Governance

Clinical accountability and regulatory posture

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.

The molecular assays are performed to accredited laboratory standards. Our registration of the genomic tests as IVD medical devices with CDSCO is in progress, with the class pending. The interpretation engine is provided for research and decision-support use, not autonomous diagnosis. We do not overstate regulatory status. Where something is investigational, we say so.

Limits we are transparent about

• 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, and we say when evidence is emerging.
• Sampling. Tissue reflects the sampled region, and tumours can be heterogeneous.
• Not an emergency service. In an emergency, contact your nearest hospital.

Quality

Sequencing and variant calling are performed by a NABL/ISO 15189, CAP and CLIA accredited laboratory partner following ACMG/AMP/ASCO/CAP guidelines and 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.