PrenatalSAFE® is a non-invasive prenatal test, that analyzing circulating cell-free fetal DNA isolated from a sample of maternal blood, and includes
8 levels of depth thanks to which is possible to achieve the most complete pregnancy informational framework available today. In fact, the test allows detecting aneuploidies and microdeletion syndromes, from the most common to the rarest, structural abnormalities in all fetus chromosomes and the presence of mutations related to severe genetic disorders.
PrenatalSAFE® is offered by the
Eurofins Genoma laboratories in
Milan and Rome and is available in
eight versions, each with a different depth level, in detail:
Combines
PrenatalSAFE®
Karyo Plus + GeneSafe™ Complete with GeneScreen® FOCUS, a
carrier screening test for both parents to identify mutations in genes linked to
the most common, and potentially transmissible, recessive inherited diseases in
Italy.
Analyzes all chromosomes in the fetal genome, identifying chromosomal aneuploidies, structural aberrations (i.e., deletions and duplications) of 7 Mb, 9 microdeletion syndromes, and severe genetic disorders in the fetus.
Through the analysis of circulating cell-free fetal DNA (cfDNA) in maternal blood, it screens for fetal karyotype and severe genetic disorders in the fetus.
It screens for aneuploidies and structural chromosomal abnormalities (deletions or segmental duplications) across the fetal genome.
Moreover allows detecting the presence in the fetus of 9 of the most common microdeletion syndromes..
It screens for Trisomy 21, Trisomy 18, Trisomy 13, sex chromosomes (X and Y) aneuploidies and includes the determination of fetal gender (optional).
In addition to PrenatalSAFE®
5 test, it also provides the option of a further analysis to detect trisomy 9 and 16 and the presence of structural chromosomal alterations, that is 6 of the most common microdeletion syndromes.
It screens for Trisomy 21, Trisomy 18, Trisomy 13 and includes the determination of fetal gender (optional).
We remember you that
PrenatalSAFE®
can be integrated with
RhSafe®
test, a non-invasive prenatal exam that, by
analyzing the fetal DNA isolated from a blood
sample of the pregnant woman, allows determining
Rh(D) fetal Factor. The
RhSafe®
test is optional, and is performed for free (on
request) in Rh(D) negative pregnant women with a
Rh(D) positive male partner.
Do you have any doubt or would you like to ask us a question?
Request a genetic counseling
Characteristics
Why PrenatalSAFE
Simple
• A simple blood sample from the pregnant woman is required
• Eurofins Genoma provides a sampling kit for free (branded CE-IVD) within 2 working days from the request
• The collection can be performed at your gynecologist’s office, an authorized center or at home.
For further information, please contact the Eurofins Genoma team.
Safe
• PrenatalSAFE®
is a NON-INVASIVE test:
no risk for both the fetus and the mother.
•
The abortion risks related to traditional
invasive prenatal diagnosis techniques, such as
amniocentesis and chorionic villus sampling have
Reliable
• Sensibility superior to 99%, with percentages of false positives <0.1%.
Rapid
• Thanks to the exclusive FAST
Technology
§, PrenatalSAFE®
results will be available after just 3-4 working days
|
Type of the
exam |
FAST Procedure
|
STANDARD Procedure
|
|
PrenatalSAFE® 3
|
3
days |
3 days |
|
PrenatalSAFE® 5
|
3 days |
3 days |
|
PrenatalSAFE® Plus
|
5 days |
7 days |
|
PrenatalSAFE® Karyo
|
4 days |
5 days |
|
PrenatalSAFE® Karyo Plus
|
5 days |
7 days |
|
PrenatalSAFE®
COMPLETE
|
4 (10-15) days *** |
5 (10-15) days *** |
|
PrenatalSAFE®
COMPLETE
Plus |
5 (10-15) days *** |
7 (10-15) days*** |
|
PrenatalSAFE®
FULL RISK |
5 days - 10/15 days - 15/20 days **** |
7 days - 10/15 days - 15/20 days **** |
***
PrenatalSAFE®
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.
****
PrenatalSAFE®
FULL RISK test report report consists of three different reports: one for the
PrenatalSAFE®
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
GeneScreen®
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.
Our Numbers
Reliability without comparison
%
PRENATALSAFE TESTS ALREADY PERFORMED
DAYS TO RECEIVE THE REPORT
PROFESSIONALS AT YOUR SERVICE
YEARS OF EXPERIENCE IN THE FIELD
During pregnancy, some fragments of the fetus’ DNA circulates in maternal blood. The fetal DNA is detectable from the 5th week of gestation. Its concentration increases in the following weeks and disappear right after the delivery.
The amount of fetal DNA circulating from the 9th-10th week of gestation is sufficient to guarantee the elevated specificity and sensitivity of the test. The test is performed through a
simple blood sample from the pregnant woman with a gestational age of at least
10 weeks.
Through a complex laboratory analysis, the circulating cell-free fetal DNA is isolated from the plasmatic component of maternal blood.
Subsequently, after an high-tech process, the chromosome regions of circulating cell-free fetal DNA are sequenced at an high reading depth (~30 million sequences), through the innovative
massive parallel sequencing technology (MPS) of the entire fetal genome, using Thermofisher and
ILLUMINA Next Generation Sequencing (NGS) sequencers.
Chromosome sequences are quantified by means of an advanced bioinformatics analysis to determine the presence of potential fetal chromosomal aneuploidies.
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 EUROFINS GENOMA laboratories.
No level of investigation of PrenatalSAFE® tests is sent in service to laboratories located abroad
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