Lesion Panel_RD007099
Research type
Research Study
Full title
cobas Lesion Panel Prototype(s) for use on the cobas® 5800/6800/8800 Systems: Early External Feasibility Testing Study
IRAS ID
346168
Contact name
Suchitra Suresh Kumar
Contact email
Sponsor organisation
Roche Diagnostics International AG
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This feasibility study evaluates the performance of the prototype assay(s) cobas Lesion Panel, which is a nucleic acid \namplification test (NAAT) in development.\n\nThe study aims to compare the performance of the cobas Lesion Panel Prototype test(s) with other nucleic acid \namplification tests (NAATs) using positive and negative specimens. Additionally, it will assess sample stability with the \ncobas Lesion Panel Prototype test(s).\n\nUp to 500 patients at Royal Liverpool University Hospital will be enrolled in this study. Patients need to be able and \nwilling to give written Informed Consent and present with a lesion which is eligible for enrollment as determined by \ntheir health care provider. Participating in the study takes approximately 75 minutes. Up to 3 specimens are \nprospectively collected from each patient and demographic and clinical data will be collected from each study \nparticipant to characterize the study population.\n\nThe results obtained from this study will not be used for product registration or patient care decisions\n
REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/PR/1190
Date of REC Opinion
25 Oct 2024
REC opinion
Further Information Favourable Opinion