The IONA® Test for Pregnant Women: Non-Invasive Prenatal Testing

10+ weeks

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.

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Click here to visit: IONA® test for Patients

TEST IONA®
Company website http://www.premaitha.com
COMPANY Premaitha Health
Test Origin UK
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
Pregnancies Screened
Singletons
Naturally conceived YES
IVF (Self) YES
IVF (Donor)  YES
Multiples (Twins)
Naturally conceived YES
IVF (Self) YES
IVF (Donor) YES
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%
Triploidy N/A
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