The IONA® test, from UK based Premaitha Health, is a non-invasive prenatal test (NIPT) for pregnant women which estimates the risk of a fetus having Down’s syndrome (Trisomy 21), Edwards’ syndrome (Trisomy 18) and Patau’s syndrome (Trisomy 13). The IONA® test is an advanced screening test that is carried out on a small maternal blood sample and women can expect the results within 3-5 working days of sample receipt. This ensures that pregnant women, their families and their doctors receive results in the shortest timeframe possible in order to reduce the associated anxiety and stress. The IONA® test is greater than 99% accurate at detecting trisomy conditions, which means fewer pregnant women will undergo unnecessary invasive follow up procedures.
The IONA test is a screening test. Results should be discussed in detail with your healthcare provider and high risk results should be confirmed by a follow up invasive test.
The IONA® test is a regulated CE marked product which ensures a quality assured, reliable and robust test that gives accurate results. The test is performed in Premaitha’s clinical laboratory based in Manchester, UK which is accredited by the Care Quality Commission (CQC).
Premaitha Health is a UK molecular diagnostics company based in Manchester. Premaitha’s mission is to develop diagnostic products that will have a positive impact on human health.
|Laboratory Location||UK: Manchester|
|Type of cfDNA analysis||Next Generation Sequencing|
|Screen Population||GENERAL & HIGH RISK|
|Number of tests performed||~2800 (similar technology has been used on >400,000)|
|Clinical data number re test performance||1195|
|About the test|
|Gestational age||10+ weeks|
|Risk analysis||All give individualized risk score plus high / low result for each patient|
|Fetal fraction redraw level||<1.2%|
|Fetal fraction quoted||Included within the analysis, but number not reported|
|Redraw rate||<0.1% (excluding FF redraw)|
|Chance of result after 2nd blood sample||99%|
|Chromosomes analysis||Current Validated Detection Rates 01/11/2015|
|Combined false positive rate T12/T18/T13||<0.1%|
|T21 Down’s syndrome||>99%|
|T18 Edwards’ syndrome||>99%|
|T13 Patau’s syndrome||>99%|
|Fetal sex / presence of Y chromosome: accuracy||Yes: 97% Singleton Only|
|Sex Aneuploid Conditions||Y aneuploidy (n/a)|
|X0 (Turner syndrome)||NO|
|XXX (Triple X)||NO|
|XYY (Jacob’s syndrome)||NO|
|XXY (Klinefelter syndrome)||NO|
|Micro deletions (Optional)||NO|
|Turnaround Time (TAT) working days||3 to 5|