25 November 2019

BioRep launches NATIVA® NEXT: the new non-invasive prenatal screening test from the NATIVA range. 

NATIVA® The range of non-invasive prenatal tests branded BioRep, is completed with a new test. 

From November 25th, 2019 the new service NATIVA® NEXT will be available on the market. 

NATIVA® NEXT uses VeriSeq™ NIPT Solution v2 technology from Illumina Inc. This whole-genome next generation sequencing (NGS) technology offers coverage at karyotype resolution across the genome, increasing the number of genetic diseases that can be detected. Next to standard NIPT tests which detect trisomies 13, 18 and 21 as well as sex chromosome abnormalities, the genome-wide option allows the risk of rare aneuploidies of the autosomes to be determined, which may have clinical relevance for fetal development and prenatal care. 

NATIVA® NEXT provides expectant mothers with accurate information early in their pregnancy to help them better prepare for their baby and minimize the need for higher-risk invasive procedures. NATIVA® NEXT can detect abnormalities down to 7 Mb in size across the entire genome. 

The clinical accuracy of the VeriSeq NIPT Solution v2 technology used for NATIVA® NEXT, with respect to outcomes determined by a clinical reference standard assessment, was demonstrated by evaluating more than thousands plasma samples from pregnant women with singleton and twin pregnancies undergoing prenatal screening for fetal chromosome aneuploidies and partial deletions and duplications of 7 Mb or greater. The study determined that VeriSeq NIPT Solution v2 provided highly sensitive and specific results – 98.8 percent passed assay quality control on the first pass. 

The technological update VeriSeq™ NIPT Solution v2 achieved by BioRep also through the acquisition of the new NextSeq™ 550Dx sequencer Illumina Inc., which has been certified CE-IVD and FDA approval for NGS analysis of diagnostic panels. 

BioRep is a Sapio Group company that since 2003 operates in the biotechnology sector worldwide. BioRep is a laboratory accredited by Regione Lombardia for Laboratory Medicine Services (SMeL) in the field of Molecular Genetics. 

BioRep has been the first company to introduce to the Italian market the fully certified for in vitro diagnostics (CE-IVD) non- invasive prenatal testing (NIPT) with Illumina, Inc. VeriSeq NIPT system. https://nativaprenatale.it. 

Moreover, BioRep is a biological resource center that provides complete solutions for long-term storage of biological samples and laboratory services to public and private research institutions (hospitals, universities, clinics), biotech and pharmaceutical companies, ensuring the highest levels quality and safety. https://www.biorep.it. 

About the test: VeriSeq NIPT Solution v2 (CE-IVD) is available across most countries in Europe. More information can be found on: www.illumina.com/inlabNIPT. 

Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis from maternal blood is a screening test, not a diagnostic test. Results should be confirmed by diagnostic testing prior to making any pregnancy management decisions. Illumina’s VeriSeq NIPT Solution provides expectant mothers with accurate information about their pregnancy and helps minimize the need for higher-risk invasive procedures.