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Arina Hayat Danesh presents the IONA® test, the advanced NIPT solution for clinical laboratories in Iran since 2015

There are six provinces which already offer the full protocol around the Country and we are hoping to expand this rate soon 
The IONA® test is the first complete CE-IVD product for labs wishing to offer their own in-house non-invasive prenatal testing (NIPT) service 
The IONA® test is an advanced prenatal screening test which is offered to pregnant women to estimate the risk that their fetus may be affected with

  • Trisomy 21 (Down’s syndrome)

  • Trisomy 18 (Edwards’ syndrome)

  • Trisomy 13 (Patau’s syndrome)

  • Fetal sex determination optional

The analysis is performed on cell-free placental DNA from a maternal blood sample, with test results available with a turnaround time of just 3 days. By offering this service locally, laboratories can broaden their offering and provide pregnant women fast, reliable results that reduce the need for invasive tests and the associated stress and anxiety.

Key Features of the IONA® test

Excellent Support

  • CE-IVD: no tech transfer required, no hidden costs

  • World class technical support including CPD accredited workflow training

  • Verified and validated - so you don’t have to

  • Backup service laboratory

Robust and Reliable

  • >99% detection and <1% false positive rate

  • Highly scalable workflow to match your demands

  • Low re-draw rate <0.5%

  • Measures fetal fraction, requiring ≥2%

Fast and Easy to Use

  • Three days turnaround time

  • IONA® Software for analysis - trusted and reliable reporting

  • Premaitha Workflow Manager for complete paper-free sample tracking

Technology

The IONA® test directly measures the change in the proportion of chromosome 21, 18 and 13 in maternal plasma samples using a whole genome, shotgun sequencing approach. This is achieved in just 3 days using the highly automated and validated IONA® test workflow to give the highest quality results with the lowest amount of hands-on time (HOT) possible. All steps from DNA extraction through to analysis are included, eliminating the need for lengthy validation and optimisation processes

The IONA® Software for analysis

Yourgene Health has developed its own custom, dedicated bioinformatics analysis software as part of the IONA® test clinical workflow. The IONA® software employs highly efficient, multi-core analysis algorithms. It analyses the relative amount of chromosomes 21, 18 and 13 to calculate a risk score for the presence of a trisomy. This result is then further detailed by automatically combining it with the age-related risk of the mother at the time of sampling to calculate an adjusted probability of the fetus being affected. A results report is generated individually for each patient. The IONA® Software allows secure local data analysis, it is not cloud-based and no bioinformatics personnel are required: installation and CPD accredited training are provided by Yourgene Health

Flexible and scalable IONA® workflow

The IONA® test has been validated on a highly flexible and scalable workflow, suitable for low to high volume sample throughput, enabling clinical laboratories to meet and grow with their rising demands. It is available as both an automated and manual workflow. Every IONA® test system comes with the fully validated and robust IONA® software for easy and automated results analysis

Quality control and Fetal Fraction

The IONA® test has been optimised to deliver the most accurate results while simultaneously keeping the number of sample failures due to low fetal fraction at a minimum. This is achieved by using a unique approach of two fetal fraction evaluations. All samples must have at least ≥2% fetal fraction. In addition, all samples at risk of a false negative or false positive result are evaluated using our proprietary dynamic fetal fraction assessment. This adapts the level of required fetal fraction for the sample to the quality of the sequencing data. Unlike other NIPT methods, the IONA® test has a very low re-draw rate of <0.5%

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