PrenatalSAFE Karyo

analyzes every chromosome in the genome, providing karyotype-level insight.


 test prenatale non invasivo tecnologicamente più avanzato
PrenatalSAFE®Karyo is the only non-invasive pre-natal test carried out in Europe in our laboratories. Unlike other tests on the market, it is NOT outsourced to external laboratories in the US or China.

The FAST technology provides test results within only 5 working days with the same levels of sensitivity and specificity as for the standard test.

Please feel free to contact us for any enquire! One of our genetic counselors will provide you all information you may need.

PrenatalSAFE®Karyo ® is the next level in non-invasive prenatal testing.



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



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is a new cell-free fetal DNA (cfDNA)-based noninvasive prenatal test that analyzes every chromosome in the fetal genome.

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


is

SIMPLE

A simple blood sample (8ml) from pregnant women at 10^ week of gestation is required.

SAFE

The PrenatalSAFE®Karyo test is non-invasive and, for this reason, it is completely safe for the patient and the fetus. The risk of a spontaneous miscarriage related with the traditional invasive pre-natal diagnostic techniques, such as amniocentesis and villocentesis, is thus avoided.

FAST

We have introduced a high-resolution FAST technology, which provides test results within only 5 working days, while maintaining the same levels of sensitivity and specificity as for the standard test.

RELIABLE

The test has demonstrated a sensitivity >99% in detecting chromosome aneuploidies (trisomy 21, trisomy 18, trisomy 13, Monosomy X), with a false positive rate <0.1%.

Procedure





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.

This test uses a technology called "Massively Parallel DNA Sequencing" to count the number of copies of these chromosomes, and then uses a calculation method to determine if there are too many or too few copies of these chromosomes present in your fetus.



PrenatalSAFE®Karyo test  analyzes every chromosome in the genome, providing karyotype-level insight. It provides information about gains or losses of chromosome material e 10 Mb across the genome.

How it works





The 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.

Patients not living in the Italy, do not have to go to the GENOMA Lab to collect a blood sample for the PrenatalSAFE®Karyo test. Once we have received your request, the Lab will send you, within two working days, a Samples Shipping Kit that should be used for packaging and shipping of human blood specimens to Genoma.

The Samples Shipping Kit includes everything you may need for packaging and shipping biological samples. Instructions are user friendly; our staff is available to provide you support.

Test results will be ready in 3 to 7 business days and medical reports are sent via e-mail. You can also have an on-line access to the report by log-in to your reserved area.

The PrenatalSafe Karyo technology ensures the best result

High resolution

Whole genome

Precision rate

> 99%

False positive percentage

< 0.1%

FAST technology

Results within only 5 days

OUR NUMBERS

Unparalleled reliability

PrenatalSAFE tests carried out till today

25500

Genoma is leader in Prenatal Genetics since

1997

Human resources Genoma team more than

80

TARGETING



PrenatalSAFE®Karyo test is intended for patients at 10 weeks or greater of gestation (calculated from the date of the latest menstruation) 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 involving one of the tested chromosomes
• Patients wanting early, accurate testing and are at average risk of aneuploidy
• Low-risk pregnancies


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

ARE YOU INTERESTED IN TEST PrenatalSAFEKaryo®?

Call us +39 068811270 or fill in the online form

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BENEFITS



PrenatalSAFE®Karyo test identifies 92.6% of chromosomal anomalies prenatally detected and 96.2% of those anomalies observed at birth, achieving a level of detection rate very closed to the traditional fetal karyotyping (96.9%), obtained with invasive, pre-natal diagnostic techniques.
View PrenatalSAFE®Karyo Tables Performance
(last update: May 2016)

RESULTS


PrenatalSAFE®Karyo results will tell your healthcare provider whether too few or too many copies of the chromosomes being tested for are present. If a chromosomal abnormality is detected, follow up testing (such as amniocentesis or chorionic villus sampling) is recommended to confirm the result.

Our reports will include one of three possible results: 
Abnormality Detected

The test result means that PrenatalSAFE®Karyo test 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.
 

No Abnormality Detected

This test result means that PrenatalSAFE®Karyo test identified the expected number of copies of chromosomes reported.

Abnormality Suspected

This test result means that PrenatalSAFE®Karyo test identified more copies than expected of the chromosomes reported. Your provider should follow up on this result to obtain more information. There is also a chance that the sample submitted will not return any results; in this case a second sample may be requested to repeat the test.

PrenatalSAFE® Karyo is a screening test, it does not aim to provide diagnostic results. A negative test does not ensure an unaffected pregnancy. Chorionic villus sampling and amniocentesis provide definitive diagnostic information, but may pose harm to the fetus.

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 8811270
Toll free number 800 501 651

One of our genetic counselor will provide you will all the information you may need.

Our headquarters

ROME: Via Castel Giubileo, 11

Tel: 06 8811270 (6 lines PBX)

E-mail: info@laboratoriogenoma.eu



MILAN: Via Enrico Cialdini, 16 (Affori Centre)

Tel: 02 36637460 (12 lines PBX)

E-mail: info@genomamilano.it

Opening hours

Mon/Fri 9.00 - 18.00

Sat 9.00 - 13.00

Sunday Closed

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).