BioRep_Nativa_ ENG

Press release
BIOREP LAUNCHES NATIVA IN ITALY, THE NEXT
GENERATION NON-INVASIVE PRENATAL TEST
An automated and CE-IVD certified process for
the most advanced DNA sequencing test based on Next-Generation Sequencing
(NGS) technology
Milan, San Raffaele Scientific Park, 3 rd May 2017 – BioRep, a Sapio Group biotech company,
launches Nativa in Italy, the last generation non-invasive prenatal test (NIPT), CE-IVD certified for
21, 18 e 13 trisomies and sexual aneuploidies, with due regard to the Italian National Health
Regulation.
Nativa analyzes DNA fragments resulting from placental trophoblasts that freely circulate in
mother’s blood. Resulting in a higher accuracy and sensitivity than the combined test, Nativa could
decrease the recourse to invasive diagnostic exams, reducing the related risk of abortion. Only in
case of positive results, individuals could confirm with invasive diagnostic techniques, such as
amniocentesis or chorionic villus sampling test, thereby reducing dramatically the number of
effective invasive procedures, and risk of abortion.
Nativa provides accurate information about fetal chromosome status as early as 10 weeks gestation
using a single maternal blood draw. Nativa is the only test based on NGS technology currently
available in Italy completely CE-IVD certified, introducing innovative and standardized protocols
for sample preparation and a new algorithm for the chromosome analysis. Nativa is based on a
technology which sequences the whole genome and gives an outcome even if the fetal fraction is
less than 4 %.
BioRep has chosen ILLUMINA Inc., the global leader of sequencing, as provider for the new NGS
platform. The Illumina technology, through the tiny read of every single base that composes DNA
filaments, permits the accurate analysis and count of fetal chromosomes, starting from a maternal
blood sample.
The Nativa workflow is CE-IVD certified (In-Vitro Diagnostic) and is performed into the SmeL
accredited (Lombardy Region Clinical Laboratory Services) BioRep laboratory, placed in Milan into
the San Raffaele Scientific Park. CE-IVD certification ensures the safety and quality: attests that
Nativa satisfies the essential requirements and performance levels for medical devices and it is
released only if the product comply with 98/79/CE Directive.
Nativa represents a rapid and out of risks exam for both mother and baby. This is because it is noninvasive
(a simple blood draw is enough) and permits to obtain an outcome on the possible presence
of fetal chromosomal abnormalities, such as Down Syndrome and other common ones, very quickly
Ufficio Stampa • GLEBB & METZGER
Antonella Desiderio, tel. +39 011 5618236, mob. +39 335 8087257, adesiderio@glebb-metzger.it

(only 5 days from the arrival of the blood sample). Moreover, the test also permits to determine the
sex of the newborn.
“We are proud to being available to clinicians and their patients the experience gained by BioRep in
the field of genetics and DNA sequencing, as a support to laboratories and research institutes in Italy
and worldwide”, declared Maurizio Colombo, President of BioRep and Vice President of Sapio
Group. “With Nativa we make available a new prenatal test in our Country that uses an innovative
and highly advanced technology, able to provide quick results with due regard to National Health
Regulation”.
Nativa is ideal for all pregnant women and it can be carried out by the 10th week of gestation. The
simplicity of implementation and the non-invasivity, permits the test execution also in case of:
• Twin pregnancy;
• Pregnancy conceived by ovodonation;
• Surrogacy;
• Women that suffered solid organ transplant or bone marrow transplant.
Nativa is particularly indicated when:
• Mother’s age is over 35 years;
• Positivity of I and II trimester serum screening;
• Pregnancy at risk of spontaneous miscarriage;
• Placental detachment;
• Evidence of aneuploidies;
• Family history suggests chromosomal abnormalities.
BIOREP is a company belonging to Sapio Group that operates at international level in the biotechnology field. Born in
2003, BioRep is a Biological Research Centre that is able to give complete solutions for long-term conservation of
biological material and laboratory services to public and private research institutes (Hospitals, Universities, Clinics),
biotech and pharmaceutical companies, guaranteeing the highest levels of quality and safety. For many years, BioRep
has been the global landmark for the processing and storage of biological material for the advancement of medical
research and scientific discoveries on behalf of important American foundations involved in neurodegenerative diseases.
Thank to the most advanced sequencing technologies of Next Generation Sequencing (NGS), BioRep also offers services
of DNA analysis for research and diagnostic purpose. BioRep is certified UNI EN ISO 9001 and authorized for Clinical
Laboratory Services (SmeL) and it is equipped with one of the most advanced word-class technological infrastructure.
Ufficio Stampa • GLEBB & METZGER
Antonella Desiderio, tel. +39 011 5618236, mob. +39 335 8087257, adesiderio@glebb-metzger.it