Self-screen
Self-screen B.V. is a Dutch molecular diagnostics company developing CE-IVD real-time PCR and methylation-based assays for cervical and anal cancer screening and triage, distributed globally through partners such as QIAGEN and Fujirebio to national screening programs and clinical laboratories.
- Company typePrivate
- Founded2008
- HeadquartersAmsterdam, Netherlands
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Self-screen does
Self-screen B.V. is a privately held Dutch molecular diagnostics company founded in 2008 as a spin-off from VUmc Amsterdam, headquartered since July 2023 at the Sanquin Health Innovation District in Amsterdam with a headcount of 1–10. The company develops and commercializes real-time PCR-based in vitro diagnostic assays for cervical and anal cancer screening and triage, anchored by two CE-IVD products: the HPV-Risk Assay (rebranded by QIAGEN as QIAscreen HPV PCR Test), which detects 15 high-risk HPV genotypes by targeting the E7 region to avoid false negatives from viral integration, and PreCursor-M+/QIAsure, a methylation-specific qMSP assay for FAM19A4 and miR124-2 markers used to triage HPV-positive women for colposcopy. Supporting RUO offerings include PreCursor-M AnoGYN (ASCL1/ZNF582 for anal specimens), PreCursor-M Gold (broader sample-type compatibility including urine) and a Methylated DNA Control Sample for QC.
The company monetizes through IVD kit sales and licensing royalties to global distribution partners — QIAGEN for HPV-Risk Assay and QIAsure, Fujirebio Europe for PreCursor-M+ and PreCursor-M AnoGYN, and regional distributors Gamidor Diagnostics (Israel) and Biodiagnostico (Uruguay) — supplemented by contract research and validation services. End users are national cervical cancer screening programs (notably the Netherlands' RIVM-led program, Amsterdam UMC, Symbiant, and the Uruguayan Ministry of Health following its March 2025 endorsement), clinical laboratories running HPV and methylation workflows, and academic collaborators such as University of Antwerp and Amsterdam UMC. To date, capital formation has relied on non-dilutive European public funding, including the Horizon 2020 SME Instrument Valid-screen grant (described as the largest SME grant awarded to a Dutch SME) and the Eurostars CASUS project for urine-based self-sampling.
Self-screen firmographics
Firmographics- Name
- Self-screen
- Legal name
- Self-screen B.V.
- Website
- https://self-screen.nl
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Self-screen B.V. is a Dutch molecular diagnostics company developing CE-IVD real-time PCR and methylation-based assays for cervical and anal cancer screening and triage, distributed globally through partners such as QIAGEN and Fujirebio to national screening programs and clinical laboratories.
- Ownership category
- akta.pro rank
Self-screen industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (6215)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)
- akta.pro secondary industries
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)
Keywords
Where Self-screen is headquartered
LocationHeadquarters
- HQ city
- Amsterdam
- HQ country
- Netherlands
- HQ region
- Europe
Offices1 record
Markets served
Self-screen business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Infrastructure, Marketing or Sales
Revenue model
- IVD Assay Sales: Sale of molecular diagnostic assays including HPV-Risk Assay (CE-IVD) and PreCursor-M+ methylation test (CE-IVD). Products sold directly to clinical laboratories and healthcare institutions through distribution partners.
- Research Use Only (RUO) Products: Sale of RUO assays including PreCursor-M AnoGYN and PreCursor-M Gold for research applications, and Methylated DNA Control Samples for quality control in methylation testing.
- Licensing and Distribution Royalties: Revenue from licensing agreements with distribution partners including Fujirebio Europe, Gamidor Diagnostics, and QIAGEN. Partners receive distribution rights in exchange for royalties and revenue sharing arrangements.
- Contract Research Services: Technical and clinical assay validation services, claim extension development, and R&D project collaborations with academic and commercial partners. Includes validation on various commercial PCR platforms.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Other | Direct sales and distribution partner pricing for IVD assays |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels5 records
Self-screen product offering
Product offeringCore offering
Self-screen develops and commercializes CE-IVD validated molecular diagnostic assays for HPV-based cervical cancer screening and DNA methylation-based triage. Its portfolio includes the HPV-Risk Assay (QIAscreen HPV PCR Test) for primary detection of 15 high-risk HPV genotypes via the E7 region, and the PreCursor-M+/QIAsure Methylation Test for triage of HPV-positive women to identify progressive precancerous lesions. The company also offers RUO methylation assays for anal cancer detection and urine-based screening, plus methylation DNA controls for quality assurance, distributed globally through IVD partners.
Product overview
Self-screen offers a portfolio of molecular diagnostic assays for cervical and anal cancer screening and triage. The core offering consists of two CE-IVD validated assays: the HPV-Risk Assay (QIAscreen HPV PCR Test) for primary HPV-based cervical cancer screening targeting 15 high-risk HPV genotypes via the E7 region, and the PreCursor-M+/QIAsure Methylation Test for methylation-based triage of HPV-positive women to identify those with progressive precancerous lesions. The portfolio is extended by RUO methylation assays (PreCursor-M AnoGYN for anal cancer detection and PreCursor-M Gold with broader sample type compatibility including urine), plus a Methylated DNA Control Sample for quality assurance. The company also provides contract research services for assay development, validation, and claim extensions.
Differentiator
Problem solved
Functional benefit
Brands
- QIAsure Methylation Test: Real-time PCR-based molecular assay to distinguish women with cervical (pre)cancer by detecting cancer-like methylation profile (FAM19A4/miR124-2 markers). Distributed by QIAGEN.
- HPV-Risk Assay / QIAscreen HPV PCR Test
- PreCursor-M+
- PreCursor-M AnoGYN
- PreCursor-M Gold
- Methylated DNA Control Sample
Products and services
- HPV-Risk Assay / QIAscreen HPV PCR Test CE-IVD real-time PCR-based DNA assay for qualitative detection of 15 high-risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68) targeting the E7 region of the HPV genome. Clinically validated for primary cervical cancer screening with 97.1% sensitivity for CIN2+. Distributed globally by QIAGEN as QIAscreen HPV PCR Test.
- PreCursor-M+ / QIAsure Methylation Test CE-IVD multiplex real-time methylation-specific PCR (qMSP) assay for qualitative detection of elevated methylation levels of cervical cancer biomarkers FAM19A4 and miR124-2. Used as triage for HPV-positive women and women with ASC-US/LSIL cytology to identify those at high short-term risk for cervical precancer requiring colposcopy referral. Demonstrates 78.6% clinical sensitivity for CIN3+ with 96.9% NPV and is distributed globally by QIAGEN as QIAsure Methylation Test.
- PreCursor-M AnoGYN Methylation Assay RUO multiplex quantitative methylation-specific PCR assay for detection of promoter hypermethylation of ASCL1 and ZNF582 genes in anal specimens. Developed on RotorGeneQ, Mic, and ViiA7 cyclers with 0.81 diagnostic performance for AIN3+ detection. Intended for Research Use Only in anal cancer and precancer detection.
- PreCursor-M Gold Assay RUO multiplex real-time methylation-specific PCR assay for detection of promoter hypermethylation levels of 2 cervical cancer-associated tumor suppressor genes (different target genes from QIAsure). Validated for physician-taken cervical scrapes, self-collected cervico-vaginal specimens, and urine samples. Currently available for Research Use Only indications with potential applications in HPV-positive triage, treatment guidance, and test of cure.
- Methylated DNA Control Sample RUO quality control sample consisting of human DNA combined with a strongly methylated cell line for verifying bisulfite conversion and methylation-specific PCR (MSP) testing. Optimized for use with Self-screen methylation-specific PCR kits and compatible with other MSP kits. Cat. No. QCS17100, 10 reactions (2 tubes × 100μl each).
Quantifiable outcome
- Reduces colposcopy referral rate to 41.2% (vs 66.3% for HPV16/18/31/33/45 genotyping) in HPV-positive women with ASC-US/LSIL cytology
- +4 more outcomes
Companies that use Self-screen
Customer profileNamed customers7 records
Segments4 records
Ideal customer profiles3 records
Self-screen technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature5 records
Self-screen partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered regional, core and minor.
- BiodiagnosticoregionalDistribution partnership for HPV Risk Assay in Uruguay. Biodiagnostico is the leading distribution hub for laboratory instruments and reagents in the South Cone with operations in Argentina, Uruguay, and Paraguay, and long-standing expertise in Women's Health diagnostics.
- Gamidor DiagnosticsregionalCommercial collaboration for distribution of PreCursor-M family of methylation-specific molecular assays in Israel. Gamidor distributes the PreCursor-M+ IVD assay, PreCursor-M Gold, and PreCursor-M AnoGYN to the Israeli market, complementing their Women's Health and HPV-specific molecular test portfolio.
- Fujirebio EuropecoreCommercial partnership for distribution of PreCursor-M+ methylation assay. Fujirebio received exclusive distribution rights to market the methylation-specific molecular IVD assay for cervical cancer triage of HPV-positive women. The partnership complements Fujirebio's HPV-specific molecular test portfolio. Expanded in March 2024 to include PreCursor-M AnoGYN for anal cancer detection.
- GC biotechminorCollaboration to develop automated 'Methydect' assay for methylation testing. GC biotech brings laboratory automation expertise to robotize Self-screen's methylation procedure. Project partly funded by MIT of South Holland province, aiming to combine multiple steps into one automated workflow.
- NovosaniscoreEurostar-funded CASUS project collaboration to develop a complete cervical cancer screening solution based on first-void urine self-sampling. Combines Novosanis's Colli Pee urine collection device with Self-screen's HPV and methylation CE-IVD tests. Academic partners include University of Amsterdam and Amsterdam UMC.
- University of Amsterdam / Amsterdam UMCcoreAcademic partners in CASUS Eurostar project for urine-based cervical cancer screening. Amsterdam UMC (Vrije Universiteit Amsterdam) collaborates on development and validation of self-sampling methodologies and assay performance evaluation.
Scale indicators5 records
Recent moves7 records
Expansion highlights6 records
Self-screen competitors and assessment
Company assessmentDirect peers
- Oncgnostics: German specialty molecular diagnostics company whose lead product, GynTect, is a methylation-based PCR assay for triaging HPV-positive women to detect cervical precancer/cancer. Direct competitor to Self-screen's PreCursor-M+/QIAsure on the same triage use case, regulatory pathway (CE-IVD), and customer segment (national screening programs).
- MDxHealth: Belgium-listed (now US-headquartered) molecular diagnostics company commercializing methylation-based (epigenetic) tests - ConfirmMDx for prostate and emerging cervical cancer assays. Direct peer in epigenetic/methylation-based cancer diagnostics using qMSP technology and similar laboratory workflows.
Broad incumbents
- QIAGEN: Global leader in sample-prep and molecular diagnostics that also distributes Self-screen's HPV-Risk Assay (as QIAscreen) and QIAsure Methylation Test. Comparable in HPV molecular diagnostic category, target customers (clinical labs and national screening programs), and regulatory pathway, though QIAGEN serves a much broader portfolio beyond cervical screening.
- Fujirebio: Global IVD company with 50+ years in HPV diagnostics and exclusive distribution rights for Self-screen's PreCursor-M+ and PreCursor-M AnoGYN (Oct 2022, expanded March 2024). Head-to-head comparable on HPV molecular testing customer base, while operating as a broad infectious-disease and oncology diagnostics incumbent.
- Hologic: Major women's-health diagnostics company with the Aptima HPV assay (and ThinPrep cytology) used widely in US and global cervical screening programs. Broad incumbent competing for the same national screening program contracts with a much larger commercial infrastructure and diversified diagnostic portfolio.
- Roche Diagnostics: Operates the cobas HPV Test on the widely deployed cobas 4800/6800/8800 automated PCR platforms and dominates primary HPV screening tenders. Direct comparable in HPV molecular testing category, with incumbency advantages in platform integration and global sales coverage.
- Abbott Molecular: Markets the Alinity m HR HPV and m2000-based RealTime HR HPV tests used in cervical screening programs worldwide. Comparable in primary HPV molecular screening category and customer base, though Abbott operates across a vastly broader IVD portfolio.
- BD (Becton Dickinson): Sells the BD Onclarity HPV Assay covering extended genotyping directly relevant to triage workflows. Comparable on HPV primary screening/triage category and customer base, with BD's broad global IVD distribution reach.
- Cepheid (Danaher): Develops the GeneXpert-based Xpert HPV test for rapid, decentralized molecular HPV testing. Comparable in molecular HPV diagnostics and target customers (clinical laboratories), within a broader infectious-disease and oncology menu on the GeneXpert platform.
Emerging players
- Novosanis: Belgian developer of the Colli Pee first-void urine self-collection device and Self-screen's co-development partner in the CASUS Eurostar project (Dec 2018). Highly relevant as the upstream sample-collection enabling technology for Self-screen's urine-validated PreCursor-M Gold.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat1 record
Key risks5 records
Key highlights7 records
Customer concentration
Self-screen social profiles
Digital presenceSelf-screen compliance and trust
Trust signalCompliance1 record
Self-screen financial estimates
Financial estimateRevenue estimate
Valuation estimate
Self-screen leadership team
Management profileNumber of profiles
Profiles3 records
Self-screen funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Self-screen 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 Self-screen
What does Self-screen do?
Self-screen develops and commercializes CE-IVD validated molecular diagnostic assays for HPV-based cervical cancer screening and DNA methylation-based triage. Its portfolio includes the HPV-Risk Assay (QIAscreen HPV PCR Test) for primary detection of 15 high-risk HPV genotypes via the E7 region, and the PreCursor-M+/QIAsure Methylation Test for triage of HPV-positive women to identify progressive precancerous lesions. The company also offers RUO methylation assays for anal cancer detection and urine-based screening, plus methylation DNA controls for quality assurance, distributed globally through IVD partners.
Is Self-screen a public or private company?
Self-screen is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Self-screen founded?
Self-screen was founded in 2008. It employs 1 to 10 people.
Where is Self-screen based?
Self-screen is headquartered in Amsterdam, Netherlands, in the Europe region.
How does Self-screen make money?
Four revenue lines are on record. IVD Assay Sales are the primary driver. The others are research Use Only (RUO) Products, licensing and Distribution Royalties and contract Research Services.
Who are Self-screen's main competitors?
Direct peers on record are Oncgnostics and MDxHealth. Broad incumbents are QIAGEN, Fujirebio, Hologic, Roche Diagnostics, Abbott Molecular, BD (Becton Dickinson) and Cepheid (Danaher). Novosanis is listed as an emerging player.
Does Self-screen have an API?
No public API is recorded for Self-screen.
What industry is Self-screen in?
Self-screen's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAGADAF, Molecular & Genetic Testing (PCR/NGS/qPCR), with a secondary code of HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 541714 and its SIC code is 2835.