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How is the PrenaTest® carried out?

Your physician takes 20 ml blood from you, after you were informed in detail and subjected to genetic counseling by your physician and have signed the declaration of consent for the PrenaTest®. This blood is sent to the diagnostics laboratory. The analysis generally takes 20 days. Your physician then receives a letter with the result and will inform you about the outcome of the analysis.
The expenses for the PrenaTest® are generally not covered by health insurance. Thus, you have to pay these expenses yourself.

When is it sensible to carry out the PrenaTest®?

Carrying out the PrenaTest® is optional. Doing so makes sense if you belong to a risk group or if one of the mentioned trisomies is suspected in your unborn child based on ultrasound findings or previous blood tests.
Please consult your physician about how high your personal risk is that your unborn child carries a trisomy 13, 18 or 21.

Scientific associations reccomendations

The consensus among scientific associations is that NIPT technology should be viewed positively, as an alternative to direct invasive testing of pregnant women at risk of fetal trisomy. For example, Fetal Medicine Foundation (FMF) UK guidelines currently recommend offering invasive diagnostics to pregnant women with risk levels of 1:300 or higher after first-trimester screening (FTS). FMF Germany sets this risk group as 1:150 or higher, and also defines an intermediate risk range of 1:500 to 1:151, for whom additional second- trimester ultrasounds are recommended to detect any possible anomalies.
In this respect, the use of NIPT for pregnant women with elevated risk has the potential to prevent procedure related fetal losses, because it is a further aid to decide for or against invasive procedures.

Clinical trials have validated the PrenaTest® for use with certain types of pregnancies with elevated risk, especially those involving one or more of the following risk factors: advanced maternal age, abnormal serum markers, suspicious sonographic findings, or structural or numerical chromosomal aberrations in one parent. Prior first-trimester screening was not required. The women included in the studies were in Gestational Weeks 11(+0) to 32(+1).

Although scientific associations advise against using NIPT with pregnant women without elevated risk of the trisomies in question until the appropriate “low-risk collective“ clinical trials have been performed, the German Society of Human Genetics brings an additional aspect into this discussion:
“With non-invasive prenatal diagnostic methods, there is no longer a need to weigh intervention-related risks against the probability of the child having an illness or health condition; as such, NIPT examinations should be made available to all pregnant women, or no pregnant woman should be denied oneâ€.
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