Clinical and Laboratory Standards Institute

What Clinical and Laboratory Standards Institute does

Clinical and Laboratory Standards Institute (CLSI), founded in 1968 and headquartered in Wayne, Pennsylvania, is a nonprofit, member-based organization that develops and publishes more than 300 international consensus standards and guidelines covering all areas of laboratory medicine, including antimicrobial susceptibility testing (AST), method evaluation, quality management systems, preexamination processes, and veterinary diagnostics. The organization operates a consensus-driven development model, engaging nearly 2,000 volunteer subject matter experts across committees and working groups, and serves a global community of 26,000+ laboratory professionals, with adoption of its standards in 170 countries.

CLSI generates revenue through five primary streams: (1) one-time sales of standards documents at $80-$200 per title with member discounts of up to 70%; (2) annual membership fees at organization and individual tiers providing enterprise-wide access to standards and member pricing; (3) subscription products such as Method Navigator for laboratory-developed test (LDT) reference resources; (4) education and training programs including the 13-credit Laboratory Quality Management System (LQMS) certificate course and customized training; and (5) event registration for virtual learning events like CLSI Applied and Testing With Confidence, priced at $400-$550 and awarded P.A.C.E. continuing education credits. Member-based reach spans enterprise health systems (HealthPartners, Geisinger, Stanford Cancer Center South Bay), international laboratories (Asiri Laboratories in Sri Lanka), academic institutions (Texas A&M), and government health ministries across Zambia, Kenya, Tanzania, Zimbabwe, China, Kazakhstan, and the Dominican Republic.

The go-to-market motion is community-led, anchored by CLSI's ANSI-recognized consensus process, FDA-recognized standards used to satisfy regulatory requirements, and alignment with ISO 15189 accreditation frameworks. Distribution is direct via the clsi.org e-commerce storefront, with a fully remote operating model across an 11-50 employee base. Recent strategic activity under CEO Dr. Barb Jones (appointed 2022, third CEO in the organization's history) includes the 2025 launch of Method Navigator, EUCAST and LymeX Diagnostics Prize partnerships, the CLSI Applied 2026 virtual learning event, and an ANSI Board appointment, all reinforcing the organization's positioning at the intersection of regulatory recognition, laboratory quality, and emerging laboratory technology.

Name

Clinical and Laboratory Standards Institute

Legal name

Clinical and Laboratory Standards Institute

Website

https://clsi.org

Company type

Private

Founded year

1968

Operating status

Operating

Headcount range

11–50 employees

Short description

CLSI is a nonprofit, member-based standards organization founded in 1968 that develops and publishes 300+ international consensus standards and guidelines for clinical and veterinary laboratories, serving 26,000+ laboratory professionals across 170 countries with standards sales, memberships, education, and subscription products.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Standards & Guidelines

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Veterinary Compliance, Quality & Regulatory Reporting Systems (HLAMAMAJ)

akta.pro secondary industries

Veterinary Lab/Imaging Integration & LIS/PACS Connectivity (HLAMAMAG), Point-of-Care & In-Clinic Diagnostics (Rapid Tests, Benchtop Analyzers) (HLAMADAI), Reference Laboratory Testing (Clinical Pathology & Chemistry) (HLAMADAA)

Keywords

• Clinical laboratory standards
• Antimicrobial susceptibility testing
• Quality management systems
• Laboratory accreditation services
• Veterinary diagnostic standards

Headquarters

HQ city

Wayne

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, Others

Revenue model

1. Standards and Guidelines Sales: CLSI publishes and sells over 300 standards and guidelines covering microbiology, method evaluation, quality management systems, and veterinary medicine. Documents are available in print and electronic formats with pricing ranging from $80-$200 per document.
2. Membership Fees: Organization and individual membership tiers providing access to standards, training discounts, and member-exclusive pricing on products and events.
3. Education and Training Programs: Webinars, courses, certificate programs (LQMS), and customized training programs offered for continuing education credits.
4. Event Registration: Virtual learning events like CLSI Applied and Testing With Confidence with registration fees ($550 non-members, $400 members) and P.A.C.E. credits.
5. Subscription Products: Products like Method Navigator offered on subscription basis for ongoing access to LDT resources.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels7 records

Core offering

CLSI develops and publishes over 300 international consensus standards and guidelines covering all areas of clinical and veterinary laboratory medicine, including antimicrobial susceptibility testing, method evaluation, quality management systems, preexamination processes, and veterinary diagnostics. It also delivers subscription tools (e.g., Method Navigator), certificate courses (e.g., LQMS), and virtual learning events (e.g., CLSI Applied, Testing With Confidence) for laboratory professionals.

Product overview

Clinical and Laboratory Standards Institute (CLSI) is a nonprofit membership organization that publishes over 300 standards and guidelines in all areas of laboratory medicine. The portfolio includes core standards documents organized into specialty areas such as Antimicrobial Susceptibility Testing (M100, M02, M07), Method Evaluation (EP49, EP46, EP23), Preexamination Processes (PRE01, PRE02), Quality Management Systems (QMS28), and Veterinary Standards (VET01, VET09, VET02, VET03). Products include individual standards documents, subscription offerings like Method Navigator for LDT resources, and education programs including the LQMS Certificate Course and virtual events like CLSI Applied. The organization serves over 26,000 laboratory professionals with almost 2,000 subject matter experts participating in standards development, with CLSI standards used in 170 countries.

Differentiator

Problem solved

Functional benefit

Products and services

• CLSI M100 - Performance Standards for Antimicrobial Susceptibility Testing International standard providing performance standards for antimicrobial susceptibility testing, serving as the national reference standard for AST in multiple countries including Sri Lanka. Targeted at clinical microbiology laboratories and antimicrobial stewardship programs.
• CLSI EP49 - Framework for Clinical Validity of Medical Laboratory Test Methods Framework document providing guidance for developing evidence of clinical validity for medical laboratory test methods in method evaluation. Intended for IVD manufacturers and clinical laboratories.
• CLSI EP46 Plus - Allowable Total Error Goals and Limits Provides developers and end users with concepts related to setting allowable total error goals and limits for quantitative measurement procedures; FDA-recognized standard for regulatory compliance.
• CLSI M67 - Verification of Laboratory Automation in Microbiology Standard addressing verification of laboratory automation systems in microbiology settings.
• CLSI QMS28 - Laboratory Safety Management Quality Management System standard focused on laboratory safety management practices for clinical laboratories.
• CLSI AUTO15 - Autoverification of Medical Laboratory Results Standard providing guidelines for designing, validating, and implementing autoverification systems in laboratories to automatically validate test results based on defined criteria.
• CLSI VET09 - Antimicrobial Stewardship in Veterinary Settings Second edition document providing species-specific AST procedures and breakpoints for veterinary settings including dogs, cats, horses, cattle, pigs, fish, and poultry.
• CLSI VET01 - Antimicrobial Disk and Dilution Susceptibility Tests for Animals Sixth edition standard providing disk diffusion and dilution susceptibility testing methods for aerobic bacteria isolated from animals.
• CLSI VET01S - Performance Standards Supplement for Bacteria Isolated From Animals Seventh edition supplemental tables providing current information for antimicrobial agent selection, interpretation, and quality control for veterinary AST.
• CLSI VET02 - Quality Control for Antimicrobial Agents in Veterinary Medicine Fourth edition providing guidance for developing QC ranges, breakpoints, and interpretive categories for antimicrobial susceptibility tests for aerobic bacteria isolated from animals.
• CLSI VET03 - Susceptibility Testing for Aquatic Animals Second edition providing methods for broth dilution and disk diffusion susceptibility testing of bacteria isolated from aquatic animals.
• CLSI PRE01 - Patient and Laboratory Specimen Identification Processes First edition standard covering procedures for patient and specimen identification, collection, transport, and handling applicable to medical laboratory specimens.
• CLSI PRE02 - Collection of Diagnostic Venous Blood Specimens Eighth edition providing procedures for collection of diagnostic venous blood specimens including line draws, blood culture collection, and venipuncture in children.
• CLSI EP23 - Laboratory Quality Control Based on Risk Management Second edition guideline providing recommendations based on risk management for developing quality control plans tailored to measuring systems and clinical applications.
• CLSI M07 - Dilution Antimicrobial Susceptibility Tests for Aerobic Bacteria Twelfth edition providing essential guidance for antimicrobial susceptibility testing using broth macrodilution, broth microdilution, and agar dilution methods.
• Method Navigator Subscription product enabling users to easily reference and access resources for establishment and implementation of laboratory-developed tests (LDTs) or other regulatory-approved commercial test methods.
• LQMS Quality Management Certificate Course 13-credit Laboratory Quality Management System course providing comprehensive training in quality management systems for laboratory accreditation and improvement.
• EP23 IQCP eLearning Course eLearning course on Individualized Quality Control Plan based on risk management for medical laboratory testing.
• CLSI Applied Virtual Events Virtual learning events including the Testing With Confidence series and annual CLSI Applied summits addressing laboratory innovation, regulatory changes, and emerging technologies including AI.
• CLSI EP LDT Quick Guide Quick reference guide for laboratory-developed tests supporting regulatory navigation under FDA oversight.

Quantifiable outcome

• CLSI standards are used in 170 countries globally
• +5 more outcomes

Named customers10 records

Segments6 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• EUCAST (European Committee on Antimicrobial Susceptibility Testing)coreStrategic or Co-development Partner · 19 August 2025CLSI and EUCAST partnered to publish guidance on appropriate use and modification of reference antimicrobial susceptibility testing (AST) methods during development of new drugs, providing important guidance for antimicrobial developers.
• ANSI (American National Standards Institute)coreStrategic or Co-development PartnerCLSI CEO Dr. Barb Jones was appointed to the ANSI Board of Directors, strengthening CLSI's role in the standards development ecosystem.
• LymeX Diagnostics PrizeminorStrategic or Co-development PartnerCLSI partnered with LymeX Diagnostics Prize to support Phase 4 teams advancing Lyme disease diagnostics, helping teams implement clinical validation plans and complete FDA regulatory submissions.
• Zambia Ministry of Health and CIDRZcoreStrategic or Co-development PartnerCLSI supported laboratories in Zambia since 2010 through the CIDRZ LIFE project, strengthening quality management systems and building capacity for international accreditation.
• Tanzania Ministry of Health and CDCcoreStrategic or Co-development PartnerFor over 15 years, CLSI collaborated with CDC Tanzania through PEPFAR and GHSA programs to support Tanzania's national laboratory system strengthening goals.
• Kenya Ministry of Health and CDCcoreStrategic or Co-development PartnerCLSI worked with Kenya Ministry of Health and CDC since 2010 to implement Quality Management Systems and help laboratories achieve international accreditation aligned with ISO 15189.
• Zimbabwe Ministry of Health and Child CarecoreStrategic or Co-development PartnerCLSI collaborated with Zimbabwe MOHCC, Medical Laboratory Council, and Biomedical Research and Training Institute to support laboratory quality improvement and domestic ISO 15189 accreditation.
• People's Republic of China (PRC)coreStrategic or Co-development PartnerCLSI partnership with PRC since 2012 supporting China's laboratory medicine quality improvement through academic collaboration, standards training, and accreditation preparedness.
• Kazakhstan Ministry of HealthcareminorStrategic or Co-development PartnerCLSI helped Kazakhstan modernize laboratories through Field Epidemiology and Laboratory Training Program, supporting quality management system implementation.
• UNAIDS (Joint United Nations Programme on HIV/AIDS)coreStrategic or Co-development PartnerCLSI partnered with UNAIDS to provide HIV testing training in Dominican Republic, supporting the 90-90-90 initiative goals for diagnosis and treatment.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• ISO (International Organization for Standardization): Develops ISO 15189 (medical laboratories — quality and competence), the global accreditation framework CLSI standards often align with and underpin. Both organizations publish consensus standards relied upon by clinical laboratories worldwide.
• College of American Pathologists (CAP): Operates the CAP Laboratory Accreditation Program with checklist requirements closely aligned to CLSI quality and method evaluation standards. CAP is a primary competitor in setting clinical lab practice standards in the US.
• ASTM International: Develops consensus standards including E29 series for laboratory testing and precision. Comparable consensus-driven, member-funded standards development model with similar document pricing and subscription structure.
• AOAC International: Standards organization focused on analytical methods validation in food, microbiological, and environmental testing. Overlaps with CLSI's method evaluation (EP series) and microbiology (M series) content areas.
• WOAH (World Organisation for Animal Health): Publishes the WOAH Terrestrial and Aquatic Manuals setting international standards for animal disease diagnostics including antimicrobial susceptibility testing. Directly competes with CLSI's VET01/VET02/VET03 series.

Broad incumbents

• Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC): Scientific and professional society for clinical chemistry and laboratory medicine. Overlaps with CLSI in clinical chemistry standards and continuing education, serving overlapping laboratory professional audiences.
• Joint Commission: Major US healthcare facility accreditation body including laboratory services. Sets requirements overlapping with CLSI QMS and safety standards, competing for institutional standards authority in clinical lab settings.

Emerging players

• American Society for Veterinary Clinical Pathology (ASVCP): Veterinary specialty organization publishing guidance on veterinary clinical pathology practices, overlapping with CLSI's VET series. Smaller in standards output but with deep veterinary domain authority.
• Westgard QC: Provides QC rules, validation tools, and training aligned with CLSI EP23 and related quality standards. Commercial competitor offering digitized QC implementation tools as an alternative to CLSI's traditional documents.

Regional players

• American Association for Laboratory Accreditation (A2LA): US-based accreditation body offering ISO 17025 and clinical laboratory accreditation programs. Operates downstream of CLSI standards by accrediting labs against requirements CLSI's content helps them meet.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCfvQrLzswA20lWnTy_VqOBA/feed
• Facebookfacebook.com/425686044180103
• LinkedInlinkedin.com/company/25241
• Instagraminstagram.com/clsi_labnews
• Xx.com/clsi_labnews

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

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 Clinical and Laboratory Standards Institute