TY - JOUR AU - Willing, Eva-Maria AU - Vollbrecht, Claudia AU - Vössing, Christine AU - Weist, Peggy AU - Schallenberg, Simon AU - Herbst, Johanna M AU - Schatz, Stefanie AU - Jóri, Balázs AU - Bataillon, Guillaume AU - Harter, Philipp AU - Salutari, Vanda AU - Martin, Antonio Gonzáles AU - Vergote, Ignace AU - Colombo, Nicoletta AU - Roeper, Julia AU - Berg, Tobias AU - Berger, Regina AU - Kah, Bettina AU - Noettrup, Trine Jakobi AU - Falk, Markus AU - Arndt, Kathrin AU - Polten, Andreas AU - Ray-Coquard, Isabelle AU - Selzam, Franziska AU - Pirngruber, Judith AU - Schmidt, Stefanie AU - Hummel, Michael AU - Tiemann, Markus AU - Horst, David AU - Sehouli, Jalid AU - Pujade-Lauraine, Eric AU - Tiemann, Katharina AU - Braicu, Elena Ioana AU - Heukamp, Lukas C TI - Development of the NOGGO GIS v1 Assay, a Comprehensive Hybrid-Capture-Based NGS Assay for Therapeutic Stratification of Homologous Repair Deficiency Driven Tumors and Clinical Validation. JO - Cancers VL - 15 IS - 13 SN - 2072-6694 CY - Basel PB - MDPI M1 - DKFZ-2023-01442 SP - 3445 PY - 2023 AB - The worldwide approval of the combination maintenance therapy of olaparib and bevacizumab in advanced high-grade serous ovarian cancer requires complex molecular diagnostic assays that are sufficiently robust for the routine detection of driver mutations in homologous recombination repair (HRR) genes and genomic instability (GI), employing formalin-fixed (FFPE) paraffin-embedded tumor samples without matched normal tissue. We therefore established a DNA-based hybrid capture NGS assay and an associated bioinformatic pipeline that fulfils our institution's specific needs. The assay´s target regions cover the full exonic territory of relevant cancer-related genes and HRR genes and more than 20,000 evenly distributed single nucleotide polymorphism (SNP) loci to allow for the detection of genome-wide allele specific copy number alterations (CNA). To determine GI status, we implemented an KW - BRCA1 (Other) KW - BRCA2 (Other) KW - DNA repair (Other) KW - HRD (Other) KW - HRR (Other) KW - LOH (Other) KW - OS (Other) KW - PAOLA-1 (Other) KW - PARP inhibition (Other) KW - PARPi (Other) KW - PFS (Other) KW - breast cancer (Other) KW - diagnostics (Other) KW - genomic instability (Other) KW - homologous repair deficiency (Other) KW - molecular pathology (Other) KW - ovarian cancer (Other) KW - somatic mutation (Other) LB - PUB:(DE-HGF)16 C6 - pmid:37444554 C2 - pmc:PMC10341077 DO - DOI:10.3390/cancers15133445 UR - https://inrepo02.dkfz.de/record/277725 ER -