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Quality & accreditation

Accredited. Certified. Compliant.

OnKommon testing runs in CAP-accredited, NABL-accredited and ISO-certified laboratories — and clinical and genomic data are handled to HIPAA and GDPR standards, from sample to signed report.

Accreditation & compliance

Five frameworks. One standard of care.

  • CAP-accredited

    College of American Pathologists

    Testing runs in CAP-accredited laboratories, inspected against the College of American Pathologists' checklists for molecular pathology, quality control and proficiency testing.

  • NABL-accredited

    National Accreditation Board for Testing and Calibration Laboratories

    Accredited to ISO 15189 — the international standard for quality and competence in medical laboratories.

  • ISO-certified

    International Organization for Standardization

    Certified quality management, with documented processes, internal audits and continual improvement across the workflow.

  • HIPAA-compliant

    Health Insurance Portability and Accountability Act

    Protected health information is handled under HIPAA's privacy and security safeguards, from sample to signed report.

  • GDPR-compliant

    General Data Protection Regulation

    Personal and genetic data are processed lawfully, minimally and transparently, with every right GDPR guarantees.

Layers of assurance

Quality, built in at every level

Laboratories, systems, assays and software are each held to their own standard — together, they carry every result from sample to signature.
  1. 01

    Accredited laboratories

    CAP and NABL accreditation, assessed laboratory by laboratory for a defined scope of tests.

  2. 02

    Certified systems

    ISO-certified quality management across sample handling, analysis, reporting and review.

  3. 03

    Validated assays

    Every assay is validated for accuracy, sensitivity and limits of detection before it reports a result.

  4. 04

    Governed software

    The Twin platform is versioned, tested and change-controlled — and every report is signed by the treating oncologist.

Quality practices

How every result earns its place in the report

  • 01

    Quality management

    A documented quality management system spans sample receipt to signed report, audited internally and by accreditation bodies.

  • 02

    Laboratory and assay quality

    Every run carries controls, every assay is enrolled in external proficiency testing, and each sample passes quality metrics before analysis begins.

  • 03

    Technical validation

    Analytical layers and bioinformatics pipelines are validated against reference data before release, and re-validated whenever they change.

  • 04

    Documentation and traceability

    Every report finding traces back to its input data, analysis version and evidence source.

  • 05

    Data integrity and information security

    Role-based access, audit trails and encryption protect clinical and genomic data, in line with HIPAA and GDPR.

  • 06

    Review, approval and change control

    Changes to analytical methods, evidence sources and report templates are reviewed and approved before release.

  • 07

    Corrective action and continuous improvement

    Deviations are logged, investigated and corrected, and every lesson feeds back into the workflow.

Accreditation certificates and scope documents are available to institutions on request.

Continue the journey

OnKommon

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