QST*R Sample Stability Study
Research type
Research Study
Full title
Pre Clinical Sample Stability testing of the QST*R Product range
IRAS ID
340889
Contact name
Joanne Mason
Contact email
Sponsor organisation
Yourgene Health
Duration of Study in the UK
0 years, 1 months, 3 days
Research summary
During routine pregnancy screening, many women undergo diagnostic procedures to diagnose fetal chromosomal abnormalities. This requires an Amniocentesis or chorionic villus sampling traditionally undertaken using standard cytogenetic techniques. These techniques, involving tissue culture and microscopic analysis, can take up to 14 days to provide a diagnosis. In particular, fluorescent in situ Hybridisation (FISH) using interphase cells is expensive, time consuming and unsuitable for high throughput use.
Yourgene’s range of QST*R kits take advantage of the QF-PCR (Quantitative Fluorescence-Polymerase Chain Reaction) technique to detect the most common chromosomal abnormalities in a fraction of the time. Using PCR amplification, fluorescent dye labelled primers target highly polymorphic regions of DNA sequence, short tandem repeats (STRs), located on the chromosomes of interest.
The QST*R product range is currently cleared for in-vitro diagnostic (IVD) use by a number of regulatory authorities. However, it is now necessary for additional pre clinical sample stability studies to be carried out to provide additional data in order to maintain access to key markets as well as allowing submissions to be made to new territories. These additional studies will help demonstrate the performance and utility of the sample type used in Yourgene QST*R products when used as directed in the product Instructions for Use and so will provide supporting information for future regulatory submissions of this product and so enable access to new and existing markets.We have identified the necessary samples required for this project, however, the work required falls outside of the current patient consent and therefore requires ethics committee approval.
REC name
London - Bromley Research Ethics Committee
REC reference
24/PR/1346
Date of REC Opinion
19 Dec 2024
REC opinion
Further Information Favourable Opinion