PrenatalSafe ® is the first prenatal screening test that can detect everything from the most common fetal aneuploidies (13, 18, 21, X and Y) to the rarest aneuploidies (all chromosomes of the fetal karyotype). PrenatalSafe ® is also the only non-invasive prenatal screening test that can highlight subchromosomal structural abnormalities across the entire fetal karyotype and mutations related to serious genetic diseases. The test also provides information about the sex of the fetus (optional).

PrenatalSafe® can be performed by all pregnant women with a gestational age of at least 10 weeks. PrenatalSafe ® can be applied in singleton pregnancies, in both homologous and heterologous pregnancies achieved through IVF (IVF, ICSI), and in twin pregnancies, even if achieved through assisted, homologous and heterologous fertilization techniques.

PrenatalSafe ® Complete and PrenatalSafe ® COMPLETE PLUS are particularly suitable for couples with advanced paternal age.

PrenatalSafe® is offered from the 10th week of pregnancy onwards. There is no deadline for performing the test, because fetal DNA remains in the mother's bloodstream throughout the pregnancy.

The PrenatalSafe ® screening test has a sensitivity and specificity higher than 99%, with a very low false-positive incidence of below 0.1%. Prenatal SAFE ® detects abnormalities affecting the fetal genome even at low amounts of fetal DNA (FF ≥ 2%).

No. Screening tests are indirect statistical tests based on ultrasound examinations of the fetus and/or biochemical examinations of the mother's blood, in which certain substances whose levels may change in the presence of some chromosomal pathologies are measured. The Prenatal SAFE ® test is a screening test that analyzes cell-free DNA of placental origin; a high-risk result must be confirmed by CVS or amniocentesis.

Prenatal screening tests such as the double test may indicate a high risk for fetal trisomy even when the result is actually negative (false positive), or may indicate a low risk for fetal trisomy when the pregnancy is in fact positive (false negative). These non-invasive tests, such as the combination of nuchal translucency with free-b-HCG and PAPP-A proteins, have a false-positive rate of up to 5% and fail to detect approximately 10-15% of fetal trisomy 21 cases. The false-positive rate is very low; however, the accuracy of a high-risk result varies depending on the case and must be confirmed with a diagnostic test.

The PrenatalSafe ® screening test is completely safe for both the mother and the fetus. Although diagnostic tests such as amniocentesis or CVS are accurate for the diagnosis of fetal trisomies, they are invasive, carry a non-negligible risk of miscarriage, and require appropriate antibiotic treatment.