Clinical Validation: TSO Comp (DRAGEN) for detection of HER2 Variants
Research type
Research Study
Full title
Clinical Validation Study: Evaluation of TruSight™ Oncology Comprehensive (DRAGEN) in Detecting HER2 Variants in Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
327078
Contact name
Cheryl McFarlane
Contact email
Sponsor organisation
Illumina, Inc
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
In this clinical validation study, tumour tissue or extracted nucleic acid sample (DNA) derived from tumour tissue collected from commercially sourced samples and residual 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. The study is retrospective, non-interventional, and no results will be used for patient care during the study.
The research performed by Almac is limited to acting as a test site for analysis of tumour tissue and DNA samples. The data obtained will be used in the registration of the device as a Companion Diagnostic in EU and US. Subject recruitment and tissue collection are outside the scope of the study.REC name
HSC REC B
REC reference
23/NI/0057
Date of REC Opinion
15 May 2023
REC opinion
Favourable Opinion