fbpx Yourgene Health plc - Home
Infectious Disease
Clarigene RUO
Clarigene CE-IVD
Clarigene SARS-CoV-2 CE-IVD
Clarigene™ Feature Notes
NIPT
IONA® Nx
For Clinical Laboratories
Overview
Workflow
Clinical Performance
Benefits of the IONA® Nx NIPT Workflow
Instruments
IONA® Software
Atlas Workflow Manager
MyNIPT®
Technical Support
Quality and Regulatory
Choose IONA® Nx NIPT Workflow
Post-Market Surveillance
the IONA® test
For Clinical Laboratories
Overview
Technology
CE-IVD
Clinical Performance
Results
MyNIPT®
Application Support
FAQs
Choose IONA®
Laboratory Customer Login
For Pregnant Women
For Healthcare Professionals
Overview
Background
Clinical Performance
Results
MyNIPT®
Who can have the IONA® Test
FAQs
Responsible Screening
Choose IONA®
Resources
Contact Us
Sage™ Prenatal Screen
For Clinical Laboratories
Overview
Technology
Clinical Performance
Results
Choose Sage™
Sage QS 32plex
For Pregnant Women
Advantages of the Sage™ prenatal screen
Overview
Who can have the Sage™ test
Results
For Healthcare Professionals
Overview
Background
Who can have the Sage™ test
Clinical Performance
Results
Clinical Performance
Results
Contact Us
Reproductive Health
Cystic Fibrosis
Cystic Fibrosis Analysis
Choose CF-EU2
Male Infertility
Pregnancy Loss
Rapid Aneuploidy Analysis
QST*R Range
QST*R Feature Notes
Thrombosis Risk Panel
Precision Medicine
Elucigene DPYD
DPYD Overview
DPYD Testing Workflow
Clinical Performance
Choose Elucigene DPYD
Yourgene Flex™
DNA Size Selection / Enrichment
Ranger Technology
LightBench®
Overview
Get to the DNA you care about in NIPT
Get to the DNA you care about in Liquid Biopsy
NGS QC
LightBench® Feature Notes
Yourgene® QS250
Yourgene® SP150

Technical characteristics of the IONA® test following post-market surveillance on 9,575 singleton and monochorionic twin pregnancies

 The IONA® 

Nx test

 Sensitivity

(Detection or True Positive Rate)

 False Negative Rate (FNR)

 Specificity (True Negative Rate)

False Positive Rate (FPR) 

 Positive predictive value (PPV)

(Precision)*

Negative predictive value (NPV)* 

 

 The proportion of truly affected pregnancies that screen positive.

The proportion of pregnancies that have the syndrome but have screened negative.

The proportion of truly unaffected pregnancies that screen negative. 

 The proportion of pregnancies that do not have the syndrome, but have screened positive.

The likelihood that a screened positive pregnancy is truly affected with a trisomy.

The likelihood that a screened negative pregnancy really doesn't have a trisomy.

 Trisomy 21

Down's sydnrome

(201 / 9,575)

 >99.99%

(200/200)

<0.001%

(0/200)

99.97%

(9,374/9,375)

 0.01%

(1/9,375)

99.50%

(200/201)

 >99.99%

(9,374/(9,375-201)

 Trisomy 18 

Edwards' syndrome

(61 / 9,575)

98.33%

(59/60)

1.67%

(1/60)

99.97%

(9,513/9,515)

0.02%

(2/9,515)

96.72%

(59/61)

99.99%

(9,513/9,575-61))

Trisomy 13

Patau's syndrome

(15 / 9,575)

>99.99%

(15/15)

<0.001%

(0/15)

>99.99%

(9,560, 9,560)

<0.001%

(0/9,560)

>99.99%

(15/15)

>99.99%

(9,560/(9,575-15))

 What does it mean for the pregnancy?

       

 The high IONA® PPV implies that the false positive results are minimised (unaffected fetus tested positive); meaning less unnecessary diagnostic procedures are required.

 The high IONA® NPV implies that the false negative results are minimised (affected fetus tested negative), meaning fewer syndromes are being missed. 


Observed performances are based on Post-Market Surveillance of the IONA® Nx test in over 9,575 singleton and monochorionic twin pregnancies, from a population of women who are predominantly at a higher risk of having a fetus with Down's syndrome. 

Performances are dependant of laboratories fully reporting discordant results to Yourgene Health Plc. From Data held on file by Yourgene Health. Correct as of 11th June 2021.

Click here for IONA® Nx Clinical Validation data.