test has a sensitivity and specificity higher than
99% with a very low incidence of false positives, below
0,1% of cases.
PrenatalSAFE® KARYO PLUS
highlights the 99,1% of fetal chromosomal aneuploidies observed at the delivery, reaching a detection rate level very similar to the one of traditional fetal karyotype (96.9) and molecular fetal karyotype obtained through invasive prenatal diagnosis techniques.
Reliability without comparison
SENSITIVITY AND SPECIFICITY OF THE TEST
DAYS TO RECEIVE THE REPORT
PROFESSIONALS AT YOUR SERVICE
YEARS OF EXPERIENCE IN THE FIELD
Response and report delivery
Thanks to the recent introduction in the clinical practice of
PrenatalSAFE® test of the high resolution FAST§ Technology (read depth ~ 30 millions sequences), the exam results will be available only
after 3-4 working days, maintaining the same sensitivity and specificity parameters.
FAST procedure is applicable only to
, PrenatalSAFE® KARYO
Type of the
PrenatalSAFE® Karyo Plus
4 (10-15) days ***
5 (10-15) days ***
5 (10-15) days ***
7 (10-15) days***
5 days - 10/15 days - 15/20 days ****
7 days - 10/15 days - 15/20 days ****
COMPLETE test report consists of two reports: one for the non-invasive analysis of the fetal karyotype (PrenatalSAFE®
Karyo) that will be provided in 4-5 business days, and another for inherited or de novo genetic pathologies (GENESAFE™ Complete) which will be available after 10-15 business days.
FULL RISK test report report consists of three different reports: one for the
Karyo Plus which will be provided in 5-7 business days, one for
GENESAFE™ Complete which will be available after 10-15 business days, and another for
FOCUS which will be available after 15-20 business days.
§ The above-mentioned reporting times, however, are not peremptory and could be extended in case of exam repetition, not optimal results, diagnostic investigations, or interpretative doubts.
PrenatalSAFE® is the most complete and innovative non-invasive prenatal test on fetal DNA in maternal blood available today, and is performed entirely in ITALY at GENOMA Group laboratories.
No level of investigation of PrenatalSAFE® tests is sent in service to laboratories located abroad
Other prenatal diagnosis techniques
PrenatalSAFE vs Bitest
▪ Targeted analysis, limited to 5 chromosomes
▪ Low resolution sequencing (reading depth ~1-6 million of sequences)
▪ Analysis limited to 5 chromosomes (21, 18, 13, X, Y)
▪ The algorithm carries out a risk analysis, associating the data obtained from the examination with external data (ex. pregnant woman’s age, ultrasound comparisons), producing a “risk score”
▪ High/Low risk results, similarly to the Bi-Test
▪ Longer reporting times (~10-15 working days)
▪ High percentage of test repetition (4-12%)
▪ Only some commercial tests do not allow the analysis in case of pregnancy by artificial insemination or heterologous
▪ They require a collection of 20 ml of blood and the use of 2 tubes
Comparison with invasive Prenatal Diagnosis
PrenatalSAFE® 3 e 5
tests allow to highlight, respectively,
the 71% and the
83.1% of the chromosomal
abnormalities observable during
test the detection rate reaches the
COMPLETE test represents the highest level of in-depth analysis available today for non-invasive prenatal tests on circulating free DNA in maternal blood. The test allows to measure the
95.5% of chromosomal abnormalities detectable during pregnancy (KaryoPlus level of investigation) reaching a detection rate level very similar to that of the traditional fetal karyotype (96.9%), obtained through invasive prenatal diagnosis techniques. Furthermore the test adds to these potentialities even the ability to detect mutations responsible of severe genetic disorders (association with
Alternatives: invasive prenatal diagnosis
The non-invasive prenatal
exam that analyzes fetal DNA
present in maternal blood is just one of
the options for the pregnant woman to
determine the risk of chromosomal
pathologies during pregnancy.
There are several screening that can be
In particular, a more
accurate cytogenetic analysis can be
obtained through the “invasive
prenatal diagnosis”, which can
be performed on chorionic villi
collection (placental tissue
that, although separated from the fetus,
it contains the same DNA), or chorionic
villus sampling, is performed between
the 11th and the 12th week of gestation
and consists in the collection, under
ultrasound control, of a little sample
of chorionic villi through an injection
across the maternal abdomen. This
collection implicates an abortion risk
lower than 2%.
testing is conducted on the DNA
extracted by the fetal cells contained
in chorionic villi.
collection of the amniotic fluid,
or amniocentesis, is
performed through an ultrasound-guided
transabdominal injection between the
16th and the 18th week of pregnancy and
implicates a risk of miscarriage lower
In this case, the
cytogenetic testing is conducted on the
fetal cells present in the amniotic
The aforementioned investigations can, furthermore, provide a complete chromosomal analysis of the fetus and are particularly recommended to pregnant women over the age of 35.
Why choose PrenatalSAFE