Because of my advanced age, I was
not allowed to do an Amnio, so I had
the choice either to proceed with an
NT Scan or go with this test.
So I chose iGene®.

- Susan

What is iGene®


iGene® is a safe and highly accurate prenatal test that analyses the cell-free DNA present in your blood. This DNA comes from the placenta and circulates freely in the maternal bloodstream. Unlike some other tests that also require the father’s DNA for analysis, iGene® delivers definitive results about the health of your baby from just 10ml of maternal blood.


Using cutting-edge Next Generation Sequencing (NGS) technology, iGene® is totally non-invasive and detects Trisomy 21 (Down Syndrome), Trisomy 18 (Edwards Syndrome) and Trisomy 13 (Patau Syndrome), with more than 99% accuracy.1,2


iGene™ also tests for sex chromosome abnormalities such as Klinefelter (XXY) and Turner (X) syndrome, as well as deletions.


Source:

1. Dan et al., Prenatal Diagnosis 2012;32;1-8
2. Jiang F et al, BMC Medical Genomics, 2012, 5:57

What We Test


iGene® provides superior accuracy for the screening of Trisomy 21, 18, 13, sex chromosome aneuploidies and deletion syndromes. iGene® is suitable for at-risk expectant mothers who may be considering, or have been offered, invasive prenatal diagnostic testing for fetal trisomy.


While the iGene® test can be done as early as 10 weeks, we recommend waiting till the 12th week, when the pregnancy is more stable. All pregnancies carry a 2-5% risk of spontaneous miscarriage in the first trimester, and for that reason, we suggest doing the test at the 12th week.


iGene Test Coverage For Australia

What are the Benefits


iGene® is Safe

With iGene®, you dont have to take any risk to accurately screen your baby for problems. The test poses absolutely no risk to you or your baby whatsoever and is completely stress‑free.

iGene® is Non‑Invasive

With no needles used anywhere near your baby, you can be 100% confident there is absolutely no chance of miscarriage.

iGene® is Accurate

iGene® has a proven accuracy rate of over 99% 1,2 compared to other non-invasive prenatal tests. iGene® has been validated by a study of over 146,000 cases, the world’s largest study for non-invasive prenatal tests 3.


Source: 1. Dan et al., Prenatal Diagnosis 2012;32;1-8. 2. Jiang FM, et al. BMC Medical Genomics, 2012, 5:57. 3. Zhang H, et al. (2015) Ultrasound Obstet. & Gynecol. 10. 1002/uog/14792.

How iGene® Works

1
Check your Eligibility

Are you at High-Risk?

  • Increased maternal age (>35 years)
  • A family history of an inherited condition
  • A previous pregnancy with a fetal abnormality
  • Deemed high-risk after other screening tests such as nuchal translucency and first trimester screen.

You can also contact your doctor for more information.

2
Take The
Test

You can take the test at your doctors office from as early as 10 weeks of gestation, although waiting till 12 weeks is recommended

All is required is a 10ml blood sample. Your doctor will provide you with an iGene® Request & Consent form which needs to be signed by you and your doctor.

3
Get Your Results

After approximately 7 to 10 working days, your doctor will receive your results and go through your detailed report with you.

If your result is a “Screen Negative”, it suggests a low risk for the tested trisomies.

If your result is a “Screen Positive”, it is recommended to do a confirmatory test such as amniocentesis or chorionic villus sampling (CVS).

What Mothers Say

FAQ

  • When can I take the iGene test and what does it involve?

    The iGene test can be done as early as 10 weeks of gestations, or any time later in pregnancy. All is required is a 10ml of blood sample from you. It can be done at your doctor’s office or our partner laboratories.

    Find out the nearest iGene collection centres in Australia and Malaysia.

  • Why is iGene a safer option?

    With no needles going anywhere near your baby, the iGene test is completely safe, with absolutely no risk of miscarriage. It is one of the most accurate screening tests available on the market today.

  • What will the iGene result reveal?

    If your results come back “Screen Negative” or “Low Risk”, it means it is very unlikely that your pregnancy has one of the chromosomal abnormalities that iGene screens for.

    If your results come back “Screen Positive” or “High Risk”, it means your pregnancy is at increased risk for the particular chromosomal condition. Further diagnostic tests such as Amniocentesis is recommended to confirm the abnormality.

  • How accurate is iGene?

    iGene is a highly accurate non invasive prenatal test. A study of over 146,000 pregnant women – one of the largest studies for non-invasive prenatal testing has shown that iGene delivers over 99% accuracy for Trisomy 21 (Down Syndrome). It also has a false positive rate of 0.05% and false negative rate of 0.004%.

    Source: Zhang H, et al. 2015 Ultrasound Obstet. & Gynecol. 45:530-538.

  • How long do I have to wait for my results?

    The turnaround time of iGene is approximately 7 to 10 working days from receipt of sample in the laboratory. Your iGene report will be sent to your requesting doctor.

  • How is the iGene test different from other blood tests for Down Syndrome?

    Using Whole Genome Sequencing approach, iGene detects Trisomy 21 (Down Syndrome) with more than 99% accuracy. It can be done as early as 10 weeks of gestation with just 10ml of blood draw. The currently available traditional screening tests for Down Syndromes have low detection rates vary from less than 70% to 84%, with a false positive rate of 5%.

    Learn about the technology behind iGene.

  • Why is iGene a better option?

    iGene provides a more reliable assessment of certain chromosomal conditions and can reduce the need for unnecessary invasive procedures. Being a screening test, it can be done as early as 10 weeks, at a fraction of the cost of invasive diagnostic tests.

  • What is an Amniocentesis?

    Amniocentesis is an invasive diagnostic test performed between 15 and 18 weeks of pregnancy. A small amount of amniotic fluid is extracted from the womb, and the cells obtained are cultured and tested.

  • What is Chorionic Villus Sampling (CVS)?

    CVS is an invasive diagnostic test performed between 10 and 12 weeks of pregnancy. Villus cells in the placenta are removed for testing, as they contain the same genetic composition as the cells in fetal tissue.

  • Why are invasive tests risky?

    Both Amniocentesis and CVS require inserting needles and tubes into the womb or placenta and pose a degree of risk to both mother and baby. The risk of miscarriage of both these invasive diagnostic procedures is up to 1 in 100.

  • Can iGene tests for twin pregnancies, egg donor or IVF?

    Yes. iGene can be used in twin pregnancies, egg donor pregnancies and in-vitro fertilization (IVF) pregnancies.



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