Validation of flow cytometry panels for cancers
Research type
Research Study
Full title
Validation of flow cytometry panels for cancers
IRAS ID
344912
Contact name
Anastasia Maslova
Contact email
Sponsor organisation
Cytocell Ltd
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
The aim of this study is to develop and validate assays designed for phenotyping of immunologically relevant cell populations. Such information put in a clinical context can help to better understand host defence and immune evasion strategies.
Such assays might function as a tool for disease prognosis or indicator of relapse risk.
The methods used for this study include the staining of cell surface and intracellular proteins for cell lineage analysis by flow cytometry. Thus, fluorescently labelled antibodies are used to target the respective delineating cell markers and to identify the populations of interest by respective combinations of these fluorescent labels.
Our assays used to analyse clinical samples are being validated and this is one of the main uses of the herein requested samples.
As a commercial developer of medical diagnostics, we validate our assays to meet internal and external standards and we follow the CLSI guidelines. Our diagnostic products all undergo regulatory approval in the appropriate region (Japan – PMDA, USA – FDA, Europe – EMA, UK – MHRA) and the assay technical performance and validation is an important part of these submissions.REC name
London - Stanmore Research Ethics Committee
REC reference
24/LO/0572
Date of REC Opinion
24 Jul 2024
REC opinion
Unfavourable Opinion