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 ✓✓✓