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CentoNIPT® offers genetic, non-invasive prenatal testing (NIPT) to screen for the most common fetal chromosomal abnormalities. Our test combines the latest next generation sequencing technology with expert medical reporting.

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  1. Non-Invasive Prenatal Testing

CentoNIPT® - Non invasive prenatal testing at CENTOGENE

Illumina VeriSeq™ NIPT Solution*

Conventional prenatal testing for fetal chromosomal abnormality involves either chorionic villus sampling or amniocentesis. These procedures are highly invasive and carry an elevated risk of miscarriage, but despite this have become standard practice worldwide due to their high levels of accuracy and the range of abnormalities they can detect.

With CentoNIPT® CENTOGENE now offers non-invasive prenatal testing that provides a fast and accurate screen for the most common prenatal chromosomal abnormalities.


CentoNIPT® is performed on a single maternal blood sample and combines the latest next generation sequencing technology with the highest quality medical reporting. It provides unparalleled accuracy and detection compared to other non-invasive testing methods – ultrasonography or nuchal translucency testing.

Our medical expertise is ideally suited to provide you and your patients with reliable, well supported result interpretation.

Approximately 1% of all babies will be born with a chromosomal abnormality

  • Fetal chromosomal abnormalities are causing physical disability and/or mental retardation
  • 70% of syndromic congenital abnormalities are contributed by Trisomy T21, T18 or T13 and 10% by Turner syndrome (Monosomy X)
  • The risk of trisomy increases significantly with maternal age

Trisomies

  Sensitivity Specificity
Trisomy 21 (Down syndrome) 98.9% >99.9%
Trisomy 18 (Edwards syndrome) 90.0% 99.9%
Trisomy 13 (Patau syndrome) 100.0% 99.9%

Sex chromosome aneuploidies & fetal gender

  Concordance with cytogenetic results
XX 97.4 %
XY 100.0 %
X0 (Turner syndrome) 100.0 %
XXX (Triple X syndrome) 80.0 %
XXY (Klinefelter syndrome) 100.0 %
XYY (Jacobs syndrome) 100.0 %

Why choose CentoNIPT®?


 

100% safe for mother & child
Only 9ml of maternal blood required

 

Test as early as possible
From the 10th gestational week

 

Fast & reliable results
Results within 5 working days

 

Maximum certainty
Latest NGS technology and high-quality medical reporting

 

Easy handling
Your CentoNIPT® set is provided and shipped free of charge.
For return shipment just a phone call is needed.


CentoNIPT® is the earliest and most accurate way to detect Trisomy 21

Conventional prenatal screening methods vs. CentoNIPT®


How to order CentoNIPT®


Do you already have a CentoNIPT® box?

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Prepare the maternal sample


Select your test in CentoPortal® by using the NI code on the Streck tube provided


Pack and ship the sample in your CentoNIPT® box free of charge


Sample processing and results within 5 days


Download your report from CentoPortal®

CentoNIPT® reporting information

CentoNIPT® is only designed to analyze chromosome aneuploidies of the fetus after 10 weeks of gestation. Reported are overrepresentations of chromosomes 21, 18 and 13, as well as the sex chromosome aneuploidies XO, XXX, XXY and XYY. This screening test does not test for aneuploidies in other chromosomes not mentioned above and can therefore not exclude abnormalities in these.

Chromosome aneuploidies for a twin gestation can in general be detected by this test. However, the test cannot be attributed to individual twin fetuses because in twin gestations sensitivity and specificity for detection of aneuploidies are limited. In case of twin pregnancy and detection of only one Y chromosome by the test, the fetal gender of each individual twin cannot be determined by the test.


CENTOGENE reports NIPT results as follows:

Positive result – if CentoNIPT® identifies an aneuploidy (chromosome 21, 18, 13 or gonosomal chromosomes), CENTOGENE reports presence of aneuploidy and provides data on fetal DNA fraction in the sample of mother´s peripheral blood (in percentages) and the data on fetal gender if requested. We urgently recommend doing an invasive testing and subsequent analysis by for example karyotyping to confirm the genetic result.

  • CentoNIPT® - Diagnostic sample report, positive

    Download

Negative result – if NIPT did not indicate a trisomy of chromosome 13, 18, or 21 or gonosomal abnormalities, CENTOGENE reports a negative result together with the data on fetal DNA fraction and the data on fetal gender if requested. A negative result cannot entirely exclude the possibility of fetoplacental mosaicism. Thus, CENTOGENE is giving negative results of NIPT together with the suggestion: if the fetus shows abnormalities on ultrasound investigation, or if a family history of fetal abnormalities or other genetic disorders exists, we highly suggest invasive testing and subsequent analysis by karyotyping or additional genetic analysis.

  • CentoNIPT® - Diagnostic sample report, negative

    Download

In the very unlikely case of inconclusive results of the non-invasive prenatal testing due to the limitation of the system, we recommend further follow-up of the fetal growth using ultrasound as well as 2nd trimester screens. In case of any abnormalities observed on the ultrasound examination or if there is a positive family history of fetal abnormalities or other genetic disorders, we highly suggest invasive testing and subsequent analysis by karyotyping or additional genetic analysis.

Frequently asked questions

CentoNIPT® is based on the in vitro diagnostic test Illumina VeriSeq™ NIPT Solution. This noninvasive IVD test utilizes whole-genome sequencing on cell-fetal DNA (cfDNA) fragments derived from maternal peripheral whole blood samples. After whole genome sequencing and bioinformatics analysis, chromosome read numbers and fetal fraction are combined and thus translated into chromosome ploidy. Finally, the comparison of the tested chromosomes by this test (21, 18, 13, X and Y) with reference chromosomes enables the identification of aneuploidies, which are then reported.

We report aneuploidy, the occurrence of additional chromosomes in the fetus. However, this analysis is restricted to those chromosomes where a living fetus could be born with abnormalities. These chromosomes include chromosome 13, 18, 21 and the sex chromosomes.

The analysis only reports if an additional chromosome has been identified

YES – the data indicate an extra copy of one chromosome. Invasive prenatal genetic testing must will need to be performed to confirm the genetic diagnosis.

NO – the data do not indicate any extra copy of the aforementioned chromosomes.

Yes. However, the gender information will be provided only after 12 weeks of gestation, as regulated by German law, as the test is performed in Germany.

Yes. The fetal fraction is included in the result.

This analysis is restricted to fetal cells from the placenta and not from the fetus itself. Fetoplacental mosaicism, a different chromosomal setup for placenta and fetus, is very rare but cannot be ruled out. Although sensitivity and specificity of NIPT are indeed high, it is necessary to confirm such results by additional method(s), such as echosonographic findings, maternal serum analysis; or perhaps amniocentesis for confirmation of a positive result.


Downloads for CentoNIPT®


Latest scientific articles

Notation: *Sample Preparation and analysis software are CE-IVD marked

Noninvasive prenatal testing (NIPT) based on cell-free DNA analysis from maternal blood is a screening test; it is not diagnostic. Test results must not be used as the sole basis for diagnosis. Further confirmatory testing is necessary prior to making any irreversible pregnancy decision.

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Please call or send us an email with any questions and benefit from our medical consultation services, available both before and after testing.


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