIA waiver, Class II. 26 March 2024 | K232954 |
| SPOTFIRE R/ST Panel Mini (initial) | A smaller version of the R/ST Panel (the database lists it as a Special 510(k)). The use statement was not checked here | 510(k) clearance (Special). 30 May 2024 | K241194 |
| SPOTFIRE R/ST Panel Mini (anterior nasal swab added) | Adds anterior nasal swab specimens. The company says it obtained a 510(k) clearance and a CLIA waiver together | 510(k) clearance (Dual Track), Class II. 14 August 2025 | K243544 |
| VITEK REVEAL GN AST Assay / AST System | Automated laboratory system for antimicrobial susceptibility testing (AST) directly from positive blood cultures. It uses an array of sensors that detect volatile organic compounds. Performed by laboratory health professionals; for gram-negative bacilli; organism identification is needed separately | 510(k) clearance, Class II. 20 June 2024 (applicant Specific Diagnostics, LLC) and 8 July 2026 (bioMérieux, Inc.) | K230675 / K260160 |
| SPINCHIP Analyzer / hs-cTnI | The company says it completed IVDR CE marking in July 2026. Searching the FDA 510(k) database for "SpinChip" returned no match | EU: CE mark (company announcement) / U.S.: not confirmed | - |
| SPOTFIRE Vaginitis (VG) Panel | The company says it filed a dual 510(k) and CLIA waiver application on 26 June 2026. Under review; no clearance yet | Not yet confirmed | - |
The status of each product in Japan (approval, certification or notification) could not be confirmed here Not yet confirmed (the Q2 2026 release does say that a change in Japanese reimbursement policy affected SPOTFIRE sales). For how regulatory categories relate to how a device may be used, see our explainer on medical device approval categories and home use.
The distinctive feature of bioMérieux's resources is that its capital spending reflects a business of placing instruments and then selling single-use reagents and cartridges. Main projects are automating reagent production (BIOFIRE) and preparing production (SpinChip), plus a new building to make biological raw materials such as antibodies (annual report) Sourced. Immunoassay performance depends on the antibodies, the surfaces that hold them and the stability of the signal, so keeping raw-material quality control close to the company would make sense Not yet confirmed. However, the materials of the sensors themselves (the color-changing compounds in VITEK REVEAL, the channels and detection area of SpinChip) are not given in the documents retrieved.
6. What it has done so far
| When | Event | Meaning |
|---|---|---|
| 3 February 2023 | BIOFIRE SPOTFIRE Respiratory Panel received FDA 510(k) clearance (Dual Track). The annual report says SPOTFIRE launched in 2023 | Brought a roughly 15-minute multiplex PCR to settings outside the laboratory |
| March 2024 | Took a stake of about 20% in SpinChip Diagnostics | A first foothold in point-of-care whole-blood immunoassay |
| 20 June 2024 | VITEK REVEAL (applicant Specific Diagnostics) received 510(k) clearance | U.S. entry for laboratory AST that detects bacterial growth with a sensor array |
| 13-20 January 2025 | Announced (13th) and completed (20th) the acquisition of SpinChip. Enterprise value €138 million | Added point-of-care immunoassay as a main pillar |
| 29 January 2025 | Acquired Neoprospecta (Brazil, genomic data) | Strengthens sequencing and data; separate from the sensor products |
| June 2025 | Acquired the assets of Day Zero Diagnostics | Direct-from-blood sequencing with machine-learning identification and susceptibility testing (under development) |
| 14 August 2025 | Anterior nasal swab added to the SPOTFIRE R/ST Panel Mini (510(k) clearance and CLIA waiver) | Widened the specimen options |
| December 2025 | Impairment of €140.7 million on VITEK REVEAL for a slow US launch; closure of the San José site announced | A review of the sensor-based AST business |
| 20 January 2026 | Acquired the remaining 90% of Accellix | For pharmaceutical quality control; not a biosensor product |
| 29 May 2026 | Announced an investment of more than €250 million in a new plant in France for BIOFIRE PCR tests | Strengthens supply of laboratory molecular diagnostics |
| 26 June 2026 | Filed a dual 510(k) and CLIA waiver application for the SPOTFIRE Vaginitis Panel | The company says it intends to widen the point-of-care menu into women's health |
| July 2026 | The SPINCHIP Analyzer and SPINCHIP hs-cTnI completed IVDR CE marking | A point-of-care high-sensitivity troponin I immunoassay reached the stage where it can be used in Europe |
| 28 July 2026 | First-half 2026 results. Full-year guidance kept, but the 2027-2028 medium-term outlook was lowered | The company cites changes in the geopolitical and macroeconomic environment |
7. What comes next
The primary sources also describe the following plans Not yet confirmed.
- European launch of SpinChip hs-cTnI (planned for late 2026). The annual report expects amortization of the technology to start at the time of launch, in late 2026 or early 2027
- Further SpinChip assays (NT-proBNP and D-dimer), named as first priorities in the January 2025 announcement. No launch timing was found
- The FDA decision on the SPOTFIRE Vaginitis Panel (timing not stated)
- SPOTFIRE sales in 2026 were expected in the annual report to grow 40% to 60% organically, depending on the respiratory season. The first-half 2026 result was about +22%
- Capital expenditure of about 9% of sales in 2026
The status and timing of any SpinChip submission in the United States / SpinChip's measurement principle (channel and detection design) / VITEK REVEAL sales / the number of R&D staff and R&D spending for point-of-care products alone / the status of each product in Japan / the latest treatment of the SPOTFIRE 2028 target. None appears in the official documents retrieved.
8. What the company is aiming for in biosensors
This section separates what the company says it is aiming for from what this article reads into the record. Inference marks interpretation drawn by this article from primary sources.
| What can be read | Primary source behind it | Category |
|---|---|---|
| It is moving diagnostics closer to the patient | The SpinChip acquisition was described as strengthening the strategy of bringing diagnostics closer to the patient. The CEO said the company already serves the point-of-care market with SPOTFIRE and would complement it with SpinChip (January 2025 announcement) | Sourced (company explanation) |
| It is building point of care on two pillars, molecular and immunoassay | The annual report presents SPOTFIRE (PCR) and SpinChip (immunoassay) as two future fields. The CEO said SpinChip would pave the way for growth beyond 2028 | Sourced (company explanation) |
| Sensor-based AST (VITEK REVEAL) is under review | An impairment for the slow US launch, and the closure of the San José site | Sourced / Inference (its future role) |
| SpinChip will start in Europe | Launch planned in Europe in late 2026. No US submission could be found | Inference (the U.S. may come later) |
| It is widening into genomics, data and AI diagnostics | Neoprospecta, Day Zero Diagnostics, Lumed and the MILA collaboration | Sourced (company explanation) |
The reading that "SpinChip will start in Europe" rests on how the July 2026 announcement is worded. The 28 July 2026 release says only that IVDR CE marking is complete and that the European launch is planned for late 2026 Sourced. A search of the FDA database for "SpinChip" returned no match, and the company says nothing about a U.S. submission. However, that does not show that no FDA submission exists (the database may lag, or a filing may be under another name), and the company's plans may change Not yet confirmed.
9. Map of partnerships in biosensors
Most of the relationships that can be confirmed are acquisitions and joint research. The only manufacturing partner named is Beckman Coulter, which, per the FDA document, makes the VITEK REVEAL antibiotic panels (a 96-well plate) Sourced. Suppliers of parts for SPOTFIRE and SpinChip are not named in the documents retrieved. Institut Mérieux is the controlling shareholder, not a technology partner.
10. Technologies, products and services
The annual report divides the products into molecular diagnostics, microbiology, immunoassay and industrial. The table below focuses on those used near the patient and those closest to sensors. All figures are manufacturer's stated values; test conditions and editions differ, so no ranking is made between products, or against other companies' products Sourced.
| Category | What the official sources say | Comment |
|---|---|---|
| Near the patient: BIOFIRE SPOTFIRE | Fully automated multiplex PCR. Respiratory and sore-throat panels. Results in about 15 minutes. One to four modules can be stacked, for up to 104 samples a day (8 hours; annual report). The installed base exceeded 7,200 instruments (30 June 2026). 2025 sales were €168 million | Manufacturer's stated values. PCR (nucleic-acid amplification), not an electrochemical sensor |
| Near the patient: SPINCHIP | A small benchtop immunoassay analyzer giving results from whole blood in under ten minutes. The first assay is high-sensitivity cardiac troponin I (hs-cTnI). The company describes clinical-study results showing high agreement across specimen types, including fingerstick. IVDR CE mark in July 2026; European launch planned for late 2026 | Company claim and plan. The measurement principle was not confirmed here |
| Closest to a sensor: VITEK REVEAL | A laboratory system for antimicrobial susceptibility testing directly from positive blood cultures. An array of color-changing sensors detects the volatile organic compounds given off by growing bacteria. Results in 5.5 to 6 hours on average (from gram-negative positive blood cultures). The annual report calls them "nanopore biosensors"; the FDA document describes chemical small-molecule sensors that change color | Manufacturer's stated values. The two documents use different words for the same device. Laboratory use |
| Laboratory: BIOFIRE FILMARRAY | Fully automated multiplex PCR. Seven panels covering more than 170 targets; about one hour. In June 2026 the company submitted new versions of the gastrointestinal panels to the FDA | Laboratory molecular diagnostics; about 37% of sales |
| Laboratory: VIDAS | Enzyme-linked fluorescent immunoassay. The instrument reads the fluorescent signal produced when an antibody-antigen complex forms. More than 80 clinical tests; up to 72 tests an hour | The main immunoassay line; down in 2025 because of volume-based procurement in China |
| Microbiology and industrial | BACT/ALERT (blood culture), VITEK (identification and susceptibility), industrial products such as GENE-UP, and software such as Lumed | 33% and 16% of sales; microbiology instruments rather than biosensors |
The place where bioMérieux's materials are most concrete is the VITEK REVEAL sensor panel. The FDA document describes an assembly of a frame, a clear plastic film and a membrane sheet carrying 96 sensor arrays (12 by 8), each array made of seven chemically responsive sensors. They change color in response to volatile compounds from growing bacteria, and the instrument reads the color change. The sensor panel is hermetically sealed on top of the inoculated 96-well plate, and the panel also carries a seal-quality sensor Sourced. From a materials standpoint, the permeability of the membrane to volatile compounds, the selectivity of the sensor dyes and reactants, and the sealing of the joint would bear directly on reproducibility Not yet confirmed. However, neither the FDA document nor the annual report discloses the color-changing compounds or the membrane materials.
VIDAS is an antibody-based enzyme-linked fluorescent immunoassay, and the annual report mentions multiplexing in which "a single set of SPRs (solid-phase receptacles) and cartridges" yields several immune responses. SpinChip's channel and detection design could not be confirmed. For the underlying ideas on immunoassay materials, see our explainers on biomarkers in body fluids and on label-free detection and limits of detection.
11. The risks this company carries
| Risk | Detail | Category |
|---|---|---|
| Dependence on the respiratory season | BIOFIRE respiratory panels fell 17% in the first half of 2026 because the season was weak. SPOTFIRE is also centered on respiratory tests, and the company ties its 2026 growth to the season | Sourced |
| Volume-based procurement in China and a soft market | Immunoassays fell 6% in 2025, and China was down 14% within Asia Pacific. The company says the effect of volume-based procurement continued into the first half of 2026 | Sourced |
| Lowered medium-term outlook | The 2027-2028 sales outlook moved from a 7% annual average to +3% to +6% a year. The company cites changes in the geopolitical and macroeconomic environment | Sourced |
| Ramp-up of SpinChip | No sales in 2025 and an operating loss of €19 million. The technology asset is €106.9 million, to be amortized from about the time of launch (late 2026 or early 2027). Launch outside Europe could not be confirmed | Sourced / not confirmed |
| Impairment of sensor-based AST | Slow US launch of VITEK REVEAL led to a technology impairment of €140.7 million in 2025 and the closure of the San José site | Sourced |
| U.S. exposure and tariffs | North America is 45% of sales. The annual report's 2026 outlook assumes 15% U.S. tariffs | Sourced |
| Regulatory review | The SPOTFIRE Vaginitis Panel is under review. SpinChip's US position could not be confirmed | Not yet confirmed |
| Hard to verify point-of-care products | Of the products used near the patient, only SPOTFIRE has disclosed sales. SpinChip had no sales and VITEK REVEAL sales are not disclosed separately | Not yet confirmed |
12. Glossary
- Multiplex PCR
- A method that amplifies the nucleic acids of several pathogens at once in a single test.
- CLIA waiver
- In the U.S., a category for tests judged simple and low-risk enough to be performed outside specialist laboratories.
- 510(k) clearance
- The U.S. FDA route for devices found substantially equivalent to a device already on the market. Distinct from PMA approval and De Novo authorization. "Dual Track" means a 510(k) filed together with a CLIA waiver application.
- IVDR (In Vitro Diagnostic Regulation)
- The EU regulation, Regulation (EU) 2017/746, that underlies CE marking of in vitro diagnostic devices.
- Enzyme-linked fluorescent assay (ELFA)
- A method that captures the target with antibodies and measures its amount from the fluorescence produced by an enzyme reaction. Used in VIDAS.
- Antimicrobial susceptibility testing (AST)
- A test of which antibiotics inhibit the growth of a given bacterium.
- Volatile organic compounds (VOCs)
- Gaseous substances given off as bacteria grow. VITEK REVEAL detects them through a color change.
- High-sensitivity troponin I (hs-cTnI)
- A test that measures a heart-muscle protein in the blood from very low concentrations. How to read the result is a matter for healthcare professionals.
- CEBIT
- bioMérieux's profit measure: contributive operating income before non-recurring items.
- Organic growth
- Growth excluding the effects of currency and of acquisitions or disposals.
- Volume-based procurement
- A scheme in China in which public bodies buy in bulk to push prices down.
13. References
- bioMérieux 2025 Universal Registration Document (filed with the AMF on 16 March 2026; the English version published for the shareholders' meeting). Sales, profit, R&D spending, capital expenditure, acquisitions and investments, product descriptions, shareholders, impairment and the 2026 outlook. https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf
- bioMérieux First-Half 2026 Results (press release of 28 July 2026). First-half sales and product-line sales, SPOTFIRE installed base, SpinChip CE marking, FDA submissions, investment in a new plant and the updated outlook. https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf
- bioMérieux Press release "bioMérieux strengthens its point of care presence with the acquisition of the immunoassay start-up SpinChip" (13 January 2025). Enterprise value, cash outflow, planned assays and the CEO's remarks. https://www.biomerieux.com/corp/en/journalists/press-releases/acquisition-SpinChip-immunoassay.html
- bioMérieux Company news "Extremely promising clinical trial results for the high-sensitivity Point-of-Care (POC) cardiac troponin I test of our partner SpinChip Diagnostics". The company's account of the APACE study (with Basel University Hospital and Akershus University Hospital). https://www.biomerieux.com/corp/en/who-we-are/company-news/Extremely-promising-clinical-trial-results-high-sensitivity-Point-of-Care-cardiac-troponin-test-partner-SpinChip-Diagnostics.html
- U.S. Food and Drug Administration 510(k) K213954 "BIOFIRE SPOTFIRE Respiratory (R) Panel": clearance letter and summary (3 February 2023). Intended use and design for CLIA-waived environments. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213954.pdf
- U.S. Food and Drug Administration 510(k) K232954 "BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel": clearance letter and summary (26 March 2024; dual 510(k) and CLIA waiver). https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232954.pdf
- U.S. Food and Drug Administration 510(k) K243544 "BIOFIRE SPOTFIRE R/ST Panel Mini": clearance letter and summary (14 August 2025; anterior nasal swab added). https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243544.pdf
- U.S. Food and Drug Administration 510(k) K230675 "VITEK REVEAL GN AST Assay and VITEK REVEAL AST System": clearance letter and summary (20 June 2024). https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230675.pdf
- U.S. Food and Drug Administration 510(k) K260160 "VITEK REVEAL GN AST Assay and VITEK REVEAL AST System": clearance letter and summary (8 July 2026). Sensor panel construction and contract manufacture of the antibiotic panels by Beckman Coulter. https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260160.pdf
- U.S. Food and Drug Administration (openFDA) 510(k) database API (the record for K241194 "SPOTFIRE R/ST Panel Mini"; the database was last updated on 21 September 2026). The search reported here as "no match found" for SpinChip was also run through this API. https://api.fda.gov/device/510k.json?search=k_number:K241194
- bioMérieux Official website (source of the logo image). https://www.biomerieux.com/
14. Claim-to-source audit
| Claim in the text | Category | Source |
|---|---|---|
| Legal name, headquarters (Marcy-l'Étoile), about 15,000 employees (full-time equivalent), 21 sites (19 production, 18 R&D) | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| Institut Mérieux holds 58.9%; listing on Euronext Paris | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| Sales €4,069.8 million (+6.2% organic), CEBIT €728 million (17.9%), operating income €521 million, free cash flow €462 million | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| R&D expenses of €507 million (12.5% of sales), capital expenditure of €335 million (8% of sales), about 9% expected in 2026 | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| Sales by product line (BIOFIRE, SPOTFIRE €168 million +84%, microbiology, immunoassays, industrial), sales by region, China -14% | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| Molecular diagnostics at 43% of sales; industrial applications at 16% | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| First-half 2026 sales of €1,965 million (+0.2% organic), SPOTFIRE €90 million, installed base above 7,200, BIOFIRE respiratory panels -17%, R&D of €257 million | Sourced | Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf |
| Acquisition of SpinChip Diagnostics (about 20% in March 2024, full ownership on 20 January 2025, enterprise value €138 million, cash outflow about €111-112 million) | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf Reference 3 https://www.biomerieux.com/corp/en/journalists/press-releases/acquisition-SpinChip-immunoassay.html |
| SpinChip: no sales in 2025, operating loss of €19 million, technology asset of €106.9 million, amortization expected from launch | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| Further SpinChip assays (NT-proBNP, D-dimer) and the IVDR application plan as of January 2025 | Not yet confirmed | Reference 3 https://www.biomerieux.com/corp/en/journalists/press-releases/acquisition-SpinChip-immunoassay.html |
| SPINCHIP hs-cTnI IVDR CE marking completed (July 2026); European launch planned for late 2026 | Not yet confirmed | Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf |
| SpinChip's APACE study (with Basel University Hospital and Akershus University Hospital) | Sourced | Company statement. Reference 4 https://www.biomerieux.com/corp/en/who-we-are/company-news/Extremely-promising-clinical-trial-results-high-sensitivity-Point-of-Care-cardiac-troponin-test-partner-SpinChip-Diagnostics.html |
| Neoprospecta (January 2025, about €8 million), Day Zero Diagnostics assets (June 2025, about €19 million), Accellix (January 2026, about €28 million) | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf |
| Acquisitions of Specific Diagnostics, BioFire and Lumed listed in the company history | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| Collaborations with MILA, Washington University and University of Pittsburgh hospital centers, Institut Pasteur, Prometheus IHU, Oxford Nanopore (November 2025), and European and French collaborative projects | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| R&D spending and headcount for point-of-care sensor products alone; public-grant amounts | Not yet confirmed | Not in Reference 1. Not found. We do not claim that none exists Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| VITEK REVEAL impairment of €140.7 million (2025), closure of the San José site (end of 2026), transfer to St. Louis, tangible-asset impairment of €27.5 million, restructuring costs of €12.8 million | Sourced | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| Investment of more than €250 million in a new plant for BIOFIRE PCR tests (29 May 2026, about 400 jobs) | Sourced | Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf |
| FDA 510(k) clearance of the SPOTFIRE R Panel (K213954, 3 February 2023, Class II, 21 CFR 866.3981) and design for CLIA-waived environments | Sourced | Reference 5 https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213954.pdf |
| SPOTFIRE R/ST Panel (K232954, 26 March 2024, dual 510(k) and CLIA waiver) | Sourced | Reference 6 https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232954.pdf |
| Database record for the SPOTFIRE R/ST Panel Mini (K241194, 30 May 2024, Special); the use statement was not checked | Sourced | Reference 10 https://api.fda.gov/device/510k.json?search=k_number:K241194 |
| Anterior nasal swab added to the SPOTFIRE R/ST Panel Mini (K243544, 14 August 2025) | Sourced | Reference 7 https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243544.pdf Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| FDA 510(k) clearance of VITEK REVEAL (K230675, 20 June 2024, applicant Specific Diagnostics); sensor array detecting volatile organic compounds; laboratory use | Sourced | Reference 8 https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230675.pdf |
| FDA 510(k) clearance of VITEK REVEAL (K260160, 8 July 2026, bioMérieux Inc.); sensor panel construction (96 arrays of seven sensors; seal-quality sensor); contract manufacture of the antibiotic panels by Beckman Coulter | Sourced | Reference 9 https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260160.pdf |
| The annual report's description of VITEK REVEAL ("nanopore biosensors"; 5.5 to 6 hours on average) | Sourced | The FDA document describes the same device in different words (chemical sensors that change color). Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| No match in the FDA 510(k) database (updated 21 September 2026) for "SpinChip" | Not yet confirmed | Our own search. Not confirmed; we do not claim that no submission or clearance exists Reference 10 https://api.fda.gov/device/510k.json?search=k_number:K241194 |
| Filing of a dual 510(k) and CLIA waiver application for the SPOTFIRE Vaginitis Panel (26 June 2026) | Not yet confirmed | Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf |
| Specifications of BIOFIRE FILMARRAY (about one hour; seven panels, more than 170 targets), SPOTFIRE (about 15 minutes; up to 104 samples a day) and VIDAS (more than 80 tests; 72 tests an hour) | Sourced | Manufacturer's stated values (annual report). Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| 2026 outlook (sales +3% to +5% organic, CEBIT +0% to +10%) and 2027-2028 outlook (+3% to +6% a year) | Not yet confirmed | Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf |
| The annual report's 2026 outlook (sales +5% to +7%), SPOTFIRE +40% to +60%, and the 2028 SPOTFIRE target of €450 million | Not yet confirmed | Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| The company's description of the SpinChip acquisition as strengthening the strategy of bringing diagnostics closer to the patient; the CEO's remarks | Sourced | Reference 3 https://www.biomerieux.com/corp/en/journalists/press-releases/acquisition-SpinChip-immunoassay.html |
| Status in Japan, SpinChip's measurement principle, and the latest treatment of the SPOTFIRE 2028 target | Not yet confirmed | Not in the documents retrieved. Not confirmed Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf |
| The reading that SpinChip will start in Europe | Inference | This article's interpretation. It does not mean no FDA submission exists. Reference 2 https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR-bioMerieux-Financial-Results-H1-2026.pdf.coredownload.pdf Reference 10 https://api.fda.gov/device/510k.json?search=k_number:K241194 |
| The reading that sensor-based AST is under review | Inference | This article's interpretation. Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| The reading that keeping biological raw-material production close matters for immunoassay quality | Inference | This article's interpretation. Reference 1 https://www.biomerieux.com/content/dam/biomerieux-com/investor/06---shareholder-area/en/2026/documents-made-available-for-the-shareholders-and-questions-answers/AG-2026---URD-2025.pdf |
| The VITEK REVEAL sensor panel construction and its demands on materials | Inference | This article's reading of the FDA document (sourced) into materials requirements. The color-changing compounds and membrane materials are not disclosed. Reference 9 https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260160.pdf |
| The four types of company (diabetes and continuous monitoring / in vitro diagnostics and POCT / wearables and consumer devices / materials and components) and the example company names | Our calculation | Our own classification. Company names are examples from the companies covered in this series |
| The framing "not a biosensor company but a specialist in infectious-disease diagnostics" | Our calculation | Our own framing, drawn from the sales mix (Reference 1). |
Last updated 4 October 2026 / Troy Technical
Every figure in this article comes from bioMérieux's annual report, results announcements and official announcements, and from FDA public documents. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of primary sources, not statements made by the company. The company's plans (SpinChip launch, FDA submissions, outlook) are company targets, not accomplished facts.