Epigenomics

What Epigenomics does

Epigenomics AG is a German molecular diagnostics holding company currently headquartered in Heidelberg (relocated from Berlin). Originally founded in 1998/2000 as a developer of DNA methylation biomarkers for cancer detection via liquid biopsy, the company has transitioned into an investment and holding entity that manages assets and minority investments in companies focused on minimally invasive blood-based cancer detection. The company's historical core technology centers on the proprietary SEPT9/mSEPT9 DNA methylation biomarker for colorectal cancer screening, commercialized as Epi proColon — the first CE-marked IVD test kit for colorectal cancer screening in Europe, launched in 2009 and processed on the Roche LC480 platform. A second CE-marked product, Epi proLung, extends the DNA methylation biomarker approach to lung cancer detection, with clinical data showing 79% sensitivity and 95% specificity in bronchial lavage testing. Both products are based on detecting aberrantly methylated DNA in patient blood samples as a non-invasive alternative to colonoscopy or imaging-based screening.

The company's go-to-market is structured around a non-exclusive licensing model. Epigenomics has licensed SEPT9 to three principal IVD partners covering distinct geographies: Abbott Molecular (global, integrated onto Abbott's m2000 platform), Quest Diagnostics (United States, branded as ColoVantage reference lab service), and Sysmex Corporation (Japan and broader Asia-Pacific, with co-development of an automated platform). Direct sales of Epi proColon IVD test kits have historically been limited to molecular diagnostic laboratories in the DACH region (Germany, Austria, Switzerland), with distributor relationships covering other European markets. Revenue streams historically comprised licensing royalties, R&D service fees and cost reimbursements during co-development, technology transfer payments, and modest direct IVD kit sales.

Financially, Epigenomics has shifted from an operating diagnostics business to a holding structure with effectively negligible revenue: H1 2025 sales revenue was 4 TEUR versus 0 TEUR in H1 2024. The company carries negative equity of 11,065 TEUR as of June 30, 2025, with liquid funds of 764 TEUR. The preliminary FY2025 net loss was 313 TEUR, a substantial reduction from the 3.4 million EUR loss reported in FY2024. Sustaining the entity has required multiple capital actions: a 2013 convertible bond issuance of EUR 2.68 million, a 2021/2027 mandatory convertible bond, share consolidation and relisting in September 2023, and a July 2026 capital increase of up to EUR 219,244 through issuance of up to 219,244 new shares. Ownership is highly concentrated: Wilhelm K. T. Zours controls approximately 85.81% of voting rights through Deutsche Balaton Aktiengesellschaft (22.37%), 2invest AG (3.11% direct plus instruments), DELPHI Unternehmensberatung (3.58%), and the 2021/2027 mandatory convertible bond (56.75% through instruments).

Name

Epigenomics

Legal name

Epigenomics AG

Website

https://www.epigenomics.com/

Company type

Public

Founded year

1998

Operating status

Operating

Headcount range

51–100 employees

Short description

Epigenomics AG is a Heidelberg-based holding company that historically developed CE-marked DNA methylation blood tests (Epi proColon, Epi proLung) for colorectal and lung cancer screening. It now operates as an investment entity managing assets in minimally invasive cancer detection, licensing its SEPT9 biomarker to Abbott, Quest, and Sysmex.

Ownership category

akta.pro rank

Product category

Molecular Cancer Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Proteomics & Biomarker Analytical Testing (HLAGADAG)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation) (HLAAAIAI)

Keywords

• Molecular diagnostics
• Cancer screening tests
• DNA methylation biomarkers
• Liquid biopsy IVD
• Colorectal cancer detection

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Biomarker Licensing: Non-exclusive licensing of SEPT9 DNA methylation biomarker to multiple commercial partners including Abbott Molecular, Quest Diagnostics, and Sysmex for development and commercialization of IVD tests in different geographic markets.
2. IVD Kit Sales: Direct sales of Epi proColon IVD test kits to molecular diagnostic laboratories in DACH region (Germany, Austria, Switzerland).
3. R&D Services and Technology Transfer: F&E licensing fees, technology transfer payments, and cost reimbursements from partners during product development phases.
4. Investment and Asset Management: Managing own assets, acquiring, holding and disposing of investments in companies in Germany and abroad, particularly in the field of minimally invasive blood tests for cancer detection.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

Epigenomics develops and manufactures CE-marked in vitro diagnostic (IVD) blood test kits for cancer detection based on proprietary DNA methylation biomarker technology, principally Epi proColon for colorectal cancer screening and Epi proLung for lung cancer detection. The company also licenses its SEPT9 biomarker non-exclusively to major IVD partners (Abbott, Quest Diagnostics, Sysmex) for global commercialization across North America, Europe, and Asia-Pacific markets.

Product overview

Epigenomics AG operates as a holding company focused on managing investments in minimally invasive blood-based cancer detection technologies. The company's product portfolio centers on DNA methylation biomarkers, particularly Septin9 (mSEPT9), for cancer diagnostics. The core products include Epi proColon (colorectal cancer screening test) and Epi proLung (lung cancer diagnostic test), both CE-marked IVD tests. The company employs a non-exclusive licensing strategy, partnering with major diagnostics companies like Abbott, Quest Diagnostics, and Sysmex for global commercialization of its biomarker technology.

Differentiator

Problem solved

Functional benefit

Brands

• Epi proColon: Blood-based colorectal cancer screening test using Septin9 biomarker, CE-marked IVD diagnostic product for early detection of colorectal cancer
• Epi proLung

Products and services

• Epi proColon CE-marked in vitro diagnostic blood test for colorectal cancer screening based on DNA methylation biomarkers (Septin9). The test detects methylated Septin9 DNA in blood plasma to identify colorectal cancer. It is processed on the Roche LC480 platform and sold to molecular diagnostic laboratories in the DACH region.
• Epi proLung CE-marked lung cancer diagnostic test based on blood-based DNA methylation biomarkers. Designed for early detection of lung cancer and therapy monitoring.
• Bronchial Lavage Lung Cancer Test Diagnostic test for lung cancer detection in Bronchial Lavage (lung wash) fluid samples, using DNA methylation biomarkers. Clinical studies showed 79% sensitivity and 95% specificity at Charité university hospital in Berlin.

Quantifiable outcome

• 79% sensitivity and 95% specificity for lung cancer biomarker in bronchial lavage testing
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• Quest DiagnosticscoreChannel Partner/ Reseller/ Distributor · 4 November 2009Reference laboratory partnership for Septin9-based colorectal cancer blood test (ColoVantage) in the United States. Quest Diagnostics received rights to offer the test as a laboratory service, making it available across all 50 US states. The test received approval in New York state enabling nationwide availability.
• Sysmex CorporationcoreTechnology or Integration · 22 January 2009Non-exclusive licensing and co-development partnership for mSEPT9 biomarker. Sysmex received R&D licenses and technology transfer to develop an automated platform for colorectal cancer diagnosis using Epigenomics' Septin9 biomarker in Japan and Asian markets. Epigenomics receives licensing fees, R&D payments, cost reimbursements, and sells mSEPT9 research kits to Sysmex.
• Abbott MolecularcoreTechnology or Integration · 27 September 2007Non-exclusive IVD licensing partnership for Septin9 biomarker. Abbott developing and commercializing Septin9-based diagnostic tests on their m2000 system for global markets. This partnership was part of Epigenomics' non-exclusive commercialization strategy covering North America and Europe.

Scale indicators9 records

Recent moves8 records

Expansion highlights4 records

Direct peers

• Exact Sciences: Exact Sciences markets Cologuard, the leading non-invasive colorectal cancer screening test (stool-based DNA). It is the most direct competitor to Epigenomics' Epi proColon blood-based CRC screening test and has effectively defined the non-colonoscopy CRC screening market that Epigenomics has failed to penetrate at scale.
• Guardant Health: Guardant Health is a leading liquid biopsy company offering blood-based cancer tests (Guardant360, Shield for CRC screening). Direct overlap with Epigenomics' blood-based cancer detection approach and target customer segment of molecular diagnostic laboratories and healthcare systems.
• GRAIL: GRAIL develops Galleri, a multi-cancer early detection blood test using methylation-based analysis. Highly comparable technology platform (DNA methylation) and end-use case (early cancer detection via liquid biopsy) to Epigenomics' SEPT9 and lung cancer biomarker work.
• Natera: Natera develops cell-free DNA tests for oncology and reproductive health, including Signatera for MRD and emerging CRC screening applications. Comparable as a liquid biopsy/cfDNA-based cancer diagnostics company serving similar clinical oncology customers.

Regional players

• NeoGenomics: NeoGenomics is a US-focused oncology testing laboratory offering molecular diagnostics, including methylation-based assays for solid tumors. Comparable as a cancer-focused clinical diagnostics services provider serving overlapping molecular pathology customers in North America.

Emerging players

• Freenome: Freenome is developing a multiomics blood-based test for early colorectal cancer detection, directly competing with Epigenomics' Epi proColon. Emerging-stage peer with more recent capital backing but overlapping product strategy and customer target.

Others

• Bio-Techne: Bio-Techne provides research reagents and diagnostic tools including methylation-related assay technologies used in epigenetics research and clinical diagnostics. Comparable as an adjacent tools/enabling technology provider in the same DNA methylation biomarker ecosystem.

Broad incumbents

• Abbott Molecular: Abbott Molecular is Epigenomics' largest non-exclusive licensing partner for Septin9-based IVD tests on the m2000 platform. A broad incumbent in IVD that competes in adjacent molecular diagnostic categories and represents both a channel partner and potential competitive threat.
• Quest Diagnostics: Quest Diagnostics is the US reference laboratory partner offering ColoVantage (Septin9-based CRC test). Comparable as a large US clinical laboratory with its own growing menu of molecular oncology tests, making it both a customer/channel and a competitor in the same end market.
• Sysmex Corporation: Sysmex is both a non-exclusive licensee of Epigenomics' SEPT9 biomarker for Japan/Asia and a broad incumbent in hematology and IVD instrumentation. Comparable as both a commercial partner and a larger diversified diagnostics company with overlapping cancer diagnostic offerings.

Market position

Strengths3 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

• Xx.com/EpigenomicsInc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds7 records

Investors7 records

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 Epigenomics