Hidden in our DNA are early warnings.
IronOne Genomics reads them before it's too late.

An AI-powered post-sequencing interpretation platform built for hereditary cancer today configurable for every genetic disorder tomorrow. Trusted by clinical labs and hospital oncology teams worldwide.

Request Clinical Demo → See How It Works
90%+
Classification accuracy on 1,000+ real human exomes during initial validation
20×
Faster variant interpretation versus manual specialist review
1K+
Actual genomes validated during initial testing
13+
Hereditary cancer syndromes covered and verified in initial clinical testing
ACMG / AMP Guidelines — Every variant classified to international clinical standards
FDA-Approved Dataset — Concordance-tested against ClinGen reference datasets
Cloud-Native Global Deployment — Any cloud, any region, same-day
The Clinical Challenge

Oncology teams face a genomic
interpretation crisis

Sequencing costs fell 99% in 20 years. Interpretation costs did not. As genomic testing becomes standard of care, the bottleneck has shifted from sequencing to interpretation and patients are waiting.

6–8
Hours per case, manual interpretation
Once sequencing completes, manual variant interpretation by a specialist takes 6–8 hours per case accounting for 60–70% of all avoidable delay after the lab returns data. This creates a throughput ceiling no lab can hire its way out of.
Machini et al. Genet Med 2019 · ACMG Genomic Interpretation Workflow Study 2022
41%
Of reports contain unresolved VUS
In a 1.69M-individual cohort study, 41% of patients received Variants of Uncertain Significance leaving clinicians without actionable guidance and patients in diagnostic limbo. Managing and reclassifying VUS is the single greatest ongoing clinical burden.
Chen et al. JAMA Network Open 2023 (n=1,689,845)
$200
–$300 per case in labour costs alone
Human-intensive interpretation makes high-volume genomic programmes uneconomic. At scale, this creates a hard budget ceiling that limits both access and programme expansion. IronOne reduces interpretation cost by up to 80%.
Genomenon clinical lab data 2021
~80%
Of reference data is European-ancestry
gnomAD v2 was 53% European; ClinVar submissions historically exceed 78% from similar populations leaving Asian, African, and South American patients with systematically less accurate interpretations. 75% of humanity is underrepresented.
gnomAD v2.1 · Sirugo, Williams & Tishkoff, Cell 2019
The Platform

Post-sequencing AI that plugs into
your existing workflow

No rip-and-replace required. IronOne Genomics accepts VCF files the moment sequencing completes delivering ACMG-aligned interpretation in minutes, not weeks.

01
Post-Sequencing AI Layer
Accepts raw VCF files from any WES/WGS pipeline the moment sequencing completes. Secure API connection. Zero change to existing lab infrastructure or sequencing workflows.
02
ACMG/AMP-Aligned Variant Engine
Cross-references ClinVar, gnomAD, dbNSFP and HGMD simultaneously. Classifies pathogenic and likely pathogenic variants with explainable AI scoring every decision traceable, every classification auditable.
03
Intelligent Variant Prioritisation
Clinically relevant variants surfaced first. VUS flagged with resolution confidence scores. Specialist review focused only where clinical judgment genuinely matters not on variants AI can handle reliably.
04
Clinician-in-the-Loop Governance
AI surfaces and prioritises. Clinicians retain full interpretive authority and final sign-off. Every report is physician-approved. AI augments clinical judgment it never replaces it. ACMG-compliant clinical reports, ready for direct patient communication.

Performance vs. manual review

Was: 6–8 hours
Minutes
AI interpretation time (once sequencing completes)
Was: <85% variable
90–97%
Variant classification accuracy (P/LP)
Was: 4–6 weeks
2–3 weeks
Full report turnaround time (lab + interpretation)
Was: <10% reclassified/year
30–40%
VUS resolved annually with RNA + ML models
Was: $200–300/case labour
Up to 80% less
Cost reduction per case vs. manual review
Interpretation time only. DNA sequencing typically takes 10–18 days and is lab-dependent. IronOne accelerates the interpretation step the bottleneck clinicians can act on.

Sources: Machini et al. Genet Med 2019 · Meng et al. Genet Med 2023 · Chen et al. JAMA 2023 · ACMG Classification Study 2022
Clinical Workflow

From sample to signed report
your workflow, accelerated

IronOne inserts precisely at the interpretation step. Everything before and after stays exactly as your lab operates today.

🧬
STEP 01
DNA Sample & Sequencing
Standard lab process. Blood draw, library prep, WES or WGS sequencing. Typically 10–18 days. This step is unchanged by IronOne.
Lab's existing workflow
📄
STEP 02
VCF File Generated
Sequencing returns a VCF file containing millions of variants. Secure API transfers file to IronOne platform the moment sequencing completes.
Secure API handoff
🤖
STEP 03
IronOne AI Interpretation
ACMG/AMP-aligned AI classifies every variant. ClinVar, gnomAD, dbNSFP, HGMD cross-referenced simultaneously. Pathogenic variants prioritised with confidence scores.
Minutes, not days
👨‍⚕️
STEP 04
Clinician Review & Sign-off
Prioritised variant list surfaces the clinically significant findings. Specialist reviews AI output and retains final authority. ACMG-compliant report signed and issued.
Clinician authority retained
🔒
Clinician-in-the-loop by design. AI classifies and prioritises. Clinicians decide. Every report requires physician sign-off. IronOne is a decision support system final clinical authority always rests with the treating clinician.
Clinical Validation

Proven on 1,000+ real human exomes
not a prototype

IronOne Genomics has been tested and validated on actual genomic data from real patients, under the scientific leadership of one of Asia's foremost genomic medicine researchers.

Initial Clinical Validation Results

1,000+
Real human exomes processed and validated by bioinformaticians
90 - 97%
AI classification accuracy achieved on real clinical cases
13+
Hereditary cancer syndrome types validated and covered
✓ ACMG / AMP Guidelines
✓ FDA ClinGen Dataset
✓ ClinVar · gnomAD · dbNSFP
FDA-APPROVED DATASET VALIDATION

IronOne Genomics has been concordance-tested against FDA-recognised ClinGen reference datasets the gold standard for clinical genomic variant classification. This is not internal benchmarking; this is the same regulatory benchmark used by labs pursuing FDA clearance for diagnostic submissions.

Hereditary Cancer Syndromes Validated

Breast & Ovarian Cancer Lynch Syndrome Colorectal Cancer Endometrial Cancer Gastric Cancer Thyroid Cancer Eye Cancer Adrenal Cancer Renal & Urinary Tract Brain & Nervous System Liver Cancer Multiple Endocrine Neoplasia Familial Lung Cancer
SCIENTIFIC CHAIR ACADEMIC PARTNERSHIP
Prof. Vajira H.W. Dissanayake
Chair, Genetics & Biomedical Informatics, University of Colombo
Founder Chairman, Global Genomic Medicine Collaborative · Commonwealth Centre for Digital Health · Vidya Jyothi National Honour 2019 · National Bioinformatics lead for Sri Lanka's clinical genomics programme. Scientific Chair, IronOne Genomics.
Clinical Standards

Built on the world's most rigorous
clinical genomics frameworks

Every classification IronOne produces is aligned with internationally recognised standards transparent, auditable, and defensible in any clinical or regulatory context.

🏛️
ACMG / AMP Guidelines
Every variant is classified according to the American College of Medical Genetics and Genomics / Association for Molecular Pathology framework the global standard for clinical genomic variant interpretation. Five-tier classification: Pathogenic · Likely Pathogenic · VUS · Likely Benign · Benign. Used by clinical labs globally and required for regulatory submissions.
🔬
Explainable AI Full Audit Trail
Unlike black-box AI models, IronOne's classifications are fully explainable. Every classification shows the evidence used which databases were checked, which ACMG criteria were applied, and why a specific tier was assigned. Clinicians can audit every decision. Reports are traceable and defensible in clinical, regulatory, and legal contexts.
✅
FDA-Recognised ClinGen Validation
IronOne's AI classifications have been concordance-tested against FDA-recognised ClinGen (Clinical Genome Resource) reference datasets. This validation gives hospitals, labs, and institutional investors independent confirmation that IronOne performs to the clinical standard not just internal claims.
🗄️
Comprehensive Database Integration
Simultaneous cross-referencing of ClinVar, gnomAD, dbNSFP, and HGMD for every variant the databases a specialist would consult manually, done in seconds by AI. Population frequency, functional prediction, clinical significance, and published evidence all integrated in a single classification pass.
🌐
Multi-Population Genomic Data
80% of global genomic reference data is European-ancestry. IronOne is built from inception to incorporate Asian, African, and diverse global genomic data delivering accurate classifications for patient populations that existing platforms systematically underserve. Trained on real South Asian and global genomes from our clinical validation work.
⚕️
Clinician-in-the-Loop Design
IronOne is designed to enhance, not replace, clinical judgment. The platform presents prioritised, evidence-backed classifications. Final sign-off remains with the treating clinician. This governance architecture satisfies clinical governance requirements and maintains the physician's legal and ethical responsibility for every patient report issued.
Configurable Platform

Built for oncology today.
Engineered for every genetic disorder tomorrow.

The platform uses a modular AI architecture the same interpretation engine reconfigures for any genetic disease pathway. Oncology is the beachhead. The platform is universal.

Now Live
Hereditary Cancer Oncology
BRCA1/2, Lynch Syndrome, PALB2, TP53, MLH1/MSH2. Full clinical workflow live. Reports in 2–3 weeks.
Next Roadmap
Cardiac & Neurogenetic
Hypertrophic cardiomyopathy, FH, Huntington's, hereditary Alzheimer's. Same configurable AI core retraining in weeks.
Future Vision
Any Genetic Disorder · Any Gene
The platform standard powering every hospital, lab, and pharma company worldwide. One AI architecture. Infinite diseases.
● LIVE
Hereditary Cancer

Current live platform. Highest clinical urgency globally. Full ACMG-aligned AI interpretation delivered.

BRCA1BRCA2MLH1MSH2TP53PALB2
◐ NEXT
Cardiogenetic

Sudden cardiac death prevention. Fastest-growing payer priority. Familial hypercholesterolaemia, hypertrophic cardiomyopathy, inherited arrhythmias.

MYBPC3LDLRKCNQ1SCN5A
◐ NEXT
Neurogenetic

Early genetic intervention is the #1 neurology priority. Huntington's disease, hereditary Alzheimer's, Spinocerebellar Ataxia.

HTTAPOEPRKNMECP2SCN1A
○ FUTURE
Rare & Paediatric

7,000+ rare diseases. Most patients undiagnosed for 5+ years. Cystic Fibrosis, Spinal Muscular Atrophy, PKU and beyond.

SMN1FMR1CFTRHEXA
○ FUTURE
Metabolic & Endocrine

MODY monogenic diabetes, hereditary haemochromatosis. Conditions where a genetic diagnosis fundamentally changes clinical management.

GCKHNF1AHFELDLR
○ FUTURE
Immunogenetic & Pharmacogenomics

Primary immunodeficiencies, hereditary autoinflammatory syndromes, and drug response prediction. Enabling truly personalised medicine.

CYP2D6CYP2C19TPMTDPYD
Global Equity in Genomics

Built for global genomic diversity because every ancestry deserves accuracy

⚠️
The global genomics data crisis: 80% of global genomic reference databases are European-ancestry. Asian, African, and South American patients receive systematically less accurate interpretations a structural clinical equity failure baked into every platform that relies on existing databases alone.
🌏
Asian Ancestry
4.7 Billion People
BRCA2, APC South Asian founder mutations
East Asian gastric & liver cancer variants
PALB2, MLH1 variants absent from Western databases
Highest undiagnosed FH prevalence globally
🌍
African & Global South
1.5 Billion + People
African-American BRCA variant patterns differ significantly
Sub-Saharan founder mutations underrepresented
Population-specific VUS reclassification needs
Highest proportion of uncertain classifications globally
🌎
Americas & Mixed Ancestry
500 Million + People
Multi-ethnic reference panels essential
Indigenous ancestry founder mutations
Hispanic/Latino hereditary cancer patterns
Ashkenazi Jewish BRCA1/2 founder variants (1 in 40)
IRONONE'S COMMITMENT

IronOne Genomics is building globally representative genomic datasets incorporating South Asian, East Asian, African, and diverse global genomic data from inception. Clinical validation programme is the foundation of a truly population-inclusive platform.

Strategic Value

IronOne as a partnership platform
for every healthcare stakeholder

IronOne Genomics is positioned to partner with or be integrated by the world's leading genomics, pharma, and healthcare AI organisations delivering value across the entire genomic medicine ecosystem.

🏥
Hospitals & Oncology Centres
Regional Health Systems · Academic Medical Centres · Cancer Institutes
License IronOne to launch or scale genomic medicine programmes. Eliminate interpretation backlogs. Deliver faster reports to oncology patients. White-label integration available for existing lab workflows.
🔬
Genetic Testing Laboratories
Clinical Genomics Labs · Molecular Diagnostics · Reference Labs
Reduce per-case interpretation cost by up to 80%. Scale from 50–100 to 1,000+ cases per month with identical headcount. Zero infrastructure investment. Per-case SaaS pricing that scales with your volume.
💊
Pharma & Biotech
Use IronOne's AI engine for companion diagnostic development and population-level screening programmes. Access diverse global genomic datasets for drug discovery and population health research.
☁️
Cloud & AI Platforms
Integrate IronOne's genomic AI into clinical decision support and healthcare AI infrastructure offerings. Cloud-native, API-first architecture deploys to any cloud environment without hardware or local installation.
📈
Institutional Investors & VCs
Healthcare VCs · Strategic Investors · Medical Technology Funds
Seed-stage entry into a $91.3B+ market at 22.6% CAGR. First-mover configurable genomics AI platform. Two proven IPO blueprints (SOPHiA: $1.14B Nasdaq; 3billion: KOSDAQ) validate the category. IronOne is configurable from Day 1 with a larger addressable market.
🌐
Regional Health Systems
South Asia · GCC · Africa · Southeast Asia
IronOne was built from inception for global deployment. Cloud-native, no hardware, same-day deployment in any geography. Priority focus on South Asia, GCC, and African health systems the largest underserved populations in genomic medicine.

Partner in defining genomic intelligence
for 8 billion people

Whether you're a hospital oncology team, a clinical genomics lab, an institutional investor, or a pharma organisation there's a way to work with IronOne Genomics today.

Request Clinical Demo → Investor Enquiry
🏥
For Hospitals & Labs
Request a clinical demonstration and pilot discussion. See IronOne interpret real VCF data against your current workflow.
📊
For Investors
Seed round open. USD 500K via SAFE, $8M valuation cap, 20% discount, MFN included. Full investment memorandum available.
🤝
For Strategic Partners
Platform API integration, white-label deployment, and data partnership enquiries welcome. Available in South Asia, GCC, Africa, and globally.
🔬
For Research & Pharma
Companion diagnostic development, population genomics programmes, and diverse genomic dataset access. Contact our science team.