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.
| 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 | ||||
| CNVs | Coming soon | Coming soon | ||
| Fetal sex determination – optional | ||||
| CE-IVD | ||||
| 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 | ||||
| NIPT service available from Yourgene Genomic Services | ||||
| MyNIPT® sample tracking and reporting portal | ||||
| 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 or would like to learn more about our products and services, we're here to help.