Simsen Diagnostics
Simsen Diagnostics is a Swedish biotechnology company providing ultra-sensitive tumour-informed ctDNA monitoring for pharma clinical trials, translational research laboratories, and premium oncology clinics across Europe, using its proprietary SiMSen-Seq molecular barcoding technology delivered as a service or in-house kit.
- Company typePrivate
- Founded2020
- HeadquartersGothenburg, Sweden
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Simsen Diagnostics does
Simsen Diagnostics AB is a Swedish healthcare technology company founded in 2020 as a spin-out from Sahlgrenska Academy, headquartered at AstraZeneca's BioVentureHub in Mölndal. The company develops and commercialises SiMSen-Seq, a proprietary ultra-sensitive circulating tumor DNA (ctDNA) sequencing platform that uses molecular barcoding with unique molecular identifiers (UMIs) and error suppression chemistry to achieve parts-per-million sensitivity (approximately 0.001% panel-level VAF, ~0.01% per-variant). This capability is designed to detect minimal residual disease (MRD) and tumour recurrence months earlier than standard imaging, with published lead times of 114 days in metastatic breast cancer and up to 9 months in paediatric neuroblastoma.
The flagship product, Simsen Personal, is a tumour-informed personalised monitoring service that tracks 20-30 patient-specific variants identified from a baseline tumour sample over time, supporting MRD detection, treatment response assessment, and resistance tracking. The technology is offered through two delivery models: a full-service EU-based laboratory (samples shipped to Mölndal) and LabSuite, a reagent-kit and protocol-transfer model that enables hospital and research laboratories to run SiMSen-Seq on their own validated Illumina instruments. The portfolio is completed by matched Simsen Personal Baseline and Follow-up Collection Kits for plasma and FFPE sample acquisition.
Revenue is generated through per-sample ctDNA testing fees for the full-service lab, LabSuite reagent and panel-design sales for in-house deployment, and professional services for clinical trial assay design, monitoring, and co-publication. Customers span three primary segments: pharmaceutical sponsors and CROs running European oncology clinical trials (Orion Corporation, One-carbon Therapeutics, Buzzard Pharmaceuticals, Neogap Therapeutics); translational oncology research laboratories (Sahlgrenska University Hospital, RISE, an unnamed Swedish hospital); and premium private oncology clinics (Docrates Cancer Center in Finland). Operations are restricted to Europe (EU, EEA, and UK), with samples never leaving the region, supporting GDPR-native data handling and ISO 15189-compliant laboratory practices. The company is led by CEO Pontus Rehn (appointed 2024) and CTO Stefan Filges (co-author of the original SiMSen-Seq Nature Protocols publication), has raised 10 million SEK from Nordic Ignite, and operates with 1-10 employees. Products are currently offered for Research Use Only and revenue is not publicly disclosed.
Simsen Diagnostics firmographics
Firmographics- Name
- Simsen Diagnostics
- Legal name
- Simsen Diagnostics AB
- Website
- https://simsendiagnostics.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Simsen Diagnostics is a Swedish biotechnology company providing ultra-sensitive tumour-informed ctDNA monitoring for pharma clinical trials, translational research laboratories, and premium oncology clinics across Europe, using its proprietary SiMSen-Seq molecular barcoding technology delivered as a service or in-house kit.
- Ownership category
- akta.pro rank
Simsen Diagnostics industry classification
Industry- Product category
- Liquid Biopsy Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)
- akta.pro secondary industries
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where Simsen Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Gothenburg
- HQ country
- Sweden
- HQ region
- Europe
Offices1 record
Markets served
Simsen Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- ctDNA Analysis Services: Laboratory services for ultra-sensitive circulating tumor DNA analysis, offered as tumour-informed MRD monitoring for clinical trials, research studies, and clinic patients. Revenue generated through per-sample testing fees with personalized panels.
- LabSuite Kit Sales: Sale of reagent kits and panel designs for hospital laboratories and research institutions to run SiMSen-Seq in-house on their own Illumina instruments.
- Clinical Trial Partnerships: Collaborative partnerships with pharmaceutical companies for ctDNA monitoring in drug trials, including assay design, sample analysis, and co-publication.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
Simsen Diagnostics product offering
Product offeringCore offering
Simsen Diagnostics provides ultra-sensitive tumour-informed ctDNA (circulating tumor DNA) monitoring for minimal residual disease (MRD) detection, using its proprietary SiMSen-Seq barcoded sequencing platform with unique molecular identifiers (UMIs) that achieves parts-per-million sensitivity (~0.001% VAF). The offering is delivered through two channels: a full-service EU-based laboratory model where customers ship samples for analysis, and LabSuite, where validated reagent kits and patient-specific panels are provided for customers to run SiMSen-Seq in-house on their own Illumina instruments.
Product overview
Simsen Diagnostics offers a unified portfolio anchored by Simsen® Personal, an ultra-sensitive tumour-informed ctDNA monitoring solution. The core technology is the proprietary SiMSen-Seq platform, which uses barcoded sequencing with unique molecular identifiers (UMIs) and error suppression to achieve approximately 0.001% VAF sensitivity (parts-per-million detection). Customers can access the technology through two delivery models: the full-service lab option (samples shipped to Simsen's EU-based laboratory for analysis and reporting) or LabSuite (Simsen-supplied reagent kits and patient-specific panels run in-house on the customer's own validated Illumina instruments). The portfolio also includes Simsen® Personal Collection Kits — a Baseline Kit for first-visit tumour tissue, matched normal, and initial ctDNA draws, and a Follow-up ctDNA Kit for subsequent monitoring timepoints. All offerings are provided for Research Use Only (RUO) and are not ISO 15189 accredited clinical services.
Differentiator
Problem solved
Functional benefit
Brands
- Simsen Personal: Patient-specific ctDNA monitoring solution for cancer detection and monitoring
- SiMSen-Seq
- LabSuite
Products and services
- Simsen® Personal Ultra-sensitive tumour-informed ctDNA monitoring solution for clinical trials, research laboratories, and private oncology clinics. Tracks 20-30 patient-specific variants for MRD detection and resistance tracking, enabling earlier relapse detection than imaging.
- LabSuite In-house sequencing kit enabling hospital and research laboratories to run SiMSen-Seq on their own validated Illumina instruments, with Simsen-designed patient-specific panels, reagent kits, and sample collection kits supplied. No major capital investment required for adoption.
- Simsen® Personal Baseline Collection Kit First-visit collection kit containing tumour tissue specimen box for FFPE sections, 2 × 10 mL Streck tubes for plasma, and 1 × 6 mL EDTA tube for matched normal control. Used to initiate personalized ctDNA panel design.
- Simsen® Personal Follow-up ctDNA Collection Kit Ongoing monitoring kit for patients already established with a Baseline kit. Contains 2 × 10 mL Streck tubes for ctDNA plasma draws at each monitoring timepoint. No tissue or matched normal required.
Quantifiable outcome
- 0.001% VAF panel-level MRD sensitivity; per-variant ~0.01% sensitivity
- +4 more outcomes
Companies that use Simsen Diagnostics
Customer profileNamed customers7 records
Segments3 records
Ideal customer profiles3 records
Simsen Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Simsen Diagnostics partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered major, core and minor.
- One-carbon TherapeuticsmajorCollaboration for ODIN Phase 1/2 clinical trial evaluating TH9619 (MTHFD1/2 inhibitor) in selected solid cancers. Simsen Personal provides ctDNA monitoring throughout the trial for dose escalation guidance.
- Swedish Hospital (unnamed)majorHospital laboratory partnership enabling implementation of tumour-informed ctDNA analysis in-house. First step in empowering hospital laboratories to deliver personalised cancer care with LabSuite solution.
- Buzzard PharmaceuticalsmajorPartnership for Phase IIa trial evaluating isunakinra (IL-1 inhibitor) with pembrolizumab in metastatic colorectal cancer. Simsen Personal monitors ctDNA as predictor of therapeutic response.
- Docrates Cancer CentermajorAgreement allowing Finland's only private cancer hospital to use Simsen's personalised ctDNA analysis for patient monitoring. Docrates integrates Simsen Personal for early detection of recurring cancer and treatment effectiveness monitoring.
- Neogap TherapeuticsmajorOngoing collaboration for Phase I/II T-cell immunotherapy trial in colorectal cancer. Simsen Personal monitors 36 neoantigens per patient selected by Neogap's PIOR software, tracking each mutation over time.
- Orion CorporationmajorCollaboration during First-in-Human Phase I study evaluating Orion's drug candidate ODM-212 in patients with advanced solid tumors. Simsen Personal monitors ctDNA to guide dose escalation and evaluate therapeutic potential.
- VGR/Sahlgrenska University HospitalcoreFIRM Liquid Biopsy project collaboration for monitoring immunotherapy response in lung cancer patients. Hospital serves as end user and requirement setter with clinical expertise in genetics.
- RISE Research Institutes of SwedencoreFIRM Liquid Biopsy project collaboration. RISE leads project management and provides expertise in medical technology and diagnostic products. Drive the project forward alongside Simsen.
- BiovendorminorContract signed to evaluate Simsen's kit solution for potential distribution or partnership in sample collection kit provision.
- Sahlgrenska University Hospital (Gynecological Cancers Research Group)minorAcademic collaboration with research group studying gynecological cancers. Contract signed for new types of projects exploring Simsen's technology in this cancer area.
Scale indicators3 records
Recent moves6 records
Expansion highlights6 records
Simsen Diagnostics competitors and assessment
Company assessmentEmerging players
- Cergentis: Cergentis is a European molecular diagnostics company focused on tumor-informed ctDNA analysis for pharma trial MRD endpoints. Comparable to Simsen in geographic positioning, customer base (EU pharma), and platform approach.
- Hummingbird Bioscience: Hummingbird Bioscience is a clinical-stage biotech that integrates biomarker-driven patient selection into oncology trials. Comparable to Simsen in the pharma-trial biomarker/MRD endpoint use case where ctDNA monitoring is embedded in trial design for response and resistance tracking.
- Foresight Diagnostics: Foresight Diagnostics is an emerging MRD-focused liquid biopsy company developing ultra-sensitive ctDNA assays (e.g., Foresight CLARITY) with strong academic validation. Comparable to Simsen in stage and tumor-informed approach but with US presence and venture backing from Foresite Labs.
Direct peers
- Natera: Natera's Signatera is the leading commercial tumor-informed ctDNA MRD assay with identical application (personalized panels tracking patient-specific variants for MRD monitoring). Natera also offers a dual delivery model (central lab + EmpowerDx kit). It is the most direct competitor to Simsen Personal.
- NeoGenomics (RaDaR / Inivata): RaDaR is a tumor-informed personalized MRD assay developed by Inivata (now part of NeoGenomics) using similar personalized SNV-based panel design. Direct competitor to Simsen Personal in the EU and US pharma trial endpoint market.
Broad incumbents
- Exact Sciences: Exact Sciences (via Thrive/Oncodetect and acquired genomics assets) is developing competing MRD and multi-cancer detection assays. It is a large public diagnostics company with the capital and US commercial footprint to compete across Simsen's targeted use cases.
- Personal Genome Diagnostics (PGDx / Labcorp): PGDx (now part of Labcorp) offers tissue and liquid biopsy molecular diagnostics with EU IVDR-marked kits. Comparable to Simsen in the IVD-reagent channel via LabSuite and in pharma central lab services, but with broader oncology menu.
- Guardant Health: Guardant Health offers the Guardant360 liquid biopsy CDx and Guardant Reveal MRD product (tumor-informed, ~0.01% sensitivity). It is a major incumbent with substantially more capital, FDA relationships, and pharma trial partnerships across oncology indications directly overlapping Simsen's positioning.
- Resolution Bioscience (Agilent): Resolution Bioscience (acquired by Agilent) offers NGS-based liquid biopsy kits for ctDNA analysis. Comparable to Simsen's LabSuite reagent-kit channel, serving pharma and research labs requiring validated NGS workflows on customer instruments.
Regional players
- Sophia Genetics: Sophia Genetics is a Swiss-European health data/analytics company offering molecular diagnostics interpretation and multimodal analytics for oncology, with extensive EU hospital penetration. Comparable as a European-based diagnostics platform serving pharma and hospitals across the same geography Simsen targets.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights6 records
Customer concentration
Simsen Diagnostics social profiles
Digital presenceSimsen Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Simsen Diagnostics leadership team
Management profileNumber of profiles
Profiles3 records
Simsen Diagnostics funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Simsen Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Simsen Diagnostics
What does Simsen Diagnostics do?
Simsen Diagnostics provides ultra-sensitive tumour-informed ctDNA (circulating tumor DNA) monitoring for minimal residual disease (MRD) detection, using its proprietary SiMSen-Seq barcoded sequencing platform with unique molecular identifiers (UMIs) that achieves parts-per-million sensitivity (~0.001% VAF). The offering is delivered through two channels: a full-service EU-based laboratory model where customers ship samples for analysis, and LabSuite, where validated reagent kits and patient-specific panels are provided for customers to run SiMSen-Seq in-house on their own Illumina instruments.
Is Simsen Diagnostics a public or private company?
Simsen Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Simsen Diagnostics founded?
Simsen Diagnostics was founded in 2020. It employs 1 to 10 people.
Where is Simsen Diagnostics based?
Simsen Diagnostics is headquartered in Gothenburg, Sweden, in the Europe region.
How does Simsen Diagnostics make money?
Three revenue lines are on record. ctDNA Analysis Services are the primary driver. The others are labSuite Kit Sales and clinical Trial Partnerships.
Who are Simsen Diagnostics's main competitors?
Emerging players on record are Cergentis, Hummingbird Bioscience and Foresight Diagnostics. Direct peers are Natera and NeoGenomics (RaDaR / Inivata). Broad incumbents are Exact Sciences, Personal Genome Diagnostics (PGDx / Labcorp), Guardant Health and Resolution Bioscience (Agilent). Sophia Genetics is listed as a regional player.
Does Simsen Diagnostics have an API?
No public API is recorded for Simsen Diagnostics.
What industry is Simsen Diagnostics in?
Simsen Diagnostics's product category is Liquid Biopsy Diagnostics. Its primary akta.pro industry code is HLAAANAG, Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing, with a secondary code of HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 325413 and its SIC code is 2835.