FAST Study 1 (Fluidic Automated Screening for Trisomy Study 1)
Research type
Research Study
Full title
FAST Study 1 (Fluidic Automated Screening for Trisomy Study 1)
IRAS ID
239257
Contact name
Pranav Pandya
Contact email
Sponsor organisation
BioCeryx, Inc
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
An estimated 6.4 million pregnancies occur in the United States (US) annually, resulting in 4.1 million live births. Current professional clinical guidelines recommend that all pregnant women be offered screening for aneuploidies before 20 weeks of gestation, regardless of maternal age.
Many studies have now demonstrated the ability to use cell-free DNA (cfDNA) in maternal circulation for highly accurate fetal aneuploidy detection using advanced gene sequencing technology. Clinical adoption of these technologies, primarily to provide a high accuracy non-invasive screening method for common trisomy of chromosomes 21, 18 and 13, are now used worldwide as an alternate to less accurate screening methods which measure maternal serum protein markers. A significant barrier to the widespread adoption of Non-invasive prenatal testing (NIPT), or cfDNA aneuploidy screening worldwide, particularly among women who are not considered at high-risk for aneuploidy, is cost. Improvements in technologies that would enable cost reductions and reduced complexity could effectively make NIPT available to more women.
The aim of this prospective, blinded, multi-center cohort study is to develop a low-cost, automated platform on which to analyse cfDNA for prenatal aneuploidy screening. Up to 2,000 singleton or twin pregnancies with a fetus that has a chromosomal abnormality confirmed by genetic testing, or those planning to have amniocentesis and/or chorionic villi sampling (invasive testing) for the evaluation of a suspected fetal chromosomal abnormality will be recruited. Blood samples taken from consenting participants from 10 weeks gestation will be studied by BioCeryx Inc.
A cost-effective cfDNA testing system developed by BioCeryx will enable worldwide distribution to places that currently do not have sufficient expertise to run current testing technology. The realisation of this effort will make highly accurate prenatal screening available to millions of women who choose screening but who currently do not have access to best in class cfDNA screening technology.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0077
Date of REC Opinion
12 Mar 2018
REC opinion
Favourable Opinion