Hedera Dx

What Hedera Dx does

Hedera Dx is a Swiss-headquartered molecular diagnostics company founded in 2021 that provides hospital in-house laboratories with an NGS-based liquid biopsy platform for cancer molecular profiling. The portfolio comprises four proprietary test panels (Hedera Profiling 1, 2, and 3 ctDNA panels, plus a Hedera Profiling RNA fusion/expression panel) covering SNVs, indels, CNVs, fusions, and MSI across solid tumors, with ESCAT Level I gene coverage ranging from >80% to 100% depending on the panel. Kits are commercialized together with Hedera Prime, a CE-IVDR certified and ISO 13485 compliant medical device software that integrates OncoKB and other curated knowledge bases to convert sequencing output into clinically actionable reports with regulatory-approved therapy options.

The company generates revenue primarily through one-time sales of NGS test kits bundled with Hedera Prime software to hospital molecular pathology laboratories, supplemented by professional sequencing services for biopharma and clinical trials, and a nascent real-world evidence data partnership business built on the Hedera Frame platform and the EMPATHY NSCLC multicenter clinico-genomic registry. Distribution is via direct enterprise field sales with onsite implementation, validation support, and IVDR compliance assistance under the Hedera Comply program; the company operates regional subsidiaries in Germany and Finland and has deployed solutions across 11 European countries, with an explicit geographic exclusion of the United States.

Hedera Dx was founded by Tommi Lehtonen (CEO, ex-Blueprint Genetics co-founder and Quest Diagnostics VP/GM), Damien Lapray (CCO, long-standing CCO of Sophia Genetics), and Christian Meisel (CMO, ex-Roche Global Head Translational Medicine and Molecular Health CMO), and has raised approximately €29M across a €14M seed (September 2022, Top Harvest-led) and a €15M Series A (May 2025, Vsquared Ventures-led). The team comprises 20+ professionals across eight countries, with functional leadership drawn from Sophia Genetics, J.P. Morgan, Owkin, TriNetX, GE Healthcare, Kaiku Health, Elekta, Freenome, and Berkeley Lights.

Name

Hedera Dx

Legal name

Hedera Dx

Website

https://hederadx.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Hedera Dx is a Swiss molecular diagnostics company that provides hospital in-house laboratories with CE-IVDR certified NGS liquid biopsy test panels and software for cancer molecular profiling, and operates a real-world clinico-genomic evidence platform (Hedera Frame) used by European cancer centers and biopharma partners.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), 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

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

akta.pro secondary industries

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG), Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Liquid biopsy tests
• NGS cancer profiling
• Molecular diagnostics
• Real-world evidence
• IVDR compliance

Headquarters

HQ city

Epalinges

HQ country

Switzerland

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. NGS Test Kit Sales: Sale of laboratory reagents and test kits for liquid biopsy testing including Hedera Profiling 1, 2, 3, and RNA panels. Each kit includes reagents for cfDNA extraction, library preparation, and target enrichment along with Hedera Prime software.
2. Software Licensing (Hedera Prime): CE-IVDR certified medical device software provided as part of kit purchase. Software analyzes sequencing data and generates customizable clinical reports with therapy options.
3. Sequencing Services: NGS-based tumor profiling and monitoring services through both tissue and liquid biopsy for biopharma partners and clinical trials.
4. Real-World Evidence Data Partnerships: Prospective clinico-genomic registry platform capturing longitudinal data for biopharma drug development, companion diagnostic development, and market access support.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Hedera Dx provides NGS-based liquid biopsy test panels (Hedera Profiling 1, 2, 3, and RNA) for hospital in-house cancer molecular profiling on FFPE and ctDNA samples. The kits are sold together with Hedera Prime, a CE-IVDR certified medical device software that translates NGS results into clinically actionable reports matched to regulatory-approved therapies. The platform is complemented by Hedera Frame, a real-world clinico-genomic data platform, and Hedera Comply, an IVDR implementation support program.

Product overview

Hedera Dx offers a unified platform combining laboratory reagents and software for in-house liquid biopsy testing in hospital labs. The product portfolio includes four NGS test panels: Hedera Profiling 1 (115-gene pan-cancer FFPE/ctDNA), Hedera Profiling 2 (32-gene ctDNA), Hedera Profiling 3 (43-gene ctDNA), and Hedera Profiling RNA (43-gene fusion/expression). These are powered by Hedera Prime software (CE-IVDR certified) for analysis and reporting. The platform is complemented by Hedera Frame for real-world clinico-genomic evidence, the myHedera patient app, and Hedera Comply implementation support services. The solution enables hospitals to perform blood-based cancer testing locally with ESCAT-driven actionability.

Differentiator

Problem solved

Functional benefit

Brands

• Hedera Prime: CE-IVDR certified medical device software for NGS data analysis and clinical report generation with therapy option matching.
• Hedera Profiling 1
• Hedera Profiling 2 ctDNA
• Hedera Profiling 3 ctDNA
• Hedera Profiling RNA
• Hedera Frame
• myHedera
• Hedera Comply
• EMPATHY NSCLC

Products and services

• Hedera Profiling 1 Test Panel

Quantifiable outcome

• >97% sensitivity and >99% specificity at 0.5% VAF for ESCAT Level I variants
• +5 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature7 records

Partnerships

Four partnerships are on record, tiered core, support and strategic.

• NAIPO (National Artificial Intelligence Initiative for Precision Oncology)coreStrategic or Co-development Partner · 17 September 2025Swiss Innosuisse programme led by EPFL AI Center and ETH AI Center. Brings together academic institutions, hospitals, and industry partners to develop AI-driven solutions for precision oncology using multimodal patient data including genomics, pathology, and clinical information.
• WALCE (Women Against Lung Cancer in Europe)supportOthers · 13 September 2024Patient advocacy group playing vital role in EMPATHY NSCLC study with Steering Committee oversight for responsible data use and patient privacy protection.
• EMPATHY NSCLC ConsortiumcoreStrategic or Co-development Partner · 1 June 2024First European prospective multicenter clinical validation study for in-house liquid biopsy testing. Includes leading cancer centers across Europe including University Federico II of Naples (lead site), Hospices Civils de Lyon, Cantonal Hospital Fribourg, and others.
• Limbus Technologies GmbHstrategicTechnology or IntegrationManufacturer of Hedera Prime medical device software, located in Rostock, Germany. Hedera Prime is a registered CE-IVD medical device.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Guardant Health: US-based leader in liquid biopsy for oncology, offering NGS-based ctDNA assays for tumor profiling and MRD monitoring. Most direct competitor to Hedera's liquid biopsy portfolio; primarily serves the US market which Hedera currently cannot enter.
• Natera: US-based oncology and reproductive health diagnostics company offering Signatera MRD test and other liquid biopsy assays. Directly competes in liquid biopsy for cancer molecular profiling and treatment monitoring.
• Sophia Genetics: Swiss-based healthcare AI and genomics company offering NGS analytics for hospital labs across multiple clinical areas including oncology. Strongly comparable given shared Swiss base, hospital-lab go-to-market, and overlapping leadership pedigree (Damien Lapray, Frances Rhodius Sagnier both came from Sophia Genetics).
• Freenome: US-based liquid biopsy company developing multiomics blood tests for early cancer detection using NGS and machine learning. Directly comparable given focus on liquid biopsy, NGS technology, and AI/ML approach; team pedigree overlap (Hedera's Director Bioinformatics Thomas Vetterli previously at Freenome).
• OncoDNA: Belgian molecular diagnostics company offering NGS-based tumor profiling (OncoDEEP, OncoSTRAT&GO) and liquid biopsy services across Europe. Comparable as a European-based competitor in NGS oncology profiling with similar hospital lab customer base.
• Personalis: US-based NGS-focused oncology genomics company offering tumor profiling assays (NeXT Personal) including liquid biopsy capabilities. Direct competitor in NGS-based molecular profiling for cancer treatment selection.
• Caris Life Sciences: US-based molecular profiling company offering tissue and liquid biopsy NGS assays (MI Profile, MI Cancer Seek) with biopharma partnerships for real-world evidence. Directly comparable in NGS profiling + RWE/data monetization model.

Broad incumbents

• Foundation Medicine (Roche): Roche-owned NGS tumor profiling leader offering both tissue (FoundationOne CDx) and liquid (FoundationOne Liquid CDx) biopsy assays. Largest entrenched player in oncology molecular profiling globally, with extensive biopharma CDx partnerships.
• NeoGenomics: US-based clinical oncology laboratory services company offering comprehensive tumor profiling and liquid biopsy services including Inivata-derived RaDaR MRD assay. Larger incumbent with overlapping oncology diagnostic offerings.
• Exact Sciences: US-based cancer screening and diagnostics company offering Cologuard and Oncotype products, with growing presence in liquid biopsy through Thrive acquisition. Larger incumbent expanding into adjacent liquid biopsy markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/hederadx
• LinkedInlinkedin.com/company/hedera-dx

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors10 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 Hedera Dx