Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for PARPi Access in Australia

In this multi-laboratory validation study of 145 ovarian cancer samples, the SOPHiA DDM HRD Solution was compared with the regulatory-approved Myriad myChoice HRD assay to assess clinical comparability for Class 3 in-house in vitro diagnostic medical devices (IVD) companion diagnostic use. BRCA1/2 mutation status showed 100% concordance, and genomic instability (GI) measurements demonstrated strong linear agreement, absence of bias, and high analytical precision. Receiver operating characteristic analysis suggested a threshold adjustment from 0 to -1.5, improving overall accuracy to 91.2% when combined with BRCA mutation status to assign HRD status.