PrenatalSafe®Karyo

The first non invasive prenatal test that analyzes every chromosome of your child’s DNA.
The test has shown a sensitivity and a specificity > 99.9%.
Results similar to prenatal karyotyping performed with invasive diagnostic procedures.

For Whom?

PrenatalSAFEKaryo is for patients with:

• Maternal age-related risks (≥35 years)
• Positive results on maternal serum screening
• Abnormal ultrasound finding(s)
• Prior pregnancy with aneuploidy
• Parental translocation involving one of the tested chromosomes
• Patients wanting early, accurate testing and are at average risk of aneuploidy
• Low-risk pregnancies

Test is suitable for:

• both single and twin pregnancies.
• patients whose pregnancies have been achieved by IVF techniques, including pregnancies with egg donation.

What is detected?

PrenatalSAFEKaryo is the most technologically advanced genome-wide NIPT: through cfDNA analysis from maternal plasma,
PrenatalSAFEKaryo detects aneuploidies and structural chromosomal aberrations (deletions or duplications) across the fetal genome, providing karyotype-level insight.

No other NIPT offers such an advanced level of investigation

Grafico Prenatalsafe Karyo

As shown other available non invasive prenatal tests analyze only certain fetal chromosomes such as 21, 18, 13, X and Y.

PrenatalSAFEKaryo analyzes every chromosome in the fetal genome, both common fetal aneuploidies in pregnancy such as chromosome 21 (Down Syndrome), chromosome 18 (Edwards Syndrome), chromosome 13 (Patau Syndrome) and sexual chromosomes X an Y (for example Turner Syndrome or Monosomy X) as well as other less common aneuploidies (for example chromosome Trisomy 9, 16 or 22) and segmental deletions or duplications seen on all chromosomes.

Next generation technology that identifies:

Common fetal chromosome aneuploidies
Trisomy 21	Down Syndrome
Trisomy 18	Edwards Syndrome
Trisomy 13	Patau Syndrome
Monosomia X	Turner Syndrome
XXX	Trisomy X
XXY	Klinefelter Syndrome
XYY	Jacobs Syndrome

Other fetal chromosome aneuploidies
Trisomy 1	Trisomy 9*
Trisomy 4	Trisomy 12
Trisomy 5	Trisomy 16*
Trisomy 7	Trisomy 22*
PrenatalSAFEKaryo detects aneuploidies on every chromosome in the genome. *Highest incidence among less common fetal aneuploidies

Segmental duplications or deletions
Detectable on all chromosomes

Procedure

Fetal DNA circulates in maternal blood and is detectable as of the fifth week of pregnancy, its concentration increases in the following weeks and disappears right after giving birth. PrenatalSAFEKaryo test is performed simply by drawing an 8ml blood sample as of the tenth week of pregnancy.

Cell-free Fetal DNA is then isolated from the maternal plasma.

This test uses a technology called "Massively Parallel DNA Sequencing" to count the number of copies of these chromosomes with Next Generation Sequencing (NGS) ILLUMINA, and then uses an advanced bioinformatic analysis method to determine if there are too many or too few copies of these chromosomes present in your fetus.

Benefits

PrenatalSAFEKaryo test identifies 92.6% of chromosomal anomalies prenatally detected and 96.2% of those anomalies observed at birth, achieving a detection rate very close to the traditional fetal karyotyping (96.9%), obtained with invasive, pre-natal diagnostic techniques.

If PrenatalSAFEKaryo detects an abnormality

The test result means that PrenatalSAFE®Karyo identified too many or too few copies of one of the chromosomes as seen on the report. This can indicate either a trisomy, or a sex chromosome aneuploidy, or a segmental chromosomal abnormality. If a chromosomal abnormality is detected, follow up testing (such as amniocentesis or chorionic villus sampling) is recommended to confirm the result.