About PrenatalSAFE

Information about PrenatalSAFE test
About the test

PrenatalSAFE Test


PrenatalSAFE® is a non-invasive prenatal test, that analyzing circulating cell-free fetal DNA isolated from a sample of maternal blood, and includes 6 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 Genoma Group laboratories in Milan and Rome and is available in six versions, each with a different depth level, in detail:



is the most technologically advanced non-invasive prenatal test currently available. 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.
PrenatalSAFE® Complete in its “Plus” version detects also 9 of the most common microdeletion syndromes.



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?
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Characteristics

Why PrenatalSAFE

Simple
• A simple blood sample from the pregnant woman is required
• Genoma Group 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 Genoma Group 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 not performable 7 days
PrenatalSAFE® Karyo 4 days 5 days
PrenatalSAFE® Karyo Plus not performable 7 days
PrenatalSAFE® COMPLETE 4 (10) days *** 5 (10) days  ***
PrenatalSAFE® COMPLETE Plus not performable 7 (10) days***

*** PrenatalSAFE® COMPLETE test report consists of two different reports: the first concerning the non-invasive analysis of the fetal karyotype that will be provided in 4 working days, and the second concerning inherited or de novo insurgence genetic pathologies and will be available after 10 working 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
Test performing procedure

HOW IT WORKS



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.

THE MOST INNOVATIVE AND COMPLETE PRENATAL "MADE IN ITALY" TEST

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


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