• 17 Non-Clinical Studies

    Analytical verifications

  • 6 Comparator Studies

    Verification using comparator assay (Sanger sequencing to NextGen sequencing and large rearrangement to microarray)

  • Variant Classification Validation

  • Clinical Bridging Study

    Verification of clinical study results in the QSR laboratory

  • Two extraction Studies

    Assessment of extraction methods used for clinical study samples

  • Process Validation Study

    Validation of manufacturing process

  • Equipment Qualifications

    Qualification of all QSR laboratory equipment

  • Software Validations

    Validation of software subsystems

  • Facilities Validation

    Validation of QSR laboratory facility

  • Clinical Validation Studies

    Assessment of the safety and effectiveness of Lynparza™ (conducted by AstraZeneca) and the BRACAnalysis CDx™ test