Governance — Accountability, safety & data.
The founding principle
Software informs. Humans decide.
OnKommon's governance rests on one rule: our technology may analyse, match, and model, but it never diagnoses, prescribes, or has the final word. Every clinically consequential decision is authored and signed by a licensed clinician. This principle shapes how we build, validate, and deploy everything.
Clinical Accountability
Clinical authority sits with KPCIRC's molecular tumour board — licensed clinicians who review and sign every report, who can be consulted directly, and who provide second opinions and genetic counselling. There is always a named, accountable human behind an OnKommon decision.
Regulatory Posture
OnKommon operates as a provider of decision-support and diagnostic-adjacent services. The molecular assays are performed to accredited laboratory standards, and OnKommon's registration of its genomic tests as in-vitro diagnostic (IVD) medical devices with the Central Drugs Standard Control Organisation (CDSCO) is in progress (IVD class pending). The interpretation engine is developed and provided for research and decision-support use (not autonomous diagnosis), in line with software-as-a-medical-device and clinical-AI good practice. We do not overstate regulatory status — where something is investigational or research-stage, we say so.
Data Protection
- Consent-first — testing and any research use require explicit, informed consent.
- DPDPA 2023 — personal and health data are handled under India's Digital Personal Data Protection Act.
- Security — encryption, access control, and audit trails throughout.
- Purpose limitation — data is used for your care, and for research only with separate consent.
Quality
Sequencing and variant calling are performed by an accredited laboratory partner — CAP-accredited (College of American Pathologists) and ISO 15189 — following international guidelines (ACMG/AMP/ASCO/CAP) and using a CE-IVD certified variant database. Interpretation runs against a versioned knowledge base, so every report is reproducible and states the exact version that produced it. Methods, per-gene coverage, tumour fraction and limitations are disclosed in every report.
Clear about what we can and cannot do.
Liquid-Biopsy Sensitivity
A "not detected" result depends on tumour-DNA shedding and cannot rule out disease.
Variants of Uncertain Significance
Not every finding has a clear meaning yet; we say when evidence is emerging.
Sampling
Tissue reflects the sampled region; tumours can be heterogeneous.
Not an Emergency Service
In an emergency, contact your nearest hospital.
Quality
Sequencing and variant calling are performed by an accredited laboratory partner — CAP-accredited (College of American Pathologists) and ISO 15189 — following international guidelines (ACMG/AMP/ASCO/CAP) and using a CE-IVD certified variant database. Interpretation runs against a versioned knowledge base, so every report is reproducible and states the exact version that produced it. Methods, per-gene coverage, tumour fraction and limitations are disclosed in every report.
Questions? For data, consent, or governance questions, contact our governance desk.
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