Innosieve Diagnostics

What Innosieve Diagnostics does

Innosieve Diagnostics BV is a privately held Dutch biotech founded in 2012 and headquartered in Wageningen that develops the MuScan platform, a solid phase cytometry system for rapid, non-growth-based detection and quantification of microbial contamination. The core stack comprises the MuScan LED-based optical scanning device, CFR21 Part 11 compliant GMP software, and Sieve-ID consumable diagnostic kits; together these deliver results in approximately one hour versus days for conventional compendial methods, with sensitivity of 1–5 FFU and the ability to detect viable but non-culturable (VBNC) cells missed by growth-based assays. The platform is validated to USP 71, USP 1223, Ph.Eur 5.1.6, and TR33, and the device carries a CE mark, positioning it for pharmaceutical quality control as the primary use case alongside industrial environmental monitoring, microplastics analysis, medical diagnostics (via the Exhalyzer project with RadboudUMC), and agricultural spore detection.

The company monetizes through direct enterprise sales of hardware (MuScan device), consumables (Sieve-ID kits), and software licenses (full GMP and R&D packages), supplemented by IQ/OQ/PQ validation documentation and annual preventive maintenance services. A leasing option introduced in 2022 broadens access via monthly payments, and the 2023 acquisition of Lumibyte BV consolidated full ownership of MuScan IP. Go-to-market is enterprise field sales targeting pharmaceutical and biotechnology buyers, with global distribution claims but disclosed operating geography concentrated in the Netherlands and Europe; the company is not publicly listed, has no disclosed funding rounds or revenue figures, and its ownership structure appears founder/management-controlled.

Name

Innosieve Diagnostics

Legal name

Innosieve Diagnostics BV

Website

https://innosieve.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

Innosieve Diagnostics BV is a Dutch biotech that sells the MuScan solid phase cytometry platform—hardware, Sieve-ID kits, and CFR21 Part 11 software—for rapid, non-growth-based microbial detection in pharmaceutical, industrial, microplastics, medical, and agricultural applications, validated to major pharmacopoeia standards.

Ownership category

akta.pro rank

Product category

Rapid Microbial Detection Systems

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

SIC

Laboratory Analytical Instruments (3826)

akta.pro primary industry

Microscopy, Imaging & Flow Cytometry Instruments (HLAGAIAE)

akta.pro secondary industries

Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC), Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC), Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE), Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO)

Keywords

• Rapid microbial detection
• Solid phase cytometry
• Bioburden testing equipment
• Microbiology diagnostic kits
• Pharmaceutical quality control

Headquarters

HQ city

Wageningen

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Operations, Infrastructure, Marketing or Sales

Revenue model

1. MuScan Hardware Device Sales: Sale of the MuScan detection device - an automated LED-based optical scanning instrument for microbial detection. The device is CE-marked and includes IQ/OQ documentation options.
2. GMP Software Licenses: Sale of CFR21 Part 11 compliant MuScan GMP software. Available as full CFR-compliant package or R&D package. IQ/OQ/PQ documentation can be purchased separately for installation and validation.
3. Sieve-ID Diagnostic Kits: Sale of Sieve-ID assay kits - optimized consumables specifically designed for the MuScan system. Includes Total Viable Count kits and custom diagnostic kits developed for specific customer needs.
4. Equipment Leasing: Lease option for MuScan system providing low monthly costs to enable easier access to the RMM technology. Maximum gain model for customers who prefer operational expenditure over capital expenditure.
5. Preventive Maintenance Services: Annual preventive maintenance services for MuScan systems including hardware testing, optical part evaluation, and calibration. Thorough testing following defined specifications with detailed PM reports.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Innosieve Diagnostics develops and sells the MuScan rapid microbial detection platform, consisting of an LED-based optical scanning device that uses solid phase cytometry to directly detect and quantify fluorescently stained microorganisms on membranes. The offering includes the MuScan hardware device, Sieve-ID diagnostic test kits (consumables), and CFR21 Part 11 compliant GMP software for data handling, used primarily by pharmaceutical, biotechnology, and industrial manufacturers for microbial quality control.

Product overview

Innosieve Diagnostics offers the MuScan(TM) technology platform for rapid microbial detection and quantification. The core portfolio consists of the MuScan device (LED-based optical scanner), MuScan GMP software (CFR21 Part 11 compliant), and Sieve-ID(TM) diagnostic kits. These products work together as a solid phase cytometry system that separates microbes from samples, stains them on dedicated membranes, and performs automated optical scanning with image analysis to deliver results within 1 hour—bypassing traditional growth-based methods. Applications span pharmaceutical quality control, industrial monitoring, microplastics detection, agricultural spore monitoring, and medical diagnostics (Exhalyzer project). The company also provides lease options, preventive maintenance services, and IQ/OQ/PQ documentation packages.

Differentiator

Problem solved

Functional benefit

Brands

• MuScan: LED-based optical scanning device for rapid microbial detection and quantification
• Sieve-ID
• ISeeMicroplastics

Products and services

• MuScan Device LED-based optical scanning device for rapid, automated full-field detection and quantification of fluorescently stained microorganisms. Provides in-focus scanning of complete samples within minutes using patented optical scanning regimes with optimal background reduction. Designed for pharmaceutical and industrial microbial quality control.
• Sieve-ID Diagnostic Kits Diagnostic test kits optimized for the MuScan system, enabling direct detection and quantification of microbes. Include protocol booklets and support generic staining, selective staining, and fluorescently labeled probes (DNA/RNA/PNA/antibodies). Validated according to USP 1223, Ph.Eur 5.1.6, USP 71, and TR33 guidelines.
• MuScan GMP Software CFR21 Part 11 compliant software for digital processing and handling of MuScan data. Features cyclic or linear double-eye data confirmation, complete audit trails, password management, and diagnostic algorithms for organism detection and quantification. Data stored on customer server with IQ/OQ documentation available.
• MuScan Microplastics Detection Application Rapid microplastic analysis application using MuScan technology with dedicated silicon-nitride Sieve-ID membranes. Detects, quantifies, and identifies microplastic particles down to 1µm size with automated image analysis software reporting particle count and size distribution. Used for environmental monitoring and quality control in food, water, and consumer products.
• Exhalyzer Non-invasive microbial detection system for lung infection diagnosis from exhaled air, developed in collaboration with RadboudUMC. Provides results within hours including sampling, using less traumatic procedures than current invasive methods. Aimed at diagnosis of COPD and lung diseases.
• Preventive Maintenance Service Annual preventive maintenance service for MuScan systems including hardware testing, optical part evaluation, xyz movement testing, fluorescence calibration, and performance evaluation against defined specifications. Provides detailed PM reports.

Quantifiable outcome

• 1-2 log more viable cells detected compared to growth-based compendial methods (R2A/TSA plating)
• +2 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core and minor.

• ISIS-IC GmbHcoreStrategic or Co-development PartnerGerman partner in the ISeeMicroplastics project funded by DE-NL Interreg and KPF program (Interreg 6a). Collaborated on further development of image analysis software for easy detection, quantification and identification of microplastics in samples scanned by the MuScan device.
• RadboudUMCcoreStrategic or Co-development PartnerCollaboration on the Exhalyzer project - a Dutch funded research project developing a method for detection of microbes from exhaled air from infected patients for diagnosis of COPD and lung diseases. Results obtained within few hours including sampling with non-invasive testing.
• Kadans Vastgoed BVminorOthersReal estate partner with extended contract providing doubled space in housing to meet Innosieve's development and production needs.

Scale indicators4 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Rapid Micro Biosystems: US-based direct competitor offering the Growth Direct system for automated, rapid microbial enumeration in pharmaceutical QC using similar growth-and-imaging-based detection. Most directly comparable peer in rapid microbial methods for pharma.
• Particle Measuring Systems: Specializes in contamination monitoring instruments for cleanroom and pharmaceutical manufacturing environments, addressing adjacent microbial and particulate monitoring needs similar to MuScan's environmental and WFI monitoring applications.

Broad incumbents

• Becton Dickinson (BD): Major life sciences and diagnostics company with broad microbiology product portfolio including flow cytometry and molecular platforms used in pharma and clinical microbiology, overlapping with MuScan's pharma QC customers.
• bioMérieux: Global leader in industrial and clinical microbiology diagnostics with extensive installed base in pharma QC, including BioBall and TEMPO systems. Represents the dominant incumbent MuScan competes against.
• Charles River Laboratories: Provides both lab testing services and rapid microbial detection products (including the Celsis ATP-bioluminescence platform) to pharmaceutical manufacturers, directly overlapping with MuScan's pharma QC and sterility testing value proposition.
• Mérieux NutriSciences: Subsidiary of Institut Mérieux providing food, cosmetics, and pharmaceutical testing services with microbial testing capability, overlapping with Innosieve's industrial QC and pharmaceutical testing segments.
• SGS Life Sciences: Global contract testing and laboratory services provider offering pharmaceutical microbiology and sterility testing services that overlap with the use cases served by MuScan's bioburden and sterility testing workflows.
• Beckman Coulter (Danaher): Flow cytometry and analytical instrument leader under Danaher with significant presence in microbiology research and pharma QC workflows. Competes on the imaging/cell analysis side of rapid microbial methods.

Emerging players

• bioLytical Laboratories: Rapid diagnostics developer with focus on point-of-care infectious disease testing. Comparable as a niche rapid-diagnostics company expanding core technology into adjacent clinical applications similar to Innosieve's Exhalyzer program.
• T2 Biosystems: Developed T2 Magnetic Resonance rapid diagnostic platforms for sepsis and Candida detection, providing a comparable small-cap rapid-diagnostics profile with similar regulatory and adoption dynamics in clinical microbiology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Innosieve Diagnostics