UK NEQAS for Immunocytochemistry & In Situ Hybridisation

What UK NEQAS for Immunocytochemistry & In Situ Hybridisation does

UK NEQAS for Immunocytochemistry & In Situ Hybridisation (ICC & ISH) is a London-based, not-for-profit Community Interest Company that has delivered External Quality Assessment (EQA) services to cellular pathology laboratories since 1985. Operating under the legal entity External Quality Assessment Services for Cancer Diagnostics CIC (EQAS-CD), the scheme runs three assessment runs per year across more than 20 immunocytochemistry modules and 3 in-situ hybridisation modules, evaluating biomarker staining quality for markers such as HER2, ER/PR, PD-L1, ALK, ROS1, MMR proteins, Ki-67, p16, and HPV. Participation has grown from approximately 20 UK laboratories at founding to over 500 laboratories across more than 50 countries, with over 20,000 slides assessed annually by a panel of 100+ specialist assessors.

The service is built around a proprietary assessment infrastructure that includes the Best Methods database (over 8,000 anonymised high-performing methodologies), digital image upload and analysis capabilities (including for the HER2-low module), and the Qualitopix continuous-monitoring software delivered in partnership with Visiopharm to bridge the gap between quarterly EQA runs. The scheme holds UKAS accreditation to ISO/IEC 17043 for proficiency testing, a credential that effectively anchors participation to ISO 15189 accreditation cycles for clinical laboratories in the UK and increasingly in international markets.

The commercial model is a strictly non-profit subscription arrangement in which laboratories pay annual fees, determined by the number and type of modules selected, to participate in the assessment runs. All subscription revenue funds service delivery and educational programmes; no external financial support, venture investment, or institutional funding is involved. Distribution is direct, with laboratories enrolling via the website, receiving physical slide materials by post, and accessing results, e-reports, and the Best Methods database through a secure online portal. Marketing and engagement are conducted through the website, email newsletters, annual Participants' Meetings, scientific publications, and partnerships with bodies such as UKAS, the Royal College of Pathologists, IBMS, and WHO.

Name

UK NEQAS for Immunocytochemistry & In Situ Hybridisation

Legal name

External Quality Assessment Services for Cancer Diagnostics CIC

Website

https://ukneqasiccish.org

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

11–50 employees

Short description

UK NEQAS ICC & ISH is a UKAS-accredited, not-for-profit EQA scheme that delivers External Quality Assessment services for immunocytochemistry and in-situ hybridisation testing to over 500 cellular pathology laboratories across more than 50 countries, via a subscription-based modular programme run three times per year.

Ownership category

akta.pro rank

Product category

External Quality Assessment Services for Cellular Pathology

NAICS

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

SIC

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

akta.pro primary industry

Laboratory Quality Systems, Accreditation & Proficiency Testing Programs (HLAJAIAM)

akta.pro secondary industries

Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK), Clinical Research & Trial Central Laboratories (HLAFAMAL)

Keywords

• External quality assessment
• Immunocytochemistry testing
• In situ hybridisation
• Cellular pathology proficiency
• Biomarker quality assurance

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Participant Subscription Fees: Annual subscription fees from participating laboratories cover all costs of running the EQA service. The scheme operates on a strict non-profit making basis with all subscription fees used to deliver EQA services and educational programmes.
2. Qualitopix Partnership Revenue: Revenue may be generated through the partnership with Visiopharm making Qualitopix available to participants, though specific financial terms are not disclosed.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

UK NEQAS ICC & ISH delivers External Quality Assessment (EQA) services for cellular pathology laboratories performing immunocytochemistry and in-situ hybridisation testing. The scheme provides modular, subscription-based proficiency assessment through 20+ specialised modules (e.g. breast, neuropathology, cytopathology, NSCLC biomarkers), with three assessment runs per year, expert evaluation of stained slides and digital images, scoring and performance monitoring, plus supporting tools including Qualitopix continuous monitoring software, the Best Methods Database, and an e-Journal.

Product overview

UK NEQAS ICC & ISH is a modular EQA (External Quality Assessment) service for immunocytochemistry and in-situ hybridisation testing. The service offers over 20 different assessment modules covering various pathology areas (breast, lymphoid, neuropathology, cytopathology, gastrointestinal stromal tumors, NSCLC, head & neck, sarcoma, melanoma, and others). Participants receive three assessment runs per year with samples and scoring. The scheme also provides Qualitopix (a Visiopharm partnership for continuous staining quality monitoring), a Best Methods database of over 8,000 validated methodologies, an e-Journal, referral/feedback services, and scientific meetings.

Differentiator

Problem solved

Functional benefit

Brands

• Qualitopix: A laboratory software solution developed in partnership with Visiopharm that enables daily and continuous measuring, monitoring, and documentation of staining consistency/quality for IHC staining between EQA runs.

Products and services

• Module 1: General Pathology General Pathology EQA module offering three assessment runs per year with assessment of two antigens at each run, for cellular pathology laboratories performing routine immunocytochemistry.
• Module 2A: Breast Pathology (ER only) Breast pathology EQA module focusing on estrogen receptor (ER) assessment only, with three assessment runs per year for diagnostic and predictive biomarker testing.
• Module 2B: Breast Pathology (ER and PR) Breast pathology EQA module assessing both estrogen and progesterone receptors with three runs per year, for predictive biomarker reporting in breast cancer.
• Module 3: Breast HER2 IHC Breast HER2 immunohistochemistry assessment module for the breast clinical setting, providing three assessment runs per year to support HER2 IHC quality and scoring in breast cancer diagnostics.
• Module 4: Lymphoid Pathology Lymphoid pathology EQA module with three assessment runs per year, tailored for specialist lymphoma diagnostic services.
• Module 5: Neuropathology Neuropathology EQA module with three assessment runs per year, assessing two antigens at each run for specialist neuropathology laboratories.
• Module 6: Cytopathology Cytopathology EQA module assessing antigens on cytospin or cell block preparations, with three runs per year for cytology laboratories.
• Module 7: Alimentary Tract Pathology (GIST) Alimentary tract pathology EQA module for GIST diagnosis, always assessing CD117 with a second antigen (DOG-1, CD34, Desmin, or S100) alternating per run.
• Module 8: Gastric HER2 IHC Gastric HER2 IHC assessment module for gastric cancer samples of varying HER2 expression, providing three runs per year to support HER2 testing quality in gastric cancer.
• Module 9: HER2 ISH Interpretive & Technical HER2 ISH interpretive and technical assessment on cell lines and tissue samples of varying HER2 gene status, for ISH technical and interpretive proficiency.
• Module 10: NSCLC ALK IHC NSCLC ALK IHC assessment on cell lines and tissue samples of varying ALK expression for non-small cell lung cancer biomarker testing.
• Module 11: NSCLC PD-L1 IHC (Pilot) Pilot NSCLC PD-L1 IHC assessment on cell lines and tissue samples of varying PD-L1 expression for non-small cell lung cancer immunotherapy biomarker testing.
• Module 12: NSCLC ALK/ROS1 FISH (Pilot) Pilot NSCLC ALK/ROS1 FISH assessment on cell lines of known gene status for non-small cell lung cancer molecular biomarker testing.
• Module 13: Mismatch Repair (MMR) Proteins Mismatch repair proteins EQA module assessing paired antigens (MLH1 & PMS2 or MSH2 & MSH6) alternately, for Lynch syndrome screening and colorectal/endometrial cancer diagnostics.
• Module 14: NSCLC ROS1 IHC (Pilot) Pilot NSCLC ROS1 IHC assessment on cell lines of varying ROS1 expression for non-small cell lung cancer biomarker testing.
• Module 15: PD-L1 in TNBC (Pilot) Pilot PD-L1 in triple-negative breast cancer assessment on breast cancer tissues and cell lines, supporting PD-L1 biomarker testing for TNBC immunotherapy selection.
• Module 16: Ki-67 in Breast Cancer (Pilot) Pilot Ki-67 in breast cancer assessment on breast cancer tissues and cell lines, for proliferative biomarker proficiency testing.
• Module 17A: p16 in Head & Neck Pathology (Pilot) Pilot p16 assessment in head and neck squamous cell carcinoma tumours and cell lines, supporting p16-based HPV status testing in head and neck pathology.
• Module 17B: HPV in Head & Neck Pathology (Pilot) Pilot HPV ISH assessment in head and neck squamous cell carcinoma tumours, for HPV-driven head and neck cancer diagnostics.
• Module 18: Claudin 18.2 in Gastric Cancer (Pilot) Pilot Claudin 18.2 assessment in gastric and gastroesophageal junction (GEJ) tumours for emerging targeted therapy biomarker testing.
• Module 19: Sarcoma (Pilot) Pilot sarcoma EQA module providing proficiency assessment on sarcoma specimens for specialist sarcoma diagnostic laboratories.
• Module 20: Melanoma (Pilot) Pilot melanoma EQA module providing proficiency assessment on melanoma specimens for melanoma diagnostic laboratories.
• Module 24: Low-Level HER2 in Breast Cancer (Pilot) Pilot low-level HER2 expression assessment in breast cancer, evaluating both staining and interpretation, including digital image analysis for HER2-low reporting.
• Qualitopix (Visiopharm partnership) A laboratory software solution developed in partnership with Visiopharm that enables daily and continuous measuring, monitoring, and documentation of IHC staining consistency and quality, bridging the gap between the scheme's quarterly EQA assessment runs. Made available to all UK NEQAS ICC & ISH participants.
• Best Methods Online Database A database of over 8,000 anonymised methodologies submitted by participants assessed as showing excellent staining quality, allowing filtering by Primary Antibody, Automation, Supplier, Detection Method, and Module/Pathology, to support laboratories in benchmarking their own methods against high performers.
• UK NEQAS ICC & ISH e-Journal (Immunocytochemistry Journal) Published issues of the UK NEQAS ICC & ISH Immunocytochemistry Journal containing colour prints, run summaries, frequency charts, optimal staining images, and scientific articles on EQA-relevant topics.

Named customers2 records

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability2 records

Feature3 records

Partnerships

One partnership is on record.

• VisiopharmcoreTechnology or IntegrationUnique partnership making Qualitopix, a laboratory software solution for continuous quality monitoring, available to all UK NEQAS ICC & ISH participants. Qualitopix enables daily and continuous measuring, monitoring, and documentation of staining consistency/quality between quarterly EQA runs.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• RCPAQAP: Royal College of Pathologists of Australasia Quality Assurance Programs provides EQA services in anatomical pathology including immunohistochemistry and in-situ hybridisation. Direct peer offering comparable module-based assessment services to Asia-Pacific laboratories.
• QMP-LS (Quality Management Program – Laboratory Services): Canadian-based proficiency testing provider offering EQA programs in immunohistochemistry and molecular pathology. Direct peer serving Canadian and international laboratories with module-based IHC/ISH proficiency testing.
• NordiQC: Nordic Immunohistochemical Quality Control is a directly comparable EQA provider focused on IHC and ISH proficiency testing across Nordic and European laboratories. It is the closest functional competitor to UK NEQAS ICC & ISH, running parallel assessment modules with similar scoring methodology.
• UK NEQAS Consortium (other schemes): The broader UK NEQAS charity operates multiple sister EQA schemes (e.g., for Haematology, Microbiology, Molecular Genetics). Same parent organisation, governance model, and accreditation framework, addressing adjacent cellular pathology disciplines.
• College of American Pathologists (CAP) Proficiency Testing: CAP runs the largest global proficiency testing programs, including IHC/HER2 and ISH modules. It is a direct peer in the cellular pathology EQA market, serving North American and international laboratories with a comparable subscription-based assessment model.

Others

• Visiopharm: Technology partner that co-developed Qualitopix for the scheme and also sells its own digital pathology and image analysis solutions into the same cellular pathology laboratories. Adjacent enabling technology provider with overlapping customer base.

Broad incumbents

• European Society of Pathology: European professional society that promotes quality standards in pathology across Europe and runs workshops and external quality initiatives. Broad incumbent that overlaps thematically with EQA in pathology but is not a direct module-by-module competitor.
• Clinical and Laboratory Standards Institute (CLSI): Standards development organisation that publishes laboratory quality guidelines referenced by EQA schemes. Not a direct EQA peer but an adjacent standards-setting body whose documents underpin proficiency testing methodology.
• Royal College of Pathologists: UK professional body that sets standards for pathology practice and influences EQA requirements. Broader incumbent in pathology quality and standards; not a direct EQA provider but shapes the regulatory and accreditation environment the scheme operates within.

Regional players

• IQN Path: International Quality Network for Pathology promotes harmonization of molecular and immunohistochemistry testing across regions. Listed as an associate body of UK NEQAS ICC & ISH; comparable international focus but with a broader standards-and-policy remit rather than direct EQA delivery.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/uk-neqas-icc-ish

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 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 UK NEQAS for Immunocytochemistry & In Situ Hybridisation