What HistoCyte Laboratories does

HistoCyte Laboratories Ltd, founded in 2014 in Newcastle upon Tyne, develops and manufactures cell line-based quality control materials for immunohistochemistry (IHC) and in situ hybridisation (ISH) assays used in cancer diagnostics. The company's proprietary technology processes cultured cell lines into tissue-like formalin fixed paraffin embedded (FFPE) controls that retain cellular morphology and deliver a defined dynamic range of biomarker expression (negative through high), addressing limitations of conventional archival tissue controls such as heterogeneity, finite availability, and preanalytical variability. The portfolio spans over 15 biomarker controls including ALK, BRAF V600E, ER, PR, HER2, HPV/p16, Ki67, MMR proteins, NTRK, Pan Melanoma, PD-L1, and ROS1, offered as pre-cut slides or Cell Microarray (CMA) blocks capable of producing over 300 sections each. Products are validated against major automated staining platforms and antibody clones from Roche/Ventana, Agilent, Abbott, and others.

The company monetises through one-time sales of control consumables to clinical pathology laboratories and through bespoke contract services (custom cell line development, biomarker characterisation, proof-of-concept studies) to biotech, pharmaceutical, and academic clients. Distribution is executed via a global network of more than 30 regional distributors supplemented by direct sales in the UK and uncovered geographies. Key certifications include EN ISO 13485:2016 (BSI), BIVDA membership, and supplier status to UK NEQAS ICC & ISH. In February 2021, HistoCyte was acquired by Atlas Antibodies AB and now operates as part of the Atlas Life Sciences Group under Investor AB / Patricia Industries ownership.

Name

HistoCyte Laboratories

Legal name

HistoCyte Laboratories Ltd

Website

https://histocyte.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

HistoCyte Laboratories, founded 2014 in Newcastle upon Tyne and acquired by Atlas Antibodies in 2021, manufactures proprietary cell line-based FFPE quality control materials for immunohistochemistry and in situ hybridisation assays used in cancer diagnostics, selling through global distributors to clinical pathology laboratories and biotech/pharma clients.

Ownership category

akta.pro rank

Product category

Diagnostic Pathology Controls

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Anatomic Pathology & Histology/Cytology IVD (Tissue Diagnostics) (HLAHAAAE)

akta.pro secondary industries

Cytology & Histopathology Diagnostics (IHC, ISH, tissue-based assays) (HLAAALAI), Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Immunohistochemistry controls
• Pathology quality control
• Cell line controls
• Biomarker assay controls
• In situ hybridisation reagents

Headquarters

HQ city

Newcastle

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Quality Control Products: Sale of cell line-based quality control materials for immunohistochemistry and in situ hybridisation assays. Products available as pre-cut slides or cell microarray blocks.
2. Contract Services: Bespoke contract services including custom cell line development, biomarker characterization and assessment, and proof of concept studies. Services provided to diagnostic pathology and assay development, serving academic groups, biotech and pharmaceutical companies.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

HistoCyte Laboratories develops and manufactures cell line-based formalin fixed paraffin embedded (FFPE) quality control materials for immunohistochemistry (IHC) and in situ hybridisation (ISH) assays used in diagnostic pathology. Products are offered as pre-cut slides or Cell Microarray (CMA) blocks covering cancer biomarkers such as ALK, BRAF V600E, HER2, ER, PR, PD-L1, HPV/p16, MMR proteins, ROS1, NTRK, Ki67 and Pan Melanoma. The company also provides bespoke contract services for custom cell line development and biomarker assessment for diagnostic pathology and assay development.

Product overview

HistoCyte Laboratories develops and manufactures cell line-based quality control materials for immunohistochemistry (IHC) and in situ hybridization (ISH) assays in diagnostic pathology. The product portfolio consists of two main product lines: Dynamic Range Controls providing semi-quantitative assay sensitivity testing with multiple expression levels (negative through high), and Standard Controls providing qualitative positive/negative verification. Products cover cancer biomarkers including ALK (lung and lymphoma), BRAF V600E, breast markers (ER, PR, HER2), HPV/p16, Ki67, mismatch repair proteins (MLH1, PMS2, MSH2, MSH6), NTRK, Pan Melanoma (S100, SOX10, HMB45, Melan A, PRAME), PD-L1, and ROS1. Each product is available in multiple formats: pre-cut slides (DR2 with 2 slides, DR5 with 5 slides) and Cell Microarray (CMA) blocks generating over 300 sections. The company also offers contract services for custom cell line development and biomarker assessment.

Differentiator

Problem solved

Functional benefit

Products and services

• ALK Analyte ControlDR Dynamic range quality control consisting of four cell lines demonstrating a range of expression for ALK wild type and fusion proteins including EML4-ALK and NPM-ALK. Enables determination of assay sensitivity for ALK detection in NSCLC and lymphoma, available as pre-cut slides or Cell Microarray (CMA) blocks.
• Breast Analyte ControlDR Multi-purpose dynamic range control containing five cell lines demonstrating 0, 1+, and 3+ HER2 expression levels, with heterogeneous ER and PR expression. Suitable for same-slide quality control across multiple breast cancer biomarker assays.
• ER Analyte ControlDR Dynamic range control with four cores offering negative, low (Allred 2/3), intermediate (Allred 5/6), and high (Allred 8) estrogen receptor expression for enhanced quality control sensitivity.
• HER2 Analyte ControlDR Specialized HER2 control with full dynamic range of expression including 0, 1+, 2+, and 3+ cell lines. Enhanced from multi-purpose breast control to include 2+ equivocal cell line for most reliable HER2 quality control.
• HPV/p16 Analyte ControlDR Dynamic range control with four cell lines demonstrating high, medium, low, and negative HPV types 16 and 18 by ISH, with homogeneous, heterogeneous, and negative p16 expression by IHC.
• Ki67 Analyte ControlDR Dynamic range control with three cell lines demonstrating high, intermediate, and low Ki67 expression levels for standardized quality control and assay sensitivity demonstration in proliferation biomarker testing.
• PD-L1 Analyte ControlDR Dynamic range control with four cell lines demonstrating high, intermediate, low, and negative PD-L1 expression levels. Suitable for same-slide quality control in immunotherapy biomarker testing.
• PR Analyte ControlDR Dynamic range control with four cores offering negative, low/intermediate, intermediate/high, and high progesterone receptor expression for enhanced quality control sensitivity.
• ROS1 Analyte ControlDR Dynamic range version of ROS1 control containing an additional cell line with very low ROS1 expression including FIG-ROS1 fusion protein for enhanced sensitivity testing.
• ALK-Lung Analyte Control Qualitative control with two cell lines demonstrating positive and negative EML4-ALK fusion protein expression for lung cancer testing. Validated for IHC and FISH applications.
• ALK-Lymphoma Analyte Control Qualitative control with two cell lines demonstrating positive and negative NPM-ALK expression for lymphoma testing. Positive cell line is also positive for CD30.
• BRAF Analyte Control Qualitative control with two cores providing negative and positive BRAF V600E mutation expression for immunohistochemistry quality control.
• Breast Analyte Control Multi-purpose qualitative control containing two cell lines with positive and negative expression for ER, PR, and HER2. Most cost-effective option for same-slide quality control.
• HPV/p16 Analyte Control Standard control with three cell lines demonstrating high, medium, and negative HPV types 16 and 18 by ISH, with corresponding p16 expression by IHC.
• MLH1/PMS2 Analyte Control Two-core control with intact and loss of expression for MLH1 and PMS2 mismatch repair proteins. Cost-effective option for MLH1 and PMS2 assays.
• MMR Analyte Control Four-core control with loss of and intact expression for all four mismatch repair proteins (MLH1, PMS2, MSH2, MSH6). Suitable for all MMR assays regardless of which is used.
• MSH2 Analyte Control Two-core control with intact and loss of MSH2 expression. Cost-effective option for MSH2-specific assays.
• MSH6 Analyte Control Two-core control with intact and loss of MSH6 expression. Cost-effective option for MSH6-specific assays.
• NTRK Analyte Control Qualitative control with two cell lines demonstrating positive and negative NTRK expression, recognizing wild type TRKA and fusion proteins via pan-NTRK antibodies.
• Pan Melanoma Analyte Control Comprehensive melanoma control verifying S100, SOX10, HMB45, Melan A, PRAME, and BRAF V600E with defined positive and negative expression in a single control.
• ROS1 Analyte Control Qualitative control with two cores negative and positive for ROS1 expression, with SLC34A2-ROS1 translocation. Cost-effective option for ROS1 IHC and FISH testing.
• Contract Services Bespoke contract services including proof of concept and feasibility studies, biomarker characterization and assessment, and custom cell line development and assessment for diagnostic pathology and assay development. Provided to academic groups, biotech and pharmaceutical companies.

Quantifiable outcome

• Over 300 sections can be generated from a single CMA block, providing cost-effective quality assurance across extended use
• +1 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration14 records

Feature3 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Atlas AntibodiescoreStrategic or Co-development Partner · 1 February 2021Atlas Antibodies AB acquired HistoCyte Laboratories in February 2021. Atlas Antibodies develops, produces, and globally markets advanced reagents for biomedical research, originating from the Human Protein Atlas project. HistoCyte is now part of Atlas Life Sciences Group.
• DiaceuticscoreStrategic or Co-development Partner · 1 July 2020Collaboration announced July 2020. HistoCyte joined the DXRX network allowing over 2500 clinical laboratories around the world to engage with the company. Diaceutics is at the forefront of understanding oncology and pathology field, enabling pharma to understand the best approach to introducing novel drugs and supporting laboratories.
• Cell MarquecoreChannel Partner/ Reseller/ Distributor · 1 February 2019Partnership for global distribution of HistoCyte products announced February 2019. Cell Marque distributes HistoCyte products in the USA market.
• Newcastle University (Dr Max Robinson)minorStrategic or Co-development Partner · 1 October 2017Collaboration with Dr Max Robinson, Senior Lecturer in Oral Pathology at Newcastle University, led to development of HPV/p16 products. Products were extensively tested by IHC for p16 and ISH for E6/E7 mRNA and HPV DNA.
• UK NEQAS ICC & ISHcoreStrategic or Co-development PartnerHistoCyte is a supplier of quality control materials to UK NEQAS ICC & ISH (National External Quality Assurance Scheme for Immunocytochemistry and in situ hybridisation). This partnership validates the company's quality standards and provides market credibility.

Scale indicators4 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• 3DHISTECH: Hungarian digital pathology and IHC product company that develops tissue microarrays, cell line arrays, and IHC QC products. Closest comparable to HistoCyte in producing cell-based and tissue-based controls for pathology laboratories.
• US Biomax: Provider of tissue microarrays, FFPE blocks, and cell line-based controls for IHC, ISH, and biomarker research. Direct peer in producing standardized tissue/cell controls for diagnostic pathology and oncology research.
• AMSBIO: Supplier of tissue microarrays, FFPE cell line controls, and IHC/ISH quality control materials. Direct competitor to HistoCyte in cell-based and tissue-based QC controls for pathology and research labs.
• Pantomics: Specializes in tissue microarrays and FFPE cell line controls used in IHC validation and QC workflows. Overlaps with HistoCyte's value proposition of standardized, inexhaustible biomarker controls for pathology labs.

Emerging players

• Biocare Medical: Independent IHC reagent and instrumentation company focused on anatomic pathology, providing antibodies, detection systems, and ancillaries. Comparable to HistoCyte as a specialist pathology reagent supplier, though Biocare's product emphasis is on detection kits and antibody panels rather than cell-line-based QC controls.
• Cell Marque (Merck / Sigma-Aldrich): Part of Merck Life Science; provides IHC antibodies and ancillary reagents for anatomic pathology, and is also a US distributor of HistoCyte products. Comparable as a US-market IHC reagent provider, though its primary focus is antibody reagents rather than cell-line-based QC controls.

Broad incumbents

• Roche Diagnostics (Ventana): Market leader in IHC/ISH instruments (Benchmark Ultra) and CDx antibody clones (SP263, SP142, ALK D5F3/ALK01, pan-TRK), referenced throughout HistoCyte's product validation matrix. Provides internal positive/negative controls via its staining platforms and represents both a key integration partner and a deep-pocketed competitor for IHC QC materials.
• Leica Biosystems (Danaher): Major IHC/ISH instrument and reagent provider with a broad portfolio that includes tissue controls, staining platforms, and companion diagnostics. Comparable to HistoCyte as a provider of IHC quality control materials and related workflow products, though Leica operates at a much larger scale across the entire pathology workflow.
• Bio-Techne (Novus Biologicals / ProteinSimple): Provides research antibodies, IHC reagents, and protein-analysis tools overlapping with HistoCyte's biomarker QC portfolio (HER2, PD-L1, MMR, etc.). Operates a much larger reagent catalog and serves both research and clinical IHC markets.
• Agilent (Dako) Pathology Solutions: Provides IHC antibodies, instruments, and ancillary reagents (including PD-L1 clones 22C3 and 28-8 referenced in HistoCyte's product validations). Overlaps directly with HistoCyte in supplying IHC reagents to pathology labs, though Dako is anchored on antibody clones and instruments rather than cell-line-based QC controls.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInuk.linkedin.com/in/colin-tristram-80737716

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 HistoCyte Laboratories