Abstract 515P
Background
Implementing HRD testing in limited setting areas such as Vietnam presents unique challenges but is crucial for improving cancer care and outcomes. Here we describe the first establishment of centralized laboratory for HRD testing in Vietnam, observed test results upon completion of local laboratory during 2021 - 2023, and some key lessons learnt.
Methods
We set up in-house workflow for HRD testing by analyzed a small set of samples (n=24) using the CE-IVD AmoyDx HRD Focus Panel. Verification was performed following ACCE framework. Collaboration with local hospitals ensured continuous training for laboratory and medical personel in HRD techniques, data interpretation, quality control, and practical issues. EMQN scheme was conducted yearly for external quality assessment. Data including routine test results, test failure incidents and additional observation related to test process were documented and evaluated to adherence according centralized laboratory regulations. The first batch of data obtained in the period of 2021-2023 was analyzed and described.
Results
Verification process showed that the laboratory process delivers reliability consistent with manufacturer’s specifications. The laboratory passed all registered EMQN schemes. A total of 289 samples of High grade serous ovarian cancer patients were tested for HRD status. Up to 174 samples (60%) showed defects in the HRR pathways. 42 HRD positive patients (24%) were detected with (likely) pathogenic BRCA variant. Variants BRCA1 c.5314C>T, BRCA1 c.2566T>C, and BRCA2 c.8187G>T were observed more frequently in this Vietnamese patient group. Fail rate due to sample and sequencing QC metrics was 15% and occurred less frequently after hospital collaboration was enhanced.
Conclusions
The establishment of a centralized HRD testing laboratory in Vinmec hospital marks a significant step forward in Vietnam healthcare landscape. Observed test results indicated a substantial prevalence of HRD. The initiative underscores the importance of personalized medicine for Vietnam. The key lessons learned emphasizes the need for local expertise, quality control, patient education, collaboration, and contextual adaptation to ensure the success and sustainability of such advanced diagnostic facilities.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Vinmec HiTech Center, Vinmec Healthcare System.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.