Non-Invasive Prenatal Test (NIPT)
GENOMEDICA, with the support of PERKIN ELMER, world leader in prenatal testing solutions, has installed and implements in its laboratories the unique Non-Invasive Prenatal Test (NIPT), VANADIS, which covers the wider geographical area of SE and Central Europe and Mediterranean and Middle East countries
Vanadis NIPT is a targeted screening test which, by detecting fetal DNA from the mother’s blood, accurately calculates the possibility of the baby having Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome) and Trisomy 13 (Patau syndrome). These are the most common syndromes that occur spontaneously (ie without a specific predisposition) in pregnancies. The test can also detect the sex of the fetus.
ADVANTAGES
With the new precision technology introduced by VANADIS, which relies on the imaging of individual fetal DNA molecules, more expectant mothers have access to reliable, fast and inexpensive non-invasive prenatal testing with a simple blood draw, as it achieves:
• Result in 5 to 10 working days
• Low cost
• Very high detection rates of syndromes DOWN, EDWARDS and PATAU (99.6% – 100%)
• The lowest rates of false positives compared to the competition (0.1% – 0.5%)
• The lowest percentage of unsuccessful (no-call) results (0.68%)
• High accuracy even in samples with low fetal DNA fraction (<2%)
• Certified for clinical diagnostic use as it bears the CE-IVD mark
• Developed in collaboration with the largest prenatal care center in Europe: Harris Birthright Research Center for Fetal Medicine, London and Professor Kypros Nikolaides.
How the results of the Vanadis NIPT test are reported:
Low probability (Negative): This means that it is very unlikely that the baby will be affected by Down, Edwards or Patau syndromes.
Increased probability (Positive): This means that the baby is more likely to be affected by Down, Edwards or Patau syndromes. All increased possible results should be confirmed by an invasive diagnostic test that could be chorionic villus sampling (CVS) or amniocentesis. Confirmation is required in all cases of increased likelihood (positive) as in a very small number of cases the DNA from the placenta may not represent your baby’s DNA.
Failed test: Very rarely a test could fail for technical or other reasons. In this case a new sample will be required
Uncertain result: This means that it was not possible to get a clear result. In this case and after consultation with your gynecologist, an invasive test (CVS or amniocentesis) might be required.
Report sample (to be provided)