What ZYTOMICS does

ZYTOMICS is a privately held German manufacturer of clinical cancer diagnostics products, headquartered in Berlin and operating through wholly owned subsidiaries including Zytomed Systems, ZytoVision, Diagomics, and — since August 2025 — Applied Spectral Imaging (ASI). The company was formed in 2021 by combining three established European diagnostics businesses and subsequently expanded into the US market via the ASI acquisition. Its portfolio spans immunohistochemistry (IHC) reagents and antibodies, in situ hybridization probes including ZytoLight FISH, FlexISH, ZytoMation, ZytoDot CISH, and ZytoFast CISH, and next-generation sequencing panels built on AmoyDx's proprietary HANDLE and ddCAP technologies with the ANDAS data analysis workstation. Automation is delivered through the Nova Aura IHC stainer and ZytoBrite hybridizer, while ASI contributes digital imaging and analysis platforms (HiPath Pro, PathFusion, HiBand, HiFISH, CytoPower, HiSKY) with more than 5,000 systems installed globally.

The customer base is comprised of clinical pathology and cytogenetics laboratories, hospitals, and molecular oncology research institutions, served via direct enterprise sales in Germany, Austria, Switzerland, France, and Belgium, with ASI Inc as commercial representative in the United States and a network of more than 65 distributors across over 90 countries. Revenue is generated primarily through sale of consumables (probes, reagents, antibodies, kits, control materials) and instrumentation, supported by professional training and an Experts-to-Experts program; pricing is not publicly disclosed and quotations are handled through direct sales contact. Regulation is a structural feature of the business: more than 200 products are IVDR-certified under EU Regulation 2017/746, including 159 ISH Class C reagents, with ISO 13485:2016 across all daughter companies and MDSAP certification for ZytoVision. The company cites 4.5 million diagnostic tests performed annually with its products. Leadership is led by Group CEO Bastian Eirich and Group CFO Claudia Zimmer, with VP-level oversight covering global sales, marketing, regulatory affairs, R&D, operations, HR, and imaging & digital solutions.

Name

ZYTOMICS

Legal name

Zytomics GmbH

Website

https://zytomics.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

ZYTOMICS is a Berlin-headquartered manufacturer of clinical cancer diagnostics products — IHC, FISH/CISH probes, NGS panels, automation, and digital imaging — serving pathology and cytogenetics laboratories across Europe and, via its 2025 ASI acquisition, the United States.

Ownership category

akta.pro rank

Product category

Clinical Cancer Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Microscopy, Imaging & Flow Cytometry Instruments (HLAGAIAE), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Clinical cancer diagnostics
• In vitro diagnostics
• IHC reagents
• FISH probes
• NGS panels

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Clinical Diagnostic Reagents and Consumables: Sale of consumable products including reagents, probes, antibodies, detection systems, extraction kits, NGS panels, and control materials used in cancer diagnostics. Products include IVDR-certified ISH probes, IHC antibodies, NGS assays, and automation reagents.
2. Automation Systems and Instrumentation: Sale of instrumentation including Nova Aura fully automated IHC stainer, ZytoBrite Hybridizer for FISH/CISH, and ASI digital imaging platforms (HiPath Pro, PathFusion, HiBand, HiFISH, CytoPower, HiSKY).
3. Professional Education and Training Services: The company provides regular training and professional education activities to customers and distributors to expand testing capabilities. This is referenced as part of their societal impact strategy.
4. IVDR-Certified Product Portfolio: More than 200 products IVDR-certified, including 159 ISH Class C products. Certification enables market entry for new IVDs of the same type, driving revenue through portfolio expansion.

Pricing tiers

Go-to-market motion3 records

Distribution channels7 records

Marketing channels5 records

Core offering

ZYTOMICS manufactures and supplies diagnostic reagents, probes, NGS panels, automated staining instruments, and digital pathology imaging systems for clinical cancer diagnostics. The portfolio covers immunohistochemistry (IHC) primary antibodies and detection systems, in situ hybridization probes (FISH and CISH), next-generation sequencing panels, automated staining and hybridization instruments, and digital pathology imaging platforms. Products are sold to hospital pathology laboratories, cytogenetics laboratories, molecular oncology laboratories, and cancer research institutions across more than 90 countries.

Product overview

ZYTOMICS is a leading manufacturer and provider of products and solutions for clinical cancer diagnostics, founded in 2021 as a combination of Zytomed Systems, ZytoVision, and Diagomics, with ASI acquired in 2025. The company offers a comprehensive portfolio including reagents, automation, and analytics with focus on immunohistochemistry (IHC), in situ hybridization (ISH including FISH and CISH), and next-generation sequencing (NGS) diagnostics. The product portfolio spans ZytoLight/FlexISH/ZytoMation FISH probe lines, ZytoDot/ZytoFast CISH probes, IHC primary antibodies and detection systems, AmoyDx HANDLE and ddCAP NGS panels with associated extraction kits and ANDAS analysis software, VisionArray DNA microarray chips for pathogen detection, real-time PCR assays, Cell Control Arrays, Nova Aura automation systems, ZytoBrite hybridizers, and ASI digital imaging platforms. All daughter companies hold ISO certifications and significant portions of the portfolio are IVDR certified under Regulation (EU) 2017/746.

Differentiator

Problem solved

Functional benefit

Brands

• Zytomed Systems: In-house product brand for clinical cancer diagnostics reagents and automation
• Zyto*Dot*
• Zyto*Light*
• Zyto*Mation*
• Zyto*Fast*
• F*lex*ISH
• Vision*Array*
• Nova Aura
• AmoyDx*
• ZytoBrite
• Cell Control Arrays (CCA)
• HiPath Pro
• PathFusion
• HiBand
• HiFISH
• CytoPower
• HiSKY
• ANDAS

Products and services

• ZytoLight FISH Probes A broad catalogue of fluorescence in situ hybridization (FISH) probes for the detection of gene amplifications, deletions, translocations, and chromosomal aberrations in solid tumors and hematological cancers, intended for hospital and reference pathology laboratories.
• FlexISH FISH Probes FISH probes designed for flexible hybridization times of 2 to 16 hours, allowing laboratories to optimize workflows and accommodate variable scheduling for cancer cytogenetic diagnostics.
• ZytoMation FISH Probes FISH probes formulated for fully automated use on the Leica BOND staining platform, enabling walk-away automation of FISH workflows in clinical pathology laboratories.
• ZytoDot CISH Probes Chromogenic in situ hybridization (CISH) probes for single-molecule detection of gene amplifications, deletions, and rearrangements using bright-field microscopy, intended for cancer diagnostics in pathology laboratories.
• ZytoFast CISH Probes Rapid chromogenic in situ hybridization (CISH) probes for the detection of infectious pathogens and other targets, designed for short hybridization protocols in clinical microbiology and pathology workflows.
• AmoyDx HANDLE NGS Panels Targeted next-generation sequencing panels using Halo-shape Annealing and Defer-Ligation Enrichment (HANDLE) technology, delivering fast and flexible library preparation in 5-6 hours with one-hour hands-on time for cancer molecular diagnostics.
• AmoyDx HANDLE Insight NGS Panel A targeted NGS panel built on HANDLE technology for molecular classification of endometrial carcinoma, intended for molecular pathology laboratories performing gynecological cancer diagnostics.
• AmoyDx HANDLE HRR NGS Panel A targeted NGS panel built on HANDLE technology for the detection of homologous recombination repair (HRR) gene mutations, intended to support prostate cancer and other oncology diagnostics.
• AmoyDx HANDLE Breast Cancer NGS Panel A targeted NGS panel built on HANDLE technology for breast cancer molecular profiling, intended for molecular oncology and pathology laboratories.
• AmoyDx FGFR1-4 NGS Panel A targeted NGS panel using ddCAP hybrid capture technology for the detection of FGFR1-4 fusions and mutations across solid tumors, intended for molecular pathology laboratories supporting oncology therapy decisions.
• AmoyDx ddCAP NGS Panels Hybrid capture next-generation sequencing panels for tumor profiling and biomarker detection, intended for molecular pathology and oncology laboratories.
• AmoyDx Real-Time PCR Assays Real-time PCR assays for the detection of cancer-associated mutations and gene fusions, intended for molecular diagnostics laboratories performing targeted oncology testing.
• AmoyDx Extraction Kits Nucleic acid extraction kits for the isolation of DNA and RNA from formalin-fixed paraffin-embedded (FFPE) tissues and other sample types, intended as upstream sample preparation for molecular oncology workflows.
• IHC Primary Antibodies A broad catalogue of ready-to-use and concentrated primary antibodies for clinical immunohistochemistry (IHC) staining, intended for hospital and reference pathology laboratories performing cancer diagnostics.
• VisionArray DNA Microarray Chips DNA microarray chips for the parallel detection of multiple pathogens and genetic markers, intended for use with VisionArray analysis software in clinical microbiology and pathology laboratories.
• Cell Control Arrays (CCA) Multi-spot cell control arrays produced using a patented paraffin embedding method that consolidates positive and negative cell lines onto a single slide, intended as IHC and ISH controls for clinical pathology laboratories.
• Nova Aura Fully Automated IHC Stainer A fully automated immunohistochemistry stainer for clinical pathology laboratories, providing walk-away IHC staining with standardized, reproducible results to support cancer diagnostics workflows.
• ZytoBrite Hybridizer An automated hybridization instrument for FISH and CISH workflows in clinical pathology laboratories, standardizing denaturation and hybridization conditions for in situ hybridization testing.
• ANDAS Data Analyzer A CE/IVD-classified data analysis software for interpreting next-generation sequencing results locally, intended for molecular pathology and clinical diagnostics laboratories using AmoyDx NGS panels.
• ASI Digital Imaging Platforms A suite of digital pathology, FISH, and karyotyping imaging platforms (HiPath Pro, PathFusion, HiBand, HiFISH, CytoPower, HiSKY) used by more than 5,000 installed systems in 80+ countries, intended for clinical cytogenetics and pathology laboratories performing cancer diagnostics.

Quantifiable outcome

• 4.5 million diagnostic tests performed yearly with ZYTOMICS products
• +3 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability3 records

Feature9 records

Partnerships

Two partnerships are on record, tiered core.

• Applied Spectral Imaging (ASI)coreStrategic or Co-development Partner · 6 August 2025ZYTOMICS acquired Applied Spectral Imaging (ASI) in August 2025. ASI is a global leader in biomedical imaging solutions for Pathology, Cytogenetics, and Life Sciences, with over 5,000 systems installed in over 80 countries. ASI offers platforms including HiPath Pro, PathFusion, HiBand, HiFISH, CytoPower, and HiSKY. The combination integrates ASI's imaging and analysis capabilities with ZYTOMICS' reagents, automation, and analytics to create end-to-end solutions for pathology and cytogenetics laboratories.
• AmoyDxcoreTechnology or Integration · 1 January 2015AmoyDx is a partner company providing specialized NGS panels (HANDLE and ddCAP technology), extraction kits, real-time PCR assays, and the ANDAS data analysis system. Products include HANDLE HRR NGS Panel, HANDLE Breast Cancer NGS Panel, HANDLE Insight NGS Panel, FGFR1-4 NGS Panel, and various extraction kits. Since 2015, AmoyDx products have been offered through ZYTOMICS distribution.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Hologic: Diagnostics company with strength in molecular cytogenetics, women's health, and molecular testing. Overlaps with ZYTOMICS/ASI in cytogenetic imaging and molecular oncology testing.
• Bio-Techne: Life sciences tools company with a large reagent, antibody, and assay portfolio (including ACD RNAscope and Exiqon) used in cancer diagnostics and research. Overlaps with ZYTOMICS in IHC antibodies, probes, and specialty diagnostic reagents.
• Qiagen: Global provider of sample-preparation and molecular diagnostics solutions, including QIAcuity digital PCR and oncology NGS assays. Competes with ZYTOMICS in the molecular tumor diagnostics workflow from sample extraction through variant analysis.
• Roche Diagnostics (Ventana): Global leader in clinical diagnostics with Ventana Systems as the primary IHC/FISH and digital pathology franchise. Competes with ZYTOMICS across virtually every IVDR-certified reagent category in cancer diagnostics.
• Agilent Technologies (Dako Pathology Solutions): Life sciences and diagnostics company with Dako-branded IHC antibodies, FISH probes, and pathology solutions. Overlaps with ZYTOMICS in IHC primary antibodies, ISH probes, and clinical cancer diagnostic reagents.
• Abbott Molecular (Vysis): Abbott's molecular diagnostics division historically known for Vysis FISH probes used in cancer cytogenetics. Competes with ZYTOMICS/ASI in FISH probe reagents for oncology and cytogenetic testing.

Direct peers

• MetaSystems: Germany-based provider of karyotyping, FISH, and digital imaging platforms for cytogenetics and pathology laboratories. Direct competitor to ZYTOMICS/ASI in cytogenetics imaging and FISH probe workflows.
• BioGenex Laboratories: Privately held US developer of IHC and FISH reagents, automated stainers, and molecular pathology solutions for cancer diagnostics. Closely comparable to ZYTOMICS in IHC/FISH reagent portfolio and automation offering.
• Leica Biosystems (Danaher): Division of Danaher manufacturing IHC automated stainers (BOND), FISH probes, and tissue processing instruments. Directly competes with ZYTOMICS in IHC/FISH reagents and instruments used on the same Leica BOND platform.
• CytoTest: US-based developer of FISH probes and CISH probes for cancer diagnostics and cytogenetics. Directly comparable to ZYTOMICS in IVDR-cleared FISH/CISH probe portfolio serving clinical pathology labs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/zytomics

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries4 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 ZYTOMICS