197
Clinical testing
Retrospective cases across four documented whole-genome cohorts.
Genomic interpretation software for European laboratories.
We build FOLKLORE for medical genetics laboratories. It processes panel, exome and genome VCFs and brings classification, phenotype, inheritance and literature evidence into one record for review by a qualified specialist.
Sofia · Bulgaria
Seed · TRL 6
Europe-first
Evaluation to date
We have tested the nuclear SNV/indel core across 197 retrospective cases.
Operational
Current status
FOLKLORE is in operational use within a laboratory workflow.
<10 min
WGS processing time
Classification and prioritisation on dedicated infrastructure.
TRL 6
Assessment scope
TRL 6 for the nuclear SNV/indel core and specialist-review workflow.
157
Locked-version cases
Processed under classifier version v3.39.1.
EU
Processing location
Genomic processing and model-assisted interpretation run on EU infrastructure.
Published Validation Studies
Folklore completed its largest fixed-version study across 100 real-world cases.
The programme now spans 197 cases across four cohorts. Cohort 4 completed 100/100 cases, produced 67.0% FULL plus CLINICAL agreement, and converted a bounded forensic defect set into a defined correction and full-cohort regression programme.
The runtime covers computational classification and prioritisation of a whole-genome VCF on Helena's dedicated infrastructure. Specialist review follows that processing stage.
The operating problem
Sequencing capacity has grown faster than interpretation capacity.
One case record
FOLKLORE stores annotation, deterministic classification, phenotype, inheritance and literature evidence in the same case record used for specialist review.
Per-case access
A laboratory can begin with its own cases, then purchase individual cases, prepaid volumes or an annual deployment.
EU-based processing
Primary genomic processing runs on European infrastructure. A qualified specialist reviews the evidence and authorises the final interpretation and report.
Customers and pricing
Initial customers are small and mid-volume genetics laboratories.
We are starting with laboratories and rare-disease teams that process approximately 50-500 inherited-disease WES or WGS cases each year. Hospital genomics units processing up to 3,000 cases are the next customer group.
Commercial path
Own-data pilot → pay per case → prepaid volume packs → annual commitment or private instance
Internal market model
European serviceable market
500-1,000 qualified EU/EEA accounts, based on internal bottom-up planning assumptions.
€4.5m–€40m
Five-year base case
50 paying accounts processing an average of 250 cases.
€1.0m
Five-year growth case
125 accounts plus a limited number of enterprise and API contracts.
~€5.1m
We calculate these ranges from account counts, expected annual case volume and net revenue per case. We will qualify and deduplicate the European laboratory list country by country.
Commercial and research relationships
Laboratory use, distribution and research agreements.
We work with CellGenetics in the current laboratory environment and with ELTA 90 through our signed Bulgarian reseller agreement. Our research memoranda cover genomic data integration, laboratory systems and academic work.
CellGenetics
Active clinical-validation relationship and operational RUO use in a real laboratory workflow.
ELTA 90
Signed exclusive reseller for the Bulgarian channel, with contracted pricing, onboarding and support roles.
Research network
Cooperation with IICT-BAS, the Bulgarian Association for Intelligent Systems and the Bulgarian Society of Robotics.
Academic collaboration
Scientific and educational cooperation with the Faculty of Biology at Sofia University.
24-month execution plan
Work planned for the next 24 months.
- A locked FOLKLORE Clinical v1 configuration with defined intended purpose and module boundaries.
- Independent evaluation at 3-5 sites in at least two EU/EEA countries.
- Two production API/LIS integrations and entry into 3-5 priority EU/EEA markets.
- 20-30 paying or contracted accounts and EUR 0.5-0.8m annualised revenue.
- A configuration ready to enter IVDR conformity assessment.
Financing plan
The current round funds validation and European deployment.
We have financed the product, European infrastructure, laboratory deployment and retrospective evidence programme without institutional investment.
We are seeking financing to expand our commercial reach across Europe and support additional laboratory deployments.
Completed foundation
Founder-financed product and evidence programme
Operational RUO platform, laboratory workflow, four evidence cohorts and initial commercial agreements.
Current financing
Validation and European deployment
Independent validation, regulated product preparation, operational hiring and European deployment.
Months 18-24
Growth financing
Intended for broader European growth after independent evidence, initial recurring revenue and progress towards conformity assessment.
Operating team
Current team and planned hires.
We currently operate with founder leadership, scientific governance and external validation support. With financing, we plan to add clinical, regulatory, engineering and commercial capacity.
Leadership
Vladimir Mitev
Founder & CEO
Vladimir leads product architecture, software engineering, infrastructure, company strategy and commercial deployment.
Scientific governance
Academician Prof. Draga Toncheva, MD, DSc
Founding Chair, Scientific & Clinical Advisory Board
Draga Toncheva provides scientific direction, clinical validation oversight and human governance across genetics, genomics and molecular biology.
Validation contributors
External evidence review
Molecular geneticists review classifier behaviour against case evidence, identify discrepancies and help refine the evidence workflow.
Daniela Maneva and Spasimir Shishinyov
Company information
Helena Bioinformatics
Our legal and operating details are listed below for investors, financing programmes and external company databases.
- Legal name
- Helena Bioinformatics EOOD
- Headquarters
- Sofia, Bulgaria
- Stage
- Seed
- Product
- FOLKLORE
- Sector
- Bioinformatics, clinical genomics, health software
- Business model
- B2B software, usage-based and volume access
- Geographic focus
- Europe, with the Balkans as the initial commercial region
- Regulatory status
- Research Use Only; not CE-marked
- EU Participant Identification Code
- 866588592
