Bridging Study for AmoyDx® HRD Complete Panel
Research type
Research Study
Full title
Bridging Study for AmoyDx® HRD Complete Panel
IRAS ID
320175
Contact name
Cheryl McFarlane
Contact email
Sponsor organisation
Amoy Diagnostics Co., Ltd.
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Research Summary
In this study, leftover tumour tissue and deoxyribonucleic acid (DNA) samples collected as part of a clinical trial, will be analysed at Almac Diagnostic Services laboratory in Craigavon, United Kingdom using an investigational in vitro diagnostic (IVD) device and results will be compared to other diagnostic tests (reference results).
This study is being undertaken to establish the clinical effectiveness of the IVD as a diagnostic test in accordance with the EU IVD Regulation 2017/746,and, to provide data to demonstrate the product is safe and effective for its intended use.The data obtained will be used in the registration of the device as a Companion Diagnostic in EU, China and Japan.
The research performed by Almac is limited to acting as a study site responsible for conducting the study including sample receiving, processing and storage, DNA extraction, testing using HRD complete panel, test result generation, data storage and transfer and Research ethical committee approval submission (REC). Subject recruitment and tissue collection are outside the scope of the study.Summary of results
In this study, leftover tumor tissue and deoxyribonucleic acid (DNA) samples collected as part of a previous clinical trial were analyzed using an in vitro diagnostic (IVD) device and results compared to other diagnostic tests (reference results). The research performed was limited to acting as a study site responsible for conducting the study, including sample receipt, processing and storage prior to DNA extraction, testing using IVD device, test result generation, data storage and transfer. Subject recruitment and tissue collection were outside the scope of the study. The data obtained is intended to be used in the registration of the device as a Companion Diagnostic in the EU, China and Japan. In total, 576 samples were processed. Of these, 401 failed Quality Control (QC), leaving 175 samples reported.
REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0212
Date of REC Opinion
15 Mar 2023
REC opinion
Favourable Opinion