Simple

A simple blood sample (8-10 ml) collected
at 10^ weeks of gestation is required

Reliable

Sensitivity and Specificity >99%

Complete

it detects both genome-wide chromosomal abnormalities and single-gene disorders, providing the most comprehensive information available from a noninvasive prenatal test to date

Clinical Utility

The only genome-wide NIPT with a published prospective study demonstrating its clinical utility

Validated

The only genome-wide NIPT with a clinical validation study performed on a cohort of over 12.000 pregnant women, with performance data published on prominent scientific journals.

PrenatalSAFE Karyo A cutting-edge NIPT that analyzes every chromosome in the fetal genome, providing karyotype-level insight.

PrenatalSAFE® Karyo test is the most technologically advanced genome-wide non-invasive prenatal test (NIPT) currently available.Through cell free fetal DNA (cfDNA) analysis from maternal plasma, PrenatalSAFE® Karyo detects: aneuploidies and structural chromosomal aberrations (deletions or duplications) across the fetal genome, providing karyotype-level insight.

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PrenatalSAFE Karyo

is the next level in non-invasive prenatal testing





Unlike any other noninvasive prenatal test (NIPT) available to date, focusing only on detection of common aneuploidies (Trisomy 21, Trisomy 18, Trisomy 13 and Sex Chromosomes aneuploidy), PrenatalSAFE®Karyo offers a level of information previously only available from a fetal karyotype analysis, performed with invasive prenatal diagnosis procedures (amniocentesis and CVS).
PrenatalSAFE Karyo

The Next Generation NIPT

Italian Technology

Test entirely
performed in Italy

PrenatalSAFE® Karyo is the most advanced and complete 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® test is sent in service to laboratories located abroad.

Customer Care

Pre-post test
Genetic Counselling

Qualified molecular biologists and geneticists are always available to help clients on the interpretation of the results in case of positive outcome for aneuploidy, structural chromosomal abnormality or the presence of genetic mutation. Free follow-up of abnormal results.

Fast reporting

Test results in just
4 working days

Thanks to the recent introduction of the new high-resolution FAST Technology for PrenatalSAFE® Karyo test (read depth ~30 million sequences), the exam results will be available after only 4 working days, keeping the same sensitivity and specificity parameters.

Screening Levels

Two levels of genome-wide screening

screens for common aneuploidies, structural chromosomal aberrations (deletions or duplications), rare aneuploidies (e.g. Trisomy 9, 16, 22), across the entire fetal genome.


screens for the chromosomal abnormalities tested with PrenatalSAFE® Karyo test, but also analyzes 9 clinically significant microdeletion regions, providing information about gains or losses of chromosome material = 7 Mb across the fetal genome.


is the first non invasive prenatal test that screens for genome-wide chromosomal abnormalities and severe genetics disorders in the fetus. PrenatalSAFE® COMPLETE represents the evolution of NIPT.

PrenatalSAFE Karyo

The most comprehensive information available from a non-invasive prenatal test to date.

PrenatalSAFE® Karyo test couples leading technology with unparalleled insights to offer the most advanced information available from a non-invasive test. PrenatalSAFE® Karyo is a cell-free fetal DNA (cfDNA)-based noninvasive prenatal test that analyzes every chromosome in the fetal genome.

Like most NIPTs, it can screen for common chromosomal abnormalities, such as Trisomy 21 (Down Syndrome), Trisomy 18 (Edwards Syndrome), Trisomy 13 (Patau Syndrome) and sex chromosome aneuploidies (Monosomy X, Trisomy X, XXY and XYY). But it can also find other chromosomal changes that may go undiagnosed at birth, such as structural chromosomal aberrations (deletions or duplications), rare aneuploidies (e.g. Trisomy 9, 16, 22), across the entire fetal genome, and analyzes 9 clinically significant microdeletion regions, something other NIPTs do not currently do.

How It works

maternal blood

PrenatalSAFE®Karyo test is performed on a maternal blood sample which contains DNA (genetic material) from both the mother and fetus.

It is available for women who are at least 10 weeks pregnant.
The physical risk to you of obtaining the blood sample is usually minimal.

More info
PrenatalSAFE Karyo

The only genome-wide NIPT with a published prospective study demonstrating its clinical utility


Our latest prospective study, including samples from more than 12.000 pregnant women, published in Prenatal Diagnosis journal, demonstrated the clinical utility of PrenatalSAFE®Karyo test, reporting a significant higher sensitivity of PrenatalSAFE®Karyo test as compared with standard cfDNA screening for the detection of common aneuploidies (100% vs 92.64%, p<0.001).



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Indication

All the pregnant women of at least 10 weeks of gestation
can perform the test.



This test is intended for patients at 10 weeks or greater gestation who meet any of the following criteria:

• Maternal age-related risks (=35 years)
• Positive results on maternal serum screening
• Abnormal ultrasound finding(s)
• Prior pregnancy with aneuploidy
• Parental translocation
• Low risk pregnancies
• Patients wanting early, accurate testing and are at average risk of aneuploidy
• Advanced paternal age (men that are >40 years old)
• Abnormal ultrasound finding(s) suggestive of monogenic disorder
• Patients wishing to avoid an invasive diagnostic procedure
• Patients at risk for genetic conditions screened

The test is suitable for:
• Both single and twin pregnancies
• Patients whose pregnancies have been achieved by IVF techniques, including pregnancies with egg donation or surrogacy.

PrenatalSAFE Karyo

The PrenatalSafe Karyo technology ensures the best results

Benefits

PrenatalSAFE® Karyo Plus detects 99,1% of chromosomal abnormalities observed at birth

PrenatalSAFE® Karyo test identifies 92.6% of chromosomal anomalies prenatally detected and 96.2% of those anomalies observed at birth.

PrenatalSAFE® Karyo Plus test identifies 95.5% of chromosomal anomalies prenatally detected and 99.1% of those anomalies observed at birth, achieving a level of detection rate very closed to the traditional fetal karyotyping (96.9%), obtained with invasive, prenatal diagnostic techniques

PrenatalSAFE® Karyo Performances


Unlike any other non-invasive prenatal test available to date PrenalSAFE Karyo offers a level of information previously only available from a fetal karyotype analysis, performed with invasive prenatal diagnosis procedures (amniocentesis and CVS)




PrenatalSAFE Complete

represents the evolution of NIPT.

It works as a complementary screen to traditional and genome-wide NIPT PrenatalSAFE® Karyo.
PrenatalSAFE® Complete screens for several life-altering genetic disorders that are not screened with current NIPT technology, allowing a more complete picture of the risk of a pregnancy being affected by a genetic disorder.



karyo + GeneSAFE

Discover GENESAFE

Results

What information provides the PrenatalSAFE®Karyo test

POSITIVE Result

Aneuploidy or structural chromosomal abnormality detected::
It indicates the test produced a result compatible with an aneuploidy or a fetal structural chromosomal abnormality, on one, or more, chromosomes investigated.


NEGATIVE Result

Aneuploidy or structural chromosomal abnormality not detected::
It indicates the test didn’t detect aneuploidies or structural chromosomal abnormalities on the chromosomes investigated, in the resolution limits of the method.


PrenatalSAFE© Karyo Sample lab report

PrenatalSAFE© Karyo Technical Report

GeneSAFE Sample lab report

GeneSAFE Technical Report
PrenatalSAFE®COMPLETE (PrenatalSAFE®Karyo + GeneSAFE) test, as well as indicating whether the presence of aneuploidies or chromosomal abnormalities have been detected, provides a High Risk result for the genetic disorders investigated when the presence of mutations in the genes involved was detected, and a Low Risk one when no mutation was identified.

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Eurofins Genoma Group

Advanced molecular diagnostics solutions using state-of-the art technologies
Test performed in Italy (Rome or Milan)
20 years experience in molecular diagnostics
ISO 17025 accredited laboratories
Over 200.00 genetic tests/year
Fast TAT:
10 days
Dedicated
R&D team
Test available
worldwide
Personalized genetic counseling

Brochures

 Brochure PrenatalSAFE Karyo

PrenatalSAFE® Karyo test

 Brochure GeneSAFE

GeneSAFE test

Useful forms

 Test Requisition Form

Test Requisition Form

 Patient Consent Formt

Patient Consent Form

Sample lab Report

Sample lab Report

Technical Analysis Report

Technical Analysis Report

Research material

PrenatalSAFEKaryo Performances

PrenatalSAFE© Karyo Performances

PrenatalSAFEKaryo Case studies

PrenatalSAFE© Karyo Case studies

Validazione preclinica del test PrenatalSAFE Karyo

PrenatalSAFE© Karyo preclinical Validation

Utilità clinica del test PrenatalSAFE® Karyo rispetto ai NIPT tradizionali

PrenatalSAFE© Karyo clinical Utility


Analysis Software Declaration of Conformity

Are you interested
in PrenatalSAFE® Karyo test?


Call us +39 06164161500 or fill in the online form

Request information

Contacts

To request a free, personalized counseling or for further information on the costs of our services, please contact us at the following numbers:
Office number: +39 06 164161500
Toll free number 800 501 651 (only from Italy)
One of our genetic counselor will provide you with all the information you may need.

Our Headquarters

Genoma Group


ROME - Via Castel Giubileo, 11
Contact Center: +39 06 164161500 (12 lines PBX)
MILAN - Via Enrico Cialdini, 16
Contact Center: +39 06 164161500 (12 lines PBX)
Opening Hours
Monday - Friday 9.00 - 18.00
Saturday 9.00 - 13.00

Information Request

To request PrenatalSAFE Karyo®, please fill out the on-line form with the required information (your personal information is used only to satisfy your request in compliance with all privacy regulations).


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