What Accugen does

Accugen Laboratories, Inc. (DBA Accugen Labs) is an FDA-registered, ISO 17025-accredited independent contract microbiology testing laboratory founded in 1997 and headquartered in a single facility at 2121 W. Army Trail Road in Addison, Illinois. The company provides full microbiological testing services to manufacturers across pharmaceutical, cosmetic and personal care, food and beverage, disinfectant and sanitizer, medical device, materials/textiles/polymers, environmental, and veterinary/dental verticals. Its core technology is execution of standardized microbiological methods rather than proprietary instrumentation; the laboratory follows USP (51, 61, 62, 71, 85, 1072, 1227), AOAC use-dilution and germicidal protocols, ASTM antimicrobial and fungal resistance standards, AATCC textile antimicrobial methods, ISO 846 and 22196, JIS Z 2801, EPA, USDA, and CTFA protocols. Service lines include microbial enumeration, pathogen detection, sterility testing, LAL endotoxin testing (sensitivity as low as 0.005 EU/ml), preservative and antimicrobial effectiveness testing, bioburden, stability, zone of inhibition, time-kill, MIC/MBC, microbial identification with STAT turnaround within 48 hours, and consulting plus R&D support.

The business operates on a quote-based contract testing model: clients initiate contact by email, phone, or fax, receive a price quotation and sample submission form, ship physical samples to the Addison facility, and receive final signed reports electronically. Payment is accepted via check, money order, credit card, or wire transfer, and new clients may establish credit through a 2-3 week application process. The company has no resellers, distributors, or marketplace channels; all revenue flows through direct client engagement from a single domestic site. The GTM motion is sales-led and relationship-driven, supported by a comprehensive website organized by industry, agency, standard, and method as the primary information hub, plus toll-free and direct phone lines for inbound quotation requests. No management team, board, or named leadership is disclosed in the source data, consistent with a privately held, founder-operated structure with no external funding rounds, M&A activity, or parent company relationships on record.

Name

Accugen

Legal name

Accugen Laboratories, Inc.

Website

https://accugenlabs.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

11–50 employees

Short description

Accugen Laboratories is an FDA-registered, ISO 17025-accredited independent contract microbiology testing laboratory founded in 1997. The single-facility lab serves pharmaceutical, cosmetic, food, disinfectant, medical device, and materials manufacturers from Addison, Illinois.

Ownership category

akta.pro rank

Product category

Contract Microbiology Testing Services

NAICS

Medical Laboratories (621511), Testing Laboratories and Services (541380)

SIC

Services-Medical Laboratories (8071), Services-Testing Laboratories (8734)

akta.pro primary industry

Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE)

akta.pro secondary industries

Microbiology & Infectious Disease Testing Laboratories (HLAFAMAD), Food Testing Laboratories (Microbiological, Chemical, Allergen) (AFALAAAA), Sanitation Chemical Efficacy Testing & Disinfectant Validation (Quat/PAA Verification) (AFALAEAL)

Keywords

• Microbiology testing services
• Contract laboratory testing
• USP compliance testing
• LAL endotoxin testing
• Disinfectant efficacy testing

Headquarters

HQ city

Willowbrook

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Microbiology Testing Services: Accugen Labs generates revenue through providing microbiological testing services on a contract basis. Clients contact the laboratory to request a price quotation, submit samples with a signed submission form, and receive a final signed report with results. Payment options include check, money order, Visa, MasterCard, or wire transfer. New clients may establish credit via a credit application process taking 2–3 weeks.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Accugen Laboratories, Inc. is an FDA-registered, ISO 17025 accredited independent contract microbiology testing laboratory. It delivers full microbiological testing services — including microbial enumeration, pathogen detection, sterility and LAL endotoxin testing, preservative/antimicrobial effectiveness testing, bioburden analysis, stability testing, and disinfectant efficacy testing — to pharmaceutical, cosmetic, food, medical device, disinfectant, textile, and related manufacturers from a single facility in Addison, Illinois.

Product overview

Accugen Laboratories is an FDA-registered, ISO 17025 Accredited independent contract microbiology laboratory offering a comprehensive portfolio of microbiological testing services. The company provides full microbiological testing across multiple industry verticals including pharmaceutical, cosmetic, food, beverage, medical device, and antimicrobial products. Their core offerings include USP compliance testing (USP 51, 61, 62, 71, 1227), AOAC disinfectant efficacy testing, ASTM antimicrobial testing, AATCC textile testing, ISO standards testing, and LAL endotoxin testing. The laboratory also offers specialized services including Time Kill testing, Zone of Inhibition testing, Minimum Inhibitory Concentration testing, Bioburden testing, Stability testing, and Food Pathogen testing. Additional services include expertise and consulting, quality control, and research and development support.

Differentiator

Problem solved

Functional benefit

Products and services

• Microbiological Testing Laboratory Services Core laboratory service portfolio covering microbial enumeration, pathogen detection, preservative effectiveness testing, sterility testing, and bioburden analysis for pharmaceutical, cosmetic, food, disinfectant, and related manufacturers.
• AOAC Use-Dilution Test Quantitative test measuring the efficacy of liquid chemical disinfectants against Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa on stainless steel cylinder carriers per AOAC methodology.
• Time Kill Test Susceptibility test evaluating antimicrobial reduction of test materials or disinfectants against selected bacteria or fungi including Staphylococcus aureus, Salmonella cholerasuis, Pseudomonas aeruginosa, E. coli, Aspergillus niger, and Trichophyton mentagrophytes.
• Zone of Inhibition / Kirby-Bauer Testing Disc diffusion (ZOI, Kirby-Bauer) test demonstrating activity and potency of antimicrobials or antibiotics by measuring the zone of inhibition against specified microorganisms.
• Minimum Inhibitory Concentration (MIC) Testing Tube dilution or agar dilution testing that identifies the lowest concentration of a material preventing microbial growth (MIC) and the minimum lethal concentration (MLC).
• LAL Endotoxin Testing Bacterial endotoxin testing using Gel Clot, Chromogenic, and Turbidimetric methods to detect endotoxins from gram-negative organisms in pharmaceutical, biopharmaceutical, medical device, and research products, with sensitivity as low as 0.005 EU/ml.
• USP 61 Microbial Enumeration Testing USP 61 quantitative test determining Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) on non-sterile products using pour-plate, surface-spread, or membrane filtration methods.
• USP 62 Specified Microorganisms Testing USP 62 testing for the presence of specified microorganisms including Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia, Salmonella, and Candida albicans in non-sterile products.
• USP 71 Sterility Testing Official USP 71 sterility test using Direct Transfer-Immersion, Membrane Filtration open system, or Steritest closed system methods with incubation at specific temperatures for at least 14 days.
• Bioburden Testing Bioburden analysis providing total bacteria and fungi counts on products, with recovery efficiency validation to determine pre-sterilization microbial load on pharmaceutical or medical products.
• Stability Testing Stability testing following FDA and ICH guidelines including Long Term/Real-time, Intermediate, and Accelerated Stability Testing to establish re-test periods and shelf life with recommended storage conditions.
• USP 51 Antimicrobial Effectiveness Testing USP 51 preservative efficacy test challenging products with high concentrations of Staphylococcus aureus, E. coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis, evaluated over 28 days.
• USP 1227 Neutralization Validation Testing USP 1227 test evaluating methods to neutralize the antimicrobial properties of a product prior to estimating the number of viable microorganisms, ensuring validity of test results.
• Food Pathogen Testing Comprehensive food microbiology testing including Aerobic Plate Count, Yeast & Mold, E. coli, E. coli O157:H7, Coliforms, Salmonella, Staphylococcus aureus, Listeria monocytogenes, Bacillus cereus, Campylobacter jejuni, Clostridium botulinum, and Shigella.
• ISO 22196 Antibacterial Activity Testing ISO 22196 measurement of antibacterial activity on plastics and other non-porous, treated surfaces using a bacterial suspension with a 24-hour contact period.
• JIS Z 2801 Antimicrobial Activity Testing JIS Z 2801 Japanese Industrial Standard test evaluating antimicrobial activity and efficacy of antimicrobial products on treated surfaces.
• ASTM G21 Fungal Resistance Testing ASTM G21 practice determining resistance of synthetic polymeric materials to fungi on paint, plastics, paper, and cardboard using five fungi species over 28 days under controlled temperature and humidity.
• AATCC 100 Antimicrobial Textile Testing AATCC 100 quantitative assessment of antibacterial finishes on textile materials, evaluating antimicrobial activity over a 24-hour contact period against Staphylococcus aureus and Klebsiella pneumoniae.
• Hard Surface Disinfectant Testing Disinfectant efficacy testing service including AOAC Use Dilution Tests, Germicidal Spray Products Tests, Chlorine Disinfectants Testing, Fungicidal Activity Tests, Sporicidal Activity Tests, Tuberculocidal Activity Tests, Virucidal Efficacy Tests, and EPA submission support.
• Microbial Identification Services Identification of aerobes, anaerobes, yeast, fungi, Mycobacteria, and Actinomyces for pharmaceutical, medical device, cosmetics, food, and research industries, with STAT results in 48 hours.
• Expertise and Consulting Services Microbiology consulting covering testing program design, regulatory compliance guidance, and test method development for manufacturers needing microbiology expertise beyond routine testing.
• Quality Control (QC) Services Quality control testing services supporting product quality assurance and regulatory compliance testing for client-manufactured products.
• Research and Development (R&D) Services Custom research microbiology services and development of custom testing protocols for specialized testing needs not addressed by standard compendial methods.

Quantifiable outcome

• STAT microbial identification results reported within 48 hours
• +1 more outcomes

Segments8 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators3 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• Microbac Laboratories: Microbac operates contract microbiology labs serving pharmaceutical, food, cosmetic, and consumer product clients with sterility, pathogen, and preservative efficacy testing — a multi-vertical contract testing peer with a similar footprint to Accugen.
• Eurofins Scientific: Eurofins is the largest global contract testing laboratory network with deep pharmaceutical microbiology, sterility, and disinfectant testing capabilities across multiple continents — the most direct scaled analogue to Accugen's service model.
• BioReliance (Merck KGaA): BioReliance provides biologics safety and microbiology testing services for biopharma clients including sterility, mycoplasma, and endotoxin testing — directly comparable to Accugen's USP 71 and LAL endotoxin offerings for biopharma manufacturers.
• Nelson Laboratories: Nelson Labs (a Steris company) specializes in microbiology and sterility testing for medical devices and pharma, providing USP 71 sterility, bioburden, and LAL endotoxin services that directly overlap Accugen's regulated sterility portfolio.
• Pacific BioLabs: Pacific BioLabs is a contract microbiology and analytical testing lab serving pharma, biotech, and medical device manufacturers with USP sterility, endotoxin, bioburden, and antimicrobial efficacy services — closely aligned to Accugen's offering portfolio.
• Microchem Laboratory: Microchem is a contract microbiology testing lab specializing in antimicrobial and disinfectant efficacy testing (AOAC Use-Dilution, time-kill, zone of inhibition) — directly competing with Accugen's core disinfectant testing service line.
• Charles River Laboratories: Charles River's Microbial Solutions and Manufacturing Services segments provide USP sterility, endotoxin, and bioburden testing for pharma and medical device manufacturers — closely overlapping Accugen's pharmaceutical sterility and LAL endotoxin practice.

Broad incumbents

• SGS: SGS is a global testing, inspection, and certification giant offering microbiological and sterility testing services across pharma, food, and cosmetics — competing with Accugen at the high end for regulated multinational clients.
• Pace Analytical: Pace Analytical is a major US life sciences and environmental testing network with microbiology service lines for food, pharma, and consumer products — a broader-scale incumbent alternative that competes with Accugen on multi-site enterprise accounts.
• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with laboratory testing services for biologics, pharma, and medical devices — competing with Accugen for outsourced sterility and microbial testing, particularly from international pharma sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/accugen-laboratories-inc

Compliance12 records

Revenue estimate

Valuation estimate

Number of profiles

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 Accugen