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How is Dante Labs NIPT done?

Dante Labs NIPT 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.

What Does the Dante Labs result mean?

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

  1. YES – the data indicate an extra copy of one chromosome. Invasive prenatal genetic testing must need to be performed to confirm the genetic diagnosis.
  2. NO – the data do not indicate any extra copy of the afore mentioned chromosomes.

Does Dante Labs NIPT include fetal sex determination?

Yes. However, the gender information will be provided only after 12 weeks of gestation, as regulated by European regulations.

Does Dante Labs NIPT report fetal fraction on the test result?

Yes. The fetal fraction is included in the results.

Will I need additional result validation after Dante Labs NIPT?

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.

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