Bridging Study for AmoyDx® BRCA Plus Panel
Research type
Research Study
Full title
Bridging Study for AmoyDx® BRCA Plus Panel
IRAS ID
338364
Contact name
Cheryl McFarlane
Contact email
Sponsor organisation
Amoy Diagnostics Co., Ltd.
Research summary
In this study blood samples collected as part of the OlympiA clinical trial (D081CC00006), will be extracted, and deoxyribonucleic acid (DNA) analysed at Almac Diagnostic Services laboratory in Craigavon, United Kingdom using an investigational in vitro diagnostic (IVD) device and results will be compared with historical reference results.
This study is being undertaken to generate clinical performance data for companion diagnostic (CDx) development 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 application for CE certification of the device as a CDx.
Clinical performance will be evaluated using clinical efficacy analysis, primarily IDFS endpoint analysis, for the OlympiA study subpopulation defined as Amoy gBRCAm.
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 the investigational device, test result generation, data storage and transfer, and Research ethical committee approval submission (REC).REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0156
Date of REC Opinion
22 Feb 2024
REC opinion
Favourable Opinion