Compliance

Regulatory posture

Omnigenetica’s service is designed to align with the regulatory expectations applicable to clinical-genomic decision-support services delivered to healthcare facilities in the European Union.

Reports are decision-support

Omnigenetica reports are intended to support, not replace, clinical decision-making by qualified healthcare professionals. Treatment decisions remain the responsibility of the attending clinician.

Variant classification

Variants are classified following ACMG (American College of Medical Genetics and Genomics) guidance, where applicable, with rationale and supporting evidence linked to each finding.

Quality controls

Sequencing and analysis pipelines operate under defined quality-control protocols at the processing laboratory, with internal validation against established benchmarking datasets.