More women deserve the right to NIPT

Vanadis® NIPT will make it possible to serve their needs

Noninvasive prenatal testing (NIPT) consists in analyzing cell-free DNA (cfDNA) circulating in the maternal blood in order to detect Down's syndrome and other fetal chromosomal abnormalities.


From a simple blood test, NIPT has demonstrated its superior efficacy to detect trisomies and helped reduce the number of unnecessary invasive procedures associated with miscarriages.

By enabling safe and early access to reliable results, NIPT has quickly been integrated in the screening program across the world. However, cell-free DNA testing for aneuploidy screening has been so far limited by the complexity, cost and capacity of existing NIPT technologies.





Screening has been so far limited by the complexity, cost and capacity of existing NIPT technologies

Traditional combined screening has shown limitations

Traditional combined screening

  • 85-90% detection rate for T21
  • 10-15% undiagnosed aneuploidies
  • Up to 5% false positives
  • Unnecessary invasive procedures

Spencer K, Souter V, Tul N, Snijders R, Nicolaides KH. A screening program for trisomy 21 at 10-14 weeks using fetal nuchal translucency, maternal serum free beta-human chorionic gonadotropin and pregnancy-associated plasma protein-A. Ultrasound Obstet Gynecol 1999;13:231–237

Noninvasive prenatal testing (NIPT)

  • >99% detection rate for T21
  • <1% false positives
  • Reduces unnecessary invasive procedures

Gil MM, Accurti V, Santacruz B, Plana MN, Nicolaides KH. Analysis of Cell-Free DNA in Maternal Blood in Screening For Aneuploidies: Updated Meta-Analysis. Ultrasound Obstet Gynecol DOI: 10.1002/uog.17484

Currently in many countries the access to NIPT is limited to high-risk women due to cost and complexity. Vanadis® NIPT System is an automated solution designed to solve these challenges and allow laboratories to screen more women with NIPT.


Vanadis® NIPT System

vanadis-extract

Vanadis Extract®

Cell Free DNA Extraction Unit

vanadis-core

Vanadis Core®

Cell Free DNA Analysis Unit

vanadis-view

Vanadis View®

Molecule Counting Unit

Learn more about the Vanadis® NIPT System, the NIPT solution developed by PerkinElmer.

Visit Vanadis® NIPT System product page

Why choose Vanadis® NIPT?

Noninvasive prenatal testing has known a rapid expansion worldwide as it proved its higher efficacy in detecting aneuploidies and thereby reducing the number of invasive tests associated with miscarriage. Despite its improved performance, a major concern arose in relation with patients who received a “no-call” as they were shown to be at an increased risk of aneuploidy.¹

Offering an invasive test to these patients is not a satisfactory option, especially when the use of NIPT is being expanded to lower risk pregnancies.² ³ It is therefore essential to minimize the no-call rate but while most NIPT solutions provides a >99% detection rate for T21, the number of failures varies largely across brands.¹ ²


Based on a breakthrough in advanced genetic analytics, the Vanadis® NIPT System is a high-precision NIPT platform designed to improve the access to NIPT to more women and reduce the no-call rate in order to improve the overall performance of the screening programme.⁴

Sources:

1. Yaron Y., The implications of NIPT failures: a review of an under-discussed phenomenon, Prenat. Diag 2016 May;36(5):391-6. doi:10.1002/pd.4804
2. Cuckle  H., cfDNA screening performance: accounting for and reducing test failures. Ultrasound Obstet Gynecol. 2017 Jun;49(6):689-692. doi: 10.1002/uog.17492.
3. Palomaki G. et al, The clinical utility of DNA-based screening for fetal aneuploidy by primary obstetrical care providers in the general pregnancy population, Genet Med 2017 Jan;19 (7): 778–786
4. Dahl F. et al, Imaging single DNA molecules for high precision NIPT, Sci. Rep. 2018 Mar;8:4549. doi:10.1038/s41598-018-22606-0

High precision solution to analyze more samples

The Vanadis® NIPT System is a high-precision NIPT platform designed to enable the targeted analysis of chromosomes without PCR amplification. The high precision achieved through incorporating high-yield counting and eliminating PCR improves the detection and false positive rates while minimizing the no-call rate.

Products compiling the Vanadis® NIPT system are CE-marked in vitro diagnostic products and clinical validation studies have been reviewed by a Notified Body. Vanadis® NIPT is used for the screening for the risk of trisomy 21, 18, and/or 13. Sex determination will be offered as an option for nonmedical purposes, only in countries where permitted.


Vanadis NIPT* Detection rate False positive rate
T21 100% 0.00%
T18 88.9% 0.48%
T13 100.0% 0.10%
The observed no call rate was 0.25% (Total aggregate number of no-calls across all studies in the kit insert). Source: Vanadis kit insert. 

Vanadis® NIPT Technology

Highly precise, the Vanadis NIPT system converts target chromosomes into spherical fluorescent DNA fragments that simplify data analysis.


cfDNA is extracted from maternal plasma

Thousands of targeted cfDNA fragments are captured and converted to DNA circles

Rolling circle products are labelled with chromosome specific fluorophores and individually counted using a microplate scanner

Products may not be licensed in accordance with the laws in all countries, such as the United States and Canada. Please check with your local representative for availability.
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