Non-Invasive Prenatal Testing (NIPT)

Yourgene provides four complementary screening solutions to meet more of our lab customers’, clinicians’ and pregnant women’s needs across different international locations.

The IONA® Nx NIPT Workflow is a CE-marked in vitro diagnostic (IVD) for prenatal screening which enables clinical laboratories around the world to establish their own quality assured non-invasive prenatal screening service. This test is registered as a regulated IVD in many different regions. Yourgene Genomic Services use the IONA® Nx NIPT Workflow in our Manchester laboratory to offer a quality NIPT testing service.

The Yourgene Nx NIPT Workflow is a product which is available for life science or human diagnostics research. Users can validate their own Laboratory Developed Test (LDT) to measure or detect one or more analytes.

The IONA® test was the first CE-marked IVD for prenatal screening which also allows clinical laboratories to establish their own quality assured non-invasive prenatal screening service. The IONA® test is registered as a regulated IVD in many different regions.

The Sage™ Prenatal Screen is available in regions where a regulated NIPT is not required for trisomy screening. Sage™ provides highly accurate screening results for a greater clinical depth of chromosomal conditions including trisomies, sex chromosomal aneuploidies, autosomal aneuploidies and some select microdeletions

Click for further information on the IONA® Nx NIPT Workflow, Yourgene Nx NIPT Workflow, the IONA® test or the Sage™ Prenatal Screen or contact us to learn which test is right for you in your laboratory.

Our NIPT Solutions

IONA® Nx NIPT Workflow

IONA® Nx NIPT Workflow

CE-IVD Illumina NextSeq 550 Dx Sequencer

the IONA® test

the IONA® test

CE-IVD Thermo Ion Torrent Sequencer

Sage™ Prenatal Screen

Sage™ Prenatal Screen

RUO Thermo Ion Torrent Sequencer

Yourgene Nx NIPT Workflow

Yourgene Nx NIPT Workflow

LDT Customisable Workflow Illumina NextSeq 500 Dx Sequencer

Feature
IONA® Nx NIPT Workflow (CE-IVD)
Yourgene Nx NIPT Workflow (LDT)
The IONA® test (CE-IVD)
Sage™ prenatal screen (RUO)
Platform
Illumina NextSeq 550Dx
Illumina NextSeq 550Dx
Thermo Fisher Ion Torrent Systems
Thermo Fisher Ion Torrent Systems
Clinical content
Comprehensive whole-genome analysis
LDT validated whole-genome analysis*
Comprehensive whole-genome analysis
Comprehensive whole-genome analysis
Trisomy 21, 18, 13
Sex chromosomal aneuploidies (SCAs) – optional
Autosomal aneuploidies (AAs) – optional
Microdeletions – optional
x
CNVs
Coming soon
Coming soon
x
x
Fetal sex determination – optional
CE-IVD
x
Suitable for low to high throughput laboratories

24-48 plex

24-48 plex

Up to 24 plex

Up to 24 or 64 plex
Fully automated workflow with workflow manager for full sample traceability
x
NIPT service available from Yourgene Genomic Services
x
MyNIPT® sample tracking and reporting portal
x
x
Minimum fetal fraction required using proprietary dynamic method
≥2%
≥2%
≥2%
≥3.5%
Installation, complete training and technical support

*Analytical and performance characteristics are not established. Available for human diagnostics or life science research only.

If you have a question, need further information, or are interested in purchasing our products, we're here to help.