Therawis

What Therawis does

Therawis is a privately held Munich-based oncology company operating through two distinct German limited liability entities: therawis healthcare GmbH (founded April 2014) and therawis diagnostics GmbH (founded 2015). The company executes a dual business model: (1) therawis diagnostics develops proprietary exosome-based immunodiagnostics built on its ELAEXIA biopeptide technology — which binds specifically to phosphatidylethanolamine on exosome membranes — combined with mass spectrometry-based proteomics, AI-driven bioinformatics (LASSO, Bayesian modelling, graph-based machine learning), and the exID/exAI explainable AI platform for immune signature detection; (2) therawis healthcare provides fee-for-service Clinical & Medical Affairs support (oncology trial liaison, KOL management, regulatory submissions) and IVDR regulatory consulting (strategy, conformity assessment, performance evaluation, post-market surveillance) to pharmaceutical, biotech, and IVD manufacturer clients across Europe.

The diagnostics division's commercialized asset is the CE-certified therascreen PITX2 RGQ PCR Kit, co-developed and exclusively distributed by QIAGEN under a May 2016 licensing and development agreement; this methylation-based predictive test guides anthracycline-based chemotherapy decisions in high-risk breast cancer patients. Additional diagnostic offerings include the ELAEXIA FITC molecular probe for flow cytometry. Diagnostics revenue flows through licensing fees and royalties from QIAGEN, while healthcare revenue is generated directly from enterprise clients. The company holds DIN EN ISO 9001:2015 certification across both entities, is described as profitable, and is controlled by founder Prof. Dr. Olaf G. Wilhelm (CEO), with Marko Wilhelm as CFO. Customer segments span IVD medical device manufacturers, pharmaceutical and biotech companies, healthcare providers and laboratories, and secondary life science researchers.

Name

Therawis

Legal name

therawis healthcare GmbH; therawis diagnostics GmbH

Website

https://therawis.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Therawis is a privately held Munich-based oncology company operating two divisions: therawis diagnostics develops exosome-based immunodiagnostics (ELAEXIA technology, exID/exAI platform) licensed to QIAGEN, and therawis healthcare provides Clinical & Medical Affairs and EU-IVDR regulatory consulting to pharmaceutical, biotech, and IVD manufacturers across Europe.

Ownership category

akta.pro rank

Product category

Oncology Diagnostics & Regulatory Services

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)

akta.pro secondary industries

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Clinical Research & Trial Central Laboratories (HLAFAMAL), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Exosome diagnostics
• Oncology biomarkers
• Clinical affairs services
• IVDR compliance consulting
• Precision medicine diagnostics

Headquarters

HQ city

Munich

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Diagnostic Product Licensing & Royalties: Therawis diagnostics develops proprietary diagnostic technologies and licenses them to commercialization partners. The therascreen PITX2 RGQ PCR Kit was developed with QIAGEN and is commercially distributed by QIAGEN. Therawis receives licensing fees and royalties from product sales through its partner.
2. IVDR Consulting & Regulatory Services: Therawis healthcare provides IVDR strategy, preparedness, conformity assessment, and performance evaluation services to clients. The team supports development of optimal IVDR strategy, prepares conformity documentation, and conducts performance evaluation activities.
3. Clinical & Medical Affairs Services: Therawis healthcare provides Clinical Trial Liaison, Medical Affairs, and Project Management services for oncology clinical trials Phase 1-3. Services include support for study execution, KOL relationship management, and regulatory submissions.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Therawis operates two divisions: therawis diagnostics develops proprietary exosome-based immunodiagnostic products including the CE-certified therascreen PITX2 RGQ PCR Kit (commercialized via QIAGEN) and the ELAEXIA FITC molecular probe; therawis healthcare delivers B2B Clinical & Medical Affairs and IVDR regulatory consulting services to pharmaceutical and diagnostics clients across Europe. The company pursues a theranostic strategy combining predictive oncology diagnostics with therapeutic development support.

Differentiator

Problem solved

Functional benefit

Products and services

• therascreen PITX2 RGQ PCR Kit CE-certified IVD DNA methylation test for determination of percent methylation ratio (PMR) in the PITX2 gene promoter using methylation-specific real-time PCR. Predictive for response to anthracycline-based chemotherapy in high-risk breast cancer patients, with a PMR cut-off value of 12. Commercially distributed via QIAGEN across Europe.
• ELAEXIA FITC First-in-kind molecular probe designed for detection of exosomes by flow cytometry. Binds specifically to phosphatidylethanolamine (PE) on the outer leaflet of exosome membranes, excludes lipoproteins, and is compatible with antibody co-staining and multiparametric analysis. For life science research applications.
• IVDR Services B2B regulatory consulting services covering IVDR strategy, preparedness, conformity assessment, and performance evaluation under EU-IVDR 2017/746 for in vitro diagnostic medical device manufacturers. Includes systematic literature reviews for scientific validity, clinical utility, and medical risk assessments, plus clinical performance studies and post-market surveillance support. The therawis team has supported over 30 IVD products with performance evaluation and conformity assessment in the last five years.
• Clinical & Medical Affairs Services B2B services for pharmaceutical and biotech clients including Clinical Trial Liaison, Medical Affairs, and Project Management support for oncology clinical trials Phase 1-3. Covers study execution support, KOL relationship management, and regulatory submissions to FDA and EMA, delivered across an established European-wide network of oncology specialists.

Quantifiable outcome

• Clinically validated CE-certified diagnostic test with PMR cut-off value of 12 for predicting anthracycline-based chemotherapy response in high-risk breast cancer patients
• +2 more outcomes

Named customers1 record

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 capability5 records

Feature5 records

Partnerships

One partnership is on record.

• QIAGENflagship / coreOEM/ Whitelabel/ Licensing Partner · 26 May 2016QIAGEN serves as the exclusive licensing and development partner for therawis diagnostics' proprietary biomarkers. The partnership, established in May 2016, led to the co-development of the therascreen PITX2 RGQ PCR Kit. QIAGEN commercializes the CE-certified IVD test across Europe, guiding treatment decisions for high-risk breast cancer patients. Therawis retains ownership of the underlying biomarker technology while QIAGEN handles manufacturing and distribution.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• QIAGEN: Global molecular diagnostics and sample-technology incumbent; Therawis' flagship licensing/distribution partner for therascreen PITX2 and the most direct reference point for evaluating therawis diagnostics' assay development and commercial pathway in PCR-based IVDs.
• Veracyte: Genomic diagnostics company with multi-cancer oncology menu; relevant broad incumbent in molecular oncology Dx that helps frame Therawis' commercial sizing and partnership-value discussions.
• Natera: Cell-free DNA and molecular oncology diagnostics company; analogous scalable liquid-biopsy oncology peer against which any ELAEXIA-based assay will compete on sensitivity, turnaround time, and reimbursement.
• Eurofins Scientific (Genomics & IVD services): Global testing-services platform with extensive IVD performance evaluation, genomics, and clinical trial lab capabilities; relevant scaled incumbent in the same IVDR services and clinical-trial support addressable market.

Direct peers

• Bio-Techne (Exosome Diagnostics): Through its Exosome Diagnostics franchise (e.g., ExoDx Prostate), Bio-Techne commercializes exosome-based liquid-biopsy oncology tests — the closest functional peer to Therawis diagnostics' ELAEXIA/exID pipeline in terms of analyte and clinical application.
• MDxHealth: Molecular diagnostics company focused on epigenetic and methylation-based oncology biomarkers; a direct comparator for PITX2 methylation-style assays and for the regulatory/clinical evidence strategy Therawis uses with QIAGEN.
• Sysmex Inostics: Subsidiary of Sysmex Corporation providing ultra-sensitive blood-based molecular oncology assays (liquid biopsy); competes in the same oncology blood-based diagnostic category Therawis targets with ELAEXIA/exID.
• Qserve Group: Specialist regulatory and quality consulting firm for medical devices and IVDs under EU-MDR/IVDR; the most direct peer to Therawis healthcare's IVDR services line and a useful benchmark for pricing and market share.

Emerging players

• HTG Molecular Diagnostics: Developer of sample-sparing molecular biomarker profiling platforms used in pharma services and translational oncology; comparable to Therawis' mass-spec + bioinformatics biomarker discovery pipeline.
• NanoString Technologies: Spatial omics and gene-expression biomarker platform company with oncology research and diagnostic applications; comparable to Therawis on biomarker-discovery workflow (mass-spec-style proteomics with AI/bioinformatics).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/therawis-diagnostics-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 Therawis