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Heidelberg Epignostix

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uuid0002fzd

Namestring
Heidelberg Epignostix
Legal namestring
Heidelberg Epignostix GmbH
Websiteurl
epignostix.com
Company typeenum
Private
Founded yearint
2023
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersHeidelberg, Germany
HQ citystring
Heidelberg
HQ countrystring
Germany
HQ regionstring
Europe
Markets served

Serves global market

Keyword5 values
methylation-based diagnostics, tumor classification software, AI cancer diagnostics, molecular pathology tools, CNS tumor classifier
Industry3 codes
1Molecular Diagnostics & Genomics Laboratories
CodeHLAFAMAEPrimaryYes
2Multi-Omics Precision Medicine Platforms (genomics/proteomics/metabolomics)
CodeHLAAANAFPrimaryNo
3Epigenomics & Chromatin Profiling Services
CodeHLAGANAFPrimaryNo
NAICS code1 code
  • Medical and Diagnostic Laboratories6215
SIC code1 code
  • Services-Medical Laboratories8071
Product category
Molecular Diagnostics Software
Social media profiles1 record
Cost components4 values
Personnel, Technology or R&D, Operations, Marketing or Sales
GTM typeB2B
B2B
Offering typeSoftware
Software
Brand1 of 3 records shown
1Heidelberg Brain Tumor Classifier (Heidelberg CNS Tumor Methylation Classifier)
Description

Flagship AI-based DNA methylation classifier for central nervous system (CNS) tumor classification; lead commercial product of Heidelberg Epignostix.

epignostix.com
+2 more records
Core offering1 text field

Heidelberg Epignostix develops and licenses AI-based DNA methylation classifiers that classify central nervous system (CNS) and sarcoma tumors from methylation array data. Its cloud-hosted Classifier App accepts Illumina 450K/EPIC IDAT files and returns hierarchical classification scores, confidence scores, copy number profiles, and MGMT promoter methylation status predictions. The CNS Tumor Methylation Classifier (Heidelberg Brain Tumor Classifier) and Sarcoma Methylation Classifier are offered free for academic research, with commercial and diagnostic use licensed separately to hospital and reference laboratories.

Differentiator
Functional benefit
Problem solved
Product overview1 text field

Heidelberg Epignostix offers a single integrated product platform—the Heidelberg Epignostix Research App (Classifier App) at app.epignostix.com—delivered alongside a portfolio of two core AI-based, DNA methylation tumor classifiers: the flagship CNS Tumor Methylation Classifier (Heidelberg Brain Tumor Classifier) and the Sarcoma Methylation Classifier. Both classifiers operate on the same underlying random-forest AI architecture and the same input data format (Illumina Human Methylation 450K / EPIC v1 / EPIC v2 BeadChip IDAT files), and they share a common web portal experience that returns classification scores, confidence scores, copy number profiles, and MGMT promoter methylation status predictions as downloadable PDF reports. The CNS classifier (covering 184 subclasses) is the flagship and is also the basis of the company's IVD-R / CE-mark diagnostic certification push and its proprietary CPT code 0020M for U.S. Medicare reimbursement, while the Sarcoma classifier extends the platform to mesenchymal tumors (covering 120 sub-classes as of mid-2025). On the roadmap sit additional classifiers for other cancer types (e.g., epithelial cancers such as skin cancer) and a Nanopore-sequencing-compatible classifier, all expected to plug into the same portal/AI platform. The classifiers are currently offered Research Use Only for academic research, with clinical/diagnostic use licensed separately to hospital labs.

Product and service2 records
1CNS Tumor Methylation Classifier (Heidelberg Brain Tumor Classifier)
CategoryMolecular Diagnostics Software
Description

Flagship AI-based DNA methylation classifier for central nervous system (CNS) tumors, trained on a reference set of 7,495 samples covering 184 CNS tumor subclasses. Uses a random forest ensemble algorithm to compare new methylation profiles against the reference cohort and outputs classification scores at four hierarchy levels (methylation subclass, class, family, superfamily) with confidence scores between 0 and 1.

2Sarcoma Methylation Classifier
Recent move7 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers10 records
TypeBroad incumbent
Description

Global molecular diagnostics and sample-preparation leader; Epignostix's CEO Helge Lubenow was previously Head of Diagnostics Business at QIAGEN. Overlapping in oncology molecular diagnostics and methylation/PCR-based workflows.

TypeBroad incumbent
Description

Leader in comprehensive genomic profiling for cancer (FoundationOne CDx). Comparable as an AI-enabled molecular oncology diagnostics provider serving clinicians and biopharma, though focused on DNA sequencing rather than methylation arrays.

TypeBroad incumbent
Description

Multi-omics molecular profiling company (MI Profile, Caris Assure) for oncology. Comparable as a broad molecular tumor-classification and therapy-guidance platform, competing for the same oncology diagnostics customer wallet.

TypeBroad incumbent
Description

AI-enabled precision medicine company combining multi-modal molecular data and clinical records for oncology. Comparable as a data- and AI-driven cancer diagnostics player targeting similar clinical and biopharma customers.

TypeBroad incumbent
Description

Oncology-focused clinical laboratory services and molecular diagnostics provider. Comparable as a channel through which methylation-based classifiers like Epignostix's could be distributed, and as a competing molecular oncology menu.

TypeBroad incumbent
Description

Genomic diagnostics company with proprietary molecular tests across oncology indications. Comparable business model of building a portfolio of AI/molecular tests sold to pathology and oncology clinicians.

TypeDirect peer
Description

Provider of spatial genomics and methylation profiling products (nCounter, GeoMx, CosMx). Comparable as a seller of methylation-based molecular profiling tools to research and clinical pathology customers, with overlapping array-based technologies.

TypeEmerging player
Description

Spatial biology company offering multiplex profiling (PhenoCycler, PhenoImager). Comparable as a next-generation molecular profiling platform serving translational and clinical research in oncology.

TypeEmerging player
Description

AI-based digital pathology and cancer diagnostics company (FDA-authorized prostate cancer AI). Comparable as an AI-first pathology diagnostics company targeting similar clinical oncology use cases and reimbursement pathways.

TypeEmerging player
Description

AI-powered pathology company combining deep learning with histology and biomarker data. Comparable as an AI-driven diagnostics company in oncology with a focus on improving pathologist accuracy and clinical decision support.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat6 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
Yes

Docs URL, Description

Integration1 record

Each record includes

Title, Type, Description, Source

AI capability5 records

Each record includes

Type, Description, Source

AI maturity
App detail

Has app

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles13 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
Compliance3 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds1 record

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors4 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Heidelberg Epignostix

Molecular Diagnostics Softwareepignostix.com

Heidelberg Epignostix firmographics

Firmographics
Name
Heidelberg Epignostix
Legal name
Heidelberg Epignostix GmbH
Website
https://epignostix.com
Company type
Private
Founded year
2023
Operating status
Operating
Headcount range
11–50 employees
Ownership category
akta.pro rank

Heidelberg Epignostix industry classification

Industry
Product category
Molecular Diagnostics Software
NAICS
Medical and Diagnostic Laboratories (6215)
SIC
Services-Medical Laboratories (8071)
akta.pro primary industry
Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)
akta.pro secondary industries
Multi-Omics Precision Medicine Platforms (genomics/proteomics/metabolomics) (HLAAANAF), Epigenomics & Chromatin Profiling Services (HLAGANAF)

Keywords

  • Methylation-based diagnostics
  • Tumor classification software
  • AI cancer diagnostics
  • Molecular pathology tools
  • CNS tumor classifier

Where Heidelberg Epignostix is headquartered

Location

Headquarters

HQ city
Heidelberg
HQ country
Germany
HQ region
Europe

Markets served

Heidelberg Epignostix business model

Business model
GTM type
B2B
Offering type
Software
Cost components
Personnel, Technology or R&D, Operations, Marketing or Sales

Heidelberg Epignostix product offering

Product offering

Core offering

Heidelberg Epignostix develops and licenses AI-based DNA methylation classifiers that classify central nervous system (CNS) and sarcoma tumors from methylation array data. Its cloud-hosted Classifier App accepts Illumina 450K/EPIC IDAT files and returns hierarchical classification scores, confidence scores, copy number profiles, and MGMT promoter methylation status predictions. The CNS Tumor Methylation Classifier (Heidelberg Brain Tumor Classifier) and Sarcoma Methylation Classifier are offered free for academic research, with commercial and diagnostic use licensed separately to hospital and reference laboratories.

Product overview

Heidelberg Epignostix offers a single integrated product platform—the Heidelberg Epignostix Research App (Classifier App) at app.epignostix.com—delivered alongside a portfolio of two core AI-based, DNA methylation tumor classifiers: the flagship CNS Tumor Methylation Classifier (Heidelberg Brain Tumor Classifier) and the Sarcoma Methylation Classifier. Both classifiers operate on the same underlying random-forest AI architecture and the same input data format (Illumina Human Methylation 450K / EPIC v1 / EPIC v2 BeadChip IDAT files), and they share a common web portal experience that returns classification scores, confidence scores, copy number profiles, and MGMT promoter methylation status predictions as downloadable PDF reports. The CNS classifier (covering 184 subclasses) is the flagship and is also the basis of the company's IVD-R / CE-mark diagnostic certification push and its proprietary CPT code 0020M for U.S. Medicare reimbursement, while the Sarcoma classifier extends the platform to mesenchymal tumors (covering 120 sub-classes as of mid-2025). On the roadmap sit additional classifiers for other cancer types (e.g., epithelial cancers such as skin cancer) and a Nanopore-sequencing-compatible classifier, all expected to plug into the same portal/AI platform. The classifiers are currently offered Research Use Only for academic research, with clinical/diagnostic use licensed separately to hospital labs.

Differentiator

Problem solved

Functional benefit

Brands

  • Heidelberg Brain Tumor Classifier (Heidelberg CNS Tumor Methylation Classifier): Flagship AI-based DNA methylation classifier for central nervous system (CNS) tumor classification; lead commercial product of Heidelberg Epignostix.
  • Sarcoma Methylation Classifier
  • Heidelberg Epignostix Classifier App

Products and services

  • CNS Tumor Methylation Classifier (Heidelberg Brain Tumor Classifier) Flagship AI-based DNA methylation classifier for central nervous system (CNS) tumors, trained on a reference set of 7,495 samples covering 184 CNS tumor subclasses. Uses a random forest ensemble algorithm to compare new methylation profiles against the reference cohort and outputs classification scores at four hierarchy levels (methylation subclass, class, family, superfamily) with confidence scores between 0 and 1.
  • Sarcoma Methylation Classifier

Companies that use Heidelberg Epignostix

Customer profile

Ideal customer profiles2 records

Heidelberg Epignostix technology and API

Technology

Technology focussed Yes

API detail

Has API
Yes
API docs
API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability5 records

Heidelberg Epignostix partnerships and signals

Strategic signal

Recent moves7 records

Expansion highlights6 records

Heidelberg Epignostix competitors and assessment

Company assessment

Broad incumbents

  • QIAGEN: Global molecular diagnostics and sample-preparation leader; Epignostix's CEO Helge Lubenow was previously Head of Diagnostics Business at QIAGEN. Overlapping in oncology molecular diagnostics and methylation/PCR-based workflows.
  • Foundation Medicine (Roche): Leader in comprehensive genomic profiling for cancer (FoundationOne CDx). Comparable as an AI-enabled molecular oncology diagnostics provider serving clinicians and biopharma, though focused on DNA sequencing rather than methylation arrays.
  • Caris Life Sciences: Multi-omics molecular profiling company (MI Profile, Caris Assure) for oncology. Comparable as a broad molecular tumor-classification and therapy-guidance platform, competing for the same oncology diagnostics customer wallet.
  • Tempus Labs: AI-enabled precision medicine company combining multi-modal molecular data and clinical records for oncology. Comparable as a data- and AI-driven cancer diagnostics player targeting similar clinical and biopharma customers.
  • NeoGenomics: Oncology-focused clinical laboratory services and molecular diagnostics provider. Comparable as a channel through which methylation-based classifiers like Epignostix's could be distributed, and as a competing molecular oncology menu.
  • Veracyte: Genomic diagnostics company with proprietary molecular tests across oncology indications. Comparable business model of building a portfolio of AI/molecular tests sold to pathology and oncology clinicians.

Direct peers

  • NanoString Technologies (a Bruker company): Provider of spatial genomics and methylation profiling products (nCounter, GeoMx, CosMx). Comparable as a seller of methylation-based molecular profiling tools to research and clinical pathology customers, with overlapping array-based technologies.

Emerging players

  • Akoya Biosciences: Spatial biology company offering multiplex profiling (PhenoCycler, PhenoImager). Comparable as a next-generation molecular profiling platform serving translational and clinical research in oncology.
  • Paige.AI: AI-based digital pathology and cancer diagnostics company (FDA-authorized prostate cancer AI). Comparable as an AI-first pathology diagnostics company targeting similar clinical oncology use cases and reimbursement pathways.
  • PathAI: AI-powered pathology company combining deep learning with histology and biomarker data. Comparable as an AI-driven diagnostics company in oncology with a focus on improving pathologist accuracy and clinical decision support.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

Heidelberg Epignostix social profiles

Digital presence

Heidelberg Epignostix compliance and trust

Trust signal

Compliance3 records

Heidelberg Epignostix financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Heidelberg Epignostix leadership team

Management profile

Number of profiles

Profiles13 records

Heidelberg Epignostix funding detail

Funding detail

Funding overview

Funding rounds1 record

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Heidelberg Epignostix M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Heidelberg Epignostix

What does Heidelberg Epignostix do?

Heidelberg Epignostix develops and licenses AI-based DNA methylation classifiers that classify central nervous system (CNS) and sarcoma tumors from methylation array data. Its cloud-hosted Classifier App accepts Illumina 450K/EPIC IDAT files and returns hierarchical classification scores, confidence scores, copy number profiles, and MGMT promoter methylation status predictions. The CNS Tumor Methylation Classifier (Heidelberg Brain Tumor Classifier) and Sarcoma Methylation Classifier are offered free for academic research, with commercial and diagnostic use licensed separately to hospital and reference laboratories.

Is Heidelberg Epignostix a public or private company?

Heidelberg Epignostix is a private company. It is classified as venture growth investor backed and is currently operating.

When was Heidelberg Epignostix founded?

Heidelberg Epignostix was founded in 2023. It employs 11 to 50 people.

Where is Heidelberg Epignostix based?

Heidelberg Epignostix is headquartered in Heidelberg, Germany, in the Europe region.

Who are Heidelberg Epignostix's main competitors?

Broad incumbents on record are QIAGEN, Foundation Medicine (Roche), Caris Life Sciences, Tempus Labs, NeoGenomics and Veracyte. NanoString Technologies (a Bruker company) is listed as a direct peer. Emerging players are Akoya Biosciences, Paige.AI and PathAI.

Does Heidelberg Epignostix have an API?

Yes. Heidelberg Epignostix offers global access to cloud-based API services (AIaaS) for state-of-the-art diagnostics tools. Interested parties are directed to contact [email protected]. The APIs enable programmatic access to the company's methylation-based tumor classification tools. The classifier tool can also be deployed as a local copy installed by medical professionals. Specific details on API type (REST/GraphQL), authentication, rate limits, versioning, and sandbox availability are not specified.

What industry is Heidelberg Epignostix in?

Heidelberg Epignostix's product category is Molecular Diagnostics Software. Its primary akta.pro industry code is HLAFAMAE, Molecular Diagnostics & Genomics Laboratories, with a secondary code of HLAAANAF, Multi-Omics Precision Medicine Platforms (genomics/proteomics/metabolomics). Its NAICS code is 6215 and its SIC code is 8071.

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Live signals
deutsche-startups.de7 aufstrebende Startups aus Heidelberg, die alle kennen solltenSeven Heidelberg startups are profiled, including Cirql One, blue activity, FLEXOO, Enzo, paretos, become.1, and Heidelberg Epignostix. They cover enterprise AI, clean tech, sensors, insurance, analytics, benefits, and cancer diagnostics. The startups aim to address specific industry challenges with AI and data-driven solutions.GenomeWebHeidelberg Epignostix Eyes Clinical Testing Market with Epigenetic Tumor ClassifiersGerman startup Heidelberg Epignostix has secured a Current Procedural Technology code and CMS reimbursement of $2,500 per test for its CNS tumor methylation analysis assay, with the company targeting $250 per test for the use of its classifier software. The Heidelberg-based company, a spinout of the German Cancer Research Center and Heidelberg University established in 2022, currently has 2,000 institutional accounts globally and is planning accelerated commercial rollout in the US while pursuing EU regulatory approval under In Vitro Diagnostic Regulation. The company raised €4.3 million in seed funding in June 2024 and plans to launch a €15 million Series A round, with the goal of expanding into additional cancer types and integrating methylation data with histopathology analysis.DkfzAI-supported molecular cancer diagnosis for brain tumorsResearchers at the Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ), Heidelberg University, and Heidelberg University Hospital have released an updated version of their AI-based methylation classifier for brain tumor diagnosis, now capable of identifying 184 tumor types—double the 91 types from the previous version—after training on approximately 7,500 tumor samples. The classifier analyzes DNA methylation patterns to classify central nervous system tumors, providing probability scores that help pathologists assess diagnostic reliability. The tool, originally published in Nature in 2018, was made available as a diagnostic product in 2022 through spin-off company Heidelberg Epignostix GmbH, and has been used to analyze over 160,000 brain tumor samples globally.FinSMEsHeidelberg Epignostix Raises €4.3M in Seed FundingHeidelberg Epignostix raised €4.3M in seed funding led by CARMA FUND I Capital, with participation from High-Tech Gründerfonds, LBBW Venture Capital, and Start-up BW Seed Fonds. The funds will expand development of its brain tumor classifier, which has been applied to over 150,000 patient samples.deutsche-startups.deHeidelberg Epignostix erhält 4,3 MillionenThe article summarizes several investment and merger deals in the DACH region, including a €4.3 million investment by Carma Fund and others into Heidelberg Epignostix for AI-based cancer diagnostics. It also reports on Taxfix acquiring UK-based TaxScouts to strengthen its position in European fintech, and Vivid Money acquiring Pile to expand business banking services.HighHTGF Seed Heidelberg EpignostixHeidelberg Epignostix secured €4.3 million in seed funding led by CARMA FUND I Capital to commercialize its AI-powered diagnostic tumor classifier for brain tumors. The investment will support the company's efforts to bring its Heidelberg Brain Classifier to market as an approved diagnostic test by 2025, leveraging technology developed through research at German institutions like DKFZ and KiTZ.