Pranav Dorwal, Liyan Song, Priscillia Siswara, Amit Kumar, Julie Robin, Noel Djitro, Anna Fong Na Goh, Ravikiran Vedururu, Bin Yuan, Ashleigh Levine, Suzanne Svobodova, Beena Kumar
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Poly ADP-ribose polymerase inhibitors, olaparib and niraparib, have been approved in Australia for advanced (FIGO III-IV), high-grade serous or other high-grade ovarian, fallopian tube or primary peritoneal carcinoma with homologous recombination deficiency (HRD).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>HRDsig (Roche Inc) is a new HRD biomarker that is part of the AVENIO Tumor Tissue CGP Kit V2. We have studied the performance of HRDsig against two NATA (National Association of Testing Authorities, Australia) accredited HRD assays in the cases of high-grade ovarian carcinomas. We have evaluated the performance of HRDsig using a total 40 HRD results against the two accredited HRD assays, as well as against commercial controls and inter-laboratory comparison samples.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>HRDsig has demonstrated a high concordance rate for HRD by comparing it with two different locally accredited HRD assays in cases of ovarian cancers.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>These findings provide real-world evidence of the performance of a new HRD assay (HRDsig) in ovarian carcinomas.</p>\n </section>\n </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"39 17","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.70085","citationCount":"0","resultStr":"{\"title\":\"Performance Evaluation of a New HRD Assay (HRDsig) in Ovarian Carcinomas in Australia\",\"authors\":\"Pranav Dorwal, Liyan Song, Priscillia Siswara, Amit Kumar, Julie Robin, Noel Djitro, Anna Fong Na Goh, Ravikiran Vedururu, Bin Yuan, Ashleigh Levine, Suzanne Svobodova, Beena Kumar\",\"doi\":\"10.1002/jcla.70085\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Homologous recombination repair (HRR) is the preferred pathway for repairing double-strand DNA breaks, using proteins like BRCA1 and BRCA2, among others, while the PARP-mediated repair pathway is primarily used for single-strand breaks. 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Performance Evaluation of a New HRD Assay (HRDsig) in Ovarian Carcinomas in Australia
Background
Homologous recombination repair (HRR) is the preferred pathway for repairing double-strand DNA breaks, using proteins like BRCA1 and BRCA2, among others, while the PARP-mediated repair pathway is primarily used for single-strand breaks. When a tumour becomes HRR-deficient (HRD), then those tumour cells become reliant on PARP-mediated repair. Poly ADP-ribose polymerase inhibitors, olaparib and niraparib, have been approved in Australia for advanced (FIGO III-IV), high-grade serous or other high-grade ovarian, fallopian tube or primary peritoneal carcinoma with homologous recombination deficiency (HRD).
Methods
HRDsig (Roche Inc) is a new HRD biomarker that is part of the AVENIO Tumor Tissue CGP Kit V2. We have studied the performance of HRDsig against two NATA (National Association of Testing Authorities, Australia) accredited HRD assays in the cases of high-grade ovarian carcinomas. We have evaluated the performance of HRDsig using a total 40 HRD results against the two accredited HRD assays, as well as against commercial controls and inter-laboratory comparison samples.
Results
HRDsig has demonstrated a high concordance rate for HRD by comparing it with two different locally accredited HRD assays in cases of ovarian cancers.
Conclusion
These findings provide real-world evidence of the performance of a new HRD assay (HRDsig) in ovarian carcinomas.
期刊介绍：
Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.
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