Experimental Pathology Laboratorie

What Experimental Pathology Laboratorie does

Experimental Pathology Laboratories, Inc. (EPL) is a US-based preclinical pathology services firm founded in 1971 and employee-owned since 1992. Headquartered in Sterling, Virginia with regional offices in West Lafayette (IN), Collegeville (PA), and Boston (MA), EPL provides histopathology, toxicologic pathology, peer review, Pathology Working Groups, whole slide imaging, design-based stereology, immunohistochemistry, electron microscopy, and SEND-compliant data services to pharmaceutical, biotechnology, chemical, medical device, CRO, academic, and government clients (notably the NCI/NTP program). The company operates through four US regional hubs plus international alliances in Greater China and Taiwan, processing up to 50,000 tissues per month and conducting roughly 180-250 peer reviews annually.

EPL's technical platform combines wet-lab histology capabilities with proprietary software: the PQA pathology peer review system that runs on portable laptops and interfaces study data via ASCII text files; design-based stereology conducted across three anatomical planes for unbiased quantitative measurements; high-throughput whole slide imaging for digital pathology workflows; and validated TranSEND/Ascentos pipelines for SEND-compliant FDA submissions. The subsidiary Aclairo Pharmaceutical Development Group (acquired January 2016) layers nonclinical, regulatory, and ADME/DMPK consulting on top of the pathology core. EPL differentiates from full-service CROs through a 'scale without mass' specialist model — over 100 highly trained staff including board-certified veterinary pathologists, several former presidents of the Society of Toxicologic Pathology, and senior scientists recruited from GlaxoSmithKline, AstraZeneca, Hoffmann-La Roche, and Biogen.

Commercially, EPL is a project-based professional services firm selling customized preclinical pathology engagements on multi-year contract terms via direct business development, conference presence (SOT, STP, ACT, SETAC), and on-site pathologist travel to client laboratories. Pricing is quote-driven and varies by protocol, species, tissue count, regulatory pathway, and turnaround. Revenue is not publicly disclosed; the company has no venture or private equity backing, has never raised outside capital, and operates as an independent employee-owned entity, with growth funded internally through organic hiring and selective alliances rather than M&A or capital markets activity.

Name

Experimental Pathology Laboratorie

Legal name

Experimental Pathology Laboratories, Inc.

Website

https://epl-inc.com

Company type

Private

Founded year

1971

Operating status

Operating

Headcount range

51–100 employees

Short description

Experimental Pathology Laboratories (EPL) is a US-based, employee-owned preclinical pathology services firm founded in 1971, providing histopathology, toxicologic pathology, peer review, and SEND-compliant data services to pharmaceutical, biotech, chemical, medical device, and government clients including the NCI/NTP program.

Ownership category

akta.pro rank

Product category

Preclinical Pathology Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Pathology & Histopathology Services (HLAGAFAI)

akta.pro secondary industries

Anatomic Pathology & Histopathology (Trial Support) (HLAGAEAC), Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN), Veterinary Anatomic Pathology (Histopathology & Cytology) (HLAMADAB)

Keywords

• Preclinical pathology services
• Toxicologic pathology evaluation
• Histopathology peer review
• SEND-compliant data services
• Nonclinical safety assessment

Headquarters

HQ city

Sterling

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Pathology Services: EPL generates revenue through project-based professional services contracts for histopathology, toxicologic pathology evaluation, pathology peer review, Pathology Working Groups, consulting, and specialized laboratory services including stereology, immunohistochemistry, and electron microscopy. Services are provided to pharmaceutical, biotechnology, chemical companies, government agencies, and academia on a per-project basis.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Experimental Pathology Laboratories, Inc. (EPL) provides preclinical histopathology and toxicologic pathology services on a project basis to pharmaceutical, biotechnology, and chemical companies as well as government agencies and academia. Services span histology (H&E, immunohistochemistry, specialty stains, necropsy), pathology evaluation (carcinogenicity, peer review, Pathology Working Groups, aquatic/avian pathology), digital whole slide imaging and stereology, transmission electron microscopy, SEND-compliant data services, and expert scientific/regulatory consulting.

Product overview

Experimental Pathology Laboratories, Inc. (EPL) is a preclinical pathology services company offering a comprehensive portfolio of histopathology and toxicologic pathology services. Founded in 1971 and employee-owned since 1992, the company provides histology services (including routine H&E, immunohistochemistry, and specialty stains), pathology evaluation (carcinogenicity studies, peer review, working groups), imaging services (whole slide scanning, image analysis, stereology), SEND-compliant data services, and toxicology/consulting support. The company also operates Aclairo Pharmaceutical Development Group as a wholly owned subsidiary providing regulatory and nonclinical consulting. EPL leverages proprietary software including the PQA pathology peer review system and validated TranSEND/Ascentos platforms for SEND submissions. Services are delivered through laboratories in Sterling, VA (headquarters), North Carolina, Midwest (West Lafayette, IN), Northeast (Collegeville, PA), and Boston, MA.

Differentiator

Problem solved

Functional benefit

Products and services

• Histology Services Histology services including aquatic animal and avian histology, immunohistochemistry, necropsy, routine H&E staining, and specialty histochemical stains for pharmaceutical, biotechnology, chemical companies, government agencies, and academia.
• Pathology Services Toxicologic pathology evaluation including aquatic and avian pathology, carcinogenicity and chronic studies, organ-based expertise, pathology working groups, peer review, research animal models, and transmission electron microscopy.
• Whole Slide Imaging Services High-throughput whole slide imaging using advanced digital pathology technologies for consultation, peer review, education, and quantitative analysis through high-quality digital slide capture and secure image sharing.
• Image Analysis Image analysis services for quantitative analysis of tissue samples, supporting toxicologic pathology and nonclinical safety studies.
• Stereology Services
• Stereology Services Design-based stereology for unbiased, quantitative measurements of structures within biological tissues, providing more objective and accurate results compared to traditional semi-quantitative grading. EPL has been conducting design-based stereology in industry environments for 10 continuous years.
• SEND Data Services Standard for Exchange of Nonclinical Data (SEND) compliant dataset preparation and submission services using validated Ascentos and TranSEND software, providing FDA-ready datasets for NDA/BLA/ANDA submissions initiated after December 2016 and IND submissions after December 2017.
• Pathology Peer Review Third-party pathology peer review using proprietary PQA software to improve quality of pathology data and ensure regulatory compliance, conducted on-site or remotely. Over 250 peer reviews conducted in two years; 189 peer reviews in 2017 alone.
• Pathology Working Groups (PWG) Expert pathologist panels convened to answer specific questions and provide independent unbiased opinions regarding study results for regulatory and sponsor needs.
• Consulting Services Expert scientific and regulatory consulting for preclinical drug development, nonclinical safety assessment, and regulatory strategy.
• Toxicology Services Comprehensive toxicology support services for preclinical safety testing and drug development programs.
• Immunohistochemistry (IHC) Services Immunohistochemistry services for identification and localization of tissue antigens using validated protocols for formalin-fixed paraffin embedded tissues, with digital imaging and image analysis capabilities.
• Transmission Electron Microscopy (TEM) Electron microscopy services provided in partnership with Virginia Tech Laboratory for Neurotoxicity Studies, offering GLP-compliant transmission electron microscopy for nonclinical studies through the alliance established August 25, 2014.
• Aclairo Pharmaceutical Development Group Wholly owned subsidiary providing independent and objective nonclinical and regulatory advice to the pharmaceutical industry, including FDA strategy, due diligence, and product development consulting. Acquired by EPL on January 1, 2016.

Quantifiable outcome

• Processing up to 50,000 tissues per month
• +3 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Quality Scientific Solutions, LLC (QS3)coreStrategic or Co-development Partner · 7 May 2020Strategic alliance announced May 2020 to provide EPL's preclinical pathology expertise as an important resource to QS3. QS3 is a research and consulting company with six principals having over 200 years of combined research experience and more than 1,000 publications. Specialists in mode and mechanisms of action of chemicals, environmental transport, fate, and effects. QS3 principals include Drs. Charles Breckenridge, Ralph Cooper, Bob Handa, Peter Hertl, Tony Plant, and Jim Simpkins.
• PDS Life SciencescoreTechnology or Integration · 27 July 2017Technology partnership for SEND-compliant data solutions. EPL validated the Ascentos pathology information management system and TranSEND software solution by PDS Life Sciences. Through TranSEND software, EPL provides SEND-compliant datasets ready for FDA submission. SEND formats required for studies started after Dec 2016 for NDAs/BLAs/ANDAs and Dec 2017 for INDs.
• WestChina-Frontier PharmaTech Co., Ltd. (WCFP)coreStrategic or Co-development Partner · 28 March 2017Strategic alliance to enhance preclinical services. EPL provides Pathology Peer Review Services for WCFP projects being submitted to international regulatory agencies. WCFP, founded in February 2000 in Chengdu, China, is a professional CRO providing GLP safety and efficacy evaluations. WCFP has OECD, CAP, CFDA-GLP, and AAALAC accreditation with 380 staff including CFDA New Drug Reviewers and national-class pathologists.
• Expedient Solutions International (ESI) and Dr. Ada H.C. KungcoreStrategic or Co-development Partner · 10 March 2017Strategic alliance with EPL, Aclairo, and ESI to enhance Preclinical Pathology and Regulatory Consulting Services to the Greater China pharmaceutical and biotechnology industry. Initial focus on pathology peer reviews, pathology training, and IND application review for US FDA submissions. Dr. Kung formed ESI in 2008 and has rare combination of China and US drug development expertise, having submitted two of the first INDs to US FDA using data from China labs.
• Aclairo Pharmaceutical Development Group, Inc.coreStrategic or Co-development Partner · 1 January 2016EPL acquired Aclairo Pharmaceutical Development Group, Inc. on January 1, 2016. Aclairo is now a wholly owned subsidiary of EPL and provides independent and objective nonclinical, regulatory, and clinical ADME/DMPK expert strategy and implementation to pharmaceutical and drug device industries. Aclairo's team includes industry and ex-FDA experts providing specialized consultancy services. Leadership includes Dr. Hilary Sheevers (President), Dr. Susan Wilson (Vice President), Dr. Robert Guttendorf (Chief Scientific Officer), Dr. Laura Dill Morton (Director of Toxicology), and Dr. Tacey White (Director of Operations).
• Laboratory for Neurotoxicity Studies (LNS) at Virginia-Maryland College of Veterinary Medicine, Virginia TechcoreTechnology or Integration · 25 August 2014Electron microscopy services alliance. LNS is a fully GLP-compliant, state-of-the-art transmission electron microscopy laboratory supporting regulatory studies for over 25 years. Located at Virginia-Maryland College of Veterinary Medicine in Blacksburg, VA. Directed by Dr. Bernard Jortner, a board-certified veterinary pathologist with over 40 years of experience in neuropathology, toxicology, and ultrastructural research.
• ToxStrategiesminorStrategic or Co-development Partner · 31 July 2014Collaborative research partnership investigating morphologic effects of environmental contaminant hexavalent chromium on small intestines using histopathology, image analysis, and X-ray fluorescence spectromicroscopy. EPL provides pathology expertise and advanced imaging techniques for multidisciplinary research projects.
• HistionminorStrategic or Co-development Partner · 1 January 2014Strategic alliance to enhance medical device and biomaterial testing capabilities. Histion is an Everett, Washington-based preclinical laboratory specializing in GLP-compliant routine and specialty histology and evaluation services. Alliance targeted to expand capabilities for medical device and novel biomaterial testing.

Scale indicators7 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Charles River Laboratories: Large global CRO offering preclinical toxicology and anatomic pathology services to pharma and biotech; competes directly with EPL for toxicologic pathology, peer review and SEND-related work but as part of a much broader services portfolio.
• Inotiv: Preclinical research services and contract research organization providing toxicology, pathology and animal model services; competes with EPL for outsourced toxicologic pathology and safety assessment work.
• Seventh Wave Laboratories: Mid-sized preclinical CRO focused on safety assessment, toxicology and pathology services for emerging biopharma; comparable specialty focus and client base to EPL.
• Labcorp Drug Development: Full-service CRO (formerly Covance) providing preclinical safety, pathology and bioanalytical services; overlaps EPL on toxicologic pathology and SEND data services within an integrated early-development offering.
• Absorption Systems: Preclinical CRO offering toxicology, pathology and ADME services to pharma and biotech; competes with EPL on toxicologic pathology and SEND-enabled safety packages.
• Wuxi AppTec: Global preclinical and clinical CRO with extensive toxicologic pathology capacity; direct competitor for international pharma sponsors and a natural alternative to EPL's US-China peer review pathway.

Emerging players

• ToxStrategies: Scientific consulting firm with capabilities in toxicologic pathology, risk assessment and regulatory strategy; partial overlap with EPL's consulting and pathology peer review offerings.

Broad incumbents

• Eurofins Discovery: Broader discovery and preclinical services platform including safety assessment and pathology; overlaps with EPL on toxicologic pathology within a much wider CRO and testing portfolio.

Regional players

• WestChina-Frontier PharmaTech (WCFP): China-based GLP CRO providing safety and efficacy evaluations; EPL's alliance partner and a regional peer for pathology peer review services tied to FDA-bound China studies.

Others

• PDS Life Sciences: Provider of preclinical software including the Ascentos and TranSEND SEND platforms that EPL has validated; adjacent technology enabler rather than direct pathology services competitor.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/epl_2
• Xx.com/eplinc

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Experimental Pathology Laboratorie