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Infectious Disease
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NIPT
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Yourgene Flex™
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Clinical Performance

Test performance observed following validation metrics for singleton and twin pregnancies

IONA® Nx validation studya
 SensitivitySpecificity
Trisomy 21

>99.99%
(46/46)
95% CI: 92.3 - 100%

>99.99% 
(426/426)
95% CI: 99.1 – 100%
Trisomy 18

>99.99%
(20/20)
95% CI: 83.2 – 100%

>99.99%
(452/452)
95% CI: 99.2 – 100%
Trisomy 13

>99.99%
(10/10)
95% CI: 69.2 – 100%

>99.99%
(462/462)
95% CI: 99.2 – 100%

a The Validation performance has been demonstrated by evaluating 472 clinical samples from singleton and twin pregnancy and comparing to a reference result of an amniocentesis or chorionic villus sampling (CVS) sample or a birth outcome.

This has been demonstrated using the IONA® Nx cfDNA Library Preparation DX kit and the IONA® analysis software version 2.0.2. Data held on file by Yourgene Health Plc.