Performance Evaluation of non-CE marked IVD - QIAGEN FGFR Kit
Research type
Research Study
Full title
A non-interventional, retrospective study, for testing of RNA extracted from Formalin-Fixed Paraffin Embedded (FFPE) tissue samples, derived from banked urothelial cancer patient biopsy specimens, using the QIAGEN therascreen FGFR RGQ RT-PCR Kit, and comparing it to the Janssen FGFRi Clinical Trial Assay results and a validated reference method.
IRAS ID
213690
Contact name
Adrian Moody
Contact email
Sponsor organisation
QIAGEN
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A new, in vitro diagnostic (IVD) assay has been developed by QIAGEN for the detection of FGFR gene alterations (QIAGEN FGFR kit). This new assay claims to be more sensitive than other assays used for detection of FGFR alterations in RNA extracted from human tissue. The assay is designed to be used in conjunction with clinical information and other laboratory results for prediction of response to a novel bladder treatment, and to aid clinicians in treatment decisions. \n\nQIAGEN have designed studies to evaluate the analytical and clinical performance of the IVD for CE marking, using clinical samples previously obtained from patients with bladder cancer during a Phase II clinical trial sponsored by Pharma Company Janssen. \n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0005
Date of REC Opinion
15 Jan 2018
REC opinion
Favourable Opinion