What Microbiologics does

Microbiologics is a privately held specialty biotechnology company founded in 1971 and headquartered in St. Cloud, Minnesota, that manufactures and distributes biological reference materials and quality control microorganisms for laboratories in pharmaceutical, clinical diagnostic, food safety, personal care, water/environmental, cannabis, and education markets. Its product architecture centers on ready-to-use, lyophilized microbial preparations in proprietary single- or multi-use formats (KWIK-STIK, LYFO DISK, Epower CRM, EZ-Accu Shot, EZ-CFU, EZ-PEC, Lab-Elite CRM), molecular diagnostic reference standards (Helix Elite Inactivated and Synthetic Standards, SensID oncology and precision medicine controls), and chromogenically marked organisms (UV-BioTAG with Green Fluorescent Protein markers). The portfolio spans more than 2,391 SKUs across 900+ microbial strains, with manufacturing and R&D facilities in St. Cloud, Kalamazoo, and Lexington, and a CRO and sales office in San Diego; the firm operates ISO 17025 accredited reference material production and cGMP-compliant processes, plus BSL-3 laboratory capacity for high-containment work.

The company's commercial model combines direct enterprise sales, segmented by US territory and by clinical, industrial, and CRO laboratory channels, with an international distributor network covering Asia-Pacific, Latin America/Canada, Europe, and the Middle East/Africa, supported by instrument-locked QC Sets and Panels for platforms from BD MAX, Cepheid Xpert, Bruker MALDI Biotyper, BIOLOG, IDEXX, and Charles River. Revenue streams include one-time catalog sales of reference materials and clinical molecular controls under quote-based pricing, plus professional services revenue from custom manufacturing, diagnostic partnerships, BSL-3 testing, antibacterial/antifungal and antiviral assay services, viral stock production, and a Global Genomics Center. Growth to date has come primarily through acquisitions (Phthisis Diagnostics in 2013, Cryologics in 2022, and SensID in 2024) to broaden into cryopreservation, virology services, and oncology molecular diagnostics, complemented by capacity expansions such as BSL-3 lab scale-up and product-line extensions including GFP-marked controls for food safety.

Strategic posture, as evident from both the website and third-party market references, is that of a category-leading specialist in regulated microbial and molecular QC, rather than a broad-line life sciences tools vendor; revenue is not publicly disclosed, the firm is privately held, and ownership/PE backing is not disclosed in the available materials, although the multi-site footprint, broad product portfolio, and global distribution indicate an established mid-market specialty biotech.

Name

Microbiologics

Legal name

Microbiologics

Website

https://microbiologics.com

Company type

Private

Founded year

1971

Operating status

Operating

Headcount range

1–10 employees

Short description

Founded in 1971, Microbiologics is a St. Cloud, Minnesota-based specialty biotech that manufactures ready-to-use microbial reference materials, molecular diagnostic controls, and certified reference strains for pharmaceutical, clinical diagnostic, food safety, and other regulated QC laboratories worldwide.

Ownership category

akta.pro rank

Product category

Biotechnology reference materials and CRO laboratory services

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), Biological Products, (No Disgnostic Substances) (2836), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC)

akta.pro secondary industries

Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE), Laboratory Consumables & Plasticware (Tips, Tubes, Plates, Filters) (HLAGAIAH), Microbiological Reference Cultures, Strains & Controls (Food Micro) (AFALAKAF)

Keywords

• Microbial reference materials
• Quality control microorganisms
• Molecular diagnostic standards
• Viral safety testing
• Contract research laboratory services

Headquarters

HQ city

Saint Cloud

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Microbial Reference Materials Products: Sale of ready-to-use microbial control strains including KWIK-STIK, LYFO DISK, Epower, EZ-Accu Shot, and other formats for quality control testing across pharmaceuticals, food safety, clinical diagnostics, and other industries.
2. Molecular Diagnostic Controls: External quality controls and reference materials for molecular diagnostic instruments including Helix Elite products for syndromic testing panels.
3. CRO Laboratory Services: Contract research organization services including antibacterial/antifungal testing, antiviral testing, BSL-3 testing, viral stock production, microbial growth and preservation, proficiency solutions, and assay development.
4. Custom Manufacturing: Custom manufacturing services including environmental isolate controls, diagnostic partnerships, and custom microbial/viral production.

Go-to-market motion2 records

Distribution channels5 records

Marketing channels4 records

Core offering

Microbiologics manufactures and sells biological reference materials, including lyophilized microbial quality control organisms and molecular diagnostic standards, across multiple proprietary formats (KWIK-STIK, EZ-Accu Shot, Epower CRM, Helix Elite, UV-BioTAG). The company also provides CRO laboratory services spanning antibacterial/antifungal testing, antiviral testing, BSL-3 testing, viral stock production, microbial growth and preservation, and genomics.

Product overview

Microbiologics is a biotechnology company offering a comprehensive portfolio of microbiology, molecular diagnostic, and virology products and CRO laboratory services. The product portfolio includes multiple quality control reference material formats (KWIK-STIK™, LYFO DISK™, Epower™ CRM, EZ-Accu Shot™, EZ-CFU™, EZ-PEC™, Helix Elite™, UV-BioTAG™) organized by industry verticals (Clinical, Pharmaceutical, Food Safety, Personal Care/Cosmetics, Water/Environmental, Cannabis, Education) and regulatory standards (CLSI, FDA BAM, USP, ISO). The company also provides extensive CRO laboratory services including viral safety solutions, BSL-3 testing, antibacterial/antifungal testing, antiviral testing, and genomics services, enabling customers to access both products and contract research support from a single provider.

Differentiator

Problem solved

Functional benefit

Brands

• Epower: Versatile quantitative QC microorganisms for enumeration methods, available in CRM (Certified Reference Material) format for ISO 17025 accredited laboratories.
• KWIK-STIK
• LYFO DISK
• EZ-Accu Shot
• EZ-PEC
• UV-BioTAG
• Helix Elite
• Lab-Elite CRM
• SensID

Products and services

• KWIK-STIK 2 Pack All-in-one device containing a lyophilized microorganism pellet, rehydration fluid, and inoculating swab for qualitative culture-based QC testing with traceability to reference cultures. Targeted at pharmaceutical, clinical, food safety, and other QC laboratories.
• LYFO DISK Packaged in a glass vial containing 6 qualitative lyophilized organism pellets for qualitative culture-based QC testing. Targeted at QC laboratories across multiple industries.
• Epower CRM ISO 17025 accredited Certified Reference Materials providing quantitative QC microorganisms for measurement traceability to SI units, one passage from reference culture. Targeted at ISO 17025 accredited enumeration laboratories.
• EZ-Accu Shot Ready-to-use quantitative lyophilized microorganism pellets for Growth Promotion Testing with zero prep required. Targeted at pharmaceutical QC laboratories performing GPT.
• EZ-Accu Shot Select Top 6 control organisms for Growth Promotion Testing combined in one convenient kit. Targeted at pharmaceutical QC laboratories.
• EZ-CFU One Step Delivers 10-100 CFU for Growth Promotion Testing using a quick warming step. Targeted at pharmaceutical QC laboratories performing GPT.
• EZ-PEC Quantitative QC microorganism preparations designed to provide required microorganism challenge concentrations for Antimicrobial Effectiveness Testing (USP <51>) and Preservative Efficacy Testing. Targeted at pharmaceutical and personal care QC laboratories.
• Helix Elite Molecular Standards External, third-party molecular reference standards available in inactivated and synthetic nucleic acid ready-to-use formats for QC of molecular instruments and assays. Targeted at clinical molecular diagnostic laboratories.
• UV-BioTAG QC microorganisms with Green Fluorescent Protein (GFP) markers integrated into the chromosome, allowing easy differentiation of control strains from contaminants under UV light. Targeted at food safety, pharmaceutical, and clinical QC laboratories.
• Lab-Elite CRM Qualitative control strains as Certified Reference Material for ISO 17025 accredited labs. Targeted at accredited QC laboratories requiring traceable qualitative reference strains.
• QC Sets and Panels Bundled sets and panels of microorganisms for QC of instruments and standards, including Helix Elite, KWIK-STIK, and KWIK-STIK 2-Pack variants tailored for specific diagnostic platforms. Targeted at clinical diagnostic laboratories.
• SensID Quality Controls & Reference Materials Oncology and precision medicine reference materials and quality controls designed to elevate molecular diagnostic accuracy and reliability, supporting liquid biopsy, cancer diagnostics, and infectious disease testing. Targeted at molecular diagnostic laboratories and precision medicine researchers.
• Viral Safety Reference Material Reference materials for viral safety testing to ensure safety, quality, and regulatory compliance of biologics. Targeted at biopharmaceutical manufacturers performing viral safety assessment.
• Enumerated Mycoplasma Quality control strains for compliance with USP <63> and Ph. Eur. 2.6.7 for Mycoplasma testing in biopharmaceutical production. Targeted at biopharmaceutical QC laboratories.
• BSL-3 Laboratory Services Biosafety Level 3 testing and biomaterial design services for BSL-3 agents including SARS-CoV-2, Chikungunya, and other emerging pathogens. Targeted at biopharma, vaccine developers, and public health researchers.
• Antibacterial & Antifungal Testing Services Wide range of standard and custom antimicrobial assays, advanced microbial identification, extraction and preservation, and strategic consulting services. Targeted at biopharma, personal care, and academic research clients.
• Antiviral Testing Services Comprehensive testing services to support antiviral drug and vaccine development for biopharma companies worldwide. Targeted at antiviral drug and vaccine developers.
• Viral Stock Production Production of live virus preparations, inactivated intact virus, and quantitated viral nucleic acids. Targeted at biopharma and vaccine developers requiring characterized viral biomaterials.
• Global Genomics Center Comprehensive solutions from Sanger sequencing to next-generation sequencing (NGS), spanning sample preparation through bioinformatics analysis. Targeted at clinical, biopharma, and academic research clients requiring genomic characterization.

Segments7 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• CryologicscoreStrategic or Co-development Partner · 25 April 2022Acquisition of Cryologics, a leader in cryopreservation of environmental isolates, to expand capacity in microbiology research and services. The deal enhances Microbiologics' offerings for pharmaceutical and personal care product safety, leveraging Cryologics' expertise in GMP practices.
• SensIDcoreStrategic or Co-development PartnerAcquisition of SensID to expand expertise in diagnostic quality controls. SensID products include oncology and precision medicine reference materials and quality controls for molecular diagnostics, supporting liquid biopsy, cancer diagnostics, and infectious disease testing applications.
• Diagnostic Technology DeveloperscoreStrategic or Co-development PartnerPartnerships with infectious disease diagnostic technology developers to co-create biological reference materials that accelerate commercialization and increase market adoption. Collaboration spans from product conception through market adoption.

Scale indicators2 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Bio-Rad Laboratories: Bio-Rad's Life Science segment directly competes with Microbiologics in microbial QC controls, molecular diagnostic reference materials, and infectious disease diagnostics controls used by clinical and pharmaceutical laboratories.
• ATCC: ATCC supplies authenticated microbial strains and biological reference materials to the same pharmaceutical, clinical, and academic customers that Microbiologics serves with its KWIK-STIK, LYFO DISK, and Epower product lines.
• LGC Group (including SeraCare): LGC's diagnostics and genomics division produces molecular QC reference materials and proficiency testing panels that compete head-to-head with Microbiologics' Helix Elite and SensID molecular diagnostic controls.
• Hardy Diagnostics: Hardy Diagnostics manufactures microbiology culture media and QC organisms serving clinical, food safety, and pharmaceutical laboratories, overlapping directly with Microbiologics' KWIK-STIK and Epower product lines.
• ZeptoMetrix: ZeptoMetrix provides molecular QC controls and infectious disease reference materials, directly competing with Microbiologics' Helix Elite molecular standards and clinical diagnostic QC panels.
• Charles River Laboratories: Charles River's microbial solutions and Avian Vaccine services compete with Microbiologics' CRO services for antibacterial/antifungal testing, viral safety, and endotoxin/microbiology QC services supplied to biopharma manufacturers.

Broad incumbents

• Thermo Fisher Scientific: Thermo Fisher's Microbiology and Life Sciences Solutions divisions offer culture media, QC organisms, and molecular diagnostic controls as part of a broader portfolio, competing with Microbiologics across pharma and clinical end-markets.
• Merck KGaA (MilliporeSigma): MilliporeSigma supplies microbiology QC products, reference materials, and sterility testing consumables as part of its life science portfolio, overlapping with Microbiologics' pharmaceutical and personal care product QC offerings.
• Sartorius: Sartorius' bioprocessing and laboratory products divisions supply microbial QC and sterility testing consumables to pharmaceutical manufacturers, competing with Microbiologics on the pharma manufacturing QC side.
• bioMérieux: bioMérieux's Industrial Microbiology division supplies QC organisms and culture-based identification products to pharmaceutical and food safety customers, overlapping with Microbiologics' pharmaceutical and food safety segments.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/Microbiologics
• YouTubeyoutube.com/user/Microbiologics
• Facebookfacebook.com/Microbiologics
• LinkedInlinkedin.com/company/microbiologics-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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

M&A3 records

Investments1 record

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

Frequently asked questions about Microbiologics