Performance Evaluation of the BRAF V600E IVD
Research type
Research Study
Full title
A non-interventional, retrospective study, for testing of DNA extracted from Formalin-Fixed Paraffin Embedded (FFPE) tissue samples, derived from banked colorectal and metastatic colorectal cancer (CRC and mCRC) patient specimens using the QIAGEN therascreen BRAF V600E RGQ PCR Kit. The testing results will be used to determine analytical performance characteristics.
IRAS ID
264740
Contact name
Jonathan Perkins
Contact email
Sponsor organisation
QIAGEN
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
A new, in vitro diagnostic (IVD) assay has been developed by QIAGEN for the detection of the BRAF V600E mutation (QIAGEN BRAF V600E kit). The assay is designed to be used together with clinical information and other laboratory results for prediction of response to a novel combined targeted therapy, and to aid clinicians in patient management treatment decisions.
QIAGEN will conduct laboratory studies to measure the analytical performance of the IVD for regulatory (PMA & CE) marking, using clinical samples previously obtained from patients with colorectal cancer during a Phase III clinical trial sponsored by the Pharmaceutical Company Array Biopharma.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0148
Date of REC Opinion
8 Jul 2019
REC opinion
Further Information Favourable Opinion