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ORIGINAL RESEARCH article
Front. Mol. Biosci.
Sec. Molecular Diagnostics and Therapeutics
Volume 12 - 2025 |
doi: 10.3389/fmolb.2025.1524594
This article is part of the Research Topic Molecular Studies and Therapeutic Approaches on BRCA-associated Cancers View all 3 articles
Homologous Recombination Deficiency (HRD) Test Validation for Patients with High-Grade Advanced Ovarian Cancer
Provisionally accepted- Oncoclinicas Group, São Paulo, Brazil
demonstrated high concordance in HRD status with reference test (Kappa 0.8, 95% CI 0.60-0.98). Overall accuracy, sensitivity and specificity were 90%. Six samples had BRCA1/2 mutations in myChoice ® HRD Plus CDx, all detected by GS Focus HRD test.In summary, the results demonstrate substantial agreement and high accuracy of NGS-based GS Focus HRD test as compared to myChoice ® HRD Plus CDx.Our in-house assay is eligible for diagnostic test approval and market access as per Brazilian regulations.
Keywords: ovarian cancer, homologous recombination deficiency (HRD), BRCA1/2, Validation, NGS
Received: 07 Nov 2024; Accepted: 07 Jan 2025.
Copyright: © 2025 Rodrigues, Souto, de Andrade, Gomes, Koide, e Silva, de Souza, Massaro, de Melo, Borges, Giro, de Andrade, da Costa, Gimenes, de Mello, de Oliveira, Lima, Lopes, Bretas, Jacob, Silva, Notaro, Alves, Moitinho, da Silva, Abramoff, Rauber, Dienstmann and Koyama. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Angelica Nogueira Rodrigues, Oncoclinicas Group, São Paulo, Brazil
Andreza Karine de Barros Almeida Souto, Oncoclinicas Group, São Paulo, Brazil
Diocésio Alves Pinto de Andrade, Oncoclinicas Group, São Paulo, Brazil
Larissa Müller Gomes, Oncoclinicas Group, São Paulo, Brazil
Sandra Satie Koide, Oncoclinicas Group, São Paulo, Brazil
Renata de Godoy e Silva, Oncoclinicas Group, São Paulo, Brazil
Bruno Batista de Souza, Oncoclinicas Group, São Paulo, Brazil
Juliana Doblas Massaro, Oncoclinicas Group, São Paulo, Brazil
Andréia Cristina de Melo, Oncoclinicas Group, São Paulo, Brazil
Andrea Morais Borges, Oncoclinicas Group, São Paulo, Brazil
Camila Giro, Oncoclinicas Group, São Paulo, Brazil
Carlos Augusto Vasconcelos de Andrade, Oncoclinicas Group, São Paulo, Brazil
Cesar Martins da Costa, Oncoclinicas Group, São Paulo, Brazil
Daniel Luiz Gimenes, Oncoclinicas Group, São Paulo, Brazil
Eduardo Caminha Bandeira de Mello, Oncoclinicas Group, São Paulo, Brazil
Fernanda Cesar de Oliveira, Oncoclinicas Group, São Paulo, Brazil
Frederico Müller de Toledo Lima, Oncoclinicas Group, São Paulo, Brazil
Gabriel Lima Lopes, Oncoclinicas Group, São Paulo, Brazil
Gustavo de Oliveira Bretas, Oncoclinicas Group, São Paulo, Brazil
Herika Lucia da Costa Silva, Oncoclinicas Group, São Paulo, Brazil
Juliana Ferrari Notaro, Oncoclinicas Group, São Paulo, Brazil
Lara Ladislau Alves, Oncoclinicas Group, São Paulo, Brazil
Marcos Veloso Moitinho, Oncoclinicas Group, São Paulo, Brazil
Mirian Cristina da Silva, Oncoclinicas Group, São Paulo, Brazil
Roberto Abramoff, Oncoclinicas Group, São Paulo, Brazil
Thais Amaral da Cunha Rauber, Oncoclinicas Group, São Paulo, Brazil
Fernanda Christtanini Koyama, Oncoclinicas Group, São Paulo, Brazil
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