Non-Invasive Prenatal Testing (NIPT)
FisherDX provides two complementary screening solutions to meet more of our lab customers’, clinicians’ and pregnant women’s needs across different international locations.
The IONA® test is the first CE marked in vitro diagnostic (IVD) for prenatal screening which allows clinical laboratories around the world 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 IONA® test is available as a service from FisherDX accredited laboratories.
The Sage™ prenatal screen is available in additional 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.
| Features | The IONA test® (CE-IVD) | Sage ™ prenatal screen |
|---|---|---|
| Clinical content: | ||
| • Trisomy 21,18,13 | ✓ | ✓ |
| • Sex chromosomal aneuploidies | ✓ | |
| • Autosomal aneuploidies | ✓ | |
| • Microdeletions | ✓ | |
| • Fetal sex determination-optional | ✓ | ✓ |
| CE-IVD | ✓ | |
| Fully automated workflow | ✓ | |
| NIPT service available from accredited laboratory services | ✓ | ✓ |
| MyNIPT® sample tracking & reporting portal | ✓ | |
| Suitable for low to high throughput labs | ✓ | |
| Minimum fetal fraction required | ≥2% | ≥3.5% |
| Technical support and lab installation | ✓✓✓ | ✓ |